Advanced Solid TumorPhase 1/2NCT05785741
A Study of DB-1310 in Advanced/Metastatic Solid Tumors
A Phase 1/2 study testing DB-1310, Trastuzumab and Osimertinib in people with Advanced Solid Tumor, run by DualityBio Inc. at 24 sites in 2 countries.
Trial summary
This is a dose-escalation and dose-expansion Phase 1/2a trial to evaluate the safety and tolerability of DB-1310 in subjects with advanced solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumor
- What is being tested?
- DB-1310, Trastuzumab and Osimertinib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 24 sitesin 2 countries
- Study dates
- 17 Aug 2023to 30 Apr 2028
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female adults (defined as ≥ 18 years of age or acceptable age according to local regulations at the time of voluntarily signing of informed consent).
- Have relapsed or progressed on or after standard systemic treatments, or intolerable with standard treatment, or for which no standard treatment is available. Documented radiological disease progression during/after most recent treatment regimen for advanced/unresectable, or metastatic disease.
- At least one measurable lesion as assessed by the investigator according to response evaluation criteria in solid tumors (RECIST) version 1.1 criteria.
- Has a life expectancy of ≥ 3 months.
- Has an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1.
- Has LVEF ≥ 50% by either echocardiography (ECHO) or multiple-gated acquisition (MUGA) within 28 days before enrollment.
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- Is willing to provide archived tumor tissue or undergo fresh tumor biopsy for the retrospective measurement of human epidermal growth factor receptor 3 (HER3) level and other biomarkers if no contraindication. For HER2 IHC 0 breast cancer subjects, it is highly recommended to collect additional tumor sample (Refer to Lab Manual).
- Is capable of comprehending study procedures and risks outlined in the informed consent and able to provide written consent and agree to comply with the requirements of the study and the schedule of assessments.
- Male and female subjects of reproductive/childbearing potential must agree to use adequate contraceptive methods (e.g., double barrier or intrauterine contraceptive) during the study and for at least 4 months and 7 months after the last dose of study drug, respectively.
- Females must be using highly effective contraceptive measures during the study and for at least 7 months after the last dosing of study drug, and must have a negative pregnancy test prior to start of dosing if of child-bearing potential, or must have evidence of non-child-bearing potential by fulfilling one of the following criteria at screening:
- Post-menopausal defined as aged 50 years or more and amenorrhoeic for at least 12 months following cessation of all exogenous hormonal treatments
- Women under 50 years old would be considered postmenopausal if they have been amenorrhoeic for 12 months or more following cessation of exogenous hormonal treatments and with LH and FSH levels in the post-menopausal range for the institution
- Documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy or bilateral salpingectomy but not tubal ligation
- Male subjects must not freeze or donate sperm starting at screening and throughout the study period, and at least 4 months after the final study drug administration.
- Female subjects must not donate, or retrieve for their own use, ova from the time of screening and throughout the study treatment period, and for at least 7 months after the final study drug administration.
- Phase 1 monotherapy subjects (Phase 1 monotherapy ONLY):
- Pathologically documented advanced/unresectable, or metastatic solid tumors that is refractory to or intolerable with standard treatment, or for which standard treatment is not available.
Who cannot join
- Prior treatment with HER3 targeted therapy.
- Prior treatment with antibody drug conjugate with topoisomerase I inhibitor (except topoisomerase I inhibitor HER2 ADC for backfilled subjects in Combo A of Phase 1 and subjects in Cohort 2e of Phase 2a, and not applicable for subjects enrolled for DLT observation in Phase 1).
- Has a medical history of symptomatic congestive heart failure (CHF) (New York Heart Association [NYHA] classes II-IV) or serious cardiac arrhythmia requiring treatment.
- Has a medical history of myocardial infarction or unstable angina or cerebrovascular accident including transient ischemic attack (TIA) within 6 months before first dose. Or has uncontrolled hypertension (defined as systolic blood pressure > 160 mmHg or diastolic blood pressure > 100 mmHg).
- Has any clinically important abnormalities in rhythm, conduction or morphology of resting electrocardiogram (ECG), e.g., complete left bundle branch block, third-degree heart block, second-degree heart block, or PR interval > 250 milliseconds (ms).
- Has an average of Fredericia's formula-QT corrected interval (QTcF) prolongation to > 470 millisecond (ms) based on a 12-lead electrocardiogram (ECG) in triplicate.
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- Unable or unwilling to discontinue concomitant drugs that are known to prolong the QT interval.
- For Combo B of Phase 1 and Cohort 2g, 2k of Phase 2a, patients currently receiving (or unable to stop use prior to receiving the first dose of Osimertinib) medications or herbal supplements known to be strong inducers of CYP3A4 (at least 3-week prior) (refer to Section 6.9.1) are ineligible, and all patients must try to avoid concomitant use of any medications, herbal supplements and/or ingestion of foods with known inducer effects on CYP3A4.
- Has a history of (non-infectious) ILD/pneumonitis and/or radiation pneumonitis that required glucocorticoids, or has current ILD/pneumonitis and/or radiation pneumonitis, or where suspected ILD/pneumonitis and/or radiation pneumonitis cannot be ruled out by imaging at screening.
- Have a lung-specific intercurrent clinically significant illness including, but not limited to, any underlying pulmonary disorder (e.g., pulmonary emboli within 3 months prior to Cycle 1 Day 1, severe asthma, severe chronic obstructive pulmonary disorder, restrictive lung disease, significant pleural effusion etc.), and any autoimmune, connective tissue or inflammatory disorder with pulmonary involvement (e.g., rheumatoid arthritis, Sjogren's syndrome, sarcoidosis etc.), and/or prior pneumonectomy (complete).
- Has an uncontrolled infection requiring intravenous injection of antibiotics, antivirals, or antifungals.
- Know human immunodeficiency virus (HIV) infection. Subjects should be tested for HIV prior to enrollment if required by local regulations or by the IRB/ EC.
- Subjects have active viral (any etiology) hepatitis are excluded.
- Is a lactating mother (women who are willing to temporarily interrupt breastfeeding will also be excluded), or pregnant as confirmed by serum pregnancy tests performed within 7 days prior to Cycle 1 Day 1.
- Has clinically active central nervous system (CNS) metastases, defined as untreated, or symptomatic, or requiring therapy with glucocorticoids or anticonvulsants to control associated symptoms. However, subjects with asymptomatic CNS metastases who are radiologically and neurologically stable for at least 4 weeks following CNS-directed radiotherapy or surgery, and who are on stable or decreasing doses of glucocorticoids equivalent to ≤10 mg/day prednisone are eligible for study entry.
- Has unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) not yet resolved to NCI-CTCAE version 5.0, grade ≤ 1 or baseline.
- Has multiple primary malignancies within 5 years before enrollment, except adequately resected non-melanoma skin cancer (e.g., resected basal or squamous cell skin cancer), curatively treated in-situ disease (e.g., carcinoma in situ of the cervix or breast), other solid tumors curatively treated (e.g., < T1 urothelial carcinoma), or contralateral breast cancer.
- Has substance abuse or any other medical conditions that would increase the safety risk to the subject or interfere with participation or evaluation of the clinical study in the opinion of the investigator.
- Has known hypersensitivity to either the drug substances or inactive ingredients in the drug product.
- Patients with other reasons that, in the opinion of the Investigator, make them unsuitable to participate in this study.
- For Combo B of Phase 1 and Cohort 2g, 2k, 2m of Phase 2a, patients with refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product or previous significant bowel resection that would preclude adequate absorption of Osimertinib or capecitabine are ineligible.
- NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Trial locations and contacts
24 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
Lingling Gu contact
24 sites in 2 countries
United States15 sites, 12 recruiting
- Recruiting
Research Site 111
Atlanta, Georgia, 30322
Jacqueline Brown, MD
- Recruiting
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
Julia Rotow, MD
- Recruiting
Carl & Edyth Lindner Center for Research & Education at The Christ Hospital and The Christ Hospital Cancer Center
Cincinnati, Ohio, 45219
Brittany-Belle Gordon, MD,
- Withdrawn
Research Site 117
Coral Gables, Florida, 33146
- Recruiting
Henry Ford Health System
Detroit, Michigan, 48202
Amy Weise, DO
- Recruiting
NEXT Virginia
Fairfax, Virginia, 22031
A Spira, MD
- Active, not recruiting
Research site 119
Florham Park, New Jersey, 07932
- Withdrawn
D&H Cancer Research Center LLC
Margate, Florida, 33063
- Recruiting
Tennessee Oncology, PLLC
Nashville, Tennessee, 37203
Erika P. Hamilton, MD
- Recruiting
Sarah Cannon Research Institute at Florida Cancer Specialists
Orlando, Florida, 32827
Cesar Batista, MD
- Recruiting
BRCR global
Plantation, Florida, 33322
H Amin, MD
- Recruiting
University of California, Davis Comprehensive Cancer Center
Sacramento, California, 95817
Tianhong Li, PhD
- Recruiting
UCLA Hematology/Oncology - Santa Monica
Santa Monica, California, 90404
Aaron E. Lisberg, MD
- Recruiting
Florida Cancer Specialists
Sarasota, Florida, 34232
Judy SZ Wang, MD
- Recruiting
BRCR Medical Center Inc.
Tamarac, Florida, 33321
Chintan Gandhi
China9 sites, 9 recruiting
- Recruiting
The first hospital of Jilin University
Changchun, Jilin, 130021
Jiuwei Cui
- Recruiting
Hunan cancer hospital
Changsha, Hunan, 410000
Lin Wu
- Recruiting
Sichuan Provincial People's Hospital
Chengdu, Sichuan, 610030
Haitao Lan
- Recruiting
Research Site 222
Chengdu, Sichuan, 610041
- Recruiting
Jiangsu Province hospital
Nanjing, Jiangsu, 210000
Yong mei Yin
- Recruiting
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, 200030
Shun Lu
- Recruiting
The First Hospital of China Medical University
Shenyang, Liaoning, 110010
Ming fang Zhao
- Recruiting
Affiliated Hospital of Jiangnan University
Wuxi, Jiangsu, 214000
Yong Mao
- Recruiting
Henan Cancer Hospital
Zhengzhou, Henan, 450003
Qiming Wang
About this study
Official title: A Phase 1/2a, Multicenter, Open-Label, First in Human Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of DB-1310 in Subjects With Advanced/Metastatic Solid Tumors
This is a dose-escalation and dose-expansion Phase 1/2a trial to evaluate the safety and tolerability of DB-1310 in subjects with advanced solid tumors.
Read the detailed description
This is a multicenter, open-label, multiple-dose, FIH Phase 1/2a study. Phase 1 adopts the standard "3+3" design to identify: the MTD and/or RP2D of DB-1310 as monotherapy, the RCD_A of DB-1310 in combination with trastuzumab or approved trastuzumab biosimilar and the RCD_B of DB-1310 in combination with Osimertinib; Phase 2a is a dose expansion phase to confirm the safety, tolerability and explore efficacy in selected malignant solid tumors treated with DB-1310 as monotherapy or in combination with trastuzumab or approved trastuzumab biosimilar or in combination with Osimertinib, or in combination with capecitabine
- Conditions
- Advanced Solid Tumor
- Being tested
- DB-1310, Trastuzumab, Osimertinib, capecitabine
- Keywords
- HER3, NSCLC, CRPC, HNSCC, BC, non-small cell lung cancer, castration-resistant prostate cancer, head and neck squamous cell carcinoma, breast cancer, ESCC, BTC
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck, Carcinoma, Non-Small-Cell Lung, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DB-1310Drug
Administered I.V.
TrastuzumabDrug
Administered I.V.
OsimertinibDrug
Oral
capecitabineDrug
Oral
| Study group | Role | What they receive |
|---|---|---|
| DB-1310 Dose Level 1 | Experimental | Enrolled Subjects will receive a single-dose of DB-1310 at Dose Level 1 on Day 1 of each cycle Q3W Receives: Drug: DB-1310 |
| DB-1310 Dose Level 2 | Experimental | Enrolled Subjects will receive a single-dose of DB-1310 at Dose Level 2 on Day 1 of each cycle Q3W Receives: Drug: DB-1310 |
| DB-1310 Dose Level 3 | Experimental | Enrolled Subjects will receive a single-dose of DB-1310 at Dose Level 3 on Day 1 of each cycle Q3W Receives: Drug: DB-1310 |
| DB-1310 Dose Level 4 | Experimental | Enrolled Subjects will receive a single-dose of DB-1310 at Dose Level 4 on Day 1 of each cycle Q3W Receives: Drug: DB-1310 |
| DB-1310 Dose Level 5 | Experimental | Enrolled Subjects will receive a single-dose of DB-1310 at Dose Level 5 on Day 1 of each cycle Q3W Receives: Drug: DB-1310 |
| DB-1310 Dose Level 6 | Experimental | Enrolled Subjects will receive a single-dose of DB-1310 at Dose Level 1 on Day 1 of each cycle Q3W Receives: Drug: DB-1310 |
| DB-1310 Dose Level 7 | Experimental | Enrolled Subjects will receive a single-dose of DB-1310 at Dose Level 1 on Day 1 of each cycle Q3W Receives: Drug: DB-1310 |
| DB-1310 Dose Level 8 | Experimental | Enrolled subjects with HER2 positive BC who will receive DB-1310 on a selected dose level in combination with Trastuzumab Receives: Drug: DB-1310; Drug: Trastuzumab |
| DB-1310 Dose Level 9 | Experimental | Enrolled subjects with HER2 positive BC who will receive DB-1310 on a selected dose level in combination with Trastuzumab Receives: Drug: DB-1310; Drug: Trastuzumab |
| DB-1310 Dose Level 10 | Experimental | Enrolled subjects with HER2 positive BC who will receive DB-1310 on a selected dose level in combination with Trastuzumab Receives: Drug: DB-1310; Drug: Trastuzumab |
| DB-1310 Dose Level 11 | Experimental | Enrolled subjects with NSCLC subjects with EGFR Ex19del or L858R, G719X, S768I, L861Q alone or in combination with other EGFRm who will receive DB-1310 on a selected dose level in combination with Osimertinib Receives: Drug: DB-1310; Drug: Osimertinib |
| DB-1310 Dose Level 12 | Experimental | Enrolled subjects with NSCLC subjects with EGFR Ex19del or L858R, G719X, S768I, L861Q alone or in combination with other EGFRm who will receive DB-1310 on a selected dose level in combination with Osimertinib Receives: Drug: DB-1310; Drug: Osimertinib |
| DB-1310 Dose Level 13 | Experimental | Enrolled subjects with NSCLC subjects with EGFR Ex19del or L858R, G719X, S768I, L861Q alone or in combination with other EGFRm who will receive DB-1310 on a selected dose level in combination with Osimertinib Receives: Drug: DB-1310; Drug: Osimertinib |
| DB-1310 Dose Expansion 1 | Experimental | Enrolled Subjects with advanced/unresectable, or metastatic adenocarcinoma NSCLC with EGFR activating mutation who have progressed on or after standard systemic treatments will receive a single-dose of DB-1310 on a selected dose level (RP2D) Day 1 of each cycle Q3W Receives: Drug: DB-1310 |
| DB-1310 Dose Expansion 2 | Experimental | Enrolled Subjects with advanced/unresectable, or metastatic NSCLC without EGFR activating mutation who have progressed on or after standard systemic treatments will receive a single-dose of DB-1310 on a selected dose level (RP2D) Day 1 of each cycle Q3W Receives: Drug: DB-1310 |
| DB-1310 Dose Expansion 3 | Experimental | Enrolled Subjects with advanced/unresectable, or metastatic CRPC who have progressed on or after standard systemic treatments will receive a single-dose of DB-1310 on a selected dose level (RP2D) Day 1 of each cycle Q3W Receives: Drug: DB-1310 |
| DB-1310 Dose Expansion 4 | Experimental | Enrolled Subjects with advanced/unresectable, or metastatic HNSCC who have progressed on or after standard systemic treatments will receive a single-dose of DB-1310 on a selected dose level (RP2D) Day 1 of each cycle Q3W Receives: Drug: DB-1310 |
| DB-1310 Dose Expansion 5 | Experimental | Enrolled Subjects with advanced/unresectable, or metastatic BC with HER2-positive (IHC3+, or IHC2+ and ISH+) who have progressed on or after HER2 targeted systemic treatments will receive a single-dose of DB-1310 on a selected dose level Day 1 of each cycle Q3W in combination with trastuzumab deruxtecan. Receives: Drug: DB-1310; Drug: Trastuzumab |
| DB-1310 Dose Expansion 6 | Experimental | Enrolled Subject with other advanced/unresectable, or metastatic solid tumors who have progressed on or after standard systemic treatment, or for which no standard systemic treatment is available will receive a single-dose of DB-1310 on a selected dose level (RP2D) Day 1 of each cycle Q3W Receives: Drug: DB-1310 |
| DB-1310 Dose Expansion 7 | Experimental | Enrolled subjects with advanced/unresectable, or metastatic non-squamous NSCLC with EGFR exon 19 deletion or L858R mutation who haven't received any treatment in locally advanced, or metastatic disease will receive a single-dose of DB-1310 on a selected dose level Day 1 of each cycle Q3W in combination with Osimertinib. Receives: Drug: DB-1310; Drug: Osimertinib |
| DB-1310 Dose Expansion 8 | Experimental | Enrolled subjects with NSCLC with EGFR who will receive DB-1310 on a selected dose level in combination with Osimertinib Receives: Drug: DB-1310; Drug: Osimertinib |
| DB-1310 Dose Expansion 9 | Experimental | Enrolled subjects with NSCLC with KRAS mutation who will receive DB-1310 on a selected dose level (RP2D) Receives: Drug: DB-1310 |
| DB-1310 Dose Expansion 10 | Experimental | Enrolled subjects with ESCC who will receive DB-1310 on a selected dose level (RP2D) Receives: Drug: DB-1310 |
| DB-1310 Dose Expansion 11 | Experimental | Enrolled subjects with BTC who will receive DB-1310 on a selected dose level (RP2D) Receives: Drug: DB-1310 |
| DB-1310 Dose Expansion 12 | Experimental | Enrolled subjects with HR+/HER2- BC who will receive DB-1310 on a selected dose level in monotherapy or combination with capecitabine Receives: Drug: DB-1310; Drug: capecitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase 1: Percentage of Participants with Dose-Limiting Toxicities (DLTs) as assessed by CTCAE v5.0. Percentage of participants in Part 1 with DLTs
Percentage of participants in Part 1 with DLTs
Measured: up to 21 days after Cycle 1 Day 1
Phase 1: Percentage of Participants with Treatment Emergent Adverse Events (TEAEs) as assessed by CTCAE v5.0.
