RightFit
RecruitingPhase 1 / Phase 2

JAB-23E73 in Adult Participants With Advanced Solid Tumors With KRAS Alteration

A Phase 1/2a, Multicenter, Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Anti-tumor Activity of JAB-23E73 Monotherapy and in Combination With Other Agents in Adult Patients With Advanced Solid Tumors With KRAS Alteration

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests the safety of JAB-23E73, a drug that blocks KRAS, alone and with other drugs. It is for adults with advanced solid tumors that have a change in the KRAS gene.

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

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be age 18 or older and sign a form agreeing to join the study.
  • For Part A: Have a solid tumor confirmed by testing that has grown nearby or spread, cannot be treated with the goal of a cure, and has already been treated with medicines that work throughout the body.
  • For Part B1: Have confirmed colon or rectal cancer that has grown nearby or spread and cannot be removed by surgery. The cancer must have worsened during, or you could not tolerate, at least one standard treatment using fluorouracil-type drugs, oxaliplatin, irinotecan, or FDA-approved immune or targeted drugs.
  • Have a tumor with a change in the KRAS gene.
  • Provide a stored tumor sample.
  • Be expected to live at least 3 months.
  • Be fully active or able to do light work, with limits on hard physical activity.
  • Have at least one tumor that can be measured using the study's rules.

Who can't join

  • Cannot swallow pills, or have stomach or bowel problems that may greatly affect how your body takes in the study drug.
  • Have used KRAS G12C, KRAS G12D, pan-RAS, pan-KRAS, multi-KRAS inhibitors, or similar drugs that block these proteins.
  • For Part B1: Have used cetuximab or other EGFR antibodies, drugs that block the EGFR protein.
  • Have a known serious allergy to JAB-23E73 or any of its ingredients.
  • Have a tumor that started in the brain or spinal cord.
  • Have uncontrolled fluid buildup around the lungs, around the heart, or in the belly that needs repeated draining or medical treatment.
  • Have a QT interval over 470 milliseconds, meaning a longer time for the heart to reset between beats.
  • Have a heart pumping measurement of 50% or less on a heart ultrasound or MUGA heart scan.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 sites (4)

MN

MO

OH

UT