RecruitingPhase 1/2

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

China334 participantsStarted 2024-11-22

Plain-language 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.

Who can participate

SexALL

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Inclusion criteria

✓. Histological or cytologically proven diagnosis of a locally advanced, unresectable, and/or metastatic solid tumor cancer with evidence of KRAS gene alteration (including gene mutation and wild type amplification).
✓. Able to provide an archived tumor tissue sample or fresh biopsy sample.
✓. Life expectancy ≥3 months at the start of treatment.
✓. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
✓. ≥1 measurable lesion per RECIST v1.1.
✓. Adequate organ function.

Exclusion criteria

✕. Unable to swallow oral medications or with gastrointestinal dysfunction or gastrointestinal disease that significantly alters the absorption of medication.
✕. Previous treatment with rat sarcoma (RAS) targeting agents.
✕. Symptomatic, untreated, or actively progressing known central nervous system (CNS) metastases.
✕. Impaired cardiovascular function or clinically significant cardiac disease.
✕. Mean QT interval corrected using Fridericia's formula (QTcF) \>470 msec.
✕. Females who are pregnant or breastfeeding.

What they're measuring

Phase 1: Number of participants with dose limiting toxicities (DLT)

Timeframe: Up to 21 days

Phase 2a: Objective response rate (ORR)

Timeframe: Up to approximately 2 years

Trial details

NCT IDNCT06959615

SponsorJacobio Pharmaceuticals Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-12-31

Contact for this trial

Jacobio Pharmaceuticals

86 10 56315466 clinicaltrials@jacobiopharma.com

View on ClinicalTrials.gov More Advanced Solid Tumor trials