Advanced/Metastatic Solid TumorsPhase 1NCT07141706
A Study of DB-1317 in Selected Advanced/Metastatic Solid Tumors
A Phase 1 study testing DB-1317 in people with Advanced/Metastatic Solid Tumors, run by DualityBio Inc. at 14 sites in 3 countries.
Trial summary
This is a multicenter, open-label, multiple-dose, FIH Phase 1a/1b study. Phase 1a adopts an accelerated titration design and a BOIN design to identify the MTD or MAD of DB-1317; Phase 1b includes one randomized dose expansion cohort and two single-arm dose expansion cohorts to further evaluate the safety, tolerability… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced/Metastatic Solid Tumors
- What is being tested?
- DB-1317
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 253 participants
- Where
- 14 sitesin 3 countries
- Study dates
- 23 Sep 2025to Jun 2028
- Phase
- Phase 1
- 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
- Unresectable advanced or metastatic selected solid tumors that have relapsed or progressed on or after standard systemic treatments.
- Only applicable to backfilling participants in Phase 1a and participants in Phase 1b: At least one measurable lesion as assessed by the investigator according to RECIST version 1.1 criteria. Participants with non-measurable disease are allowed for CRPC participants.
- Has a life expectancy of ≥ 3 months.
- Has an ECOG PS of 0-1.
- Has LVEF ≥ 50% within 28 days before enrollment.
- Is willing to provide pre-existing resected tumor samples or undergo fresh tumor biopsy for the measurement of ADAM9 expression level and other biomarkers if no contra-indication.
- Male and female participants of reproductive/childbearing potential must agree to use adequate contraceptive methods
Who cannot join
- Prior treatment with ADAM9 targeted therapy.
- Prior treatment with antibody-drug conjugate with topoisomerase I inhibitor.
- Has a medical history of symptomatic congestive heart failure or serious cardiac arrhythmia requiring treatment.
- Has a medical history of myocardial infarction or unstable angina within 6 months before enrollment.
- Has any clinically important abnormalities in rhythm, conduction or morphology of resting ECG
- Has an average of Fredericia's formula-QT corrected interval (QTcF) prolongation to > 470 ms in males and females
Show all 15Show fewer
- Has a history of (non-infectious) ILD/pneumonitis
- Has a lung-specific intercurrent clinically significant illness
- Has an uncontrolled infection requiring intravenous injection of antibiotics, antivirals, or antifungals.
- Known human immunodeficiency virus (HIV) infection;Chronic, active, or uncontrolled hepatitis B;
- Known chronic, active, or uncontrolled hepatitis C
- Has clinically significant corneal disease.
- Has clinically active brain metastases
- Has unresolved toxicities from previous anticancer therapy Concurrent malignancy < 3 years.
- NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Trial locations and contacts
14 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
Zhaochuan Wang contact
14 sites in 3 countries
United States6 sites, 6 recruiting
- Recruiting
USA05-0
Ann Arbor, Michigan, 48109
- Recruiting
USA01-0
Fairfax, Virginia, 22031
- Recruiting
USA02-0
Houston, Texas, 77030
- Recruiting
USA04-0
Los Angeles, California, 90025
- Recruiting
Site USA06-0
Pittsburgh, Pennsylvania, 15232
- Recruiting
USA03-0
San Antonio, Texas, 78229
Australia4 sites, 4 recruiting
- Recruiting
AUS03-0
Liverpool, New South Wales, 2170
- Recruiting
AUS02-0
Nedlands, Western Australia, 6009
- Recruiting
AUS01-0
Randwick, New South Wales, 2031
- Recruiting
AUS04-0
Westmead, New South Wales, 2145
China4 sites, 4 recruiting
- Recruiting
Chn01-1/Chn01-2
Guangzhou, Guangdong, 510060
- Recruiting
CHN05-0
Harbin, Heilongjiang
- Recruiting
CHN04-0
Jinan, Shandong
- Recruiting
CHN03-0
Zhengzhou, Henan
About this study
Official title: A Phase 1a/1b, Multicenter, Open-Label, First-in-Human Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of DB-1317 in Participants With Selected Advanced/Metastatic Solid Tumors
This is a multicenter, open-label, multiple-dose, FIH Phase 1a/1b study. Phase 1a adopts an accelerated titration design and a BOIN design to identify the MTD or MAD of DB-1317; Phase 1b includes one randomized dose expansion cohort and two single-arm dose expansion cohorts to further evaluate the safety, tolerability and preliminary efficacy of DB-1317 in selected solid tumors and to identify optimal RP2D.
Read the detailed description
Phase 1a (Dose Escalation and Backfilling)
Approximately 5 increasing dose levels of DB-1317 dosing every 3 weeks (Q3W) will be evaluated using an accelerated titration design at the first dose level, followed by a BOIN design at subsequent dose levels with the oversight of a Safety Monitoring Committee (SMC). For safety reasons, in any dose level of the dose escalation where a number of participants ≥ 2, a staggered dosing is required. The second participant in each dose level should start dosing no sooner than at least 24 hours after the initial dosing of the first participant. If no safety concerns arise during these 24 hours, the remaining participants can be enrolled into the same dose level with no additional staggering required. Each dose level will be subject to the DLT assessment. After completing the 21-day DLT observation period (Cycle 1), participants will continue to the next treatment cycle and receive DB-1317 on Day 1 of each cycle in the same dose level cohort. Participants who complete the DLT observation period are not allowed to switch to a higher dose level (i.e., intra-participant escalation is not allowed) unless it is deemed necessary and strongly recommended by the investigator with a written approval by the Sponsor.
Upon confirmation of MTD or MAD of DB-1317 based on data from the completed dose-escalation phase, the safety dose range of DB-1317 may be defined based on cumulative data. Following confirmation by the SMC, alternative dosing regimens, such as Q2W may be explored within the established safety dose range.
Phase 1b (Dose Expansion)
Upon completion of the Phase 1a dose escalation, following determination of MTD or MAD, and at the Sponsor's discretion, -one randomized expansion cohort and two single arm expansion cohorts will be opened each enrolling one of the selected solid tumor types, if preliminary anti-tumor activities in these tumor types are observed in Phase 1a part. GC is the tumor type pre-selected for the randomized expansion cohort CRC and PDAC are the two tumor types pre-selected for the single arm expansion cohorts based on ADAM9 expressing data, in vivo anti-tumor activities in non-clinical tumor models, and consideration of unmet medical needs. The final selection of tumor type(s) to be enrolled in the Phase 1b cohorts will be determined by Sponsor based on emerging data from Phase 1a part. Approximately 80 participants will be enrolled in the randomized expansion cohort and randomly assigned in a 1:1 ratio to two dose levels (approximately 40 each) . Approximately 40 participants will be enrolled in each single arm expansion cohort at a selected dose level, and 160 participants will be enrolled in Phase 1b. Dose levels used in Phase 1b part will be determined by Sponsor and SMC based on Phase 1a data. Based on new emerging data from the study, Sponsor may explore other randomized cohorts with other tumor types.
- Conditions
- Advanced/Metastatic Solid Tumors
- Being tested
- DB-1317
- Keywords
- ADAM9, Solid tumor, DB-1317
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DB-1317Drug
Administered I.V.
| Study group | Role | What they receive |
|---|---|---|
| DB-1317 Dose Level 1 | Experimental | Enrolled Subjects will receive a single-dose of DB-1317 at Dose Level 1 on Day 1 of each cycle Q3W Receives: Drug: DB-1317 |
| DB-1317 Dose Level 2 | Experimental | Enrolled Subjects will receive a single-dose of DB-1317 at Dose Level 2 on Day 1 of each cycle Q3W Receives: Drug: DB-1317 |
| DB-1317 Dose Level 3 | Experimental | Enrolled Subjects will receive a single-dose of DB-1317 at Dose Level 3 on Day 1 of each cycle Q3W Receives: Drug: DB-1317 |
| DB-1317 Dose Level 4 | Experimental | Enrolled Subjects will receive a single-dose of DB-1317 at Dose Level 4 on Day 1 of each cycle Q3W Receives: Drug: DB-1317 |
| DB-1317 Dose Level 5 | Experimental | Enrolled Subjects will receive a single-dose of DB-1317 at Dose Level 5 on Day 1 of each cycle Q3W Receives: Drug: DB-1317 |
| DB-1317 Dose Expansion 1 | Experimental | Subjects with advanced/unresectable, or metastatic Gastric cancer (GC) who have progressed on or after standard systemic treatments, a 21-day treatment cycle (i.e., once every 3 weeks) via intravenous infusion will be used for DB-1317 Receives: Drug: DB-1317 |
| DB-1317 Dose Expansion 2 | Experimental | Subjects with advanced/unresectable, or metastatic colorectal cancer (CRC) who have progressed on or after standard systemic treatments, a 21-day treatment cycle (i.e., once every 3 weeks) via intravenous infusion will be used for DB-1317 Receives: Drug: DB-1317 |
| DB-1317 Dose Expansion 3 | Experimental | Subjects with advanced/unresectable, or metastatic pancreatic ductal adenocarcinoma (PDAC) who have progressed on or after standard systemic treatments, a 21-day treatment cycle (i.e., once every 3 weeks) via intravenous infusion will be used for DB-1317 Receives: Drug: DB-1317 |
| DB-1317 Dose Level 6 | Experimental | Enrolled Subjects will receive a single-dose of DB-1317 at Dose Level 6 on Day 1 of each cycle Q2W Receives: Drug: DB-1317 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase 1a: 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 Phase 1a with DLTs
Measured: up to 21 days after Cycle 1 Day 1
Phase 1a: Percentage of Participants with Treatment Emergent Adverse Events (TEAEs) as assessed by CTCAE v5.0.
Percentage of participants with TEAEs in Phase 1a graded according to NCI CTCAE v5.0
Measured: Up to follow-up period, approximately 1 year post-treatment
Phase 1a: Percentage of Participants with Serious Adverse Events (SAEs) as assessed by CTCAE v5.0.
Percentage of Participants with SAEs in Phase 1a graded according to NCI CTCAE v5.0
Measured: Up to follow-up period, approximately 1 year post-treatment
Maximum Tolerated Dose (MTD) of DB-1317
MTD on the data collected during Phase 1a
Measured: Up to the completion of Phase 1a (assessed up to 12 months)
Recommended Phase 1b Dose (RP2D) of DB-1317
RP2D of DB-1317 based on the data collected during Phase 1a
Measured: Up to the completion of Phase 1a (assessed up to 12 months)
Phase 1b: Percentage of Participants with Treatment Emergent adverse events (TEAEs) as assessed by CTCAE v5.0.
Percentage of participants with TEAEs in Phase 1b graded according to NCI CTCAE v5.0
Measured: Up to follow-up period, approximately 1 year post-treatment
Phase 1b: Percentage of participants with Serious Adverse Events (SAEs) as assessed by CTCAE v5.0.
Percentage of participants with SAEs in Phase 1b graded according to NCI CTCAE v5.0
Measured: Up to follow-up period, approximately 1 year post-treatment
Phase 1b: Objective Response Rate (ORR) as determined by investigator
Phase 1b: Objective Response Rate (ORR) as determined by investigator per RECIST 1.1 in non-CRPC. The percentage of participants 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
Phase 1b: duration of response (DoR)
DoR will be determined from tumor assessments by investigator per response evaluation criteria in solid tumors version 1.1 (RECIST v1.1)
Measured: Up to follow-up period, approximately 1 year post-treatment
Phase 1b: disease-control rate (DCR)
DCR will be determined from tumor assessments by investigator per response
Measured: Up to follow-up period, approximately 1 year post-treatment
Phase 1b: Time to Response (TTR)
TTR will be determined from tumor assessments by investigator per response
Measured: Up to follow-up period, approximately 1 year post-treatment
Secondary outcomes (13)
Phase 1a: Objective response rate (ORR)
ORR will be determined from tumor assessments by investigator per response evaluation criteria in solid tumors version 1.1 (RECIST v1.1)
Measured: Up to follow-up period, approximately 1 year post-treatment
Phase 1a: duration of response (DoR)
DoR will be determined from tumor assessments by investigator per response evaluation criteria in solid tumors version 1.1 (RECIST v1.1)
Measured: Up to follow-up period, approximately 1 year post-treatment
Phase 1a: disease-control rate (DCR)
DCR will be determined from tumor assessments by investigator per response evaluation criteria in solid tumors version 1.1 (RECIST v1.1)
Measured: Up to follow-up period, approximately 1 year post-treatment
Phase 1a: Time to Response (TTR)
TTR will be determined from tumor assessments by investigator per response evaluation TTR criteria in solid tumors version 1.1 (RECIST v1.1)
Measured: Up to follow-up period, approximately 1 year post-treatment
Phase 1a & Phase 1b: Progression Free Survival (PFS)
PFS will be determined from tumor assessments by investigator per response evaluation PFS criteria in solid tumors version 1.1 (RECIST v1.1)
Measured: Up to follow-up period, approximately 1 year post-treatment
Phase 1a & Phase 1b: Overall Survival (OS)
OS is defined as the time from date of first dose to the date of death.
Measured: From date of first dose until the date of death or lost to follow up, approximately 1 year post-treatment
Phase 1a: Prostate-specific antigen (PSA)
Time to PSA progression, PSA50 response rate and PSA90 response rate, duration of PSA response in CRPC subjects.
Measured: From date of first dose until the date of first PSA progression, approximately 1 year post-treatment
Phase 1a & Phase 1b: Pharmacokinetic-AUC
Area under the concentration-time curve from time 0 to infinity of DB-1317 ADC, total anti-Adam 9 antibody, and unconjugated P1003
Measured: within 3 cycles (each cycle is 21 days)
Phase 1a & Phase 1b: Pharmacokinetic-Cmax
Maximum observed plasma concentration (Cmax) of DB-1317 ADC, total anti-Adam 9 antibody, and unconjugated P1003
Measured: within 3 cycles (each cycle is 21 days)
Phase 1a & Phase 1b: Pharmacokinetic-Tmax
Time to Cmax of DB-1317 ADC, total anti-Adam 9 antibody, and unconjugated P1003
Measured: within 3 cycles (each cycle is 21 days)
Phase 1a & Phase 1b: Pharmacokinetic-Cthrough
Trough concentration
Measured: within 6 cycles (each cycle is 21 days)
Phase 1a & Phase 1b: Anti-drug antibody (ADA) prevalence
Percentage of participants who are ADA positive at any point
Measured: Up to follow-up period, approximately 1 year post-treatment
Phase 1a & Phase 1b: ADA incidence
Percentage of participants having treatment-emergent ADA
Measured: Up to follow-up period, approximately 1 year post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2025
- Study start23 Sep 2025
- Primary completionJun 2028 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced/Metastatic Solid TumorsStudies 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 253 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
- NCT07141706
- Sponsor's protocol ID
- DB-1317-101
- Status last verified
- Jul 2026
- First submitted
- 18 Aug 2025
- Last updated
- 27 Jul 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1a/1b, Multicenter, Open-Label, First-in-Human Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of DB-1317 in Participants With Selected Advanced/Metastatic Solid Tumors
- ClinicalTrials.gov ID
- NCT07141706
- Acronym / sponsor ID
- DB-1317-101
- Conditions
- Advanced/Metastatic Solid Tumors
- Keywords
- ADAM9, Solid tumor, DB-1317
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 253 participants (estimated)
- Lead sponsor
- DualityBio Inc.Industry (pharma, biotech, devices)
- Study start
- 23 Sep 2025 (actual)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 26 Aug 2025 (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 multicenter, open-label, multiple-dose, FIH Phase 1a/1b study. Phase 1a adopts an accelerated titration design and a BOIN design to identify the MTD or MAD of DB-1317; Phase 1b includes one randomized dose expansion cohort and two single-arm dose expansion cohorts to further evaluate the safety, tolerability and preliminary efficacy of DB-1317 in selected solid tumors and to identify optimal RP2D.
Detailed description
Phase 1a (Dose Escalation and Backfilling)
Approximately 5 increasing dose levels of DB-1317 dosing every 3 weeks (Q3W) will be evaluated using an accelerated titration design at the first dose level, followed by a BOIN design at subsequent dose levels with the oversight of a Safety Monitoring Committee (SMC). For safety reasons, in any dose level of the dose escalation where a number of participants ≥ 2, a staggered dosing is required. The second participant in each dose level should start dosing no sooner than at least 24 hours after the initial dosing of the first participant. If no safety concerns arise during these 24 hours, the remaining participants can be enrolled into the same dose level with no additional staggering required. Each dose level will be subject to the DLT assessment. After completing the 21-day DLT observation period (Cycle 1), participants will continue to the next treatment cycle and receive DB-1317 on Day 1 of each cycle in the same dose level cohort. Participants who complete the DLT observation period are not allowed to switch to a higher dose level (i.e., intra-participant escalation is not allowed) unless it is deemed necessary and strongly recommended by the investigator with a written approval by the Sponsor.
Upon confirmation of MTD or MAD of DB-1317 based on data from the completed dose-escalation phase, the safety dose range of DB-1317 may be defined based on cumulative data. Following confirmation by the SMC, alternative dosing regimens, such as Q2W may be explored within the established safety dose range.
