QTX3034 in Patients With KRAS G12D Mutation

NCT ID: NCT06227377

Last Updated: 2025-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-05

Study Completion Date

2027-04-01

Brief Summary

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

Detailed Description

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Conditions

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Solid Tumors

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Part 1a: QTX3034 monotherapy dose-escalation

QTX3034 will be administered at protocol defined dose based on cohort assignment

Group Type EXPERIMENTAL

QTX3034

Intervention Type DRUG

QTX3034 will be administered at protocol defined dose

Part 1b: QTX3034 combination with cetuximab dose-escalation

QTX3034 will be administered at protocol defined dose in combination with cetuximab based on cohort assignment

Group Type EXPERIMENTAL

QTX3034

Intervention Type DRUG

QTX3034 will be administered at protocol defined dose

Cetuximab

Intervention Type COMBINATION_PRODUCT

Cetuximab will be administered at protocol defined dose.

Part 2: QTX3034 monotherapy dose-expansion

QTX3034 will be administered at protocol defined dose in combination with cetuximab based on cohort assignment

Group Type EXPERIMENTAL

QTX3034

Intervention Type DRUG

QTX3034 will be administered at protocol defined dose

Part 3: QTX3034 combination with cetuximab dose-expansion

QTX3034 will be administered at protocol defined dose in combination with cetuximab based on cohort assignment

Group Type EXPERIMENTAL

QTX3034

Intervention Type DRUG

QTX3034 will be administered at protocol defined dose

Cetuximab

Intervention Type COMBINATION_PRODUCT

Cetuximab will be administered at protocol defined dose.

Interventions

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QTX3034

QTX3034 will be administered at protocol defined dose

Intervention Type DRUG

Cetuximab

Cetuximab will be administered at protocol defined dose.

Intervention Type COMBINATION_PRODUCT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Quanta Therapeutics

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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UCLA Hematology/Oncology

Los Angeles, California, United States

Site Status RECRUITING

Sarah Cannon Research Institute (SCRI)

Denver, Colorado, United States

Site Status RECRUITING

Yale Cancer Center

New Haven, Connecticut, United States

Site Status RECRUITING

Florida Cancer Specialists

Sarasota, Florida, United States

Site Status RECRUITING

Moffitt Cancer Center

Tampa, Florida, United States

Site Status RECRUITING

NYU Langone Health

New York, New York, United States

Site Status RECRUITING

Montefiore Medical Center

The Bronx, New York, United States

Site Status RECRUITING

Duke University

Durham, North Carolina, United States

Site Status RECRUITING

Stephenson Cancer Center

Oklahoma City, Oklahoma, United States

Site Status RECRUITING

SCRI- Nashville

Nashville, Tennessee, United States

Site Status RECRUITING

MD Anderson

Houston, Texas, United States

Site Status RECRUITING

START San Antonio, LLC

San Antonio, Texas, United States

Site Status RECRUITING

University of Utah, Huntsman Cancer Center

Salt Lake City, Utah, United States

Site Status RECRUITING

NEXT Oncology Virginia

Fairfax, Virginia, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Quanta Therapeutics Clinical Trials

Role: CONTACT

Phone: 415-599-3892

Email: [email protected]

Facility Contacts

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Jenna Davis

Role: primary

Front Desk

Role: primary

Ingrid Palma

Role: primary

Carly Taylor

Role: primary

Kaela D. Malone-Larry

Role: primary

Jovica Gasic

Role: backup

DL_Phase1Screening

Role: primary

Gunnar Lauer

Role: primary

Sabina Wlazlo

Role: primary

Michelle Johnson

Role: primary

Lana Seibert

Role: backup

askSarah

Role: primary

Ly Nguyen

Role: primary

Isabel Jimenez, RN, MSN

Role: primary

Susan Sharry

Role: primary

Blake Patterson

Role: primary

Other Identifiers

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QTX3034-001

Identifier Type: -

Identifier Source: org_study_id