Percentage of participants with TEAE in Part 1 graded according to NCI CTCAE v5.0
Measured: Up to follow-up period, approximately 1 year post-treatment
Phase 1: Percentage of Participants with Serious Adverse Events (SAEs) as assessed by CTCAE v5.0.
Percentage of Participants with SAEs in Part 1 graded according to NCI CTCAE v5.0
Measured: Up to follow-up period, approximately 1 year post-treatment
Maximum Tolerated Dose (MTD) of DB-1310
MTD on the data collected during Part 1
Measured: 12 months
Phase 1: Recommended Phase 2 Dose (RP2D) of DB-1310
RP2D of DB-1310 based on the data collected during Part 1
Measured: 12 months
Phase 2a: Percentage of Participants with Treatment Emergent adverse events (TEAEs) as assessed by CTCAE v5.0.
Percentage of participants with TEAE in Part 2 graded according to NCI CTCAE v5.0
Measured: Up to follow-up period, approximately 1 year post-treatment
Phase 2a: Percentage participants with Serious Adverse Events (SAEs) as assessed by CTCAE v5.0.
Percentage of participants with SAEs in Part 2 graded according to NCI CTCAE v5.0
Measured: Up to follow-up period, approximately 1 year post-treatment
Phase 2a: Percentage of Objective Response Rate (ORR) as assessed by RECIST 1.1.
The percentage of subjects who had a best response rating of CR and PR, for Part 2 only which was maintained ≥4 weeks
Measured: Up to follow-up period, approximately 1 year post-treatment
Secondary outcomes (9)
Phase 1 & Phase 2a: Pharmacokinetic-AUC
Area under the concentration-time curve from time 0 to infinity of DB-1310, total antibody and payload
Measured: within 8 cycles (each cycle is 21 days)
Phase 1 & Phase 2a: Pharmacokinetic-Cmax
Maximum observed plasma concentration (Cmax) of DB-1310, total antibody and payload
Measured: within 8 cycles (each cycle is 21 days)
Phase 1 & Phase 2a: Pharmacokinetic-Tmax
Time to Cmax of DB-1310, total antibody and payload
Measured: within 8 cycles (each cycle is 21 days)
Phase 1 & Phase 2a: Pharmacokinetic-T1/2
Phase 1 \& Phase 2a: Pharmacokinetic-T1/2 of DB-1310, total antibody and payload
Measured: within 8 cycles (each cycle is 21 days)
Phase 1: ORR will be determined from tumor assessments by investigator per RECIST 1.1
Phase 1: ORR will be determined from tumor assessments by investigator per RECIST 1.1
Measured: with 8 cycles (each cycle is 21 days)
Phase 1 & Phase 2a: duration of response (DoR) will be determined from tumor assessments by investigator per RECIST 1.1
Phase 1 \& Phase 2a: duration of response (DoR) will be determined from tumor assessments by investigator (by BICR in cohort 3 in Phase 2a) per RECIST 1.1
Measured: with 8 cycles (each cycle is 21 days)
Phase 1 & Phase 2a: disease-control rate (DCR)
Phase 1 \& Phase 2a: disease-control rate (DCR)
Measured: with 8 cycles (each cycle is 21 days)
Phase 1 & Phase 2a: progression free survival (PFS) will be determined from tumor assessments by investigator per RECIST 1.1
Phase 1 \& Phase 2a: progression free survival (PFS) will be determined from tumor assessments by investigator per RECIST 1.1
Measured: with 8 cycles (each cycle is 21 days)
Phase 1 & Phase 2a: overall survival (OS)
Phase 1 \& Phase 2a: overall survival (OS)
Measured: with 8 cycles (each cycle is 21 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2023
- Study start17 Aug 2023
- Primary completion30 Dec 2027 (estimated)
- Study completion30 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorStudies of the same condition, open and under way.
- More trials run by DualityBio Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- DualityBio Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lily Hu, Study director, DualityBio Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05785741
- Sponsor's protocol ID
- DB-1310-O-1001
- Other IDs
- CTR20231736
- Status last verified
- Mar 2026
- First submitted
- 14 Mar 2023
- Last updated
- 6 Apr 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2a, Multicenter, Open-Label, First in Human Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of DB-1310 in Subjects With Advanced/Metastatic Solid Tumors
- ClinicalTrials.gov ID
- NCT05785741
- Acronym / sponsor ID
- DB-1310-O-1001
- Conditions
- Advanced Solid Tumor
- Keywords
- HER3, NSCLC, CRPC, HNSCC, BC, non-small cell lung cancer, castration-resistant prostate cancer, head and neck squamous cell carcinoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- DualityBio Inc.Industry (pharma, biotech, devices)
- Study start
- 17 Aug 2023 (actual)
- Primary completion
- 30 Dec 2027 (estimated)
- Study completion
- 30 Apr 2028 (estimated)
- First posted
- 27 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a dose-escalation and dose-expansion Phase 1/2a trial to evaluate the safety and tolerability of DB-1310 in subjects with advanced solid tumors.
Detailed description
This is a multicenter, open-label, multiple-dose, FIH Phase 1/2a study. Phase 1 adopts the standard "3+3" design to identify: the MTD and/or RP2D of DB-1310 as monotherapy, the RCD_A of DB-1310 in combination with trastuzumab or approved trastuzumab biosimilar and the RCD_B of DB-1310 in combination with Osimertinib; Phase 2a is a dose expansion phase to confirm the safety, tolerability and explore efficacy in selected malignant solid tumors treated with DB-1310 as monotherapy or in combination with trastuzumab or approved trastuzumab biosimilar or in combination with Osimertinib, or in combination with capecitabine
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 25
| Arm | Type | Receives |
|---|---|---|
| DB-1310 Dose Level 1 | Experimental | Drug: DB-1310Enrolled Subjects will receive a single-dose of DB-1310 at Dose Level 1 on Day 1 of each cycle Q3W |
| DB-1310 Dose Level 2 | Experimental | Drug: DB-1310Enrolled Subjects will receive a single-dose of DB-1310 at Dose Level 2 on Day 1 of each cycle Q3W |
| DB-1310 Dose Level 3 | Experimental | Drug: DB-1310Enrolled Subjects will receive a single-dose of DB-1310 at Dose Level 3 on Day 1 of each cycle Q3W |
| DB-1310 Dose Level 4 | Experimental | Drug: DB-1310Enrolled Subjects will receive a single-dose of DB-1310 at Dose Level 4 on Day 1 of each cycle Q3W |
| DB-1310 Dose Level 5 | Experimental | Drug: DB-1310Enrolled Subjects will receive a single-dose of DB-1310 at Dose Level 5 on Day 1 of each cycle Q3W |
| DB-1310 Dose Level 6 | Experimental | Drug: DB-1310Enrolled Subjects will receive a single-dose of DB-1310 at Dose Level 1 on Day 1 of each cycle Q3W |
| DB-1310 Dose Level 7 | Experimental | Drug: DB-1310Enrolled Subjects will receive a single-dose of DB-1310 at Dose Level 1 on Day 1 of each cycle Q3W |
| DB-1310 Dose Level 8 | Experimental | Drug: DB-1310, Drug: TrastuzumabEnrolled subjects with HER2 positive BC who will receive DB-1310 on a selected dose level in combination with Trastuzumab |
| DB-1310 Dose Level 9 | Experimental | Drug: DB-1310, Drug: TrastuzumabEnrolled subjects with HER2 positive BC who will receive DB-1310 on a selected dose level in combination with Trastuzumab |
| DB-1310 Dose Level 10 | Experimental | Drug: DB-1310, Drug: TrastuzumabEnrolled subjects with HER2 positive BC who will receive DB-1310 on a selected dose level in combination with Trastuzumab |
| DB-1310 Dose Level 11 | Experimental | Drug: DB-1310, Drug: OsimertinibEnrolled subjects with NSCLC subjects with EGFR Ex19del or L858R, G719X, S768I, L861Q alone or in combination with other EGFRm who will receive DB-1310 on a selected dose level in combination with Osimertinib |
| DB-1310 Dose Level 12 | Experimental | Drug: DB-1310, Drug: OsimertinibEnrolled subjects with NSCLC subjects with EGFR Ex19del or L858R, G719X, S768I, L861Q alone or in combination with other EGFRm who will receive DB-1310 on a selected dose level in combination with Osimertinib |
| DB-1310 Dose Level 13 | Experimental | Drug: DB-1310, Drug: OsimertinibEnrolled subjects with NSCLC subjects with EGFR Ex19del or L858R, G719X, S768I, L861Q alone or in combination with other EGFRm who will receive DB-1310 on a selected dose level in combination with Osimertinib |
| DB-1310 Dose Expansion 1 | Experimental | Drug: DB-1310Enrolled Subjects with advanced/unresectable, or metastatic adenocarcinoma NSCLC with EGFR activating mutation who have progressed on or after standard systemic treatments will receive a single-dose of DB-1310 on a selected dose level (RP2D) Day 1 of each cycle Q3W |
| DB-1310 Dose Expansion 2 | Experimental | Drug: DB-1310Enrolled Subjects with advanced/unresectable, or metastatic NSCLC without EGFR activating mutation who have progressed on or after standard systemic treatments will receive a single-dose of DB-1310 on a selected dose level (RP2D) Day 1 of each cycle Q3W |
