QTX3046 in Patients With KRAS G12D Mutations

Advanced Solid Tumor Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06428500
• Other study ID #: QTX3046-101
• Status: Recruiting
• Phase: Phase 1
• Start date: May 30, 2024
• Est. completion date: July 1, 2027

Study information

• Verified date: June 2024
• Source: Quanta Therapeutics
• Contact: Quanta Therapeutics Clinical Trials
• Phone: 415-599-3892
• Email: clinicaltrials[@]quantatx.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: July 1, 2027
• Est. primary completion date: July 1, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Advanced Solid Tumor

Intervention

Drug:
• QTX3046
QTX3046 will be administered at protocol defined dose.

Combination Product:
• Cetuximab
Cetuximab will be administered at protocol defined dose.

Locations

Country	Name	City	State
United States	South Texas Accelerated Research Therapeutics, LLC Midwest	Grand Rapids	Michigan
United States	South Texas Accelerated Research Therapeutics, LLC San Antonio	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Quanta Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	up to 2 years
Primary	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.	up to 21 days
Secondary	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	up to 2 years
Secondary	Peak plasma concentration of QTX3046 (Cmax)	Plasma concentration data for QTX3046 will be used to evaluate peak plasma concentration (Cmax) of QTX3046	up to 2 years
Secondary	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.	up to 2 years
Secondary	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.	up to 2 years