NCT06959615 A Phase I/IIa Study of JAB-23E73 in Patients With Advanced Solid Tumors Harboring KRAS Gene Alteration
| NCT ID | NCT06959615 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Jacobio Pharmaceuticals Co., Ltd. |
| Condition | Advanced Solid Tumor |
| Study Type | INTERVENTIONAL |
| Enrollment | 334 participants |
| Start Date | 2024-11-22 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 334 participants in total. It began in 2024-11-22 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06959615 clinical trial?
This trial is open to participants of all sexes, studying Advanced Solid Tumor. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06959615 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06959615 currently recruiting?
Yes, NCT06959615 is actively recruiting participants. Contact the research team at clinicaltrials@jacobiopharma.com for enrollment information.
Where is the NCT06959615 trial being conducted?
This trial is being conducted at Hefei, China, Beijing, China, Beijing, China, Beijing, China and 11 additional locations.
Who is sponsoring the NCT06959615 clinical trial?
NCT06959615 is sponsored by Jacobio Pharmaceuticals Co., Ltd.. The trial plans to enroll 334 participants.