Cancer, BreastPhase 1/2NCT05830097
A Study of Bi-Ligand-Drug Conjugate CBP-1019 in Patients With Advanced Solid Tumors
A Phase 1/2 study testing CBP-1019 in people with Cancer, Breast and Cancer, Lung, run by Coherent Biopharma (Hefei) Co., Ltd. at 5 sites in 2 countries.
Trial summary
The primary objective of this phase I study is to evaluate the safety and potential efficacy and to determine the recommended phase 2 dose (RP2D) of CBP-1019, a bi-specific ligand conjugated drugs in patients with advanced solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Breast, Cancer, Lung, Cancer of Pancreas
- What is being tested?
- CBP-1019
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 260 participants
- Where
- 5 sitesin 2 countries
- Study dates
- 14 Mar 2023to 30 Sep 2025
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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
- Provision of informed consent form (ICF) prior to any study-specific procedures.
- Men or women ≥ 18 years old when signed ICF.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS)0-1
- Life expectancy of ≥ 3 months, in the opinion of the Investigator.
- Pathologically documented advanced solid tumor, including but not limited to advanced lung cancer, pancreatic cancer, colorectal cancer, esophageal cancer, and breast cancer, etc.
- The tumor tissue should be provided for folate receptor α (FRα) and transient receptor potential cation channel subfamily V member 6 (TRPV6) immunohistochemistry (IHC) testing, optional for low dose level (≤ 2.0 mg/kg) of phaseⅠa. Tumor FRα and TRPV6 expression as determined by an IHC assay performed by a central laboratory on previously obtained archival tumor tissue or tissue obtained from a biopsy at screening.
Show all 17Show fewer
- Subjects must have received prior standard therapy appropriate for their tumor type and stage of disease, or in the opinion of the investigator, would be unlikely to tolerate or derive clinically meaningful benefit from appropriate standard of care therapy, or absence of standard therapy.
- Progress of disease per response evaluation criteria in solid tumors (RECIST) 1.1 after the last anti-tumor treatment (solid tumors).
- At least one measurable soft tissue lesion per RECIST 1.1, lesions received prior radiotherapy can be regarded as measurable only when occurring conclusive progression after radiotherapy, optional for low dose level (≤ 2.0 mg/kg) of Phase Ⅰa.
- Adequate bone marrow and organ function, defined as:
- Absolute neutrophil count (ANC) ≥ 1.5 × 109/L.
- Platelet count ≥ 100 × 109/L.
- Hemoglobin (Hb) ≥ 90 g/L.
- Total bilirubin (TBIL) ≤ 1.5 × upper limit of normal (ULN), or ≤ 2 × ULN for subjects with liver metastases.
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 1.5 × ULN, or ≤ 2 × ULN for subjects with liver metastases.
- Creatinine clearance (CCr) ≥ 60 mL/min as calculated using Cockcroft-Gault formula
- Women of child-bearing potential (WOCBP) or male subjects whose spouse is WOCBP need to adopt a medically approved contraceptive measure (such as intra-uterine device (IUD), contraceptive pill, or condom) throughout the study and for at least 3 months in males and 6 months in females after the last dose of CBP-1019.
Who cannot join
- Known prior or suspected hypersensitivity to CBP-1019 or any component in their formulations.
- Concurrent malignancy within 5 years prior to the first dose of CBP-1019, other than clinically considered cured early malignant tumors (carcinoma in situ or stage I tumor) such as basal cell carcinoma, localized squamous cell cancer of the skin, Superficial bladder cancer, etc.
- Central nervous system (CNS) metastasis and/or carcinomatous meningitis. Treated CNS metastasis may be enrolled only if it is stable for at least 1 month, no evidence of new or expanded lesions exist, and steroid treatment has been discontinued at least 3 days before the first dose of CBP-1019.
- Poorly controlled pleural effusion, pericardial effusion, or ascites, or those need repeated drainage, such as drainage once a month or more frequently, or within 2 weeks before the dose of CBP-1019.
- Washout periods of prior anti-tumor treatments have not been completed.
- Any toxicities of prior anti-cancer therapy not resolved to Grade 1 per NCI CTCAE 5.0 or inclusion criteria, other than alopecia and fatigue.
Show all 12Show fewer
- Fever >38.5 °C of unknown cause.
- Positive Hepatitis B Surface Antigen (HbsAg) and Hepatitis B virus (HBV) DNA ≥ 500 IU/mL or 2500 copies or lower limits of normal (LLN) of positive.
