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Solid TumorPhase 1NCT06209385

A Phase 1 Study of YZJ-5053 Tablets in Participants With Advanced Solid Tumors

A Phase 1 study testing YZJ-5053 tablets in people with Solid Tumor, run by Shanghai Haiyan Pharmaceutical Technology Co., Ltd. at 4 sites 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 goal of this study is to evaluate Safety, Tolerability, Pharmacokinetics and Efficacy of YZJ-5053 Tablets in Participants with Advanced Solid Tumors Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Solid Tumor
What is being tested?
YZJ-5053 tablets
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
14 participants
Where
4 sitesChina
Study dates
11 Aug 2023to 9 Jul 2025
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female subjects are ≥ 18 years of age on the day of signing the informed consent.
  • Histologically or cytologically confirmed advanced or metastatic solid tumors who have failed standard treatment, or are ineligible for the standard treatment, or have no standard treatment, or declined standard treatment.
  • Subjects must have at least one measurable target lesion in indication expansion phase (Part 2) as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria which has not received radiotherapy (or progressive disease after radiotherapy), or at least one evaluable lesion in dose escalation phase (Part 1) .
  • Subjects with previously confirmed brain metastases were enrolled if they were clinically asymptomatic, in stable condition, and did not require steroid therapy for at least 4 weeks before the initiation of study treatment.
  • Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1;
  • Life expectancy at least 3 months;
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  • Adequate hematologic and organ function at screening and within 28 days prior to initiation of study treatment (without receiving any blood transfusion or hematopoietic stimulating factors within 2 weeks prior to screening),as evidenced by:
  • absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L； Platelets ≥ 75 x 10^9/L； Hemoglobin ≥85 g/L； aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≤ 3 x upper limit of normal (ULN) , or ≤ 5 x ULN if liver cancer or liver metastases are present.
  • Total bilirubin < 1.5 x ULN , or < 3.0 x ULN for subjects with liver cancer or liver metastases or documented Gilbert's syndrome (unconjugated hyperbilirubinemia)； Serum creatinine (Scr) <1.5×ULN, or creatinine clearance (Ccr) > 50 mL/min according to Cockcroft-Gault equation; international normalized ratio (INR) and activated partial thromboplastin time (APTT) < 1.5 ULN;
  • A woman of child-bearing potential (WOCBP) must have a negative serum pregnancy test prior to initiation of study treatment (serum pregnancy test is not required for females of nonchild-bearing potential who have undergone surgical sterilization, such as hysterectomy and/or bilateral oophorectomy, or those who have not experienced menses for 12 consecutive months and are judged to be postmenopausal based on factors such as age and castration therapy).
  • Subjects must agree to use adequate contraceptive methods prior to initiation of study treatment, during the study, and for at least 28 days following the last dose of YZJ-5053 tablets.

