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OncoMatch/Clinical Trials/NCT05532696

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

Is NCT05532696 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies ABT-101 for advanced solid tumor.

Phase 1/2RecruitingAnbogen Therapeutics, Inc.NCT05532696Data as of May 2026

Treatment: ABT-101A 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)

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Extracted eligibility criteria

Cancer type

Tumor Agnostic

Small Cell Lung Cancer

Biomarker criteria

Required: HER2 (ERBB2) mutation

Disease stage

Metastatic disease required

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

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Cannot have received: EGFR tyrosine kinase inhibitor

Exception: Part 2 only

For patients in Part 2 only: Previously treated with EGFR or HER2 TKIs.

Cannot have received: HER2 tyrosine kinase inhibitor

Exception: Part 2 only

For patients in Part 2 only: Previously treated with EGFR or HER2 TKIs.

Cannot have received: anticancer therapy

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

Lab requirements

Blood counts

Adequate organ function

Kidney function

Adequate organ function

Liver function

Adequate organ function

Cardiac function

QTcF < 470 ms

Adequate organ function; QTcF ≥ 470 ms [excluded]

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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