Phase 1b/2 Study to Evaluate ABT-101 in Solid Tumor and NSCLC Patients

• Status: Recruiting
• Trial end date: 2023-11-01
• Target enrollment: 0
• Participant gender: All

Summary

A Phase 1b/2, open-label, multicenter study to determine the recommended phase 2 (RP2D) of ABT-101in solid tumor and to explore the preliminary antitumor activities of ABT101 in patients with HER 2 mutated non-small cell lung cancer (NSCLC)

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Anbogen Therapeutics, Inc.

Criteria

Inclusion Criteria:

• Male or female aged ≥ 20 years of age time of informed consent

• Histologically or cytologically confirmed advanced solid tumor (Part 1) or NSCLC with HER2 mutations as determined by the central result (Part 2)

• For patient in Part 2 only: Patients has measurable disease per RECIST 1.1 criteria

• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

• Appropriate candidate for experimental therapy

• Adequate organ function

Exclusion Criteria:

• Known active or untreated central nervous system (CNS) metastases and/or carcinomatous meningitis

• Serious acute or chronic infections

• Received a live-virus vaccination

• Received prior anticancer or other investigational therapy within 28 days or 5× the half-life prior to the first dose.

• Not recovered from prior- treatment toxicities to Grade ≤1

• Major surgery within 28 days prior to the study treatment

• Concurrent malignancy within 2 years prior to first dose

• History or presence of clinically relevant cardiovascular abnormalities. QTcF >450 ms in males or >470 ms in females

• Significant gastrointestinal disorder(s) that could interfere with absorption of ABT101

• Known to have a history of alcoholism or drug abuse