Trials Sponsors Conditions Drugs Pricing

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

Interventions

HQP1351Drug

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

HQP1351 20mgHQP1351 30mgHQP1351 40mgHQP1351 50mg

Eligibility Criteria

Age12 Years+

Sexall

Healthy VolunteersNo

Age GroupsChild (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).

Sponsors & Collaborators

HealthQuest Pharma Inc.
Industrycollaborator
Ascentage Pharma Group Inc.
Industrylead

Study Sites (6)

Sun-Yat Sen University Cancer Center

Guangzhou, Guangdong, 510060, China

RECRUITING

Ruihua Xu, ProfessorCONTACT+86-20-87343468 ruihxu@163.com

Zhiwei Zhou, ProfessorCONTACT

Ruihua Xu, ProfessorPRINCIPAL INVESTIGATOR

Zhiwei Zhou, ProfessorPRINCIPAL INVESTIGATOR

Guangdong general hospital

Guangzhou, Guangdong, China

RECRUITING

Related Publications (1)

Qiu HB, Liang Z, Yang J, Zhou Y, Zhou ZW, Wan XB, Li N, Tao KX, Li Y, Wu X, Yang C, Chen Z, Wang H, Men L, Xiong Y, Liu L, Yang D, Zhai Y, Xu RH. Olverembatinib, a multikinase inhibitor that modulates lipid metabolism, in advanced succinate dehydrogenase-deficient gastrointestinal stromal tumors: a phase 1b study and translational research. Signal Transduct Target Ther. 2025 Nov 4;10(1):361. doi: 10.1038/s41392-025-02456-9.
PMID: 41184234DERIVED

MeSH Terms

Conditions

Gastrointestinal Stromal Tumors

Interventions

olverembatinib

Condition Hierarchy (Ancestors)

Neoplasms, Connective TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsDigestive System DiseasesGastrointestinal 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

Study Record Dates

First Submitted

July 1, 2018

First Posted

July 20, 2018

Study Start

July 11, 2018

Actual (reported)

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).
+5 more criteria

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Study Arms (4)

HQP1351 30mg

HQP1351 40mg

HQP1351 50mg

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (6)

Related Publications (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

HQP1351 20mg

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Study Arms (4)

HQP1351 30mg

HQP1351 40mg

HQP1351 50mg

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (6)

Related Publications (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

HQP1351 20mg

You may not qualify if:

Source record

Locations