JAB-23E73 treatment for adults with advanced solid tumors that have KRAS changes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an open-label Phase 1/2a trial that gives JAB-23E73 as a single agent to adults with advanced or metastatic solid tumors harboring KRAS alterations. The study begins with a Phase 1a dose-escalation to define the maximum tolerated dose or preliminary recommended Phase 2 dose, then proceeds to Phase 1b dose-expansion and Phase 2a indication expansion across cohorts for colorectal cancer, pancreatic ductal adenocarcinoma, and other solid tumors. Key outcomes include safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anticancer activity assessed by RECIST v1.1. Participants must be adults with measurable disease, ECOG 0–1, provide tumor tissue, and have not previously received KRAS-targeting or pan-KRAS inhibitors.

Why it matters

Who can join: the full rules

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.

Where it's running

• Mayo Clinic
  Rochester, Minnesota, United States Recruiting
• Washington University
  St Louis, Missouri, United States Recruiting
• Cleveland Clinic Foundation
  Cleveland, Ohio, United States Recruiting
• Huntsman Cancer Institute
  Salt Lake City, Utah, United States Recruiting

Study contacts

• Study coordinator: Jacobio Pharmaceuticals
• Email: clinicaltrials@jacobiopharma.com
• Phone: (781) 918-6670

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.