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Recruiting NCT06973564

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

Conditions: Advanced Solid Tumors

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE1, PHASE2
Enrollment: 344
Sponsor: Jacobio Pharmaceuticals Co., Ltd.

Location: Mayo Clinic Rochester Minnesota

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

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.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT06973564). StuddyBuddy aggregates publicly available trial information.