NCT04254939 is a Phase 1, PHASE2 clinical trial of CS3007 (BLU-285) in Gastrointestinal Stromal Tumors, sponsored by CStone Pharmaceuticals.

Who is sponsoring NCT04254939?

NCT04254939 is sponsored by CStone Pharmaceuticals.

What drugs are being tested in NCT04254939?

Interventions in NCT04254939: CS3007 (BLU-285).

What condition does NCT04254939 study?

NCT04254939 studies Gastrointestinal Stromal Tumors.

Is NCT04254939 still recruiting?

NCT04254939 is currently completed. Last updated 27 April 2023.

Last reviewed 2023-04-27 · How we verify

NCT04254939

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Study of CS3007 in Subjects With Gastrointestinal Stromal Tumor

Completed Phase 1, PHASE2 Last updated 27 April 2023

What this trial tests

Phase 1, PHASE2 trial testing CS3007 (BLU-285) in Gastrointestinal Stromal Tumors in 65 participants. Completed in 11 April 2023.

Timeline

15 August 2019

Primary endpoint
30 April 2020

11 April 2023

Quick facts

Lead sponsor	CStone Pharmaceuticals
Phase	Phase 1, PHASE2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	65
Start date	15 August 2019
Primary completion	30 April 2020
Estimated completion	11 April 2023
Sites	16 locations across China

Drugs / interventions tested

CS3007 (BLU-285) — full drug profile →

Conditions studied

Gastrointestinal Stromal Tumors — all drugs for Gastrointestinal Stromal Tumors →

Sponsor

CStone Pharmaceuticals — full company profile →

Who can join

18 and older, any sex, with Gastrointestinal Stromal Tumors. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study is an open-label, multicenter, phase I/II study to evaluate the safety, PK and clinical efficacy of avapritinib in Chinese subjects with unresectable or metastatic GIST. The study consists of two parts: dose escalation (phase I) and dose expansion (phase II).

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

Angiogenic signaling pathways and anti-angiogenic therapy for cancer.
Liu ZL, Chen HH, Zheng LL, Sun LP, et al · · 2023 · cited 808× · PMID 37169756 · DOI 10.1038/s41392-023-01460-1
Efficacy and Safety of Avapritinib in Treating Unresectable or Metastatic Gastrointestinal Stromal Tumors: A Phase I/II, Open-Label, Multicenter Study.
Li J, Zhang X, Deng Y, Wu X, et al · · 2023 · cited 8× · PMID 36477870 · DOI 10.1093/oncolo/oyac242
Serum creatine kinase elevation following tyrosine kinase inhibitor treatment in cancer patients: Symptoms, mechanism, and clinical management.
Zhang H, To KKW. · · 2024 · cited 7× · PMID 39473122 · DOI 10.1111/cts.70053
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
The Evolving Role of Second- and Third-Generation Tyrosine Kinase Inhibitors in Gastrointestinal Malignancies: Advances in Targeted Therapy with Sunitinib, Regorafenib, and Avapritinib.
Kawczak P, Bączek T. · · 2026 · PMID 41517566 · DOI 10.3390/jcm15010317

Verify or expand the search:

Other recruiting trials for Gastrointestinal Stromal Tumors

Currently open trials in the same condition.

NCT06805825 — A Study of the c-Kit Specific Antibody-Drug Conjugate NN3201 for Advanced and/or Metastatic Solid Tumors Known to Expres · Phase 1 · recruiting
NCT06326346 — GIST Oral Paclitaxel(Liporaxel) · Phase 2 · recruiting
NCT06087263 — Phase 2 Study to Evaluate the Efficacy of Regorafenib in Specific GIST Mutation Subsets (KIT Exon 17, 18, or 14 Mutation · Phase 2 · active not recruiting
NCT05366816 — ctDNA-Guided Sunitinib And Regorafenib Therapy for GIST · Phase 2 · recruiting
NCT05905887 — Rivoceranib Plus Paclitaxel in Patients With Gastrointestinal Stromal Tumor · Phase 2 · recruiting

Other CStone Pharmaceuticals trials

Trials by the same sponsor.

NCT05381753 — Safety and Efficacy of Avapritinib in Chinese Patients With Gastrointestinal Stromal Tumor (GIST) in the Real World · completed
NCT05279300 — A Study of CS5001 in Patients With Advanced Solid Tumors and Lymphomas · Phase 1 · recruiting
NCT04421352 — Safety and Tolerability Evaluation of Low-dose Radiation in Combination With CS1001 in Relapsed SCLC Patients · Phase 1 · completed
NCT04233060 — A Study of CS3005 in Advanced Solid Tumors · Phase 1 · completed
NCT04162301 — A Study of CS3002 in Subjects With Advanced Solid Tumors · Phase 1 · terminated

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04254939 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 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 CStone Pharmaceuticals
Last refreshed: 27 April 2023

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/NCT04254939.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing