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

Plain-language summary

This study investigates the drug JAB-23E73 in people with advanced solid tumors that carry a KRAS gene alteration. It enrolls patients aged 18 and older with locally advanced, unresectable, and/or metastatic cancer showing a KRAS gene alteration. It is in Phase 1/Phase 2 and is currently recruiting.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

PHASE1/PHASE2

Status

Recruiting

Sponsor

Jacobio Pharmaceuticals Co., Ltd.

Intervention

JAB-23E73, JAB-23E73

Start date

11/22/2024

Estimated completion

8/31/2027

Countries

China

Related genes

Locations

• Hefei, China
• Beijing, China
• Beijing, China
• Beijing, China
• Beijing, China
• Beijing, China
• Fuzhou, China
• Guangzhou, China
• Nanning, China
• Langfang, China
• Haerbin, China
• Zhengzhou, China
• Zhengzhou, China
• Wuhan, China
• Wuhan, China
• Changsha, China
• Nanjing, China
• Nanjing, China
• Nanjing, China
• Suzhou, China
• Nanchang, China
• Shenyang, China
• Shanghai, China
• Shanghai, China
• Shanghai, China
• Taiyuan, China
• Xi’an, China
• Chengdu, China
• Tianjin, China
• Hangzhou, China
• Hangzhou, China
• Hangzhou, China

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

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.