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Clinical Trials List

Protocol NumberBA3011-001

NCT Number(ClinicalTrials.gov Identfier)NCT03425279

Completed

2019-05-01 - 2026-12-31

Phase I/II

Recruiting4

A Phase 1/2 Dose Escalation and Dose Expansion Study of Mecbotamab Vedotin (BA3011) Alone and in Combination With Nivolumab in Adult and Adolescent Patients 12 Years and Older With Advanced Solid Tumors

Sponsor
Trial scale
Update

2026/03/01

Investigators and Locations

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 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 Yu-Min Yeh

National Taiwan University Hospital

Co-Principal Investigator

Chia-Jui Yen Division of Hematology & Oncology
Wu-Chou Su Division of Hematology & Oncology

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Undifferentiated Pleomorphic Sarcoma

Objectives

Phase 1 Objectives: Primary: Define safety data for BA3011 in patients with advanced solid tumors, including dose-limiting toxicities (DLT), confirmed maximum tolerated dose (MTD), and/or Phase 2 recommended dose (RP2D), and other safety parameters. Secondary: Evaluate the pharmacokinetics (PK) of BA3011. Evaluate the antitumor activity of BA3011. Evaluate the immunogenicity of BA3011. Phase 2 Objectives: Primary: Evaluate the antitumor activity of BA3011 as monotherapy and in combination with nivolumab. Evaluate the safety of BA3011 as monotherapy and in combination with nivolumab. Secondary: **Further understanding of the clinical activity of BA3011 as monotherapy and in combination with nivolumab.** **Exploratory:** **Pharmacokinetic (PK) assessment of BA3011 monotherapy and in combination with nivolumab.** **Immunogenicity of BA3011 monotherapy and in combination with nivolumab.** **Exploring the relationship between tumor AXL status and clinical response to BA3011.** **Evaluating the correlation between potential candidate tumors and blood biomarkers for patient selection or research and their antitumor activity with BA3011.**

Test Drug

IV infusion

Active Ingredient

CAB-AXL-ADC

Dosage Form

IV infusion

Dosage

vial

Endpoints

Primary endpoints:

Phase 1:

Safety: Assess dose-limiting toxicities (DLTs), maximum tolerated dose (MTD) and/or recommended dose for Phase 2 (RP2D), adverse events (AEs), serious adverse events (SAEs), and changes in laboratory parameters and vital signs since baseline.

Phase 2:

• Efficacy: Objective response rate (ORR).

• Safety: Adverse events (AEs), serious adverse events (SAEs), and changes in laboratory parameters and vital signs since baseline.

Inclution Criteria

Inclusion Criteria:

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

Exclusion Criteria

Exclusion Criteria:

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

The Estimated Number of Participants

Taiwan

20 participants
Global

338 participants