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NCT03594422
A Phase I Study to Assess the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Properties of Oral HQP1351 in Patients With GIST or Other Solid Tumors.
Phase 1 trial testing HQP1351 in Gastrointestinal Stromal Tumor (GIST) in 100 participants. Currently enrolling.
1 December 2027
Quick facts
| Lead sponsor | Ascentage Pharma Group Inc. |
|---|---|
| Phase | Phase 1 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 100 |
| Start date | 11 July 2018 |
| Primary completion | 1 December 2027 |
| Estimated completion | 1 December 2028 |
| Sites | 6 locations across China |
Drugs / interventions tested
- HQP1351 — full drug profile →
Conditions studied
- Gastrointestinal Stromal Tumor (GIST) — all drugs for Gastrointestinal Stromal Tumor (GIST) →
- Solid Tumor, Adult — all drugs for Solid Tumor, Adult →
Sponsor
Ascentage Pharma Group Inc. — full company profile →
Who can join
12 and older, any sex, with Gastrointestinal Stromal Tumor (GIST) or Solid Tumor, Adult. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Safety and tolerance
Time frame: 30 days after the last dose of HQP1351
Patients with HQP1351 treatment related adverse events (AE), serious adverse events (SAE) will be assessed according NCI CTCAE Version 4.03.
Sponsor's own description
This 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.
Publications & conference data
6 peer-reviewed publications reference this trial (live from Europe PMC):
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Precision Oncology in Gastrointestinal Stromal Tumors.
Mechahougui H, Michael M, Friedlaender A. · · 2023 · cited 15× · PMID 37232809 · DOI 10.3390/curroncol30050351 -
Current Drug Resistance Mechanisms and Treatment Options in Gastrointestinal Stromal Tumors: Summary and Update.
He C, Wang Z, Yu J, Mao S, et al · · 2024 · cited 9× · PMID 39441520 · DOI 10.1007/s11864-024-01272-7 -
Molecular Tailored Therapeutic Options for Advanced Gastrointestinal Stromal Tumors (GISTs): Current Practice and Future Perspectives.
Catalano F, Cremante M, Dalmasso B, Pirrone C, et al · · 2023 · cited 6× · PMID 37046734 · DOI 10.3390/cancers15072074 -
Olverembatinib, a multikinase inhibitor that modulates lipid metabolism, in advanced succinate dehydrogenase-deficient gastrointestinal stromal tumors: a phase 1b study and translational research.
Qiu HB, Liang Z, Yang J, Zhou Y, et al · · 2025 · cited 4× · PMID 41184234 · DOI 10.1038/s41392-025-02456-9 -
The Management of Unresectable, Advanced Gastrointestinal Stromal Tumours.
Foo T, Goldstein D, Segelov E, Shapiro J, et al · · 2022 · cited 4× · PMID 35290591 · DOI 10.1007/s11523-022-00869-y -
Genetic predisposition in sarcomas: clinical implications and management.
Connolly EA, Boye K, Bonvalot S, Kratz CP, et al · · 2025 · cited 2× · PMID 40291347 · DOI 10.1016/j.eclinm.2025.103203
Verify or expand the search:
- PubMed search for NCT03594422
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of HQP1351
Trials testing the same drug.
- NCT04126681 — A Pivotal Study of HQP1351 in Patients With Chronic Myeloid Leukemia in Chronic Phase · Phase 2 · completed
- NCT03882281 — Pharmacokinetics Profiles of HQP1351 Under Fasting and High-fat Meals in Patients With Chronic Myeloid Leukemia · Phase 1 · completed
Other recruiting trials for Gastrointestinal Stromal Tumor (GIST)
Currently open trials in the same condition.
- NCT07072143 — An International Study on Pediatric Patients With Rare Tumors. · recruiting
- NCT05489237 — First-in-human Study of IDRX-42 in Participants With Metastatic and/or Unresectable Gastrointestinal Stromal Tumors · Phase 1 · recruiting
- NCT04557969 — Surgery in Gastrointestinal Stromal Tumors (GISTs) for Treatment, Tumor Modeling, and Genomic Analysis · recruiting
Other Ascentage Pharma Group Inc. trials
Trials by the same sponsor.
- NCT07282093 — Pharmacokinetics of Olverembatinib in Participants With Hepatic Impairment · Phase 1 · recruiting
- NCT06640361 — A Study of Olverembatinib in SDH-deficient GIST. · Phase 3 · recruiting
- NCT06389292 — A Pivotal Study of APG-2575 (Lisaftoclax) Combined With Azacitidine in the Treatment of Acute Myeloid Leukemia · Phase 3 · recruiting
- NCT06104566 — Global Trial in APG2575 for Patients With CLL/SLL · Phase 3 · recruiting
- NCT06051409 — A Study of Olverembatinib in Patients With Newly Diagnosed Ph+ALL. · Phase 3 · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03594422 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Ascentage Pharma Group Inc.
- Last refreshed: 6 April 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03594422.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing