JYP0015 for adults with advanced RAS‑mutant solid tumors
Official title: 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
Run by Guangzhou JOYO Pharma Co., Ltd · NCT06895031 · Data updated 2026-11-12
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 | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 210 (estimated) |
| Sponsor | Guangzhou JOYO Pharma Co., Ltd Industry-sponsored |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Status | Recruiting |
| Started | March 31, 2025 |
| Main results expected | March 30, 2026 |
| Study ends | December 31, 2026 |
| Registry record updated | March 6, 2026 |
| Trial ID | NCT06895031 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
Show full inclusion / exclusion 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 it's running
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Beijing Cancer Hospital
Beijing, Beijing Municipality, China Recruiting
Study contacts
- Study coordinator: Ling Shen, M.D.
- Email: linshenpku@163.com
- Phone: 01088121122
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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BPI-572270 in RAS-mutant advanced solid tumors (including NSCLC, CRC, PDAC)
This study tests whether BPI-572270 is safe and tolerable in adults with RAS-mutant advanced solid tumors and looks for signs of clinical activity.
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RMC-5127 for advanced cancers with KRAS G12V mutation
This trial will test whether the experimental drug RMC-5127, alone or with daraxonrasib or cetuximab, helps adults with advanced KRAS G12V-mutant solid tumors.
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BMS-986523 alone and with other cancer medicines for advanced KRAS-altered solid tumors
This treatment tests whether BMS-986523, alone or combined with chemotherapy or immunotherapy, helps people with advanced KRAS-altered lung, colorectal, or pancreatic cancers.
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TH9619 for advanced solid tumors (Phase 1/2)
This trial will try different doses of TH9619 in adults with advanced solid tumors (including colorectal, head and neck, non-small cell lung, and gastroesophageal cancers) to find a recommended dose and check safety.
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Evaluating RMC-9805 for KRAS G12D-Mutant Solid Tumors
This study is testing a new drug called RMC-9805 to see if it can safely help adults with solid tumors that have a specific KRAS G12D mutation.
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Testing KO-2806 for advanced solid tumors
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.