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

JRCT ID: jRCT2031200379

Registered date:01/03/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: KRAS G12C Mutant Solid Tumors, Carcinoma;Non-Small-Cell Lung, Carcinoma;Colorectal
• Date of first enrollment: 01/03/2021
• Target sample size: 16
• Countries of recruitment: US,Japan
• Study type: Interventional

Intervention(s)

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

Outcome(s)

Primary Outcome

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 ]

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include 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

Exclude criteria

- Tumors harboring driver mutations that have approved therapies or tumors with known activating KRAS, NRAS, HRAS, BRAF or PTPN11 (SHP2) mutations, with exception of KRAS G12C mutations
- Active brain metastases
- Clinically significant cardiac disease or risk factors at screening

Related Information

• Primary Sponsor: Yonemura Masataka
• Secondary ID(s): NCT04699188