| DB-1310 Dose Expansion 3 | Experimental | Drug: DB-1310Enrolled Subjects with advanced/unresectable, or metastatic CRPC who have progressed on or after standard systemic treatments will receive a single-dose of DB-1310 on a selected dose level (RP2D) Day 1 of each cycle Q3W |
| DB-1310 Dose Expansion 4 | Experimental | Drug: DB-1310Enrolled Subjects with advanced/unresectable, or metastatic HNSCC who have progressed on or after standard systemic treatments will receive a single-dose of DB-1310 on a selected dose level (RP2D) Day 1 of each cycle Q3W |
| DB-1310 Dose Expansion 5 | Experimental | Drug: DB-1310, Drug: TrastuzumabEnrolled Subjects with advanced/unresectable, or metastatic BC with HER2-positive (IHC3+, or IHC2+ and ISH+) who have progressed on or after HER2 targeted systemic treatments will receive a single-dose of DB-1310 on a selected dose level Day 1 of each cycle Q3W in combination with trastuzumab deruxtecan. |
| DB-1310 Dose Expansion 6 | Experimental | Drug: DB-1310Enrolled Subject with other advanced/unresectable, or metastatic solid tumors who have progressed on or after standard systemic treatment, or for which no standard systemic treatment is available will receive a single-dose of DB-1310 on a selected dose level (RP2D) Day 1 of each cycle Q3W |
| DB-1310 Dose Expansion 7 | Experimental | Drug: DB-1310, Drug: OsimertinibEnrolled subjects with advanced/unresectable, or metastatic non-squamous NSCLC with EGFR exon 19 deletion or L858R mutation who haven't received any treatment in locally advanced, or metastatic disease will receive a single-dose of DB-1310 on a selected dose level Day 1 of each cycle Q3W in combination with Osimertinib. |
| DB-1310 Dose Expansion 8 | Experimental | Drug: DB-1310, Drug: OsimertinibEnrolled subjects with NSCLC with EGFR who will receive DB-1310 on a selected dose level in combination with Osimertinib |
| DB-1310 Dose Expansion 9 | Experimental | Drug: DB-1310Enrolled subjects with NSCLC with KRAS mutation who will receive DB-1310 on a selected dose level (RP2D) |
| DB-1310 Dose Expansion 10 | Experimental | Drug: DB-1310Enrolled subjects with ESCC who will receive DB-1310 on a selected dose level (RP2D) |
| DB-1310 Dose Expansion 11 | Experimental | Drug: DB-1310Enrolled subjects with BTC who will receive DB-1310 on a selected dose level (RP2D) |
| DB-1310 Dose Expansion 12 | Experimental | Drug: DB-1310, Drug: capecitabineEnrolled subjects with HR+/HER2- BC who will receive DB-1310 on a selected dose level in monotherapy or combination with capecitabine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Male or female adults (defined as ≥ 18 years of age or acceptable age according to local regulations at the time of voluntarily signing of informed consent).
- Have relapsed or progressed on or after standard systemic treatments, or intolerable with standard treatment, or for which no standard treatment is available. Documented radiological disease progression during/after most recent treatment regimen for advanced/unresectable, or metastatic disease.
- At least one measurable lesion as assessed by the investigator according to response evaluation criteria in solid tumors (RECIST) version 1.1 criteria.
- Has a life expectancy of ≥ 3 months.
- Has an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1.
Key exclusion criteria (22 listed)
- Prior treatment with HER3 targeted therapy.
- Prior treatment with antibody drug conjugate with topoisomerase I inhibitor (except topoisomerase I inhibitor HER2 ADC for backfilled subjects in Combo A of Phase 1 and subjects in Cohort 2e of Phase 2a, and not applicable for subjects enrolled for DLT observation in Phase 1).
- Has a medical history of symptomatic congestive heart failure (CHF) (New York Heart Association [NYHA] classes II-IV) or serious cardiac arrhythmia requiring treatment.
- Has a medical history of myocardial infarction or unstable angina or cerebrovascular accident including transient ischemic attack (TIA) within 6 months before first dose. Or has uncontrolled hypertension (defined as systolic blood pressure > 160 mmHg or diastolic blood pressure > 100 mmHg).
