- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05909241
A Study of BA1202 in Patients With Advanced Solid Tumors
A Multicenter, Open-label, Single-arm, Dose Escalation and Expansion Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of BA1202 in Patients With Advanced Solid Tumors
This is a multicenter, open-label, single-arm phase I study in patients with advanced solid tumors which consists of a dose escalation part (Part A) and a dose extension part (Part B).
Part A aims to evaluate the safety and tolerability of BA1202, and determine the MTD. Part B will also evaluate the preliminary efficacy of BA1202.
Study Overview
Study Type
Enrollment (Estimated)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
-
Beijing, China
- Recruiting
- Cancer Hospital, Chinese Academy of Medical Sciences
-
Contact:
- Huang Jing
- Phone Number: 13301056087
- Email: huangjingwg@163.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patients who voluntarily sign an IRB-approved informed consent form, and are willing to abide by the restrictions of the study.
- Part A: Patients with histologically and/or cytologically confirmed advanced and/or metastatic solid tumors who have progressed on Standard-Of-Care (SOC), are intolerant to SOC, or have no SOC.
- Part B: Patients with histologically and/or cytologically confirmed colorectal cancer, non-small cell lung cancer, pancreatic cancer, gastric cancer, who have progressed on Standard-Of-Care (SOC), are intolerant to SOC, or have no SOC.(Specific cohort will be determined after data of dose escalation phase is obtained)
- Part B: High expression of CEACAM5 (defined as ≥ 20% of tumor cells with IHC 2+ and/or 3+).
- Life expectancy of at least 3 months.
- At least one evaluable lesion in Part A and at least one measurable lesion in Part B according to RECIST v1.1.
- ECOG score of < 2.
- Absolute neutrophil count ≥ 1.5 x 10^9/L, platelet count ≥ 100 x 10^9/L, hemoglobin ≥ 90 g/L.
- Total bilirubin ≤ 1.5×ULN, ALT and AST ≤ 2.5×ULN (or ≤ 5.0×ULN for patients with liver metastases).
- Serum creatinine ≤ 1.5×ULN, or creatinine clearance ≥50 mL/min.
- International normalized ratio (INR) prothrombin time (PT) ≤1.5×ULN, activated partial thromboplastin time (APTT) ≤1.5×ULN.
- Blood pregnancy test results were negative for female patients with fertility potential. Patients with fertility potential must agree to use a reliable method of contraception with their sexual partners during the study period and at least 6 months after the last administration.
Exclusion Criteria:
- Other malignancies within 5 years prior to screening (other than cured stage Ib or lower cervical cancer, non-invasive basal cell or squamous cell skin cancer).
- Has a persistent or active infection that requires intravenous treatment.
- History of severe cardiovascular and cerebrovascular disease.
- Patients with autoimmune diseases requiring drug control or at risk of recurrence of autoimmune diseases.
- Received any radiotherapy (other than palliative radiotherapy for bone metastases), chemotherapy, targeted therapy, immunotherapy, cell therapy, or other investigational anticancer agents within 4 weeks prior to first dose of BA1202, unless chemotherapy or targeted therapy is less than 4 weeks after first dose but has eluted ≥5 half-lives.
- Have received any previous CEA targeting therapy, including but not limited to monoclonal antibodies, bisspecific antibodies, antibody-coupled drugs (ADCs), chimeric antigen receptor T cells (CAR-T), etc.
- A history of allergy to BA1202 or any component of Obinutuzumab, or to other monoclonal antibodies.
- Women are planning to become pregnant or are pregnant or breastfeeding.
- Other conditions considered unsuitable for enrollment by the investigator.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: BA1202
BA1202 is a bispecific antibody targeting CEA and CD3.
|
BA1202 will be administered intravenously (IV) once every 3 weeks (Q3W) until confirmed progression, death, unaccepted toxicity, initiation of other antitumor therapies, or any other conditions requiring treatment discontinuation, and the duration of administration was no more than 2 years. Part A: Patients will receive one of the following dosages of BA1202: 0.016mg, 0.08mg, 0.4mg, 1.6mg, 6.4mg, 19mg, 38mg, 56mg. Part B: Based on the data of part A, one or two dose levels will be discussed for further evaluation in part B. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Incidence and severity of adverse events (AEs)
Time Frame: From the initiation of study treatment to the completion of safety follow-up after the end of study treatment, up to 2 years.
|
From the initiation of study treatment to the completion of safety follow-up after the end of study treatment, up to 2 years.
