> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/qtx3034-in-patients-with-kras-g12d-mutation-47e5b0b3-ea28-42ce-93cf-f956ea2b59f4 > Record changed: 2026-10-13 # QTX3034 in Patients With KRAS G12D Mutation NCT06227377 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06227377) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06227377) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06227377) Participants 250 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06227377) Lead sponsor Quanta Therapeutics Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06227377) Start date 2024-02-05 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06227377) Number of sites 14 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06227377) ## Title and summary **Summary** Phase 1 study to determine the safety and tolerability of QTX3034 as a single agent or in combination with cetuximab. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06227377) **Short title** QTX3034 in Patients With KRAS G12D Mutation Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06227377) **Official title** A Phase 1 Trial Evaluating the Safety, Tolerability, PK, and Efficacy of QTX3034 in Patients With Solid Tumors With KRASG12D Mutation Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06227377) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06227377) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06227377) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06227377) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06227377) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06227377) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06227377) ## Dates **Completion date** 2027-04-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06227377) **First posted** 2024-01-26 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06227377) **Registry last updated** 2026-04-27 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06227377) **Primary completion date** 2027-04-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06227377) **Start date** 2024-02-05 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06227377) ## Size and sites **Participants** 250 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06227377) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06227377) **Planned participants** 250 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06227377) **Protocol amendments** 0 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06227377) **Number of sites** 14 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06227377) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06227377) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06227377) **Lead sponsor** Quanta Therapeutics Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06227377) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06227377) ## Identifiers **Registry ID** NCT06227377 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06227377) **ClinicalTrials.gov ID** NCT06227377 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06227377) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06227377) ## Study design **Allocation** Not randomised **Model** Single group **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06227377) ## Outcomes ### Primary outcomes 1. 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 2. Number of participants with Treatment-emergent Adverse Events (TEAEs) Timeframe: up to 2 years Defined 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 ### Secondary outcomes 1. QTX3034 pharmacokinetic parameters in plasma Timeframe: up to 2 years Plasma concentration data for QTX3034 will be used to evaluate PK parameters such as maximum concentration (Cmax), minimum concentration (Cmin), time to attain Cmax (Tmax), area under the concentration-time curve (AUC), elimination half-life (t1⁄2). 2. 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. 3. 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/NCT06227377) ## 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 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 Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06227377) ## Sites - UCLA Hematology/OncologyLos Angeles, United StatesRecruiting - Sarah Cannon Research Institute (SCRI)Denver, United StatesRecruiting - Yale Cancer CenterNew Haven, United StatesRecruiting - Florida Cancer SpecialistsSarasota, United StatesRecruiting - Moffitt Cancer CenterTampa, United StatesRecruiting - NYU Langone HealthNew York, United StatesRecruiting - Montefiore Medical CenterThe Bronx, United StatesRecruiting - Duke UniversityDurham, United StatesRecruiting - Stephenson Cancer CenterOklahoma City, United StatesRecruiting - SCRI- NashvilleNashville, United StatesRecruiting - MD AndersonHouston, United StatesRecruiting - START San Antonio, LLCSan Antonio, United StatesRecruiting - University of Utah, Huntsman Cancer CenterSalt Lake City, United StatesRecruiting - NEXT Oncology VirginiaFairfax, United StatesRecruiting Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06227377) ## 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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