QTX3544 in Patients With Advanced Solid Tumors With KRAS G12V Mutations
NCT ID: NCT06715124
Last Updated: 2025-06-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
237 participants
INTERVENTIONAL
2025-01-14
2029-01-02
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Part 1a: QTX3544 monotherapy dose escalation
QTX3544 will be administered at protocol defined dose based on cohort assignment
QTX3544
QTX3544 will be administered at protocol defined dose.
Part 1b: QTX3544 dose escalation in combination with cetuximab
QTX3544 will be administered at protocol defined dose in combination with cetuximab based on cohort assignment
QTX3544
QTX3544 will be administered at protocol defined dose.
Cetuximab
Cetuximab will be administered at protocol defined dose.
Part 2: QTX3544 monotherapy dose expansion
QTX3544 will be administered at protocol defined dose based on cohort assignment
QTX3544
QTX3544 will be administered at protocol defined dose.
Part 3: QTX3544 dose expansion in combination with cetuximab
QTX3544 will be administered at protocol defined dose in combination with cetuximab based on cohort assignment
QTX3544
QTX3544 will be administered at protocol defined dose.
Cetuximab
Cetuximab will be administered at protocol defined dose.
Interventions
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QTX3544
QTX3544 will be administered at protocol defined dose.
Cetuximab
Cetuximab will be administered at protocol defined dose.
Eligibility Criteria
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Inclusion Criteria
* Part 1: Advanced solid tumors with at least one prior systemic therapy.
* Evaluable and measurable disease per RECIST v1.1.
* Part 2 and 3: Measurable disease per RECIST v1.1.
Exclusion Criteria
* Significant cardiovascular disease
* Active infection requiring intravenous (IV) antibiotics
* Prior treatment with a KRAS inhibitor
18 Years
ALL
No
Sponsors
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Quanta Therapeutics
INDUSTRY
Responsible Party
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Locations
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Sarah Cannon Research Institute
Denver, Colorado, United States
Yale Cancer Center
New Haven, Connecticut, United States
Florida Cancer Specialists & Research Institute
Sarasota, Florida, United States
South Texas Accelerated Research Therapeutics, LLC Midwest
Grand Rapids, Michigan, United States
Duke Cancer Center
Durham, North Carolina, United States
Sarah Cannon Research Institute
Nashville, Tennessee, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States
South Texas Accelerated Research Therapeutics, LLC San Antonio
San Antonio, Texas, United States
Huntsman Cancer Institute, University of Utah
Salt Lake City, Utah, United States
South Texas Accelerated Research Therapeutics Mountain Region, LLC
West Valley City, Utah, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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QTX3544-201
Identifier Type: -
Identifier Source: org_study_id
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