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

Phase 2Active Not RecruitingNCT05194995

Allist Pharmaceuticals, Inc.48 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Advanced Colorectal Cancer Small Intestinal Cancer Appendiceal Cancer

Interventions

JAB-21822DRUG

JAB-21822 administered orally as a tablet.

CetuximabDRUG

Cetuximab administered as an intravenous (IV) infusion.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (17)

Research site31

Beijing, Beijing Municipality, China

Research site01

Beijing, Beijing Municipality, China

Research site02

Beijing, Beijing Municipality, China

Outcomes

Primary Outcomes

Dose Escalation phase: Number of participants with dose-limiting toxicities (DLTs)

A DLT is defined as the clinically significant treatment related adverse event (TRAE) or abnormal laboratory values assessment during the first 21 days of (Cycle 1) and excludes events that are deemed clearly related to underlying disease, progression, or intercurrent illness.

Time frame: At the end of Cycle 1 (each cycle is 21 days)

Dose Expansion phase: Overall response rate (ORR)

ORR is defined as the percentage of participants with complete response (CR) or partial response (PR) per RECIST v 1.1.

Time frame: Up to 4 years - from baseline to RECIST confirmed Progressive Disease

Secondary Outcomes

Dose Escalation and Dose Expansion phase: Number of participants with adverse events

Patients will be assessed for incidence and severity of adverse events (AEs) according to NCI-CTCAE criteria.

Time frame: Up to 4 years

Dose Escalation and Dose Expansion phase: Peak Plasma Concentration (Cmax)

Cmax of JAB-21822 will be measured by using plasma PK samples.

Time frame: Up to 4 years

Dose Escalation and Dose Expansion phase: Area under the plasma concentration versus time curve (AUC)

AUC of JAB-21822 will be measured by using plasma PK samples.

Time frame: Up to 4 years

Dose Expansion phase: Duration of response ( DOR )

DOR is defined as the time from the participant's initial objective response (CR or PR) to disease progression per CTCAE v1.1 or death due to any cause, whichever occurs first.

Time frame: Up to 4 years

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.