Clinical trial NCT06227377: QTX3034 in Patients With KRAS G12D Mutation
Official title: A Phase 1 Trial Evaluating the Safety, Tolerability, PK, and Efficacy of QTX3034 in Patients With Solid Tumors With KRASG12D Mutation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Solid Tumors
Lead sponsor: Quanta Therapeutics
Sponsor class: INDUSTRY
First posted: 2024-01-26
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Phase 1 study to determine the safety and tolerability of QTX3034 as a single agent or in combination with cetuximab.


Eligibility criteria: Inclusion Criteria:

* Pathologically documented, locally advanced or metastatic malignancy with KRAS G12D mutation identified through molecular testing (NGS- or PCR-based) with a Clinical Laboratory Improvement Amendments-certified (or equivalent) diagnostic
* Part 1: - Advanced solid tumors with at least 1 prior systemic therapy
* Evaluable or Measurable disease per RECIST 1.1.
* Parts 2 and 3: Measurable disease per RECIST 1.1.
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
* Adequate organ function

Exclusion Criteria:

* Prior treatment with a KRAS inhibitor
* Active brain metastases or carcinomatous meningitis
* History of other malignancy within 2 years
* Significant cardiovascular disease
* Disease or disorder that may pose a risk to patient's safety

Other protocol-defined Inclusion/Exclusion Criteria may apply

Primary outcomes:
measure: Number of participants with Dose Limiting Toxicities (DLTs)
timeFrame: up to 21 days
measure: Number of participants with Treatment-emergent Adverse Events (TEAEs)
timeFrame: up to 2 years
Secondary outcomes:
measure: QTX3034 pharmacokinetic parameters in plasma
timeFrame: up to 2 years
measure: Objective response rate (ORR)
timeFrame: up to 2 years
measure: Duration of response (DOR)
timeFrame: up to 2 years
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA Hematology/Oncology
state: California
city: Denver
country: United States
facility: Sarah Cannon Research Institute (SCRI)
state: Colorado
city: New Haven
country: United States
facility: Yale Cancer Center
state: Connecticut
city: Sarasota
country: United States
facility: Florida Cancer Specialists
state: Florida
city: Tampa
country: United States
facility: Moffitt Cancer Center
state: Florida
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: New York
country: United States
facility: NYU Langone Health
state: New York
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Oklahoma City
country: United States
facility: Stephenson Cancer Center
state: Oklahoma
city: Nashville
country: United States
facility: SCRI- Nashville
state: Tennessee
city: Houston
country: United States
facility: MD Anderson
state: Texas
city: San Antonio
country: United States
facility: START San Antonio, LLC
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah, Huntsman Cancer Center
state: Utah
city: Fairfax
country: United States
facility: NEXT Oncology Virginia
state: Virginia
Study officials:
References: