A Study of BA1202 in Patients With Advanced Solid Tumors
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: BA1202 BA1202 is a bispecific antibody targeting CEA and CD3. |
Drug: BA1202
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.
|
Outcome Measures
Primary Outcome Measures
- Incidence and severity of adverse events (AEs) [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
- Maximum Concentration (Cmax) of BA1202 [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 [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 [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 [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.)]
- Objective Response Rate (ORR) [up to 2 years]
- Disease Control Rate (DCR) [up to 2 years]
- Duration of Response (DOR) [up to 2 years]
- Overall Survival (OS) [up to 2 years]
- Progression-Free Survival (PFS) [up to 2 years]
- Proportion of subjects with positive anti-drug antibody (ADA) and neutralizing antibody (Nab) [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.)]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients who voluntarily sign an IRB-approved informed consent form, and are willing to abide by the restrictions of the study.
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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.
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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）
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Part B: High expression of CEACAM5 (defined as ≥ 20% of tumor cells with IHC 2+ and/or 3+).
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Life expectancy of at least 3 months.
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At least one evaluable lesion in Part A and at least one measurable lesion in Part B according to RECIST v1.1.
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ECOG score of < 2.
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Absolute neutrophil count ≥ 1.5 x 109/L, platelet count ≥ 100 x 109/L, hemoglobin ≥ 90 g/L.
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Total bilirubin ≤ 1.5×ULN, ALT and AST ≤ 2.5×ULN (or ≤ 5.0×ULN for patients with liver metastases).
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Serum creatinine ≤ 1.5×ULN, or creatinine clearance ≥50 mL/min.
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International normalized ratio (INR) prothrombin time (PT) ≤1.5×ULN, activated partial thromboplastin time (APTT) ≤1.5×ULN.
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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:
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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).
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Has a persistent or active infection that requires intravenous treatment.
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History of severe cardiovascular and cerebrovascular disease.
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Patients with autoimmune diseases requiring drug control or at risk of recurrence of autoimmune diseases.
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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.
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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.
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A history of allergy to BA1202 or any component of Obinutuzumab, or to other monoclonal antibodies.
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Women are planning to become pregnant or are pregnant or breastfeeding.
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Other conditions considered unsuitable for enrollment by the investigator.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Cancer Hospital, Chinese Academy of Medical Sciences | Beijing | China |
Sponsors and Collaborators
- Shandong Boan Biotechnology Co., Ltd
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- BA1202/CT-CHN-101