KQB198 in Combination With Imatinib in Participants With Advanced/Metastatic GIST in 1st Line Setting

Kumquat Biosciences Inc.

Status and phase: Enrolling; Phase 2

Conditions: Gastrointestinal Tumors; Gastro Intestinal Stromal Tumour; GIST Metastatic Cancer; GIST; GIST - Gastrointestinal Stromal Tumor

Treatments: Drug: Imatinib (Gleevec); Drug: KQB198

Study type: Interventional

Funder types: Industry

Identifiers

NCT07406633

KQB198-103

Details and patient eligibility

About

This study will test an experimental drug called KQB198 in combination with imatinib. The goal is to determine if this combination is safe and tolerable and assess how effective the combination is at treating GIST. Imatinib has been approved by the FDA for the treatment of different types of cancer including GIST.

Enrollment: 46 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

All Participants:

• Unresectable or metastatic disease
• Tissue confirmation of GIST
• Valid results from local testing of blood or tumor tissue documenting the presence of a KIT mutation (must not have exon 9 mutation) or PDGFRA mutation (must not have PDGFRA D842V).
• Measurable disease per RECIST v1.1.
• Patients must be in 1st line of treatment for advanced or metastatic disease. Prior imatinib is allowed in adjuvant or neoadjuvant setting, as long as imatinib was stopped over 1 year ago.
• Adequate organ function and performance status

Exclusion Criteria

Participants are excluded from the study if any of the following criteria apply:

• Unable to swallow or GI condition that prevents absorption.
• Other active malignancies within the last 2 years.
• History of hypersensitivity to any component of KQB198 or imatinib.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Sequential Assignment

Masking: None (Open label)

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46 participants in 1 patient group

KQB198 in Combination with Imatinib

Experimental group

Treatment:

Drug: KQB198

Drug: Imatinib (Gleevec)