RecruitingPhase 1Phase 2NCT06959615

A Phase I/IIa Study of JAB-23E73 in Patients With Advanced Solid Tumors Harboring KRAS Gene Alteration

A Multicenter, Open Phase I/IIa Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of JAB-23E73 in Patients With Advanced Solid Tumors Harboring KRAS Gene Alteration

Sponsor

Jacobio Pharmaceuticals Co., Ltd.

Enrollment

334 participants

Start Date

Nov 22, 2024

Study Type

INTERVENTIONAL

Conditions

Advanced Solid Tumor

Summary

This is a multicenter, open-label, phase I/IIa to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary antitumor activity of pan-KRAS inhibitor JAB-23E73 in patients with advanced solid tumors harboring KRAS mutations or amplification. The study consists of 2 phases: Phase 1 Dose Escalation and Phase IIa Dose Expansion.

Eligibility

Plain Language Summary

Simplified for easier understanding

This is a phase 1/2 study testing a new experimental drug called JAB-23E73 in people with advanced solid tumors that have a KRAS gene alteration. KRAS is one of the most common cancer-driving mutations and has historically been very difficult to target with drugs. This trial aims to find the right dose and assess early signs of effectiveness. **You may be eligible if...** - You have been diagnosed with an advanced, unresectable, or metastatic solid tumor with a KRAS gene mutation or amplification - You are 18 or older and in reasonably good overall health (ECOG 0–1) - You have received prior standard treatments that have stopped working - You are able to provide a tumor tissue sample - Your organ function is adequate **You may NOT be eligible if...** - You have already been treated with other drugs targeting the RAS pathway - You cannot swallow oral medications or have conditions that severely affect drug absorption - You have active, untreated brain metastases - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGJAB-23E73

Administered orally

DRUGJAB-23E73

Administered orally

Locations(32)

Anhui Provincial Cancer Hospital

Hefei, Anhui, China

National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College