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

Anbogen Therapeutics

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: HER2 Mutations; Advanced Solid Tumor; Non Small Cell Lung Cancer

Treatments: Drug: ABT-101

Study type: Interventional

Funder types: Industry

Identifiers

NCT05532696

ABT101-102

Details and patient eligibility

About

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

Full description

This study will be conducted in two parts:

Part 1: Dose- Escalation, Phase 1b, is designed to determine the RP2D. Patients with solid tumor will be enrolled into a dose finding study scheme with the assessment of dose-limiting toxicities (DLTs). DLT assessment will be conducted during treatment cycle 1

Part 2: Dose- Expansion, Phase 2, will evaluate the safety and efficacy of ABT-101 at the dosage and dosing regime determined in Phase 1b. Phase 2 will enroll NSCLC patients with HER2 mutations

Study participation for all patients includes screening period, treatment period and safety/ follow-up period. Patient will received study treatment until progressive disease or any other discontinuation or withdrawal criterion is met

Enrollment: 61 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female aged ≥ 20 years or adult age as per local regulations, at 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 patients in Part 2 only: Patients has measurable disease per RECIST 1.1 criteria
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 (Part 1), 0 to 2 (Part 2)
• Appropriate candidate for experimental therapy
• Adequate organ function

Exclusion criteria

• Known active or untreated central nervous system (CNS) metastases and/or carcinomatous meningitis
• For patients in Part 2 only: Previously treated with EGFR or HER2 TKIs.
• 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 ≥ 470 ms
• Significant gastrointestinal disorder(s) that could interfere with absorption of ABT101
• Known to have a history of alcoholism or drug abuse

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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61 participants in 1 patient group

ABT-101

Experimental group

Description:

Part 1- dose-escalation: ABT-101 in patients with advanced cancer disease Part 2- dose expansion: ABT-101 in patients with NSCLC with confirmed HER2 mutations

Treatment:

Drug: ABT-101