Phase 1b (Dose Expansion)
Upon completion of the Phase 1a dose escalation, following determination of MTD or MAD, and at the Sponsor's discretion, -one randomized expansion cohort and two single arm expansion cohorts will be opened each enrolling one of the selected solid tumor types, if preliminary anti-tumor activities in these tumor types are observed in Phase 1a part. GC is the tumor type pre-selected for the randomized expansion cohort CRC and PDAC are the two tumor types pre-selected for the single arm expansion cohorts based on ADAM9 expressing data, in vivo anti-tumor activities in non-clinical tumor models, and consideration of unmet medical needs. The final selection of tumor type(s) to be enrolled in the Phase 1b cohorts will be determined by Sponsor based on emerging data from Phase 1a part. Approximately 80 participants will be enrolled in the randomized expansion cohort and randomly assigned in a 1:1 ratio to two dose levels (approximately 40 each) . Approximately 40 participants will be enrolled in each single arm expansion cohort at a selected dose level, and 160 participants will be enrolled in Phase 1b. Dose levels used in Phase 1b part will be determined by Sponsor and SMC based on Phase 1a data. Based on new emerging data from the study, Sponsor may explore other randomized cohorts with other tumor types.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| DB-1317 Dose Level 1 | Experimental | Drug: DB-1317Enrolled Subjects will receive a single-dose of DB-1317 at Dose Level 1 on Day 1 of each cycle Q3W |
| DB-1317 Dose Level 2 | Experimental | Drug: DB-1317Enrolled Subjects will receive a single-dose of DB-1317 at Dose Level 2 on Day 1 of each cycle Q3W |
| DB-1317 Dose Level 3 | Experimental | Drug: DB-1317Enrolled Subjects will receive a single-dose of DB-1317 at Dose Level 3 on Day 1 of each cycle Q3W |
| DB-1317 Dose Level 4 | Experimental | Drug: DB-1317Enrolled Subjects will receive a single-dose of DB-1317 at Dose Level 4 on Day 1 of each cycle Q3W |
| DB-1317 Dose Level 5 | Experimental | Drug: DB-1317Enrolled Subjects will receive a single-dose of DB-1317 at Dose Level 5 on Day 1 of each cycle Q3W |
| DB-1317 Dose Expansion 1 | Experimental | Drug: DB-1317Subjects with advanced/unresectable, or metastatic Gastric cancer (GC) who have progressed on or after standard systemic treatments, a 21-day treatment cycle (i.e., once every 3 weeks) via intravenous infusion will be used for DB-1317 |
| DB-1317 Dose Expansion 2 | Experimental | Drug: DB-1317Subjects with advanced/unresectable, or metastatic colorectal cancer (CRC) who have progressed on or after standard systemic treatments, a 21-day treatment cycle (i.e., once every 3 weeks) via intravenous infusion will be used for DB-1317 |
| DB-1317 Dose Expansion 3 | Experimental | Drug: DB-1317Subjects with advanced/unresectable, or metastatic pancreatic ductal adenocarcinoma (PDAC) who have progressed on or after standard systemic treatments, a 21-day treatment cycle (i.e., once every 3 weeks) via intravenous infusion will be used for DB-1317 |
| DB-1317 Dose Level 6 | Experimental | Drug: DB-1317Enrolled Subjects will receive a single-dose of DB-1317 at Dose Level 6 on Day 1 of each cycle Q2W |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male or female adults
- Unresectable advanced or metastatic selected solid tumors that have relapsed or progressed on or after standard systemic treatments.
- Only applicable to backfilling participants in Phase 1a and participants in Phase 1b: At least one measurable lesion as assessed by the investigator according to RECIST version 1.1 criteria. Participants with non-measurable disease are allowed for CRPC participants.
- Has a life expectancy of ≥ 3 months.
- Has an ECOG PS of 0-1.
Key exclusion criteria (15 listed)
- Prior treatment with ADAM9 targeted therapy.
- Prior treatment with antibody-drug conjugate with topoisomerase I inhibitor.
- Has a medical history of symptomatic congestive heart failure or serious cardiac arrhythmia requiring treatment.
- Has a medical history of myocardial infarction or unstable angina within 6 months before enrollment.
- Has any clinically important abnormalities in rhythm, conduction or morphology of resting ECG
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-1317Administered I.V. | Drug | DB-1317 Dose Expansion 1, DB-1317 Dose Expansion 2, DB-1317 Dose Expansion 3, DB-1317 Dose Level 1, DB-1317 Dose Level 2, DB-1317 Dose Level 3, DB-1317 Dose Level 4, DB-1317 Dose Level 5, DB-1317 Dose Level 6 |
Primary outcome
Phase 1a: 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 Phase 1a with DLTs
Phase 1a: 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 TEAEs in Phase 1a graded according to NCI CTCAE v5.0
Phase 1a: 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 Phase 1a graded according to NCI CTCAE v5.0
Maximum Tolerated Dose (MTD) of DB-1317
Time frame: Up to the completion of Phase 1a (assessed up to 12 months)
MTD on the data collected during Phase 1a
Recommended Phase 1b Dose (RP2D) of DB-1317
Time frame: Up to the completion of Phase 1a (assessed up to 12 months)
RP2D of DB-1317 based on the data collected during Phase 1a
Phase 1b: 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 TEAEs in Phase 1b graded according to NCI CTCAE v5.0
Phase 1b: 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 Phase 1b graded according to NCI CTCAE v5.0
Phase 1b: Objective Response Rate (ORR) as determined by investigator
Time frame: Up to follow-up period, approximately 1 year post-treatment
Phase 1b: Objective Response Rate (ORR) as determined by investigator per RECIST 1.1 in non-CRPC. The percentage of participants who had a best response rating of CR and PR, for Part 2 only which was maintained ≥4 weeks
Phase 1b: duration of response (DoR)
Time frame: Up to follow-up period, approximately 1 year post-treatment
DoR will be determined from tumor assessments by investigator per response evaluation criteria in solid tumors version 1.1 (RECIST v1.1)
Phase 1b: disease-control rate (DCR)
Time frame: Up to follow-up period, approximately 1 year post-treatment
DCR will be determined from tumor assessments by investigator per response
Phase 1b: Time to Response (TTR)
Time frame: Up to follow-up period, approximately 1 year post-treatment
TTR will be determined from tumor assessments by investigator per response
13 secondary outcomes
Phase 1a: Objective response rate (ORR)
Time frame: Up to follow-up period, approximately 1 year post-treatment
Phase 1a: duration of response (DoR)
Time frame: Up to follow-up period, approximately 1 year post-treatment
Phase 1a: disease-control rate (DCR)
Time frame: Up to follow-up period, approximately 1 year post-treatment
Phase 1a: Time to Response (TTR)
Time frame: Up to follow-up period, approximately 1 year post-treatment
Phase 1a & Phase 1b: Progression Free Survival (PFS)
Time frame: Up to follow-up period, approximately 1 year post-treatment
Phase 1a & Phase 1b: Overall Survival (OS)
Time frame: From date of first dose until the date of death or lost to follow up, approximately 1 year post-treatment
Phase 1a: Prostate-specific antigen (PSA)
Time frame: From date of first dose until the date of first PSA progression, approximately 1 year post-treatment
Phase 1a & Phase 1b: Pharmacokinetic-AUC
Time frame: within 3 cycles (each cycle is 21 days)
Phase 1a & Phase 1b: Pharmacokinetic-Cmax
Time frame: within 3 cycles (each cycle is 21 days)
Phase 1a & Phase 1b: Pharmacokinetic-Tmax
Time frame: within 3 cycles (each cycle is 21 days)
Phase 1a & Phase 1b: Pharmacokinetic-Cthrough
Time frame: within 6 cycles (each cycle is 21 days)
Phase 1a & Phase 1b: Anti-drug antibody (ADA) prevalence
Time frame: Up to follow-up period, approximately 1 year post-treatment
Phase 1a & Phase 1b: ADA incidence
Time frame: Up to follow-up period, approximately 1 year post-treatment
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 27 Jul 2026.
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Metastatic Solid Tumors
RecruitingPhase 1
A Study to Learn About the Study Medicine Called PF-08046876 in People With Advanced Solid Tumors
Advanced/Metastatic Solid Tumors, Bladder Cancer
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.
Zhaochuan Wang contact
Lily Hu study director
DualityBio Inc.
14 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing DB-1317 in people with Advanced/Metastatic Solid Tumors, run by DualityBio Inc. at 14 sites in 3 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 8 inclusion and 15 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 27 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States, Australia, 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 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.
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 Junhua Gao (01067228087, junhua.gao@dualitybiologics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase 1a: 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 11 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 27 Jul 2026.