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Advanced Solid TumorPhase 1NCT06228846

An Phase I Study of YY001 in Patients with Advanced Solid Tumors

A Phase 1 study testing YY001 in people with Advanced Solid Tumor, run by Shanghai Yuyao Biotech Co., Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The safety and tolerability of YY001 in the treatment of patients with advanced solid tumors were evaluated, and the possible dose-limiting toxicity (DLT) and the maximum tolerated dose (MTD) or recommended phase II clinical dose (RP2D) were observed. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Advanced Solid Tumor
What is being tested?
YY001
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
16 participants
Where
1 siteChina
Study dates
14 Jul 2022to 30 May 2024
Phase
Phase 1
Are there results?
None posted in the registry

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 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 1.Patients fully understand and sign ICF, voluntarily participate in the study, and able to follow and complete all study procedures.
  • 2. Aged 18-75 years (including upper and lower limits), male or female.
  • 3. Patients with histologically or cytologically confirmed advanced unresectable or metastatic solid tumors (mainly gastrointestinal tumors such as colorectal cancer and gastric cancer, and prostate cancer)
  • 4.The standard treatment failure (disease progression after treatment or treatment side effects not tolerance), or top treatment, or shall not apply to the current standard treatment for patients
  • 5. For patients with advanced solid tumors (dose-escalation phase), at least one tumor lesion that could be evaluated according to RECIST, version 1.1; (Dose-expansion phase) At least one measurable tumor lesion according to RECIST, version 1.1 (a tumor that is located in the previously irradiated area or another locoregional treatment site and is generally not considered a measurable lesion unless there is definite progression or persistence beyond 3 months of radiation);
  • 6. ECOG physical condition≤1
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  • 7. Patients with advanced primary liver cancer should meet the Child-Pugh liver function grading: grade A and better grade B (≤7).
  • 8. With adequate bone marrow, liver and kidney organ function:
  • •Blood system within 14 days (not received blood transfusions or hematopoietic stimulating factor treatment): Absolute neutrophil count (ANC) ≥1.5×10^9/L; Platelet count (PLT) ≥75×10^9/L; Hemoglobin (Hb) ≥85g/L;
  • •Liver function: Total bilirubin (TBIL) ≤1.5×ULN; Alanine aminotransferase (ALT) ≤3×ULN; Spread to the liver or liver cancer patient: 5 or less x ULN; Aspartate aminotransferase (AST) or less 3 x ULN; Spread to the liver or liver cancer patient: 5 or less x ULN;
  • •Renal function: Creatinine (Cr) or less 1.5 x ULN; Creatinine clearance (Ccr) (calculated only when creatinine > 1.5× ULN) ≥50ml/min (calculated according to Cockcroft-Gault formula);
  • •Blood coagulation function: Activated partial thromboplastin time (APTT) ≤1.5×ULN; International normalized ratio (INR) ≤1.5×ULN;
  • •Urinary protein: Urine routine /24 hours urine protein qualitative ≤1+; Or urine protein qualitative ≥2+, 24 hours urine protein < 1g;
  • 9. Expected survival of at least 3 months.
  • 10. Women of childbearing potential had to have a negative serum or urine pregnancy test within 7 days before the first dose. Fertile male or female patients voluntarily during the study period and at the end of the study drug within 30 days of using effective birth control methods, such as abstinence, the double protective screen type cuts, condoms, contraceptive method of oral or injected contraceptives, intrauterine device, etc. All female patients will be considered fertile unless the female patient has undergone natural menopause, artificial menopause, or sterilization (e.g., hysterectomy, bilateral adnophorectomy, or radioactive ovarian irradiation).

