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OncoMatch/Clinical Trials/NCT03594422

A Study of HQP1351 in Patients With GIST or Other Solid Tumors

Is NCT03594422 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies HQP1351 for gastrointestinal stromal tumor (gist).

Phase 1RecruitingAscentage Pharma Group Inc.NCT03594422Data as of May 2026

Treatment: HQP1351This study is a Multi-center, Open-label Phase 1 Study to Determine the Recommend Phase 2 Dose (RP2D) and Evaluate PK/PD and preliminary Efficacy of HQP1351 in Patients With GIST or Other Solid Tumors.

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Extracted eligibility criteria

Cancer type

Gastrointestinal Stromal Tumor

Tumor Agnostic

Biomarker criteria

Allowed: NF1 mutation

Allowed: SDHB deficient

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Prior therapy

Must have received: imatinib (imatinib) — first-line

tumor progresses within 6 months first-line imatinib treatment

Must have received: tyrosine kinase inhibitor (imatinib)

imatinib or imatinib and at least one other TKI treatment failure (after imatinib or other TKI treatment for more than 6 months, tumor progress again after achieving tumor remission or stability)

Cannot have received: chemotherapy

Received any anti-cancer chemotherapy, biological agent treatment (e.g. Monoclonal antibody), immunotherapy (e.g. IFN) or radiotherapy with 28 days or 5 times half-time before first dose of HQP1351

Cannot have received: tyrosine kinase inhibitor

Received any TKIs within 14 days before first dose of HQP1351

Lab requirements

Blood counts

Adequate hematologic and bone marrow functions

Kidney function

Adequate renal function

Liver function

Adequate liver function

Cardiac function

Troponin(I/T) ≤ Upper Limit of Normal; Ejection fraction >40%; QTc interval ≤ 450 ms in male or ≤ 470 ms in female

Adequate hematologic and bone marrow functions. Adequate renal and liver function. Heart function index: Troponin(I/T) ≤ Upper Limit of Normal; Ejection fraction >40%; QTc interval ≤ 450 ms in male or ≤ 470 ms in female.

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

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