JYP0015 for adults with advanced RAS‑mutant solid tumors

A Multi-center, Open-label, Phase I/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of JYP0015 in Advanced Solid Tumors With RAS Mutation

This trial tests whether the oral drug JYP0015 is safe and can shrink tumors in adults whose advanced solid cancers have specific RAS mutations.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 210 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Guangzhou JOYO Pharma Co., Ltd (industry)
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT06895031 on ClinicalTrials.gov

What this trial studies

This open-label, Phase 1/2 multicenter trial gives JYP0015 orally as a single agent to adults with advanced solid tumors that carry specific RAS mutations. Phase 1 uses a dose-escalation design to define safety, tolerability, pharmacokinetics, and a recommended dose. Phase 2 expands at that recommended dose into four cohorts (pancreatic ductal adenocarcinoma, non-small cell lung cancer, colorectal cancer, and other solid tumors) to measure antitumor activity and further safety. The trial enrolls patients who have progressed on or are intolerant of standard treatments and who meet performance and organ-function requirements.

Who should consider this trial

Good fit: Adults with histologically confirmed advanced solid tumors harboring specified RAS mutations who have progressed after or are intolerant of standard therapy, with ECOG 0–1 and adequate organ function, are the intended participants.

Not a fit: Patients without RAS mutations, those with uncontrolled CNS metastases, significant GI disorders that prevent oral drug absorption, poor performance status, or advanced cardiac dysfunction are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, JYP0015 could provide an effective targeted oral option that shrinks RAS‑mutant tumors and offers benefit for patients with limited treatments.

How similar studies have performed: Directly targeting RAS is a relatively new approach—KRAS G12C inhibitors have shown clinical benefit in certain cancers, but pan‑RAS inhibitors like JYP0015 remain early-stage with limited published clinical proof so far.

Eligibility criteria

Inclusion Criteria:

1. Histologically or pathologically confirmed solid tumors with RAS mutation via molecular tests.
2. Patients with RAS mutation who have disease progression or intolerance after adequate standard treatment
3. Eastern Cooperative Oncology Group (ECOG) performance status in 0 or 1
4. Adequate organ function

Exclusion Criteria:

1. Presence of central nervous system (CNS) metastases; however, subjects with previously treated brain metastases may be enrolled if clinically stable.
2. Gastrointestinal (GI) disorders that may interfere with drug administration/absorption, including but not limited to: Dysphagia or inability to swallow tablets， Malabsorption syndrome，Refractory nausea, vomiting, or diarrhea，Chronic GI diseases (e.g., Crohn's disease, ulcerative colitis)
3. Congestive heart failure with New York Heart Association (NYHA) functional class ≥II or left ventricular ejection fraction (LVEF) \<50%.
4. Any other condition deemed by the investigator to potentially compromise study outcomes or lead to premature termination, including but not limited to: Alcohol or substance abuse，Concurrent severe medical conditions (e.g., psychiatric disorders requiring active treatment)， Familial or social circumstances that may affect patient safety, compliance, or study data collection.

Where this trial is running

Beijing, Beijing Municipality

• Beijing Cancer Hospital — Beijing, Beijing Municipality, China (RECRUITING)

Study contacts

• Study coordinator: Ling Shen, M.D.

Conditions: Solid Tumor, Pancreatic Ductal Adenocarcinoma, Non-small Cell Lung Cancer, Colorectal Cancer, PDAC, NSCLC, CRC