Study of JDQ443 in patients with advanced solid tumors harboring the KRAS G12C mutation

A phase Ib/II open-label, multi-center dose escalation study of JDQ443 in patients with advanced solid tumors harboring the KRAS G12C mutation - CJDQ443A12101

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2031200379

Enrollment

Registered

2021-03-01

Start date

2021-03-01

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

KRAS G12C Mutant Solid Tumors, Carcinoma

Interventions

ArmA : JDQ443 ArmB : JDQ443 in combination with TNO155 ArmC : JDQ443 in combination with tislelizumab ArmD : JDQ443 in combination with TNO155 and tislelizumab

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Adult patients with advanced (metastatic or unresectable) KRAS G12C mutant solid tumors - Prior treatment with a KRAS G12C inhibitor may be allowed for dose escalations of combinations

Exclusion criteria

Exclusion criteria: - Tumors harboring driver mutations that have approved targeted therapies, with the exception of KRAS G12C mutations. - Active brain metastases - Clinically significant cardiac disease or risk factors at screening

Design outcomes

Primary

Measure	Time frame
Dose Escalation: Incidence and severity of dose limiting toxicities (DLTs) during the first cycle of monotherapy or combination treatment [ Time Frame: 18 months ] Dose Escalation: Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) [ Time Frame: 24 months ] Dose Escalation: Frequency of dose interruptions and reductions, by treatment [ Time Frame: 24 months ] Dose Escalation: Dose intensity by treatment [ Time Frame: 24 months ] Dose Expansion: Overall response rate (ORR) per RECIST v1.1, by treatment [ Time Frame: 24 months ]	—

Measure

Time frame

Dose Escalation: Incidence and severity of dose limiting toxicities (DLTs) during the first cycle of monotherapy or combination treatment [ Time Frame: 18 months ] Dose Escalation: Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) [ Time Frame: 24 months ] Dose Escalation: Frequency of dose interruptions and reductions, by treatment [ Time Frame: 24 months ] Dose Escalation: Dose intensity by treatment [ Time Frame: 24 months ] Dose Expansion: Overall response rate (ORR) per RECIST v1.1, by treatment [ Time Frame: 24 months ]

—

Countries

Japan, US

Contacts

Public ContactMasataka Yonemura

Novartis Pharma. K.K.

rinshoshiken.toroku2@novartis.com+81-120-003-293

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026