A Phase 1 Trial Evaluating the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-Tumor Activity of QTX3544 in Patients With Advanced Solid Tumors With KRAS G12V Mutations
Trial Snapshot
- Phase
- Phase 1
- Status
- Recruiting
- Sponsor
- Enrollment
- 237
- Locations
- 9
- Primary Endpoint
- Number of participants with Treatment-emergent Adverse Events (TEAEs)
Study Overview
Brief Summary
Phase 1 study to determine the safety, tolerability, and anti-tumor activity of QTX3544 as a single agent or in combination with cetuximab.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Pathologically documented, locally advanced or metastatic malignancy with KRAS G12V mutations 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 one prior systemic therapy.
- •Evaluable and measurable disease per RECIST v1.
- •Part 2 and 3: Measurable disease per RECIST v1.1.
Exclusion Criteria
- •Active brain metastasis or carcinomatous meningitis
- •Significant cardiovascular disease
- •Active infection requiring intravenous (IV) antibiotics
- •Prior treatment with a KRAS inhibitor
- •Other protocol-defined Inclusion/Exclusion Criteria may apply
Arms & Interventions
Part 1a: QTX3544 monotherapy dose escalation
QTX3544 will be administered at protocol defined dose based on cohort assignment
Intervention: QTX3544 (Drug)
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
Intervention: QTX3544 (Drug)
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
Intervention: Cetuximab (Combination Product)
Part 2: QTX3544 monotherapy dose expansion
QTX3544 will be administered at protocol defined dose based on cohort assignment
Intervention: QTX3544 (Drug)
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
Intervention: QTX3544 (Drug)
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
Intervention: Cetuximab (Combination Product)
Outcomes
Primary Outcomes
Number of participants with Treatment-emergent Adverse Events (TEAEs)
Time Frame: up to 2 years
Define as adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug monotherapy and in combination with cetuximab.
Number of participants with Dose Limiting Toxicities (DLTs)
Time Frame: up to 21 days
DLTs will be defined as the occurrence of any of the toxicities as described in the protocol.
Secondary Outcomes
- Area under the plasma concentration-time curve (AUC) of QTX3544(up to 2 years)
- Peak plasma concentration of QTX3544 (Cmax)(up to 2 years)
- Objective response rate (ORR)(up to 2 years)
- Duration of response (DoR)(up to 2 years)