- Class III or IV congestive heart failure, as defined by the New York Heart Association (NYHA).
- 10 History of clinically significant vascular diseases, including acute arteriovenous embolism, acute thrombotic arteritis, thrombophlebitis, acute pulmonary embolism, acute coronary syndrome .
- 11. History of treated active gastrointestinal ulcers, perforations, and/or fistulas within 6 months prior to the first dose of CBP-1019.
- 12. History of autoimmune disease, immunodeficiency disease and organ transplantation.
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
United States4 sites, 4 recruiting
- Recruiting
TOI Clinical Research LLC
Cerritos, California, 90805
- Not yet recruiting
Next Oncology
Fairfax, Virginia, 22031
- Recruiting
Northwell Health Inc.
Manhasset, New York, 11030
- Recruiting
Florida Cancer Specialists & Research Institute
Orlando, Florida, 32827
China1 site, 1 recruiting
- Recruiting
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142
About this study
Official title: An Open-Label, Non-randomized, Multinational, Multi-center Phase I/Ⅱ Study Evaluating the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of Bi-Ligand-Drug Conjugate CBP-1019 in Patients With Advanced Solid Tumors
The primary objective of this phase I study is to evaluate the safety and potential efficacy and to determine the recommended phase 2 dose (RP2D) of CBP-1019, a bi-specific ligand conjugated drugs in patients with advanced solid tumors.
Read the detailed description
This phase Ia and Ib/II, open-label, multicenter study has two stages. The Ia stage is a dose-escalation study that will focus on safety, tolerability, pharmacokinetics, maximum tolerated dose (MTD) and phase 2 dose (RP2D). Patients with advanced solid tumor who failed from previous standard treatment or without standard therapy exists will be enrolled in the phase Ia study. Dose-limiting toxicity (DLT) observation period is 28 days.
Patients in phase Ib/II part will be recruited into certain tumor cohorts and receive RP2D CBP-1019 iv infusion every two weeks. Primary efficacy of objective response rate (ORR), disease control rate (DCR), progression free survival (PFS), etc., will be evaluated. The correlation between tumor response and the receptors will be explored. Safety information will be collected in phase Ib/II stage.
- Being tested
- CBP-1019
- Medical subject headings
- Breast Neoplasms, Lung Neoplasms, Pancreatic Neoplasms, Esophageal Neoplasms, Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBP-1019Drug
Also called CBP-1019 for injection
Light yellow to yellow loose lumps or powder；50mg/vial; Infusion for 90 minutes (± 10 minutes), once every 2 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Ia stage - CBP-1019 Dose escalation/ Ib、II stage - CBP-1019 monotherapy | Experimental | Ia:Patients will receive CBP-1019 IV infusion every 2 weeks until disease progression, intolerability, informed consent withdraw, or other reasons leading to treatment discontinue.
Ib:Patients will receive CBP-1019 RP2D IV infusion every two weeks until disease Patients will receive CBP-1019 RP2D IV infusion every two weeks until disease progression, intolerability, informed consent withdraw, or other reasons leading to treatment discontinue. Receives: Drug: CBP-1019 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of Adverse Events (AEs)
Safety and tolerability: incidence of dose limiting toxicities (DLTs)、treatment emergent adverse events、serious adverse events (SAEs)、electrocardiogram (ECG) and clinical laboratory tests per the National Cancer Institute's Common Terminology Criteria for Adverse Events, version 5.0 (NCI CTCAE 5.0).
Measured: up to 12 months
Secondary outcomes (1)
MTD/RP2D of CBP-1019.
Dose limiting toxicity (DLT) will be assessed by NCI CTCAE v5.0.Critical decisions as DLT/MTD/RP2D evaluation and dose escalation will be made by Safety monitoring committee (SMC).
Measured: Up to 28 days after the first dose of CBP-1019
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2023
- Study start14 Mar 2023
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer, BreastStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 260 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Coherent Biopharma (Hefei) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lin Shen, MD, Principal investigator, Peking University Cancer Hospital & Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05830097
- Sponsor's protocol ID
- CBP-1019-101
- Status last verified
- Dec 2023
- First submitted
- 29 Mar 2023
- Last updated
- 26 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 26 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Non-randomized, Multinational, Multi-center Phase I/Ⅱ Study Evaluating the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of Bi-Ligand-Drug Conjugate CBP-1019 in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT05830097
- Acronym / sponsor ID
- CBP-1019-101
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 260 participants (estimated)
- Lead sponsor
- Coherent Biopharma (Hefei) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 14 Mar 2023 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 26 Apr 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.
The primary objective of this phase I study is to evaluate the safety and potential efficacy and to determine the recommended phase 2 dose (RP2D) of CBP-1019, a bi-specific ligand conjugated drugs in patients with advanced solid tumors.
Detailed description
This phase Ia and Ib/II, open-label, multicenter study has two stages. The Ia stage is a dose-escalation study that will focus on safety, tolerability, pharmacokinetics, maximum tolerated dose (MTD) and phase 2 dose (RP2D). Patients with advanced solid tumor who failed from previous standard treatment or without standard therapy exists will be enrolled in the phase Ia study. Dose-limiting toxicity (DLT) observation period is 28 days.
Patients in phase Ib/II part will be recruited into certain tumor cohorts and receive RP2D CBP-1019 iv infusion every two weeks. Primary efficacy of objective response rate (ORR), disease control rate (DCR), progression free survival (PFS), etc., will be evaluated. The correlation between tumor response and the receptors will be explored. Safety information will be collected in phase Ib/II stage.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ia stage - CBP-1019 Dose escalation/ Ib、II stage - CBP-1019 monotherapy | Experimental | Drug: CBP-1019Ia:Patients will receive CBP-1019 IV infusion every 2 weeks until disease progression, intolerability, informed consent withdraw, or other reasons leading to treatment discontinue. Ib:Patients will receive CBP-1019 RP2D IV infusion every two weeks until disease Patients will receive CBP-1019 RP2D IV infusion every two weeks until disease progression, intolerability, informed consent withdraw, or other reasons leading to treatment discontinue. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Provision of informed consent form (ICF) prior to any study-specific procedures.
- Men or women ≥ 18 years old when signed ICF.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS)0-1
- Life expectancy of ≥ 3 months, in the opinion of the Investigator.
- Pathologically documented advanced solid tumor, including but not limited to advanced lung cancer, pancreatic cancer, colorectal cancer, esophageal cancer, and breast cancer, etc.
Key exclusion criteria (12 listed)
- Known prior or suspected hypersensitivity to CBP-1019 or any component in their formulations.
- Concurrent malignancy within 5 years prior to the first dose of CBP-1019, other than clinically considered cured early malignant tumors (carcinoma in situ or stage I tumor) such as basal cell carcinoma, localized squamous cell cancer of the skin, Superficial bladder cancer, etc.
- Central nervous system (CNS) metastasis and/or carcinomatous meningitis. Treated CNS metastasis may be enrolled only if it is stable for at least 1 month, no evidence of new or expanded lesions exist, and steroid treatment has been discontinued at least 3 days before the first dose of CBP-1019.
- Poorly controlled pleural effusion, pericardial effusion, or ascites, or those need repeated drainage, such as drainage once a month or more frequently, or within 2 weeks before the dose of CBP-1019.
- Washout periods of prior anti-tumor treatments have not been completed.
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 |
|---|---|---|
| CBP-1019Also: CBP-1019 for injectionLight yellow to yellow loose lumps or powder；50mg/vial; Infusion for 90 minutes (± 10 minutes), once every 2 weeks. | Drug | Ia stage - CBP-1019 Dose escalation/ Ib、II stage - CBP-1019 monotherapy |
Primary outcome
Incidence and severity of Adverse Events (AEs)
Time frame: up to 12 months
Safety and tolerability: incidence of dose limiting toxicities (DLTs)、treatment emergent adverse events、serious adverse events (SAEs)、electrocardiogram (ECG) and clinical laboratory tests per the National Cancer Institute's Common Terminology Criteria for Adverse Events, version 5.0 (NCI CTCAE 5.0).
1 secondary outcome
MTD/RP2D of CBP-1019.
Time frame: Up to 28 days after the first dose of CBP-1019
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2024.
- Individual participant dataSharing planned: No
Related trials for Cancer, Breast
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
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. This study is not recruiting at the moment.
Lin Shen, MD principal investigator
Peking University Cancer Hospital & Institute
5 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 CBP-1019 in people with Cancer, Breast and Cancer, Lung, run by Coherent Biopharma (Hefei) Co., Ltd. at 5 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 12 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: status not confirmed, as of the sponsor's last update on 26 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bin Pan (+86 13917872167 ext. 0000, bin.pan@coherentbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of Adverse Events (AEs) (time frame: up to 12 months). 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 26 Aug 2024.