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Testing JAB-23E73 in patients with advanced solid tumors and KRAS mutations

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

PHASE1; PHASE2 · Jacobio Pharmaceuticals Co., Ltd. · NCT06959615

This study is testing a new drug called JAB-23E73 to see if it can help people with advanced solid tumors that have KRAS mutations.

Quick facts

PhasePHASE1; PHASE2
Study typeInterventional
Enrollment334 (estimated)
SexAll
SponsorJacobio Pharmaceuticals Co., Ltd. (industry)
Locations32 sites (Hefei, Anhui and 31 other locations)
Trial IDNCT06959615 on ClinicalTrials.gov

What this trial studies

This multicenter, open-label phase I/IIa study evaluates the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of JAB-23E73 in patients with advanced solid tumors that have KRAS gene alterations. The study is divided into two phases: a dose escalation phase to determine the maximum tolerated dose and a dose expansion phase to further assess the drug's efficacy. Participants will receive JAB-23E73 and will be monitored for treatment response and side effects.

Who should consider this trial

Good fit: Ideal candidates include patients with unresectable or metastatic solid tumors that have confirmed KRAS gene alterations.

Not a fit: Patients with symptomatic or untreated central nervous system metastases or those who have previously received RAS-targeting agents may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced solid tumors harboring KRAS mutations.

How similar studies have performed: Other studies targeting KRAS mutations have shown promise, indicating that this approach may be viable.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. 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).
2. Able to provide an archived tumor tissue sample or fresh biopsy sample.
3. Life expectancy ≥3 months at the start of treatment.
4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
5. ≥1 measurable lesion per RECIST v1.1.
6. Adequate organ function.

Exclusion Criteria:

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

Where this trial is running

Hefei, Anhui and 31 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Advanced Solid Tumor, KRAS, KRAS mutation, KRAS G12C, KRAS G12D, KRAS G12V, KRAS G12S, KRAS G12A, KRAS G12D, Pan-KRAS, NSCLC, Pancreas cancer, Colorectal cancer

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.