Who cannot join

  • 1. The adverse reactions of previous antineoplastic therapy have not recovered to CTCAE 5.0 grade ≤1 (except for toxicities without safety risks judged by investigators, such as alopecia, grade 2 peripheral neurotoxicity, and hypothyroidism stable with hormone replacement therapy);
  • 2. Clinically symptomatic parenchymal or leptomeningeal metastases that were judged by the investigator to be ineligible for enrollment;
  • 3. Within 4 weeks before delivery for the first time received chemotherapy, radiation therapy, biological therapy and endocrine therapy, immune therapy, such as antitumor drugs, with the exception of the following situations:
  • Nitrosourea or mitomycin C within 6 weeks before first use of study drug;
  • Oral fluorouracils and small-molecule targeted agents are administered 2 weeks before first use of the study drug or within the five half-lives of the drug, whichever is longer;
  • Have antitumor indications for the study of the first use of drugs of traditional Chinese medicines before 2 weeks;
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  • 4. Received other unlisted investigational drugs or treatments within 4 weeks before the first dose;
  • 5. Previously received EP4 inhibitor (e.g. AN0025(E7046),LY3127760,ONO-4578) for anti-tumor treatment;
  • 6. Major organ surgery (excluding needle biopsy) within 4 weeks before the first dose of medication or requiring elective surgery during the trial;
  • 7. Uncontrolled malignant pleural, ascites, or pericardial effusion that was judged by the investigator to be ineligible for enrollment;
  • 8. Unable to oral drug swallowing, or by the researchers determine the condition of the seriously affect the gastrointestinal tract absorption, including but not limited to, such as inflammatory bowel disease (crohn's disease and ulcerative colitis, for example), or malabsorption syndrome, or chronic diarrhea;
  • 9. Patients who received a potent inducer or inhibitor of CYP3A4 within 1 week before the first dose or who required continued treatment with these drugs during the study;
  • 10.Patients with active gastric and duodenal ulcer, ulcerative colitis and other gastrointestinal diseases, or unresected tumor with active bleeding, or other conditions that may cause gastrointestinal bleeding or perforation as judged by the investigator;
  • 11.Thromboembolic events (including stroke events and/or transient ischemic attack) occurred within 12 months before the first dose of medication;
  • 12.Clinically significant cardiovascular disease, including but not limited to acute myocardial infarction, severe/unstable angina, or coronary artery bypass grafting within 6 months before the first dose of medication; Congestive heart failure with New York Heart Association (NYHA) grade ≥2; Left ventricular ejection fraction (LVEF) <50%; A history of primary cardiomyopathy, clinically significant prolongation of the QTc interval, or a screening QTc interval >470ms in women and >450ms in men;
  • 13.Patients with active or previous autoimmune diseases with potential recurrence (such as systemic lupus erythematosus, rheumatoid arthritis, vasculitis, etc.), excluding patients with clinically stable autoimmune thyroid diseases and type I diabetes mellitus;
  • 14.Prior immunotherapy with grade ≥3 irAE or grade ≥2 immune-related myocarditis;
  • 15.Researchers to determine the clinical significance of 3 or more electrolyte abnormalities
  • 16.Patients with active infection requiring antiinfective treatment or unexplained fever (body temperature >38.5 ° C) during screening or before the first dose of medication;
  • 17.Patients with active pulmonary tuberculosis (TB) who were receiving anti-TB treatment or had received anti-TB treatment within 1 year before the first dose; Known human immunodeficiency virus (HIV) infection; Patients with a history of hepatitis B were in the stage of active infection (HBsAg positive and HBV-DNA > the detection limit of the research center); Patients with a history of hepatitis C were in the active infection stage, defined as positive HCV antibody test and detectable HCV RNA;
  • 18.Women who are pregnant (positive pregnancy test within 14 days before medication) or are breastfeeding
  • 19.Patients with known alcohol or drug dependence;
  • 20.Patients judged by the investigator that may not be able to comply with all study procedures;
  • 21.Any other disease, metabolic abnormality, abnormal physical examinations or laboratory abnormality with significant clinical significance. Investigator reasonably suspects that the patient has a disease or state that is not suitable for using of the study drug, or will affect interpretation of study results, or put the patient at high risk.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Shanghai East Hospital

    Shanghai, Shanghai Municipality

Other trials in China

About this study

Official title: An Open-Label Phase I Study to Evaluate the Safety,Tolerability and Preliminary Efficacy of YY001 in Patients with Advanced Solid Tumors

The safety and tolerability of YY001 in the treatment of patients with advanced solid tumors were evaluated, and the possible dose-limiting toxicity (DLT) and the maximum tolerated dose (MTD) or recommended phase II clinical dose (RP2D) were observed.

Being tested
YY001

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • YY001Drug

    Oral

Study groups in NCT06228846
Study groupRoleWhat they receive
Study treatmentExperimentalMethod of Administration: Single dose period: Single oral ; Multiple dose period: Oral , QD.
Receives: Drug: YY001

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Dose limiting toxicity

    The incidence and severity of adverse events (TEAE) during treatment were graded according to the National Cancer Institute Standard for Common Terminology for Adverse Events (NCI-CTCAE, v5.0)

    Measured: Up to 24 days after the initial drug administration

  2. Maximum tolerated dose

    In the dose increment stage, the highest dose whose estimated DLT rate is closest to the target DLT rate but does not exceed the upper bound of the equivalent interval of DLT rate is selected as MTD.

    Measured: Up to 24 days after the initial drug administration

  3. Recommended Dose for Phase II Clinical Studies (RP2D)

    The RP2D is defined as the dose level chosen by the sponsor (in consultation with the investigators) for phase II study, based on safety, tolerability, efficacy, PK, and PD data collected during the dose escalation study of YY001.

    Measured: Up to 24 days after the initial drug administration

Secondary outcomes (2)

  1. Duration of Response(DoR)

    The time from the patient's first objective response to the patient's disease recurrence, progression, or death.

    Measured: Up to approximately 24 months

  2. Overall Survival (OS)

    The time from start date of study drug to death due to any cause.

    Measured: Up to approximately 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jan 2024
  2. Study start14 Jul 2022
  3. Primary completion30 Apr 2024
  4. Study completion30 May 2024

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06228846
Sponsor's protocol ID
2021-YY001-CH1
Status last verified
Jan 2025
First submitted
17 Jan 2024
Last updated
3 Jan 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing YY001 in people with Advanced Solid Tumor, run by Shanghai Yuyao Biotech 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 15 inclusion and 24 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: finished, as of the sponsor's last update on 3 Jan 2025. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose limiting toxicity (time frame: Up to 24 days after the initial drug administration). 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?

On the ClinicalTrials.gov record for NCT06228846.

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 3 Jan 2025.

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