JDQ443
Sponsors
University Hospital Maastricht, Novartis Pharma AG, Novartis Pharmaceuticals, Canadian Cancer Trials Group, Maastricht University Medical Center
Conditions
Adult patients with advanced (metastatic or unresectable) KRAS G12C
mutant solid tumorsAdvance solid tumors harboring the KRAS G12C mutationAdvanced non-small cell lung cancer harboring the KRAS G12C mutationBrain Metastases, AdultCancer of LungCancer of the LungCarcinoma, ColorectalCarcinoma, Non-Small Cell Lung
Phase 1
Study of JDQ443 in Patients With Advanced Solid Tumors Harboring the KRAS G12C Mutation
Active, not recruitingNCT04699188
Start: 2021-02-24End: 2027-01-25Updated: 2026-03-18
A Phase 1 Study to Evaluate the Pharmacokinetics of JDQ443 in Participants With Hepatic Impairment Compared to Matched Healthy Control Participants.
CompletedNCT05329623
Start: 2022-05-03End: 2024-04-07Updated: 2025-10-10
Platform Study of JDQ443 in Combinations in Patients With Advanced Solid Tumors Harboring the KRAS G12C Mutation
Active, not recruitingNCT05358249
Start: 2022-10-24End: 2026-11-30Updated: 2026-02-17
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
RecruitingCTIS2023-506716-41-00
Start: 2023-05-08Target: 200Updated: 2026-01-19
A phase Ib/II open-label, multi-center dose escalation study of JDQ443 in patients with advanced solid tumors harboring the KRAS G12C mutation
Active, not recruitingCTIS2023-508073-87-00
Start: 2024-11-14Target: 359Updated: 2026-01-16
Phase 2
Study of Efficacy and Safety of JDQ443 Single-agent as First-line Treatment for Patients With Locally Advanced or Metastatic KRAS G12C- Mutated Non-small Cell Lung Cancer With a PD-L1 Expression < 1% or a PD-L1 Expression ≥ 1% and an STK11 Co-mutation.
Active, not recruitingNCT05445843
Start: 2022-12-06End: 2026-12-31Updated: 2026-02-13
Neoadjuvant Platform Trial in Non-Small Cell Lung Cancer
Active, not recruitingNCT05714891
Start: 2023-09-15End: 2028-03-31Updated: 2026-02-12
JDQ443 for KRAS G12C NSCLC Brain Metastases
WithdrawnNCT05999357
Start: 2024-04-15End: 2028-08-31Updated: 2024-05-29
STRIDER: A phase II Study evaluaTing intRacranial effIcacy of JDQ443 in patiEnts with KRAS G12C+ NSCLC and bRain metastases
CompletedCTIS2023-505721-13-00
End: 2024-06-10Target: 42Updated: 2023-11-20
KontRASt-06: An open-label phase II trial evaluating the activity and safety of JDQ443 single-agent as first-line treatment for patients with locally advanced or metastatic KRAS G12C-mutated non-small cell lung cancer with a PD-L1 expression < 1% or a PD-L1 expression ≥ 1% and an STK11 co-mutation.
SuspendedCTIS2024-511708-18-00
Start: 2022-12-06Target: 57Updated: 2025-08-13
Phase 3
Study of JDQ443 in Comparison With Docetaxel in Participants With Locally Advanced or Metastatic KRAS G12C Mutant Non-small Cell Lung Cancer
Active, not recruitingNCT05132075
Start: 2022-06-15End: 2026-03-30Updated: 2025-11-10
KontRASt-02: A randomized, controlled, open label, phase III study evaluating the efficacy and safety of JDQ443 versus docetaxel in previously treated subjects with locally advanced or metastatic KRAS G12C mutant non-small cell lung cancer.
SuspendedCTIS2023-510082-10-00
Start: 2022-09-05Target: 68Updated: 2025-10-07