Dose escalation of JAB-21822 to determine maximum tolerated dose

JAB-21822

Jacobio Pharmaceuticals

To assess safety, tolerability, PK, preliminary efficacy and determine recommended phase 2 dose (RP2D) of JAB-21822 administered in adult participants with KRAS p.G12C-mutant advanced solid tumors.

This is a phase 1/2a, first-in-human, open-label study of JAB-21822, this study has two parts: dose escalation phase and dose expansion phase.

FIH Study of JAB-21822 in Adult Patients With Advanced Solid Tumors Harboring KRAS G12C Mutation in China

Multi-center, Open, Dose-escalation, and Expanded Phase I/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of JAB-21822 in Advanced Solid Tumors With KRAS p.G12c Mutations

Number of participants with dose limiting toxicities

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

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

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

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

DCR is defined as percentage of participants with complete response (CR), partial response (PR), or stable disease(SD) per CTCAE v1.1

PFS is defined as the interval of time between the date of first treatment to the earliest date of disease progression per CTCAE v1.1 or death which occurs first

Jacobio Pharmaceuticals Co., Ltd.

Antineoplastic Agents

All Drugs and Chemicals

Cetuximab

Antineoplastic Agents, Immunological

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

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

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

JAB-21822 (KRAS G12C inhibitor)

Cetuximab (EGFR inhibitor)

Huiqiang Wang, PhD

Ramina Mikailova

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.

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.

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

A Phase 1/2, Multi-Center, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Evidence of Antitumor Activity of JAB-21822 Monotherapy and Combination Therapy in Adult Patients With Advanced Solid Tumors Harboring KRAS G12C Mutation

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

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.

Cmax of JAB-21822 alone or JAB-21822 plus cetuximabn will be measured by using plasma PK samples

AUC of JAB-21822 alone or JAB-21822 plus cetuximab will be measured by using plasma PK samples

The percentage of participants with complete response (CR) or partial response (PR) on RECIST v 1.1.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
FIH Study of JAB-21822 in Adult Patients With Advanced Solid Tumors Harboring KRAS G12C Mutation in China	NCT05009329	NSCLC CRC Solid Tumor	JAB-21822 JAB-21822	18 Years -	Jacobio Pharmaceuticals Co., Ltd.
JAB-21822 Activity in Adult Patients With Advanced Solid Tumors Harboring KRAS G12C Mutation	NCT05002270	Advanced Solid ... NSCLC CRC	JAB-21822 (KRAS... JAB-21822 (KRAS... JAB-21822 (KRAS... Cetuximab (EGFR...	18 Years -	Jacobio Pharmaceuticals Co., Ltd.
JAB-21822 Activity in Adult Patients With Advanced Solid Tumors Harboring KRAS G12C Mutation	NCT05002270	Advanced Solid ... NSCLC CRC	JAB-21822 (KRAS... JAB-21822 (KRAS... JAB-21822 (KRAS... Cetuximab (EGFR...	18 Years -	Jacobio Pharmaceuticals Co., Ltd.
FIH Study of JAB-21822 in Adult Patients With Advanced Solid Tumors Harboring KRAS G12C Mutation in China	NCT05009329	NSCLC CRC Solid Tumor	JAB-21822 JAB-21822	18 Years -	Jacobio Pharmaceuticals Co., Ltd.

Spots Global Cancer Trial Database for kras g12c mutant advanced solid tumor; nsclc; crc