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Objective Response Rate (ORR)
Time Frame: up to 2 years
|
up to 2 years
|
Duration of Response (DOR)
Time Frame: up to 2 years
|
up to 2 years
|
Disease Control Rate (DCR)
Time Frame: up to 2 years
|
up to 2 years
|
Progression-Free Survival (PFS)
Time Frame: up to 2 years
|
up to 2 years
|
Overall Survival (OS)
Time Frame: up to 2 years
|
up to 2 years
|
Maximum Concentration (Cmax) of BA1202
Time Frame: Cycle 1: Day 1, 2, 3, 5, 8, 15; Cycle 2 Day 1; Cycle 3 Day 1; Cycle 4: Day 1, 2, 3, 5, 8, 15; Cycle 5 Day 1; Cycle 6 Day 1. (Each cycle is 21 days.)
|
Cycle 1: Day 1, 2, 3, 5, 8, 15; Cycle 2 Day 1; Cycle 3 Day 1; Cycle 4: Day 1, 2, 3, 5, 8, 15; Cycle 5 Day 1; Cycle 6 Day 1. (Each cycle is 21 days.)
|
Area under the curve (AUC) of BA1202
Time Frame: Cycle 1: Day 1, 2, 3, 5, 8, 15; Cycle 2 Day 1; Cycle 3 Day 1; Cycle 4: Day 1, 2, 3, 5, 8, 15; Cycle 5 Day 1; Cycle 6 Day 1. (Each cycle is 21 days.)
|
Cycle 1: Day 1, 2, 3, 5, 8, 15; Cycle 2 Day 1; Cycle 3 Day 1; Cycle 4: Day 1, 2, 3, 5, 8, 15; Cycle 5 Day 1; Cycle 6 Day 1. (Each cycle is 21 days.)
|
Minimum Concentration (Cmin) of BA1202
Time Frame: Cycle 1: Day 1, 2, 3, 5, 8, 15; Cycle 2 Day 1; Cycle 3 Day 1; Cycle 4: Day 1, 2, 3, 5, 8, 15; Cycle 5 Day 1; Cycle 6 Day 1. (Each cycle is 21 days.)
|
Cycle 1: Day 1, 2, 3, 5, 8, 15; Cycle 2 Day 1; Cycle 3 Day 1; Cycle 4: Day 1, 2, 3, 5, 8, 15; Cycle 5 Day 1; Cycle 6 Day 1. (Each cycle is 21 days.)
|
Time of maximum concentration (Tmax) of BA1202
Time Frame: Cycle 1: Day 1, 2, 3, 5, 8, 15; Cycle 2 Day 1; Cycle 3 Day 1; Cycle 4: Day 1, 2, 3, 5, 8, 15; Cycle 5 Day 1; Cycle 6 Day 1. (Each cycle is 21 days.)
|
Cycle 1: Day 1, 2, 3, 5, 8, 15; Cycle 2 Day 1; Cycle 3 Day 1; Cycle 4: Day 1, 2, 3, 5, 8, 15; Cycle 5 Day 1; Cycle 6 Day 1. (Each cycle is 21 days.)
|
Proportion of subjects with positive anti-drug antibody (ADA) and neutralizing antibody (Nab)
Time Frame: Cycle 1: Day 1, 15; Cycle 2 Day 1; Cycle 3 Day 1; Cycle 4 Day 1; Cycle 5 Day 1; Cycle 6 Day 1; EOT (end of treatment) visit. (Each cycle is 21 days.)
|
Cycle 1: Day 1, 15; Cycle 2 Day 1; Cycle 3 Day 1; Cycle 4 Day 1; Cycle 5 Day 1; Cycle 6 Day 1; EOT (end of treatment) visit. (Each cycle is 21 days.)
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BA1202/CT-CHN-101
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Advanced Solid Tumor
-
Aadi Bioscience, Inc.RecruitingAdvanced Solid Tumor | Tumor | Tumor, SolidUnited States
-
Impact Therapeutics, Inc.RecruitingSolid Tumor | Advanced Solid TumorChina, Taiwan, United States, Australia
-
BeiGeneRecruitingSolid Tumor | Advanced Solid TumorUnited States, New Zealand, Australia, China
-
Pyxis Oncology, IncRecruiting
-
Neurogene Inc.Merck Sharp & Dohme LLCActive, not recruitingSolid Tumor | Advanced Solid TumorUnited States, Australia, Canada
-
EMD Serono Research & Development Institute, Inc.Merck KGaA, Darmstadt, GermanyCompletedSolid Tumor | Advanced Solid TumorSpain, United States, Netherlands, United Kingdom
-
Zhuhai Yufan Biotechnologies Co., LtdRecruitingAdvanced Solid Tumor | Advanced Solid MalignanciesChina
-
Zhuhai Yufan Biotechnologies Co., LtdRecruitingAdvanced Solid Tumor | Advanced Solid MalignanciesUnited States
-
Jazz PharmaceuticalsMerck Sharp & Dohme LLCRecruitingAdvanced Solid Tumor | Metastatic Solid TumorUnited States
-
PharmaEngineNot yet recruitingAdvanced Solid Tumor | Metastatic Solid Tumor