Advanced Solid TumorsEarly Phase 1NCT06976931
Study on the Safe Dosage and Therapeutic Effect of the Drug YY2201 Tablets on Patients With Advanced Cancer
A Early Phase 1 study testing YY2201 in people with Advanced Solid Tumors, run by Jiangsu YaYao Biotechnology Co., Ltd..
Trial summary
The goal of this clinical trial is to assess the safety and tolerability of YY2201 in participants with advanced solid tumors. The main questions it aims to answer are: What medical problems do participants have when taking drug YY2201? What is the maximum tolerated dose (MTD) in patients with advanced solid tumors?… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumors
- What is being tested?
- YY2201
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- No sites listed yet
- Study dates
- 26 May 2025to 11 Oct 2027
- Phase
- Early 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1.Voluntary to participate in the clinical study, sign a written ICF, and able to comply with clinical visits and study-related procedures.
- 2.Male or female with age ≥18 when signing the ICF. 3.Has a histologically or cytologically confirmed advanced solid tumors who are refractory to or intolerant of available standard-of-care therapy or have no effective standard treatment available.
- 4.ECOG performance score of 0 or1. 5.Expected survival of at least 3 months. 6.Adequate organ function (without any supportive treatment including blood components, growth factors, etc. within 7 days prior to the laboratory test): Bone marrow: neutrophil count (ANC) ≥ 1.5×109/L, platelet count (PLT) ≥ 90×109/L, and hemoglobin (HGB) > 9.0 g/dL.
- Coagulation function: international normalized ratio (INR) and activated partial prothrombin time (APTT) prolonged to ≤1.5×ULN.
- Liver function: total bilirubin (TBIL) ≤ 1.5×ULN or ≤ 3 × ULN in case of known Gilbert disease, alanine aminotransferase (ALT), aspartate aminotransferase (AST) ≤ 2.5×ULN, if there is liver metastasis, ALT or AST ≤ 5×ULN.
- Renal function: creatinine clearance ≥ 60 mL/min (using Cockcroft-Gault formula).
- Cardiac function: left ventricular ejection fraction (LVEF) ≥ 50%. 7.At least one measurable lesion according to the RECIST v1.1 criteria. 8.Eligible patients with fertility (male and female) must agree to use reliable contraceptive methods (hormonal or barrier method) with their partners during the trial period and at least 3 months after the last administration; female patients of childbearing age must have a negative serum pregnancy test within 7 days before the first dose of YY2201.
Who cannot join
- 1.Has received chemotherapy, radiotherapy, biological therapy, endocrine therapy, immune checkpoint inhibitor therapy, other anti-tumor treatments, or other un-marketed investigational drugs within 4 weeks prior to first dose of YY2201 (or within 5 half-lives of treatment, whichever is shorter), except for the following items: Have used nitrosourea or Mitomycin C within 6 weeks prior to first dose of Y2201.
- Have used oral fluorouracil and small molecule targeted drugs within 2 weeks or 5 half-lives of the drugs prior to first dose of YY2201 (whichever is longer).
- Have used herbal therapy with anti-tumor indications are within 2 weeks prior to first dose of YY2201.
- 2.Has prior (within 2 years before screening) or concurrent other malignancy (except for cured basal cell carcinoma of the skin, carcinoma in situs of cervix, ductal carcinoma in-situ, and prostate cancer which not requiring treatment).
- 3.Has undergone major organ surgery (excluding biopsy) or have had significant trauma within 4 weeks prior to first dose of YY2201 or required elective surgery during the study period.
- 4.Is taking (or cannot be stopped at least 1 week prior to first dose of YY2201) any drug that is known to strongly or moderately inhibit or induce CYP2C8 and CYP3A4.
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- 5.The adverse reactions of previous anti-tumor treatments have not yet recovered to grade ≤1 (except for toxicity judged by the investigator to have no safety risk, such as alopecia and fantigue).
- 6.Has spinal cord compression or brain metastases and requiring corticosteroid therapy at a dose of more than 10 mg prednisone or equivalent per day for at least 4 consecutive weeks prior to initiation of study treatment (unless asymptomatic, treated, and stable) or a history of leptomeningeal metastases.
- 7.Any gastrointestinal tract related conditions that may affect the drug absorption as judged by the investigator, such as nausea and vomiting that are difficult to control, intestinal obstruction, gastric outlet obstruction, unable to swallow preparations, previous major gastrointestinal resection and so on.
- 8.Has active infection 1 week before the first dose of YY2201 and currently need systemic anti-infection treatment.
- 9.HIV infection, or active HBV infection or active HCV infection, with the exception:
- Patients with serologic evidence of chronic HBV infection and have HBV viral load below the limit of quantification with normal liver function.
- Patients with serologic evidence of HCV infection and have negative hepatitis C virus RNA test results.
- 10.History of serious cardiovascular and cerebrovascular diseases, including but not limited to: Severe cardiac rhythm or conduction abnormality, such as ventricular arrhythmia requiring clinical intervention, second-third degree atrioventricular block, etc., PR interval > 250 ms; Thromboembolic events requiring therapeutic anticoagulation, or subjects with a venous filter; Patients with Class III~IV cardiac insufficiency according to the criteria of New York Heart Association (NYHA); Acute coronary syndrome, congestive heart failure, aortic dissection, stroke or other grade 3 or higher cardiovascular and cerebrovascular events within 12 months prior to the first dose; QT interval corrected through Fridericia's formula (QTcF) prolongation (male > 450 ms, female > 470 ms); any factors that increase the risk of QTc prolongation and arrhythmia, such as heart failure, congenital long QT syndrome, family history of long QT syndrome, and QT interval prolongation caused by any concomitant drug.
- 11.History of non-infectious pneumonitis (NIP)/pneumonitis requiring systemic steroids, or active NIP/ pneumonitis, or other severe lung disease.
- 12.Substance use disorder that may interfere with the participant's involvement in the study or evaluation of the study result, as determined by the investigator.
- 13.Patient with mental disorders, severe cognitive disorder, poor compliance, or is not suitable for participating in this clinical study determined by the Investigator.
- 14.Women who are pregnant or breastfeeding. 15.Patient who cannot tolerate venous blood sampling. 16.Known allergy to YY2201 or any of its excipient. 17.History of other serious systemic diseases, or not suitable to participate in this study for other reasons as judged by the Investigator.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Dose-escalation Phase I Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumor Activity of YY2201 in Patients With Advanced Solid Tumors
The goal of this clinical trial is to assess the safety and tolerability of YY2201 in participants with advanced solid tumors. The main questions it aims to answer are:
What medical problems do participants have when taking drug YY2201? What is the maximum tolerated dose (MTD) in patients with advanced solid tumors? What is the anti-tumor efficacy of YY2201 in patients with advanced solid tumors This is a multicenter, open-label, dose-escalation phase I study.
Read more
Participants will:
Start to receive multiple doses of YY2201 orally twice daily (approximately 12 h interval) for 3 days followed by 4 days off in a 21-days treatment cycle Perform radiography tumor assessments at screening visit every 2 cycles. Keep a diary of their symptoms.
- Conditions
- Advanced Solid Tumors
- Being tested
- YY2201
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YY2201Drug
This is a multicenter, open-label, dose-escalation phase I study. participants will receive one single target dose of YY2201 on Cycle 0 Day 1 (C0D1) to observe safety and collect PK blood samples up to 48 h post-dose. On the third day after the first dose (Cycle 1 Day 1, C1D1), subjects will start to receive multiple doses of YY2201 orally twice daily (approximately 12 h interval) for 3 days followed by 4 days off in a 21-days treatment cycle.
| Study group | Role | What they receive |
|---|---|---|
| Study on the safe dosage and therapeutic effect of YY2201 tablets in patients with advanced cancer | Experimental | Not described Receives: Drug: YY2201 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of adverse events (AEs)/serious adverse events (SAEs) and Dose-limiting toxicity (DLT) events by the National Cancer Institute Common Terminology Criteria (CTCAE) version 5.0.
Electrocardiogram：12-lead ECG machine，heart rate(times/minute)； laboratory tests：blood cell analyzer(% of blood cells)，Chemistry Analyzer(Concentration of...)，Urine Analyzer(Rate of...),etc.
Measured: C0D1, C0D2, C1D1, C1D3, C1D8, C1D15, C1D17, C1D21, C2D1, C2D15, C3D1, C3D15, CnD1 (from C4), EOT+7 days and 28±7 days after the last dose of YY2201.（C=cycle,D=day,each cycle is 21 days）
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2025
- Study start26 May 2025 (estimated)
- Primary completion5 Apr 2027 (estimated)
- Study completion11 Oct 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu YaYao Biotechnology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06976931
- Sponsor's protocol ID
- 2504318-15
- Status last verified
- May 2025
- First submitted
- 30 Apr 2025
- Last updated
- 16 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Dose-escalation Phase I Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumor Activity of YY2201 in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT06976931
- Acronym / sponsor ID
- 2504318-15
- Conditions
- Advanced Solid Tumors
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Jiangsu YaYao Biotechnology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 26 May 2025 (estimated)
- Primary completion
- 5 Apr 2027 (estimated)
- Study completion
- 11 Oct 2027 (estimated)
- First posted
- 16 May 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.
The goal of this clinical trial is to assess the safety and tolerability of YY2201 in participants with advanced solid tumors. The main questions it aims to answer are:
What medical problems do participants have when taking drug YY2201? What is the maximum tolerated dose (MTD) in patients with advanced solid tumors? What is the anti-tumor efficacy of YY2201 in patients with advanced solid tumors This is a multicenter, open-label, dose-escalation phase I study.
Participants will:
Start to receive multiple doses of YY2201 orally twice daily (approximately 12 h interval) for 3 days followed by 4 days off in a 21-days treatment cycle Perform radiography tumor assessments at screening visit every 2 cycles. Keep a diary of their symptoms.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study on the safe dosage and therapeutic effect of YY2201 tablets in patients with advanced cancer | Experimental | Drug: YY2201 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 1.Voluntary to participate in the clinical study, sign a written ICF, and able to comply with clinical visits and study-related procedures.
- 2.Male or female with age ≥18 when signing the ICF. 3.Has a histologically or cytologically confirmed advanced solid tumors who are refractory to or intolerant of available standard-of-care therapy or have no effective standard treatment available.
- 4.ECOG performance score of 0 or1. 5.Expected survival of at least 3 months. 6.Adequate organ function (without any supportive treatment including blood components, growth factors, etc. within 7 days prior to the laboratory test): Bone marrow: neutrophil count (ANC) ≥ 1.5×109/L, platelet count (PLT) ≥ 90×109/L, and hemoglobin (HGB) > 9.0 g/dL.
- Coagulation function: international normalized ratio (INR) and activated partial prothrombin time (APTT) prolonged to ≤1.5×ULN.
- Liver function: total bilirubin (TBIL) ≤ 1.5×ULN or ≤ 3 × ULN in case of known Gilbert disease, alanine aminotransferase (ALT), aspartate aminotransferase (AST) ≤ 2.5×ULN, if there is liver metastasis, ALT or AST ≤ 5×ULN.
Key exclusion criteria (18 listed)
- 1.Has received chemotherapy, radiotherapy, biological therapy, endocrine therapy, immune checkpoint inhibitor therapy, other anti-tumor treatments, or other un-marketed investigational drugs within 4 weeks prior to first dose of YY2201 (or within 5 half-lives of treatment, whichever is shorter), except for the following items: Have used nitrosourea or Mitomycin C within 6 weeks prior to first dose of Y2201.
- Have used oral fluorouracil and small molecule targeted drugs within 2 weeks or 5 half-lives of the drugs prior to first dose of YY2201 (whichever is longer).
- Have used herbal therapy with anti-tumor indications are within 2 weeks prior to first dose of YY2201.
- 2.Has prior (within 2 years before screening) or concurrent other malignancy (except for cured basal cell carcinoma of the skin, carcinoma in situs of cervix, ductal carcinoma in-situ, and prostate cancer which not requiring treatment).
- 3.Has undergone major organ surgery (excluding biopsy) or have had significant trauma within 4 weeks prior to first dose of YY2201 or required elective surgery during the study period.
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 |
|---|---|---|
| YY2201This is a multicenter, open-label, dose-escalation phase I study. participants will receive one single target dose of YY2201 on Cycle 0 Day 1 (C0D1) to observe safety and collect PK blood samples up to 48 h post-dose. On the third day after the first dose (Cycle 1 Day 1, C1D1), subjects will start to receive multiple doses of YY2201 orally twice daily (approximately 12 h interval) for 3 days followed by 4 days off in a 21-days treatment cycle. | Drug | Study on the safe dosage and therapeutic effect of YY2201 tablets in patients with advanced cancer |
Primary outcome
Incidence and severity of adverse events (AEs)/serious adverse events (SAEs) and Dose-limiting toxicity (DLT) events by the National Cancer Institute Common Terminology Criteria (CTCAE) version 5.0.
Time frame: C0D1, C0D2, C1D1, C1D3, C1D8, C1D15, C1D17, C1D21, C2D1, C2D15, C3D1, C3D15, CnD1 (from C4), EOT+7 days and 28±7 days after the last dose of YY2201.（C=cycle,D=day,each cycle is 21 days）
Electrocardiogram：12-lead ECG machine，heart rate(times/minute)； laboratory tests：blood cell analyzer(% of blood cells)，Chemistry Analyzer(Concentration of...)，Urine Analyzer(Rate of...),etc.
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 16 May 2025.
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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.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing YY2201 in people with Advanced Solid Tumors, run by Jiangsu YaYao Biotechnology Co., Ltd..
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 7 inclusion and 18 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: opening soon, as of the sponsor's last update on 16 May 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 Jian Zhang (+86 21 6417 5590, syner2000@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of adverse events (AEs)/serious adverse events (SAEs) and Dose-limiting toxicity (DLT) events by the National Cancer Institute Common Terminology Criteria (CTCAE) version 5.0. (time frame: C0D1, C0D2, C1D1, C1D3, C1D8, C1D15, C1D17, C1D21, C2D1, C2D15, C3D1, C3D15, CnD1 (from C4), EOT+7 days and 28±7 days after the last dose of YY2201.（C=cycle,D=day,each cycle is 21 days）). 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 16 May 2025.