JAB-21822 in Combination With Cetuximab in Patients With Advanced CRC and Other Solid Tumors With KRAS G12C Mutation

Jacobio Pharmaceuticals

Status and phase: Active, not recruiting; Phase 2; Phase 1

Conditions: Appendiceal Cancer; Small Intestinal Cancer; Advanced Colorectal Cancer

Treatments: Drug: Cetuximab; Drug: JAB-21822

Study type: Interventional

Funder types: Industry

Identifiers

NCT05194995

JAB-21822-1007

Details and patient eligibility

About

This study is to evaluate the safety, tolerability, pharmacokinetics and antitumor activity of JAB-21822 in combination with cetuximab in patients with advanced colorectal cancer，advanced small intestine cancer and advanced appendiceal cancer with KRAS p.G12C mutation.

Full description

The primary objective of this study is to evaluate the safety and tolerability of JAB-21822 in combination with cetuximab to determine the MTD and RP2D during Dose Escalation phase; then to evaluate preliminary antitumor activity when JAB-21822 is administered in combination with cetuximab during Dose Expansion phase in patients with advanced colorectal cancer，advanced small intestine cancer and advanced appendiceal cancer with KRAS p.G12C mutation.

Enrollment: 48 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participants must be able to provide an archived tumor sample
• Histologically or cytologically confirmed advanced colorectal cancer, advanced small intestinal cancer and advanced appendiceal cancer with KRAS p.G12C mutation
• Must have received at least 1 prior standard therapy
• Must have at least 1 measurable lesion per RECIST v1.1
• Must have adequate organ function
• Must be able to swallow and retain orally administered medication

Exclusion criteria

• Has brain metastases, except if treated and no evidence of radiographic progression or hemorrhage for at least 28 days
• Active infection requiring systemic treatment within 14 days
• Active HIV, HBV or HCV
• Any severe and/or uncontrolled medical conditions
• LVEF<50% assessed by ECHO
• QT interval >470 msec

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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48 participants in 3 patient groups

Phase 1b Dose Escalation

Experimental group

Description:

Dose escalation of JAB-21822 to determine maximum tolerated dose of JAB-21822 in combination with cetuximab.

Treatment:

Drug: JAB-21822

Drug: Cetuximab

Phase 2 Dose Expansion, Cohort 1

Experimental group

Description:

Enrollment into the dose expansion cohort is for eligible participants with KRAS P.G12C mutant advanced colorectal cancer.

Treatment:

Drug: JAB-21822

Drug: Cetuximab

Phase 2 Dose Expansion, Cohort 2

Experimental group

Description:

Enrollment into the dose expansion cohort is for eligible participants with KRAS P.G12C mutant advanced small intestinal cancer and advanced appendiceal cancer.

Treatment:

Drug: JAB-21822

Drug: Cetuximab