A Study of BA1202 in Patients With Advanced Solid Tumors

NCT05909241 | Recruiting Phase 1

• 1 other identifier: BA1202/CT-CHN-101
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

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.

Conditions

Advanced Solid Tumor

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• 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

Study Arms (1)

BA1202

EXPERIMENTAL

BA1202 is a bispecific antibody targeting CEA and CD3.

Drug: BA1202

Interventions

BA1202 DRUG

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.

BA1202

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shandong Boan Biotechnology Co., Ltd: lead

Study Sites (1)

Cancer Hospital, Chinese Academy of Medical Sciences

Beijing, China

RECRUITING

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2023
• First Posted: June 18, 2023
• Study Start: August 16, 2023
• Primary Completion: February 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 25, 2024

Record last verified: 2024-04

Locations

CN (1)