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

JAB-23E73

JAB-23E73

Study Details

Brief summary:

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

Conditions

Advanced Solid Tumors

Study ID

NCT06973564

Start date

May 29, 2025

Status verified date

Nov, 2025

Completion date

Feb, 2028

Anticipated

Primary completion date

Nov, 2027

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.
  • 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, or pan/multi-KRAS inhibitors.
  • 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

294 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Dose Escalation (Phase 1a)

Evaluate overall Safety, tolerability, and determine MTD of JAB-23E73 monotherapy.

experimental: Dose Expansion / Optimization Phase (Phase 1b)

Determine RP2D of JAB-23E73 in patients with KRAS-alternated NSCLC or other selected tumors

experimental: Indication Expansion (Phase 2a)

Evaluate the preliminary antitumor activity of JAB-23E73 monotherapy at the RP2D in patients with advanced or metastatic CRC, PDAC, and other solid tumors.

Interventions

JAB-23E73

Oral administration

JAB-23E73

Oral administration

JAB-23E73

Oral administration

Primary outcome measure

  • Dose Escalation (Phase 1a): Determine the Maximum tolerated dose (MTD) of JAB-23E73 monotherapy. [ Time Frame: Up to 1 year ]
  • Dose Escalation (Phase 1a): Evaluate the overall safety and tolerability of JAB-23E73. [ Time Frame: Up to 2 years ]
  • Dose Expansion/Optimization (Phase 1b): Determine the Recommended Phase 2 Dose (RP2D) of JAB-23E73 in patients with KRAS- alternated NSCLC or other selected tumors. [ Time Frame: Up to 2 years ]
  • Indication Expansion (Phase 2a): Evaluate the preliminary antitumor activity of JAB-23E73 monotherapy at the RP2D in patients with advanced or metastatic CRC, PDAC, and other solid tumors. [ Time Frame: Up to 3 years ]
  • Dose Expansion/Optimization (Phase 1b): Determine the RP2D of JAB-23E73 in patients with KRAS- alternated NSCLC or other selected tumors. [ Time Frame: Up to 2 years ]
  • Indication Expansion (Phase 2a): Evaluate the preliminary antitumor activity of JAB-23E73 monotherapy at the RP2D in patients with advanced or metastatic CRC, PDAC, and other solid tumors. [ 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

Jan 16, 2026

Last verified

Nov, 2025

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Jacobio Pharmaceuticals Co., Ltd. on 2026-01-16.