Solid TumorPhase 2STARNCT06895031
Study of JYP0015 in Patients With Advanced Solid Tumors Harboring Specific Mutations in RAS
A Phase 2 study testing JYP0015 in people with Solid Tumor and Pancreatic Ductal Adenocarcinoma (PDAC), run by Guangzhou JOYO Pharma Co., Ltd at 1 site in China.
Trial summary
Evaluate the safety and antitumor activity of JYP0015 in adults with specific RAS mutant advanced solid tumors. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Solid Tumor, Pancreatic Ductal Adenocarcinoma (PDAC), Non-small Cell Lung Cancer (NSCLC)
- What is being tested?
- JYP0015
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 1 siteChina
- Study dates
- 31 Mar 2025to 31 Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or pathologically confirmed solid tumors with RAS mutation via molecular tests.
- Patients with RAS mutation who have disease progression or intolerance after adequate standard treatment
- Eastern Cooperative Oncology Group (ECOG) performance status in 0 or 1
- Adequate organ function
Who cannot join
- Presence of central nervous system (CNS) metastases; however, subjects with previously treated brain metastases may be enrolled if clinically stable.
- 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)
- Congestive heart failure with New York Heart Association (NYHA) functional class ≥II or left ventricular ejection fraction (LVEF) <50%.
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Xiao contact
China1 site, 1 recruiting
- Recruiting
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142
Shen Lin, M.D., 010-88196861 ext. +86, linshenpku@163.com
About this study
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
Evaluate the safety and antitumor activity of JYP0015 in adults with specific RAS mutant advanced solid tumors.
Read the detailed description
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:
- Pancreatic ductal adenocarcinoma (PDAC)
- Non-small cell lung cancer (NSCLC)
- Colorectal cancer (CRC)
- 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.
- Conditions
- Solid Tumor, Pancreatic Ductal Adenocarcinoma (PDAC), Non-small Cell Lung Cancer (NSCLC), Colorectal Cancer (CRC)
- Being tested
- JYP0015
- Keywords
- PDAC, NSCLC, CRC
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JYP0015Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| JYP0015 in RAS-Mutant Solid Tumors | Experimental | 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. Receives: Drug: JYP0015 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Up to 3 years
Overall Response Rate (ORR)
Overall response rate assessed per RECIST v1.1 criteria.
Measured: Up to 3 years
Secondary outcomes (4)
Maximum Observed Blood Concentration (Cmax) of JYP0015
Maximum plasma concentration (Cmax) of JYP0015 following administration.
Measured: Up to 16 weeks
Time to Reach Maximum Blood Concentration (Tmax) of JYP0015
Time to reach maximum plasma concentration (Tmax) of JYP0015 following administration.
Measured: Up to 16 weeks
Duration of Response (DOR)
Duration of response as assessed by RECIST v1.1.
Measured: Up to 3 years
Time to Response (TTR)
Time to response as assessed by RECIST v1.1.
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2025
- Study start31 Mar 2025
- Primary completion30 Mar 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- None (Open Label)
- Masking
- None (open label)
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangzhou JOYO Pharma Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06895031
- Sponsor's protocol ID
- JYP0015M101
- Acronym
- STAR
- Status last verified
- Mar 2026
- First submitted
- 19 Mar 2025
- Last updated
- 6 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06895031
- Acronym / sponsor ID
- STAR / JYP0015M101
- Conditions
- Solid Tumor, Pancreatic Ductal Adenocarcinoma (PDAC), Non-small Cell Lung Cancer (NSCLC), Colorectal Cancer (CRC)
- Keywords
- PDAC, NSCLC, CRC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- Guangzhou JOYO Pharma Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 31 Mar 2025 (actual)
- Primary completion
- 30 Mar 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 26 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluate the safety and antitumor activity of JYP0015 in adults with specific RAS mutant advanced solid tumors.
Detailed description
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:
- Pancreatic ductal adenocarcinoma (PDAC)
- Non-small cell lung cancer (NSCLC)
- Colorectal cancer (CRC)
- 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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- None (Open Label)
| Arm | Type | Receives |
|---|---|---|
| JYP0015 in RAS-Mutant Solid Tumors | Experimental | Drug: JYP0015This 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Histologically or pathologically confirmed solid tumors with RAS mutation via molecular tests.
- Patients with RAS mutation who have disease progression or intolerance after adequate standard treatment
- Eastern Cooperative Oncology Group (ECOG) performance status in 0 or 1
- Adequate organ function
Key exclusion criteria (4 listed)
- Presence of central nervous system (CNS) metastases; however, subjects with previously treated brain metastases may be enrolled if clinically stable.
- 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)
- Congestive heart failure with New York Heart Association (NYHA) functional class ≥II or left ventricular ejection fraction (LVEF) <50%.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| JYP0015JYP0015 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. | Drug | JYP0015 in RAS-Mutant Solid Tumors |
Primary outcome
Number of Participants with Dose-Limiting Toxicity (DLT)
Time frame: 21 days
The number of participants experiencing dose-limiting toxicities (DLT) during the dose-escalation period of the study.
Incidence and Severity of Treatment-Emergent Adverse Events (AEs) and Serious AEs
Time frame: Up to 3 years
The incidence and severity of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs), including abnormalities in laboratory values and vital signs.
Overall Response Rate (ORR)
Time frame: Up to 3 years
Overall response rate assessed per RECIST v1.1 criteria.
4 secondary outcomes
Maximum Observed Blood Concentration (Cmax) of JYP0015
Time frame: Up to 16 weeks
Time to Reach Maximum Blood Concentration (Tmax) of JYP0015
Time frame: Up to 16 weeks
Duration of Response (DOR)
Time frame: Up to 3 years
Time to Response (TTR)
Time frame: Up to 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Xiao contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing JYP0015 in people with Solid Tumor and Pancreatic Ductal Adenocarcinoma (PDAC), run by Guangzhou JOYO Pharma Co., Ltd at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ling Shen, M.D. (01088121122 ext. +86, linshenpku@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Dose-Limiting Toxicity (DLT) (time frame: 21 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2026.