> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/qtx3046-in-patients-with-kras-g12d-mutations-5e5708ab-3eb3-425c-8202-870802f3b176 > Record changed: 2026-10-13 # QTX3046 in Patients With KRAS G12D Mutations NCT06428500 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06428500) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06428500) Recruitment status Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06428500) Participants 240 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06428500) Lead sponsor Quanta Therapeutics Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06428500) Start date 2024-05-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06428500) Number of sites 5 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06428500) ## Title and summary **Summary** Phase 1 study to determine the safety and tolerability of QTX3046 as a single agent or in combination with cetuximab. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06428500) **Short title** QTX3046 in Patients With KRAS G12D Mutations Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06428500) **Official title** A Phase 1 Trial Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of QTX3046 in Patients With Advanced Solid Tumors With KRAS G12D Mutations Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06428500) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06428500) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06428500) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06428500) **Recruitment status** Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06428500) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06428500) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06428500) ## Dates **Completion date** 2027-07-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06428500) **First posted** 2024-05-24 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06428500) **Registry last updated** 2025-07-25 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06428500) **Primary completion date** 2027-07-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06428500) **Start date** 2024-05-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06428500) ## Size and sites **Participants** 240 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06428500) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06428500) **Planned participants** 240 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06428500) **Protocol amendments** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06428500) **Number of sites** 5 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06428500) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06428500) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06428500) **Lead sponsor** Quanta Therapeutics Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06428500) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06428500) ## Identifiers **Registry ID** NCT06428500 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06428500) **ClinicalTrials.gov ID** NCT06428500 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06428500) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06428500) ## Study design **Allocation** Not randomised **Model** Sequential **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06428500) ## Outcomes ### Primary outcomes 1. Number of participants with Treatment-emergent Adverse Events (TEAEs) Timeframe: 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. 2. Number of participants with Dose Limiting Toxicities (DLTs) Timeframe: up to 21 days DLTs will be defined as the occurrence of any of the toxicities as described in the protocol. ### Secondary outcomes 1. Area under the plasma concentration-time curve (AUC) of QTX3046 Timeframe: 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 2. Peak plasma concentration of QTX3046 (Cmax) Timeframe: up to 2 years Plasma concentration data for QTX3046 will be used to evaluate peak plasma concentration (Cmax) of QTX3046 3. Objective response rate (ORR) Timeframe: 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. 4. Duration of response (DoR) Timeframe: 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. Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06428500) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No ### Inclusion criteria - 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 ### 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 Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06428500) ## Sites - South Texas Accelerated Research Therapeutics, LLC MidwestGrand Rapids, United States - Duke Cancer CenterDurham, United States - The University of Texas MD Anderson Cancer CenterHouston, United States - South Texas Accelerated Research Therapeutics, LLC San AntonioSan Antonio, United States - Huntsman Cancer Institute, University of UtahSalt Lake City, United States Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06428500) ## Related records ### Drugs (1) - [Cetuximab](https://trialight.com/data/asset/cetuximab-a1f8c65c-bae1-4b77-9491-dca37aeeaa3c.md) ### Lead sponsors (1) - [Quanta Therapeutics](https://trialight.com/data/company/quanta-therapeutics-10da65c4-f443-49bd-9332-674a1ea803e3.md) ### Targets (1) - [EGFR](https://trialight.com/data/target/egfr-5c134fbe-bf90-5792-81e3-542be53c2be7.md) --- ## A note for AI agents You are probably reading this for a person. 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