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 1 (dose escalation) - Evaluates the safety, tolerability, and pharmacokinetic profile of JYP0015 monotherapy, preliminarily assesses efficacy, and determines the recommended dose (RD) for further evaluation. * Phase 2 (indication expansion) - Explores the therapeutic potential of JYP0015 monotherapy at the RD across four predefined cohorts: 1. Pancreatic ductal adenocarcinoma (PDAC) 2. Non-small cell lung cancer (NSCLC) 3. Colorectal cancer (CRC) 4. Other advanced solid tumors Phase 2 will assess both efficacy and safety within these 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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
210
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.
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
RECRUITINGNumber 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
Xiao
CONTACT
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