Recruiting
Phase 1
Phase 2

JAB-23E73

Sponsor:

Jacobio Pharmaceuticals Co., Ltd.

Code:

NCT06973564

Conditions

Advanced Solid Tumors

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

JAB-23E73

Cetuximab

Study Details

Brief summary:

This study is to evaluate the safety and tolerability of pan-KRAS inhibitor JAB-23E73 Monotherapy and in Combination with Other Agents in adult participants with advanced solid tumors

Conditions

Advanced Solid Tumors

Study ID

NCT06973564

Start date

May 29, 2025

Status verified date

Oct, 2026

Completion date

Feb, 2029

Anticipated

Primary completion date

Nov, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Written informed consent.
  • Participant must be ≥18 years of age at the time of signing the Informed Consent Form (ICF).
  • Histologically or cytologically confirmed locally advanced or metastatic solid tumors that are not suitable for curative interventions and who have received relevant prior systemic therapy.(Part A)
  • Histologically/cytologically confirmed unresectable locally advanced or metastatic CRC who progressed on or were intolerant to ≥1 standard systemic regimen with fluorouracil derivatives, oxaliplatin, irinotecan, FDA-approved immunotherapy or targeted therapies.(Part B1 only)
  • Patients must have KRAS alterations.
  • Participants are required to provide an archived tumor sample.
  • Patients with a life expectancy ≥3 months.
  • ECOG performance status score of 0 or 1.
  • Patients must have at least one measurable lesion as defined by RECIST v1.1.

Exclusion Criteria:

  • Inability to swallow oral medications, or presence of gastrointestinal dysfunction or gastrointestinal disorders that may significantly alter the absorption of the study drug.
  • Patients who have previously been treated with KRAS G12C inhibitors, KRAS G12D inhibitors, pan-RAS/pan-KRAS/multi-KRAS inhibitors, or similar agents.
  • Participants who have previously been treated with cetuximab or other EGFR antibodies (Part B1 only).
  • Known serious allergy to JAB-23E73 or excipient.
  • Patients with primary central nervous system tumors.
  • Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures or medical intervention.
  • QT interval>470 msec.
  • LVEF ≤50% assessed by ECHO or MUGA.

Study Design

Enrollment

344 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Part A

JAB-23E73 monotherapy.

experimental: Part B1

JAB-23E73 combined with cetuximab

Interventions

JAB-23E73

Oral administration

Cetuximab

Intravenous infusion

Primary outcome measure

  • Part A: Number and proportion of patients who experience at least 1 dose-limiting toxicity (DLT) with treatment of JAB-23E73 monotherapy. [ Time Frame: Up to 1 year ]
  • Part A: Safety and tolerability of JAB-23E73 monotherapy [ Time Frame: Up to 2 years ]
  • Part A: Objective response rate (ORR) of JAB-23E73 monotherapy. [ Time Frame: Up to 3 years ]
  • Part B1: Safety, tolerability and RP2D of JAB-23E73 in combination with cetuximab. [ Time Frame: Up to 2 years ]
  • Part B1: Objective response rate (ORR) of JAB-23E73 in combination with cetuximab. [ Time Frame: Up to 3 years ]

Central Contacts and Locations

Central contacts

Jacobio Pharmaceuticals

(781) 918-6670clinicaltrials@jacobiopharma.com

Locations

Mayo Clinic

Recruiting

Rochester, Minnesota, United States, 55905

Washington University

Recruiting

St Louis, Missouri, United States, 63110

Cleveland Clinic Foundation

Recruiting

Cleveland, Ohio, United States, 44195

Huntsman Cancer Institute

Recruiting

Salt Lake City, Utah, United States, 84112

More Information

Sponsor

Jacobio Pharmaceuticals Co., Ltd.

Last update posted

Oct 16, 2026

Last verified

Oct, 2026

Keywords

  • KRAS
  • KRAS mutation
  • KRAS G12C, KRAS G12D, KRAS G12V, KRAS G12S, KRAS G12A, KRAS G12D
  • Pan-KRAS
  • Targeted Therapy
  • NSCLC
  • Pancreas cancer
  • Colorectal cancer
  • KRAS-mutant tumor
  • JAB-23E73
  • Cetuximab

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-24. This information was provided to ClinicalTrials.gov by Jacobio Pharmaceuticals Co., Ltd. on 2026-10-16. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.