A Study of Olverembatinib in SDH-deficient GIST.
ConditionGIST
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age12+
SponsorAscentage Pharma Group Inc.
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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).
Trial design
Treatments tested in this trial
- Olverembatinib
Treatment groups
40 Participants
are divided into 1 treatment groupSponsors and collaborators
Ascentage Pharma Group Inc.
Lead sponsor
HealthQuest Pharma Inc.
Collaborator
Source ClinicalTrials.gov