A Study of Olverembatinib in SDH-deficient GIST.

NCT06640361 | Recruiting Phase 3

• 1 other identifier: HQP1351GG301
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

An international multicenter, open, single-arm pivotal registration phase III study to determine the efficacy and safety of olverembatinib in patients with SDH-deficient gastrointestinal stromal tumor (GIST) who have previously been treated with one-line therapy, and to evaluate the progression-free survival and clinical benefit rate of olverembatinib in patients with SDH-deficient GIST.

Conditions

GIST

Keywords

Olverembatinib; GIST

Outcome Measures

Primary Outcomes (1)

• Progression-free survival(PFS) rate

  Proportion of subjects who do not experience disease progression or death after the first dose of treatment as assessed by Independent Review Committee.

  36 months

Secondary Outcomes (2)

• Plasma concentrations of olverembatinib

  Cycle 2 to Cycle 3 (each cycle is 28 days)

• Number of participants with treatment-related adverse events as assessed by CTCAE v5.0.

  Through study completion,an average of 2 years.

Study Arms (1)

Olverembatinib

EXPERIMENTAL

Drug: Olverembatinib

Interventions

Olverembatinib DRUG

Oral administration with meal, QOD, every 28 days for a cycle.

Olverembatinib

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:

• Histologically and/or cytologically confirmed GIST, immunohistochemistry with loss of SDHB expression, and failure of at least one prior systemic therapy. Defined as disease progression or intolerable as judged by the investigator.
• Must have at least one measurable target lesion.
• ECOG≤ 2.
• Expected survival of at least 3 months.
• Adequate organ function.
• Negative serum pregnancy test result for women of childbearing potential within 7 days prior to taking the first dose of study drug.
• Males, women of childbearing potential, as well as their partners, voluntarily take effective contraceptive measures as specified in the protocol from the time of signing the informed consent form until at least 30 days after the last dose of study drug.
• Prior to initiation of any screening or study-specific procedures, the patient or his/her guardian is able to understand and voluntarily sign an informed consent form approved by the Ethics Committee in writing, voluntarily and able to complete the study procedures and follow-up examinations.

You may not qualify if:

• Received antitumor cytotoxic chemotherapy, radiotherapy, biologic drug therapy, immunotherapy, or other investigational agents within 14 days or less than 5 times the half-life prior to the first dose.
• Tyrosine kinase inhibitor (TKI) therapy within 7 days prior to the first dose.
• Use of drugs that have drug interactions with the study drug within 7 days prior to the first dose.
• Adverse events due to prior treatment have not recovered (\> NCI CTCAE v5.0 Grade 1).
• Absorption disorder syndrome or other conditions that affect the absorption of oral medications.
• With clinically significant, uncontrolled or active cardiovascular disease or thrombotic disease.
• Poorly controlled hypertension after hypertension medication.
• Severe cardiovascular and cerebrovascular diseases during previous use of TKIs.
• Uncontrolled Hyperlipidemia.
• Major surgery, open biopsy, or major traumatic injury within 14 days prior to initiation of study drug.
• With brain metastases.
• Other malignancies within 2 years.
• Uncontrolled systemic active fungal, bacterial, and/or viral infections.
• Female patients who are pregnant or lactating, or female patients who are expecting to become pregnant within the period of this study.
• Any symptoms or disease of the patient, in the judgment of the investigator or sponsor, that may jeopardize their safety or interfere with the safety evaluation of the investigational drug.

Sponsors & Collaborators

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

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510000, China

RECRUITING

MeSH Terms

Interventions

olverembatinib

Study Officials

• Ruihua Xu, M.D., Ph.D.

  Sun Yat-sen University

  STUDY CHAIR

Central Study Contacts

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

CONTACT

+86-20-28068501; yzhai@ascentage.com

Chen Yang, M.D.

CONTACT

Chen.Yang@ascentage.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2024
• First Posted: October 15, 2024
• Study Start: November 11, 2024
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): June 30, 2029
• Last Updated: December 27, 2024

Record last verified: 2024-12

Locations

CN (1)