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A Study of BA1202 in Patients With Advanced Solid Tumors

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ClinicalTrials.gov Identifier: NCT05909241
Recruitment Status : Recruiting
First Posted : June 18, 2023
Last Update Posted : April 25, 2024
Sponsor:
Information provided by (Responsible Party):
Shandong Boan Biotechnology Co., Ltd

Study Description
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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
Advanced Solid Tumor Drug: BA1202 Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 78 participants
Allocation: N/A
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : August 16, 2023
Estimated Primary Completion Date : February 2025
Estimated Study Completion Date : December 2026
Arms and Interventions
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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
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Primary Outcome Measures :
  1. 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. ]

Secondary Outcome Measures :
  1. 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.) ]
  2. 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.) ]
  3. 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.) ]
  4. 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.) ]
  5. Objective Response Rate (ORR) [ Time Frame: up to 2 years ]
  6. Disease Control Rate (DCR) [ Time Frame: up to 2 years ]
  7. Duration of Response (DOR) [ Time Frame: up to 2 years ]
  8. Overall Survival (OS) [ Time Frame: up to 2 years ]
  9. Progression-Free Survival (PFS) [ Time Frame: up to 2 years ]
  10. 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.) ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05909241


Locations
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China
Cancer Hospital, Chinese Academy of Medical Sciences Recruiting
Beijing, China
Contact: Huang Jing    13301056087    huangjingwg@163.com   
Sponsors and Collaborators
Shandong Boan Biotechnology Co., Ltd
More Information
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Responsible Party: Shandong Boan Biotechnology Co., Ltd
ClinicalTrials.gov Identifier: NCT05909241    
Other Study ID Numbers: BA1202/CT-CHN-101
First Posted: June 18, 2023    Key Record Dates
Last Update Posted: April 25, 2024
Last Verified: April 2024

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasms