QTX3046 in Patients with KRAS G12D Mutations
- Conditions
- Advanced Solid Tumor
- Interventions
- Combination Product: Cetuximab
- Registration Number
- NCT06428500
- Lead Sponsor
- Quanta Therapeutics
- Brief Summary
Phase 1 study to determine the safety and tolerability of QTX3046 as a single agent or in combination with cetuximab.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 240
- Pathologically documented, locally advanced or metastatic malignancy with KRAS G12D 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 v1.1.
- Part 2 and 3: Measurable disease per RECIST v1.1
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Part 2: QTX3046 monotherapy dose expansion QTX3046 QTX3046 will be administered orally at the recommended phase 2 dose (RP2D) based on cohort assignment Part 1a: QTX3046 monotherapy dose escalation QTX3046 QTX3046 will be administered orally at escalating doses as defined in the protocol based on dose level assignment Part 1b: QTX3046 dose escalation in combination with cetuximab Cetuximab QTX3046 will be administered orally at escalating doses as defined in the protocol in combination with intravenous cetuximab based on dose level assignment Part 1b: QTX3046 dose escalation in combination with cetuximab QTX3046 QTX3046 will be administered orally at escalating doses as defined in the protocol in combination with intravenous cetuximab based on dose level assignment Part 3: QTX3046 dose expansion in combination with cetuximab Cetuximab QTX3046 will be administered orally at the recommended phase 2 dose (RP2D) in combination with intravenous cetuximab based on cohort assignment Part 3: QTX3046 dose expansion in combination with cetuximab QTX3046 QTX3046 will be administered orally at the recommended phase 2 dose (RP2D) in combination with intravenous cetuximab based on cohort assignment
- Primary Outcome Measures
Name Time Method Number of participants with Treatment-emergent Adverse Events (TEAEs) 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) up to 21 days DLTs will be defined as the occurrence of any of the toxicities as described in the protocol.
- Secondary Outcome Measures
Name Time Method Duration of response (DoR) up to 2 years Duration of response (DoR) is defined as the time between first evidence of objective response and disease progression (as measured by RECIST 1.1) or death, whichever occurs earlier, in subjects who achieve CR or PR.
Area under the plasma concentration-time curve (AUC) of QTX3046 up to 2 years Plasma concentration data for QTX3046 will be used to evaluate the area under the plasma concentration-time curve (AUC) of QTX3046
Peak plasma concentration of QTX3046 (Cmax) up to 2 years Plasma concentration data for QTX3046 will be used to evaluate peak plasma concentration (Cmax) of QTX3046
Objective response rate (ORR) up to 2 years The ORR is defined as the proportion of patients with a best overall response of complete response (CR) or partial response (PR) based on RECIST 1.1.
Trial Locations
- Locations (5)
South Texas Accelerated Research Therapeutics, LLC Midwest
🇺🇸Grand Rapids, Michigan, United States
The University of Texas MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
Duke Cancer Center
🇺🇸Durham, North Carolina, United States
Huntsman Cancer Institute, University of Utah
🇺🇸Salt Lake City, Utah, United States
South Texas Accelerated Research Therapeutics, LLC San Antonio
🇺🇸San Antonio, Texas, United States