- Has any clinically important abnormalities in rhythm, conduction or morphology of resting electrocardiogram (ECG), e.g., complete left bundle branch block, third-degree heart block, second-degree heart block, or PR interval > 250 milliseconds (ms).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DB-1310Administered I.V. | Drug | DB-1310 Dose Expansion 1, DB-1310 Dose Expansion 10, DB-1310 Dose Expansion 11, DB-1310 Dose Expansion 12, DB-1310 Dose Expansion 2, DB-1310 Dose Expansion 3, DB-1310 Dose Expansion 4, DB-1310 Dose Expansion 5, DB-1310 Dose Expansion 6, DB-1310 Dose Expansion 7, DB-1310 Dose Expansion 8, DB-1310 Dose Expansion 9, DB-1310 Dose Level 1, DB-1310 Dose Level 10, DB-1310 Dose Level 11, DB-1310 Dose Level 12, DB-1310 Dose Level 13, DB-1310 Dose Level 2, DB-1310 Dose Level 3, DB-1310 Dose Level 4, DB-1310 Dose Level 5, DB-1310 Dose Level 6, DB-1310 Dose Level 7, DB-1310 Dose Level 8, DB-1310 Dose Level 9 |
| TrastuzumabAdministered I.V. | Drug | DB-1310 Dose Expansion 5, DB-1310 Dose Level 10, DB-1310 Dose Level 8, DB-1310 Dose Level 9 |
| OsimertinibOral | Drug | DB-1310 Dose Expansion 7, DB-1310 Dose Expansion 8, DB-1310 Dose Level 11, DB-1310 Dose Level 12, DB-1310 Dose Level 13 |
| capecitabineOral | Drug | DB-1310 Dose Expansion 12 |
Primary outcome
Phase 1: Percentage of Participants with Dose-Limiting Toxicities (DLTs) as assessed by CTCAE v5.0. Percentage of participants in Part 1 with DLTs
Time frame: up to 21 days after Cycle 1 Day 1
Percentage of participants in Part 1 with DLTs
Phase 1: Percentage of Participants with Treatment Emergent Adverse Events (TEAEs) as assessed by CTCAE v5.0.
Time frame: Up to follow-up period, approximately 1 year post-treatment
Percentage of participants with TEAE in Part 1 graded according to NCI CTCAE v5.0
Phase 1: Percentage of Participants with Serious Adverse Events (SAEs) as assessed by CTCAE v5.0.
Time frame: Up to follow-up period, approximately 1 year post-treatment
Percentage of Participants with SAEs in Part 1 graded according to NCI CTCAE v5.0
Maximum Tolerated Dose (MTD) of DB-1310
Time frame: 12 months
MTD on the data collected during Part 1
Phase 1: Recommended Phase 2 Dose (RP2D) of DB-1310
Time frame: 12 months
RP2D of DB-1310 based on the data collected during Part 1
Phase 2a: Percentage of Participants with Treatment Emergent adverse events (TEAEs) as assessed by CTCAE v5.0.
Time frame: Up to follow-up period, approximately 1 year post-treatment
Percentage of participants with TEAE in Part 2 graded according to NCI CTCAE v5.0
Phase 2a: Percentage participants with Serious Adverse Events (SAEs) as assessed by CTCAE v5.0.
Time frame: Up to follow-up period, approximately 1 year post-treatment
Percentage of participants with SAEs in Part 2 graded according to NCI CTCAE v5.0
Phase 2a: Percentage of Objective Response Rate (ORR) as assessed by RECIST 1.1.
Time frame: Up to follow-up period, approximately 1 year post-treatment
The percentage of subjects who had a best response rating of CR and PR, for Part 2 only which was maintained ≥4 weeks
9 secondary outcomes
Phase 1 & Phase 2a: Pharmacokinetic-AUC
Time frame: within 8 cycles (each cycle is 21 days)
Phase 1 & Phase 2a: Pharmacokinetic-Cmax
Time frame: within 8 cycles (each cycle is 21 days)
Phase 1 & Phase 2a: Pharmacokinetic-Tmax
Time frame: within 8 cycles (each cycle is 21 days)
Phase 1 & Phase 2a: Pharmacokinetic-T1/2
Time frame: within 8 cycles (each cycle is 21 days)
Phase 1: ORR will be determined from tumor assessments by investigator per RECIST 1.1
Time frame: with 8 cycles (each cycle is 21 days)
Phase 1 & Phase 2a: duration of response (DoR) will be determined from tumor assessments by investigator per RECIST 1.1
Time frame: with 8 cycles (each cycle is 21 days)
Phase 1 & Phase 2a: disease-control rate (DCR)
Time frame: with 8 cycles (each cycle is 21 days)
Phase 1 & Phase 2a: progression free survival (PFS) will be determined from tumor assessments by investigator per RECIST 1.1
Time frame: with 8 cycles (each cycle is 21 days)
Phase 1 & Phase 2a: overall survival (OS)
Time frame: with 8 cycles (each cycle is 21 days)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lingling Gu contact
Lily Hu study director
DualityBio Inc.
24 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing DB-1310, Trastuzumab and Osimertinib in people with Advanced Solid Tumor, run by DualityBio Inc. at 24 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in United States, China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tiana Zhao (1-626-433-3820, tiana.zhao@dualitybiologics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase 1: Percentage of Participants with Dose-Limiting Toxicities (DLTs) as assessed by CTCAE v5.0. Percentage of participants in Part 1 with DLTs (time frame: up to 21 days after Cycle 1 Day 1). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2026.