QTX3046 in Patients With KRAS G12D Mutations

Phase 1Active Not RecruitingNCT06428500

Quanta Therapeutics240 enrolled

Overview

Phase 1 study to determine the safety and tolerability of QTX3046 as a single agent or in combination with cetuximab.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

240

Conditions

Advanced Solid Tumor

Interventions

QTX3046DRUG

QTX3046 will be administered at protocol defined dose.

CetuximabCOMBINATION_PRODUCT

Cetuximab will be administered at protocol defined dose.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (5)

South Texas Accelerated Research Therapeutics, LLC Midwest

Grand Rapids, Michigan, United States

Duke Cancer Center

Durham, North Carolina, United States

The University of Texas MD Anderson Cancer Center

Houston, Texas, United States

South Texas Accelerated Research Therapeutics, LLC San Antonio

San Antonio, Texas, United States

Outcomes

Primary Outcomes

Number of participants with Treatment-emergent Adverse Events (TEAEs)

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.

Time frame: up to 2 years

Number of participants with Dose Limiting Toxicities (DLTs)

DLTs will be defined as the occurrence of any of the toxicities as described in the protocol.

Time frame: up to 21 days

Secondary Outcomes

Area under the plasma concentration-time curve (AUC) of QTX3046

Plasma concentration data for QTX3046 will be used to evaluate the area under the plasma concentration-time curve (AUC) of QTX3046

Time frame: up to 2 years

Peak plasma concentration of QTX3046 (Cmax)

Plasma concentration data for QTX3046 will be used to evaluate peak plasma concentration (Cmax) of QTX3046

Time frame: up to 2 years

Objective response rate (ORR)

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.

Time frame: up to 2 years

Duration of response (DoR)

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.

Time frame: up to 2 years

Data from ClinicalTrials.gov

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