A Phase 2 interventional study of JYP0015 in Solid Tumor, Pancreatic Ductal Adenocarcinoma (PDAC) and Non-small Cell Lung Cancer (NSCLC), sponsored by Guangzhou JOYO Pharma Co., Ltd. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-03-06.
Sponsored by Guangzhou JOYO Pharma Co., Ltd · Phase 2, Interventional, and Treatment
Evaluate the safety and antitumor activity of JYP0015 in adults with specific RAS mutant advanced solid tumors.
This is a Phase 1/2, multicenter, open-label study designed to evaluate the safety, tolerability, pharmacokinetics (PK), and clinical activity of JYP0015 in adult patients with advanced solid tumors harboring specific RAS mutations.
The study consists of two parts:
Phase 2 (indication expansion) - Explores the therapeutic potential of JYP0015 monotherapy at the RD across four predefined cohorts:
JYP0015 is a potent, orally bioavailable pan-RAS inhibitor that selectively targets the active (ON) form of wild-type and mutant RAS across all three isoforms-HRAS, NRAS, and KRAS.
Exclusion Criteria:
This arm includes participants with histologically or pathologically confirmed advanced solid tumors harboring RAS mutations, identified via molecular testing. RAS mutations are defined as nonsynonymous mutations in KRAS, NRAS, or HRAS at codons 12, 13, 61, 117, or 146 (e.g., G12, G13, Q61, K117, or A146). Participants will receive JYP0015 as an oral tablet.
Drug: JYP0015
JYP0015 is an orally bioavailable pan-RAS inhibitor designed to target the active (ON) form of wild-type and mutant RAS across KRAS, NRAS, and HRAS isoforms. The drug will be administered orally, with dosing determined by the study protocol in the dose-escalation and indication-expansion phases.
Number of Participants with Dose-Limiting Toxicity (DLT)
The number of participants experiencing dose-limiting toxicities (DLT) during the dose-escalation period of the study.
Time frame: 21 days
Incidence and Severity of Treatment-Emergent Adverse Events (AEs) and Serious AEs
The incidence and severity of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs), including abnormalities in laboratory values and vital signs.
Time frame: Up to 3 years
Overall Response Rate (ORR)
Overall response rate assessed per RECIST v1.1 criteria.
Time frame: Up to 3 years
Maximum Observed Blood Concentration (Cmax) of JYP0015
Maximum plasma concentration (Cmax) of JYP0015 following administration.
Time frame: Up to 16 weeks
Time to Reach Maximum Blood Concentration (Tmax) of JYP0015
Time to reach maximum plasma concentration (Tmax) of JYP0015 following administration.
Time frame: Up to 16 weeks
Duration of Response (DOR)
Duration of response as assessed by RECIST v1.1.
Time frame: Up to 3 years
Time to Response (TTR)
Time to response as assessed by RECIST v1.1.
Time frame: Up to 3 years
Plan to share: No
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Carcinoma, Non-Small-Cell Lung→
Guangzhou JOYO Pharma Co., Ltd