Advanced Solid TumorsPhase 1NCT06158477
A Clinical Trial Evaluating JYP0035 Capsule Monotherapy in Patients With Advanced Solid Tumors
A Phase 1 study testing JYP0035 Experimental Drug Treatment in people with Advanced Solid Tumors, run by Chengdu JOYO pharma Co., Ltd. at 1 site in China.
Trial summary
The goal of this Phase I clinical trial is to evaluate the safety, tolerability, and pharmacokinetic characteristics of the JYP0035 capsule in patients with advanced solid tumors. Read more about this study
- Who is it for?
- Ages 18 to 74 years
- Conditions the study is for
- Advanced Solid Tumors
- What is being tested?
- JYP0035 Experimental Drug Treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2024to 1 Dec 2027
- Phase
- Phase 1
- 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 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients voluntarily participate in the clinical trial and sign the informed consent form
- Age 18 years and above (inclusive), and below 75 years of age (inclusive), with no gender restrictions
- ECOG(Eastern Cooperative Oncology Group)performance status of 0 or 1
- Expected survival time of ≥3 months
- During the screening period, female patients of childbearing potential must have a negative serum pregnancy test within 7 days prior to administration of the study drug
- Participants agree to use reliable contraception methods from signing the informed consent form until 6 months after the last dose of the study drug. This includes, but is not limited to: abstinence, vasectomy in males, female sterilization, effective intrauterine devices, and effective contraceptive medications
Who cannot join
- Participants have not recovered to normal or ≤ Grade 1 from any adverse events and/or complications caused by any previous treatments before the first administration of the study drug, excluding hair loss and pigmentation
- Patients with imaging (CT or MRI) showing tumor invasion into major blood vessels (such as the aorta, pulmonary arteries and veins, vena cava, etc.)
- Patients who have had clinically significant cardiovascular or cerebrovascular diseases within 6 months before the first administration, which, in the investigator's judgment, may interfere with the patient's full participation in the study; atrial fibrillation; clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention
- Patients who had history of type 1 diabetes, type 2 diabetes, or gestational diabetes
- Individuals with other malignancies or with a history of other malignant tumors
- Individuals with a history of severe allergies, or who are allergic to any active or inactive ingredients of the study drug
- Pregnant or breastfeeding patients
- Researchers consider participants unsuitable for this clinical study due to any clinical or laboratory abnormalities or other reasons
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 311215
Zhang jian, M.D., +86 021-34778299, Syner2000@163.com
About this study
Official title: An Open-label Multicenter, Phase I Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetic Characteristics of JYP0035 Capsule Monotherapy in Patients With Advanced Solid Tumors
The goal of this Phase I clinical trial is to evaluate the safety, tolerability, and pharmacokinetic characteristics of the JYP0035 capsule in patients with advanced solid tumors. The main questions it aims to answer are:
- What is the safety profile of JYP0035 when administered to these patients?
- How does JYP0035 capsule behave in the body pharmacokinetically?
Participants will:
- Receive escalating doses of JYP0035 capsule during the dose-escalation phase (PART-1).
- Continue with the identified dose in the dose-expansion phase (PART-2).
As this is a single-arm study, there is no comparison group.
- Conditions
- Advanced Solid Tumors
- Being tested
- JYP0035 Experimental Drug Treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JYP0035 Experimental Drug TreatmentDrug
Single dose intervention
| Study group | Role | What they receive |
|---|---|---|
| JYP0035 monotherapy dose-escalation group | Experimental | PART-1 Single Dose Escalation Group Receives: Drug: JYP0035 Experimental Drug Treatment |
| JYP0035 monotherapy dose-expansion group | Experimental | PART-2 JYP0035 Monotherapy Dose Expansion Group Receives: Drug: JYP0035 Experimental Drug Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the adverse event rate of this clinical trial
Grading the adverse events using National Cancer Institute - Common Terminology Criteria for Adverse Events(NCI-CTCAE)version 5.0.
