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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
Recruiting
Phases
Phase 1Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-506716-41-00
Acronym
CJDQ443E12101
Enrollment
200
Registered
2023-12-18
Start date
2023-05-08
Completion date
Unknown
Last updated
2026-01-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adult patients with advanced (metastatic or unresectable) KRAS G12C mutant solid tumors

Brief summary

Dose escalation: Incidence and severity of dose limiting toxicities (DLTs) of each combination treatment., Dose escalation: Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) by treatment, Dose escalation: Frequency of dose interruptions and reductions, by treatment, Dose Escalation: Dose intensity by treatment, Phase II: Overall Response Rate by Blinded Independent Review Committee (BIRC) per RECIST 1.1

Detailed description

Dose escalation and Phase II: ORR by local review per RECIST 1.1, Dose escalation and Phase II: Disease Control Rate (DCR) by local review per RECIST 1.1, Dose escalation and Phase II: Duration of Response (DoR) by local review per RECIST 1.1, Dose escalation and Phase II: Progression-Free Survival (PFS) by local review per RECIST 1.1, Phase II: DCR by BIRC per RECIST 1.1, Phase II: DoR by BIRC per RECIST 1.1, Phase II: PFS by BIRC per RECIST 1.1, Phase II: Overall survival (OS)

Interventions

DRUGTMT212
DRUGMekinist 0.5 mg film-coated tablets
DRUGMekinist 2 mg film-coated tablets
DRUGLEE011
DRUGCETUXIMAB
DRUGJDQ443

Sponsors

Novartis Pharma AG
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Dose escalation: Incidence and severity of dose limiting toxicities (DLTs) of each combination treatment., Dose escalation: Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) by treatment, Dose escalation: Frequency of dose interruptions and reductions, by treatment, Dose Escalation: Dose intensity by treatment, Phase II: Overall Response Rate by Blinded Independent Review Committee (BIRC) per RECIST 1.1—

Secondary

MeasureTime frame
Dose escalation and Phase II: ORR by local review per RECIST 1.1, Dose escalation and Phase II: Disease Control Rate (DCR) by local review per RECIST 1.1, Dose escalation and Phase II: Duration of Response (DoR) by local review per RECIST 1.1, Dose escalation and Phase II: Progression-Free Survival (PFS) by local review per RECIST 1.1, Phase II: DCR by BIRC per RECIST 1.1, Phase II: DoR by BIRC per RECIST 1.1, Phase II: PFS by BIRC per RECIST 1.1, Phase II: Overall survival (OS)—

Countries

Belgium, France, Germany, Italy, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026