QTX3034 in Patients With KRAS G12D Mutation

Solid Tumors Clinical Trial

Official title:

A Phase 1 Trial Evaluating the Safety, Tolerability, PK, and Efficacy of QTX3034 in Patients With Solid Tumors With KRASG12D Mutation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06227377
• Other study ID #: QTX3034-001
• Status: Recruiting
• Phase: Phase 1
• Start date: February 5, 2024
• Est. completion date: April 1, 2027

Study information

• Verified date: May 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 QTX3034 as a single agent or in combination with cetuximab.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: April 1, 2027
• Est. primary completion date: April 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 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

Related Conditions & MeSH terms

• Solid Tumors

Intervention

Drug:
• QTX3034
QTX3034 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	Duke University	Durham	North Carolina
United States	NEXT Oncology Virginia	Fairfax	Virginia
United States	MD Anderson	Houston	Texas
United States	University of Utah, Huntsman Cancer Center	Salt Lake City	Utah
United States	South Texas Accelerated Research Therapeutics	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 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
Primary	Number of participants with Treatment-emergent Adverse Events (TEAEs)	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	up to 2 years
Secondary	QTX3034 pharmacokinetic parameters in plasma	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).	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