Measured: From 8 weeks after the first administration up to week 52
Secondary outcomes (1)
Assess Area Under the Curve(AUC)
Area under the plasma concentration-time curve from zero to infinity
Measured: From 8 weeks after the first administration up to week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2023
- Study start1 Jan 2024
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorsStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chengdu JOYO pharma Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Guangzhou JOYO Pharma Co., Ltd
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06158477
- Sponsor's protocol ID
- JYP0035M101
- Status last verified
- Nov 2024
- First submitted
- 28 Nov 2023
- Last updated
- 18 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 18 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Multicenter, Phase I Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetic Characteristics of JYP0035 Capsule Monotherapy in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT06158477
- Acronym / sponsor ID
- JYP0035M101
- Conditions
- Advanced Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Chengdu JOYO pharma Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Guangzhou JOYO Pharma Co., Ltd
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 6 Dec 2023 (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.
The goal of this Phase I clinical trial is to evaluate the safety, tolerability, and pharmacokinetic characteristics of the JYP0035 capsule in patients with advanced solid tumors. The main questions it aims to answer are:
- What is the safety profile of JYP0035 when administered to these patients?
- How does JYP0035 capsule behave in the body pharmacokinetically?
Participants will:
- Receive escalating doses of JYP0035 capsule during the dose-escalation phase (PART-1).
- Continue with the identified dose in the dose-expansion phase (PART-2).
As this is a single-arm study, there is no comparison group.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| JYP0035 monotherapy dose-escalation group | Experimental | Drug: JYP0035 Experimental Drug TreatmentPART-1 Single Dose Escalation Group |
| JYP0035 monotherapy dose-expansion group | Experimental | Drug: JYP0035 Experimental Drug TreatmentPART-2 JYP0035 Monotherapy Dose Expansion Group |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients voluntarily participate in the clinical trial and sign the informed consent form
- Age 18 years and above (inclusive), and below 75 years of age (inclusive), with no gender restrictions
- ECOG(Eastern Cooperative Oncology Group)performance status of 0 or 1
- Expected survival time of ≥3 months
- During the screening period, female patients of childbearing potential must have a negative serum pregnancy test within 7 days prior to administration of the study drug
Key exclusion criteria (8 listed)
- Participants have not recovered to normal or ≤ Grade 1 from any adverse events and/or complications caused by any previous treatments before the first administration of the study drug, excluding hair loss and pigmentation
- Patients with imaging (CT or MRI) showing tumor invasion into major blood vessels (such as the aorta, pulmonary arteries and veins, vena cava, etc.)
- Patients who have had clinically significant cardiovascular or cerebrovascular diseases within 6 months before the first administration, which, in the investigator's judgment, may interfere with the patient's full participation in the study; atrial fibrillation; clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention
- Patients who had history of type 1 diabetes, type 2 diabetes, or gestational diabetes
- Individuals with other malignancies or with a history of other malignant tumors
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 |
|---|---|---|
| JYP0035 Experimental Drug TreatmentSingle dose intervention | Drug | JYP0035 monotherapy dose-escalation group, JYP0035 monotherapy dose-expansion group |
Primary outcome
Assess the adverse event rate of this clinical trial
Time frame: From 8 weeks after the first administration up to week 52
Grading the adverse events using National Cancer Institute - Common Terminology Criteria for Adverse Events(NCI-CTCAE)version 5.0.
1 secondary outcome
Assess Area Under the Curve(AUC)
Time frame: From 8 weeks after the first administration up to week 52
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 18 Nov 2024.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing JYP0035 Experimental Drug Treatment in people with Advanced Solid Tumors, run by Chengdu 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 6 inclusion and 8 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 18 Nov 2024. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 Zhang Jian, MD (021-34778299 ext. 086, Syner2000@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess the adverse event rate of this clinical trial (time frame: From 8 weeks after the first administration up to week 52). 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 18 Nov 2024.