OncoMatch/Clinical Trials/NCT05532696
Phase 1b/2 Study to Evaluate ABT-101 in Solid Tumor and NSCLC Patients
Is NCT05532696 recruiting? Yes, currently enrolling (Jun 2026). This Phase 1/2 trial studies ABT-101 for advanced solid tumor.
Treatment: ABT-101 — 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)
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Tumor Agnostic
Non-Small Cell Lung Carcinoma
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.
Frequently asked questions
Is NCT05532696 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior EGFR tyrosine kinase inhibitor, HER2 tyrosine kinase inhibitor, anticancer therapy disqualifies patients from enrollment.
Does this trial require ERBB2?
Yes, ERBB2 mutation is a required biomarker for enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify