Clinical trial · Interventional
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
NCT05358249CI-TRIAL-00114787KontRASt-03active not recruitingPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (10)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinoma, Non-Small Cell Lung | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Colorectal Carcinoma | Colorectal Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Colorectal Neoplasms | Colorectal Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Colorectal Tumors | Colorectal Neoplasm | ALIAS | 0.90 |
| KRAS G12C Mutant Solid Tumors | — | UNRESOLVED | — |
| Neoplasms, Colorectal | Colorectal Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Nonsmall Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
| Non-Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cetuximab | Biological | Cetuximab | ALIAS |
| JDQ443 | Drug | — | UNRESOLVED |
| Ribociclib | Drug | Ribociclib | ALIAS |
| trametinib | Drug | Trametinib | ALIAS |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- JDQ443+trametinib
- description
- JDQ443 in combination with trametinib
- interventionNames
- Drug: JDQ443
- Drug: trametinib
- type
- EXPERIMENTAL
- label
- JDQ443+ribociclib
- description
- JDQ443 in combination with ribociclib
- interventionNames
- Drug: JDQ443
- Drug: Ribociclib
- type
- EXPERIMENTAL
- label
- JDQ443+cetuximab
- description
- JDQ443 in combination with cetuximab
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
Inclusion Criteria: Dose Escalation: \- Patients with advanced (metastatic or unresectable) KRAS G12C mutant solid tumors who have received standard of care therapy or are ineligible to receive such therapy. Phase II: * Patients with advanced (metastatic or unresectable) KRAS G12C mutant non-small cell lung cancer who have received platinum-based chemotherapy regimen and immune checkpoint inhibitor therapy, unless patient was ineligible to receive such therapy * Patients with advanced (metastatic or unresectable) KRAS G12C mutant colorectal cancer who have received fluropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, unless patient was ineligible to such therapy. All patients: * ECOG performance status of 0 or 1. * Patients must have a site of disease amenable to biopsy and be a candidate for tumor biopsy according to the treating institution's guidelines. Exclusion Criteria: * Tumors harboring driver mutations that have approved targeted therapies, with the exception of KRAS G12C mutations * Prior treatment with a KRAS G12C inhibitor is excluded for patients in a subset of groups in Phase II. * Active brain metastases, including symptomatic brain metastases or known leptomeningeal disease * Clinically significant cardiac disease or risk factors at screening * Insufficient bone marrow, hepatic or renal function at screening Other protocol-defined inclusion/exclusion criteria may apply
References
Publications (0)
Data not yet available
No reference posted for this study.