NCT05358249

Platform Study of JDQ443 in Combinations in Patients With Advanced Solid Tumors Harboring the KRAS G12C Mutation

KontRASt-03: A Phase Ib/II, Multicenter, Open-label Platform Study of JDQ443 With Select Combinations in Patients With Advanced Solid Tumors Harboring the KRAS G12C Mutation

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 74 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

This is Phase Ib/II, multicenter, open-label adaptive platform study of JDQ443 with select therapies in patients with advanced solid tumors harboring the KRAS G12C mutation.

Detailed description

JDQ443 will be considered "backbone" treatment in this trial and combined with selected therapies, or "partner(s)". The combination of a backbone and a partner will constitute a treatment arm. After dose escalation, treatment arms that reach a maximum tolerated dose /recommended dose and are determined to be safe may, but are not required to, proceed to Phase II to further explore safety, tolerability, and anti-tumor activity.

Conditions

• KRAS G12C Mutant Solid Tumors
• Carcinoma, Non-Small Cell Lung
• Carcinoma, Non-Small-Cell Lung
• Non-Small Cell Lung Cancer
• Non-Small Cell Lung Carcinoma
• Nonsmall Cell Lung Cancer
• Colorectal Cancer
• Colorectal Carcinoma
• Colorectal Neoplasms
• Colorectal Tumors
• Neoplasms, Colorectal

Interventions

Type	Name	Description
DRUG	JDQ443	KRAS G12C inhibitor, oral
DRUG	trametinib	MEK inhibitor, oral
DRUG	Ribociclib	CDK4/6 inhibitor, oral
BIOLOGICAL	cetuximab	EGFR inhibitor, intravenous

Timeline

• Start date: 2022-10-24
• Primary completion: 2026-07-29
• Completion: 2026-07-30
• First posted: 2022-05-03
• Last updated: 2026-04-14

Locations

13 sites across 8 countries: United States, Belgium, France, Germany, Italy, Singapore, South Korea, Spain

Regulatory

• FDA-regulated drug study