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

NCT05002270 | Completed Phase 1 FDA Drug

• 1 other identifier: JAB-21822-1001
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

CRC; Advanced Solid Tumor; NSCLC

Keywords

KRAS G12C Mutant Advanced Solid Tumor; NSCLC; CRC

Outcome Measures

Primary Outcomes (4)

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

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

• 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

  Up to 4 years

• 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

  Up to 4 years - from baseline to RECIST confirmed Progressive Disease

• 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.

  Up to 4 years

Secondary Outcomes (6)

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

  Up to 4 years

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

  Up to 4 years

• Dose Escalation phase: Overall response rate (ORR)

  Up to 4 years - from baseline to RECIST confirmed Progressive Disease

• Dose Escalation phase: Duration of response ( DOR )

  Up to 4 years

• Dose Escalation and Dose Expansion phase: Disease Control Rate ( DCR )

  Up to 4 years

Study Arms (3)

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

EXPERIMENTAL

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

Drug: JAB-21822 (KRAS G12C inhibitor)

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

EXPERIMENTAL

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

Drug: JAB-21822 (KRAS G12C inhibitor)

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

EXPERIMENTAL

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

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

Interventions

JAB-21822 (KRAS G12C inhibitor) DRUG

Administered orally

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

Cetuximab (EGFR inhibitor) DRUG

Administered IV

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jacobio Pharmaceuticals Co., Ltd.: lead

Study Sites (4)

Mayo Clinc

Phoenix, Arizona, 85054, United States

Location

Mayo Clinc

Scottsdale, Arizona, 85259, United States

Location

Mayo Clinc

Jacksonville, Florida, 32224, United States

Location

University of Utah

Salt Lake City, Utah, 84112, United States

Location

Related Publications (1)

• Li J, Deng T, Gu Y, Calles Blanco A, Li Z, Bai C, Wu L, Huang J, Li X, Yao Y, Song Z, Li Y, Liu L, Xing L, Wu W, Martinez-Perez J, Hubert A, Zugazagoitia J, Zhang J, Wang Y, Zhao Y, Wen G, Xia G, Zhong D, Chen X, Jiang K, Wang-Gillam A, Ding Y, Liu S, Rao Z, Liu X, Shen L. Efficacy and safety of glecirasib in solid tumors with KRAS G12C mutation: A pooled analysis of two phase I/II trials. Cancer Commun (Lond). 2025 Nov;45(11):1500-1512. doi: 10.1002/cac2.70056. Epub 2025 Oct 2.

  PMID: 41037823 DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Cetuximab

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2021
• First Posted: August 12, 2021
• Study Start: September 3, 2021
• Primary Completion: February 12, 2025
• Study Completion: February 12, 2025
• Last Updated: January 13, 2026

Record last verified: 2026-01

Locations

US (4)