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

Summary

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

Interventions

• JAB-23E73 · DRUG

  Oral administration

• JAB-23E73 · DRUG

  Oral administration

• JAB-23E73 · DRUG

  Oral administration

Published eligibility criteria

Verbatim from the registry. Only the site can decide how these apply to a specific patient.

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.

Sites (4)

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