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

NCT03594422 | Recruiting Phase 1

• 1 other identifier: SJ-0003
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 6

Brief Summary

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.

Conditions

Gastrointestinal Stromal Tumor (GIST); Solid Tumor, Adult

Outcome Measures

Primary Outcomes (1)

• Safety and tolerance

  Patients with HQP1351 treatment related adverse events (AE), serious adverse events (SAE) will be assessed according NCI CTCAE Version 4.03.

  30 days after the last dose of HQP1351

Secondary Outcomes (3)

• Maximum plasma concentration (Cmax) of HQP1351 on Day 1 and Day 27 post HQP1351 treatment on cycle 1.

  28 days

• Area under the plasma concentration versus time curve (AUC) of HQP1351 on Day 1 and Day 27 post HQP1351 treatment on cycle 1.

  28 days

• Anti-tumor activities of HQP1351

  3-60 months

Study Arms (4)

HQP1351 30mg

EXPERIMENTAL

30 mg QOD(Minor subjects will be enrolled based on weight)

Drug: HQP1351

HQP1351 40mg

EXPERIMENTAL

40 mg QOD(Minor subjects will be enrolled based on weight)

Drug: HQP1351

HQP1351 50mg

EXPERIMENTAL

50 mg QOD

Drug: HQP1351

HQP1351 20mg

EXPERIMENTAL

20 mg QOD (Minor subjects will be enrolled based on weight)

Drug: HQP1351

Interventions

HQP1351 DRUG

HQP1351 Orally, once every other day (QOD) for consecutive 4 weeks each cycle.

HQP1351 20mg; HQP1351 30mg; HQP1351 40mg; HQP1351 50mg

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or not pregnant or lactating women, age≥12years.
• Advanced and/or metastatic GIST or other solid tumors, confirmed by histology and/or cytology. GIST patients must be primary resistant to imatinib (tumor progresses within 6 months first-line imatinib treatment, or succinate dehydrogenase B (SDHB) deficient confirmed by immunohistochemistry, or NF1 mutation), OR 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).
• ECOG≤ 2.
• Estimated survival at least 3 months.
• 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.
• Negative serum pregnancy test (for women of childbearing potential) documented within the 24-hour prior to the first dose of investigational product.
• Willing to use contraception by a method that is deemed effective by the investigator by Subject and their partners throughout the treatment period and for at least 30 days following the last dose of study drug.
• Ability to understand and willingness to sign a written informed consent form (the consent form must be signed by the subject prior to any study-specific procedures).
• Willing and ability to comply with study procedures and follow-up examination.

You may not qualify if:

• 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.
• Received any TKIs within 14 days before first dose of HQP1351.
• Attended any clinical trials on other drugs within 14 days before first dose of HQP1351.
• Have not recovered (\> Grade 1 by CTCAE, v. 4.0) from AEs (except alopecia) due to agents previously administered.
• Malabsorption syndrome or other diseases that affect the absorption of oral drugs.
• Cardiovascular diseases of clinical significance, uncontrollable or active, including but not limited to: history of myocardial infarction; unstable history of angina pectoris; a history of congestive heart failure or lower left ventricular ejection fraction (LVEF) than normal limit within 6 months; the history of atrial arrhythmias was judged by the researchers to have important clinical significance; history of ventricular arrhythmias, etc.
• Hypertension was still poorly controlled after medication treatment (SBP \> 140 mmHg and/or DBP \> 90 mmHg).
• Concurrent use any medication led to prolong QT interval.
• Pulmonary mean arterial pressure\>35 mmHg by ECHO.
• Significant severe cardiovascular conditions during previous TKI treatment.
• Uncontrollable hypertriglyceridemia.
• Performed major surgery (except for intravenous catheterization or bone marrow biopsy) within 14 days of first dose of HQP1351.
• Arterial thrombosis or embolism events such as cerebrovascular accident (including transient ischemic attack, TIA), or venous thrombosis events or pulmonary embolism within 6 months before the first dose of HQP1351 or deep vein thrombosis within 3 months before the first dose of HQP1351.
• Brain metastasis.
• Had other primary malignant tumors in the last three years (exception of the tumors being cured for 5 years or more, or complete removal of non-melanoma skin cancer or successful treatment of carcinoma in situ, or the controlled prostate cancer).

Sponsors & Collaborators

• Ascentage Pharma Group Inc.: lead
• HealthQuest Pharma Inc.: collaborator

Study Sites (6)

Sun-Yat Sen University Cancer Center

Guangzhou, Guangdong, 510060, China

RECRUITING

Guangdong general hospital

Guangzhou, Guangdong, China

RECRUITING

Henan cancer hospital

Zhengzhou, Henan, China

RECRUITING

Union Hospital Tongji Medical College of Huazhong University of Science ang Technology

Wuhan, Hubei, 215316, China

RECRUITING

Chinese PLA general hospital, Beijing, China

Beijing, China

RECRUITING

Fudan University Shanghai Cancer Center

Shanghai, China

RECRUITING

MeSH Terms

Conditions

Gastrointestinal Stromal Tumors

Interventions

olverembatinib

Condition Hierarchy (Ancestors)

Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases

Study Officials

• Ruihua Xu, Professor

  Sun Yat-Sen University Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yifan Zhai, M.D., Ph.D.

CONTACT

+86-20-28069260; yzhai@ascentagepharma.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Patients will be randomized at 1:1:1 ratio into the three dose cohorts: 30 mg QOD, 40 mg QOD and 50 mg QOD.Non-randomized selected adult subjects will receive a 40 mg QOD dosing regimen. And the minor will be enrolled to the three dose cohorts: 20mg QOD, 30 mg QOD, 40 mg QOD according to the weight.

Study Record Dates

• First Submitted: July 1, 2018
• First Posted: July 20, 2018
• Study Start: July 11, 2018
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2028
• Last Updated: April 9, 2026

Record last verified: 2026-04

Locations

CN (6)