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Clinical Trials List

Protocol NumberBA3011-001
NCT Number(ClinicalTrials.gov Identfier)NCT03425279

2019-05-01 - 2026-12-31

Phase I/II

Recruiting4

A Phase 1/2 Dose Escalation and Dose Expansion Study of BA3011 in Patients with Advanced Solid Tumors

  • Trial Applicant

    COVANCE TAIWAN SERVICES LIMITED

  • Sponsor

    BioAtla, Inc.

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2025/08/20

Investigators and Locations

Principal Investigator Tai-Jan Chiu Division of Hematology & Oncology
Kaoshiung Chang Gung Memorial Hospital of the C.G.M.F.

Co-Principal Investigator

  • 陳彥仰 Division of Hematology & Oncology

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Wen-Cheng Chang Division of Hematology & Oncology
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chueh-Chuan Yen 醫學研究部
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Yu-Min Yeh Division of Hematology & Oncology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Advanced Solid Tumors

Objectives

The objective of this study is to assess safety and efficacy of CAB-AXL-ADC in solid tumors.This is a multi-center, open-label, Phase 1/2 study designed to evaluate the safety, tolerability, PK, immunogenicity, and antitumor activity of BA3011, a conditionally active biologic (CAB) AXL-targeted antibody drug conjugate (CAB-AXL-ADC) in patients with advanced solid tumors in Phase 1 and BA3011 alone and in combination with a PD-1 inhibitor in Phase 2.Phase 1 of this study will consist of a dose escalation phase (enrollment complete as of Oct 2019) and a dose expansion phase (still enrolling).Phase 2 is targeted to begin in Q3 2020 and will include both adult and adolescents age 12 and over.

Test Drug

BA3011

Active Ingredient

CAB-AXL-ADC

Dosage Form

IV infusion

Dosage

5ml/vial (10 mg/mL)

Endpoints

Primary Outcome Measures:
1. Phase 1: Safety Profile.
2. Phase 1: Safety Profile.
3. Phase 1 and 2: Safety Profile.
4. Phase 2: Confirmed overall response rate (ORR) per RECIST v1.1.

Secondary Outcome Measures:
1. Phase 1: Pharmacokinetics.
2. Phase 1: Pharmacokinetics.
3. Phase 1: Pharmacokinetics.
4. Phase 1: Overall response rate (ORR).
5. Phase 1: Immunogenicity.
6. Phase 1 and 2: Duration of response (DOR).
7. Phase 1 and 2: Progression-free survival (PFS).
8. Phase 1 and 2: Best overall response (OR).
9. Phase 1 and 2: Disease control rate (DCR).
10. Phase 1 and 2: Time to response (TTR).
11. Phase 1 and 2: Overall survival (OS).
12. Phase 1 and 2: Tumor size.

Inclution Criteria

1. Patients must have measurable disease.
2. Age ≥ 12 years (Phase 2).
3. Adequate renal function.
4. Adequate liver function.
5. Adequate hematological function.
6. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
7. Life expectancy of at least three months.

Exclusion Criteria

1. Patients must not have clinically significant cardiac disease.
2. Patients must not have known non-controlled CNS metastasis.
3. Patients must not have a history of ≥ Grade 3 allergic reactions to mAb therapy as wellas known or suspected allergy or intolerance to any agent given during this study.
4. Patients must not have had major surgery within 4 weeks before first BA3011 administration.
5. Patients must not have had prior therapy with a conjugated or unconjugated auristatin derivative/vinca-binding site targeting payload.
6. Patients must not have known human immunodeficiency virus (HIV) infection, active hepatitis B and/or hepatitis C.
7. Patients must not be women who are pregnant or breast feeding.

The Estimated Number of Participants

  • Taiwan

    20 participants

  • Global

    338 participants

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