JAB-21822 Activity in Adult Patients With Advanced Solid Tumors Harboring KRAS G12C Mutation

Jacobio Pharmaceuticals

Status and phase: Completed; Phase 2; Phase 1

Conditions: Advanced Solid Tumor; CRC; NSCLC

Treatments: Drug: Cetuximab (EGFR inhibitor); Drug: JAB-21822 (KRAS G12C inhibitor)

Study type: Interventional

Funder types: Industry

Identifiers

NCT05002270

JAB-21822-1001

Details and patient eligibility

About

This study is to evaluate the safety and tolerability of JAB-21822 monotherapy and combination therapy in adult participants with advanced solid tumors harboring KRAS G12C mutation.

Full description

The primary objective of this study is to evaluate the safety and tolerability of JAB-21822 monotherapy to determine the MTD and PR2D during Dose Escalation phase; then to evaluate preliminary antitumor activity when JAB-21822 administered alone and combination with cetuximab during Dose Expansion phase in adult participants with advanced solid tumors harboring KRAS G12C mutation.

Enrollment: 29 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 solid tumors with KRAS 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 or spinal metastases, except if treated and no evidence of radiographic progression or hemorrhage for at least 28 days
• Active infection requiring systemic treatment within 7 days
• Active HBV or HCV
• Any severe and/or uncontrolled medical conditions
• LVEF ≤50% assessed by ECHO or QTcF
• QT interval >470 msec
• Experiencing unresolved CTCAE 5.0 Grade >1 toxicities

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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29 participants in 3 patient groups

Arm A0, JAB-21822 monotherapy, Phase 1, Dose Escalation

Experimental group

Description:

Dose escalation of JAB-21822 will be administered alone to determine the MTD and RP2D

Treatment:

Drug: JAB-21822 (KRAS G12C inhibitor)

Drug: JAB-21822 (KRAS G12C inhibitor)

Drug: JAB-21822 (KRAS G12C inhibitor)

Arm A1, JAB-21822 monotherapy, Phare 2, Dose Expansion

Experimental group

Description:

JAB-21822 will be administered alone at RP2D in selected cancer type patients to evaluate the preliminary antitumor activity.

Treatment:

Drug: JAB-21822 (KRAS G12C inhibitor)

Drug: JAB-21822 (KRAS G12C inhibitor)

Drug: JAB-21822 (KRAS G12C inhibitor)

Experimental: Arm B, JAB-21822 combination with Cetuximab, Phase 2, Dose Expansion

Experimental group

Description:

JAB-21822 will be administered together with Cetuximab in mCRC patients to evaluate the preliminary antitumor activity.

Treatment:

Drug: JAB-21822 (KRAS G12C inhibitor)

Drug: JAB-21822 (KRAS G12C inhibitor)

Drug: Cetuximab (EGFR inhibitor)

Drug: JAB-21822 (KRAS G12C inhibitor)