Who cannot join

  • Female subjects who are pregnant or breast-feeding.
  • History of malignancy within 3 years prior to screening, with the exception of the cancer under investigation in this study and curatively treated carcinoma in situ of the cervix, non-melanoma skin cancer, localized prostate cancer or any other tumor that has been treated curatively and with no evidence of disease for at least 3 years (for indication expansion phase [1b] only).
  • Presence of uncontrolled pleural effusion, pericardial effusion, or ascites that require recurrent drainage procedures (monthly or more frequently).
  • Impaired cardiac function or clinically significant cardiovascular disease.
  • Conditions or diseases that impair gastrointestinal (GI) function which may significantly alter the absorption of YZJ-5053 tables (e.g. ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection).
  • Subjects with active infection requiring intravenous (IV) antibiotics at the time of screening or within 2 weeks prior to initiation of study treatment.
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  • Subjects with positive HIV antibody, or positive hepatitis B surface antigen (HBsAg) with hepatitis B virus (HBV) DNA ≥2×10^3 IU/ml (equivalent to 10^4 copies/ml), or positive hepatitis C virus antibody at the time of screening;
  • Have received chemotherapy within 3 weeks, and radiotherapy, biological therapy, endocrine therapy, targeted therapy, immunotherapy or any other anti-tumor therapy within 4 weeks prior to initiation of study treatment.
  • Subject who could not discontinue use of strong inhibitors or strong inducers of Cytochrome P450 3A (CYP3A) and Cytochrome P450 2C8 (CPY2C8) during the study period.
  • Subjects who have received a live vaccine or live attenuated vaccine within 4 weeks prior to initiation of study treatment.
  • Subjects who have previously received adenosine A2a receptor (A2aR) antagonists or A2aR/adenosine A2b receptor (A2bR) antagonists.
  • Adverse events (AEs) from previous antitumor therapy have not recovered to baseline or to CTCAE Grade 1 prior to initiation of study treatment, excluding subjects with alopecia (any grade), peripheral sensory neuropathy (Grade ≤ 2), and any other toxicities of no clinical significance (Grade ≤ 2);
  • Subjects with a known history of autoimmune thyroid disease such as diffuse toxic goiter (Graves disease) , acute or subacute thyroiditis. Subjects with active autoimmune diseases or a known history of autoimmune diseases that potentially relapsing, exception:
  • Subjects with autoimmune-related hypothyroidism requiring stable dose thyroxine replacement only are eligible; Subjects with type I diabetes mellitus controlled on a stable insulin regimen are eligible;
  • Subjects who have received systemic corticosteroids (> 10 mg/day prednisone equivalent) or other systemic immunosuppressants (including but not limited to prednisone, dexamethasone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor drugs) within 4 weeks prior to the initiation of study treatment, but excluded:
  • Locally, ocularly, intra-articularly, intranasally, or inhaled corticosteroids; Subjects receiving acute low-dose systemic immunosuppressive drugs (e.g., single dexamethasone for nausea) may be enrolled after discussion with and approval from medical monitor ; Alternative steroid doses for diseases such as adrenal or pituitary insufficiency are ≤ 10 mg/day in prednisone equivalents; Corticosteroids hydrochloride (eg fludrocortisone) for orthostatic hypotension; Short-term (≤ 7 days) use of steroids for the prevention or treatment of non-autoimmune allergic diseases; Single ues of glucocorticoids before enhanced-imaging for prevention of contrast agent allergy;
  • Major surgical procedures, within 4 weeks prior to initiation of study treatment, or anticipation of need for major surgical procedure during the study period.
  • Other severe and/or uncontrolled concomitant medical conditions that could cause unacceptable safety risks or compromise compliance with the protocol.
  • Presence of other conditions, therapy, or laboratory abnormalities that, in the opinion of the investigator, might confound the results of the study and interfere with the subject's participation.

Trial locations and contacts

4 sites in 1 country.

China4 sites

  • The Second Affiliated Hospital Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310000

  • Shandong Cancer Hospital

    Jinan, Shandong, 250000

  • The First Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi, 330000

  • Shanghai East Hospital

    Shanghai, Shanghai Municipality, 200120

Other trials in China

About this study

Official title: A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of YZJ-5053 Tablets in Participants With Advanced Solid Tumors

The goal of this study is to evaluate Safety, Tolerability, Pharmacokinetics and Efficacy of YZJ-5053 Tablets in Participants with Advanced Solid Tumors

Read the detailed description

Part1(phase 1a) :To define the maximum tolerated dose (MTD) and/or a recommended phase 2 dose(RP2D). To evaluate the safety and tolerability of YZJ-5053 tables in participants with advanced solid tumors.

Part2(phase 1b) : To define the RP2D. To evaluate the safety and tolerability of YZJ-5053 tables in subjects with advanced solid tumors

Conditions
Solid Tumor
Being tested
YZJ-5053 tablets

What participants receive

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

  • YZJ-5053 tabletsDrug

    Also called SHY-1901

    YZJ-5053 tablets will be administrated orally QD for 21 days

Study groups in NCT06209385
Study groupRoleWhat they receive
YZJ-5053 tabletsExperimentalYZJ-5053 tablets will be administrated orally quaque die (QD) for 21 days
Receives: Drug: YZJ-5053 tablets

What is being measured

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

  1. Determination of Maximum Tolerated Dose (MTD) of YZJ-5053

    The MTD will be based on dose limiting toxicity (DLT)

    Measured: 21days as a cycle

  2. To identify a recommended Phase 2 dose (RP2D) of YZJ-5053

    RP2D will be be based on MTD

    Measured: 21days as a cycle

  3. Number of participants with treatment-related adverse events as assessed by National Cancer Institute-Common Terminology Criteria for Adverse Events version 5.0 (NCI-CTCAE v5.0)

    All events with a Grade 3 or above toxicity (defined by the NCI-CTCAE 5.0) will be tabulated by event and by relationship to YZJ-5053

    Measured: 21days as a cycle

Secondary outcomes (10)

  1. Maximum observed plasma concentration (Cmax) of YZJ-5053

    Maximum plasma concentration of YZJ-5053 after single and multiple dose administration of YZJ-5053

    Measured: single dose: predose, 0.5、1、2、4、6、8、12、24、48、72 hours post-dose. multiple dose: predose on days 1、3、4、5、6, and 0.5、1、2、4、6、8、12 hours post-dose on day 5

  2. Time to reach Cmax (Tmax) of YZJ-5053

    The amount of time to reach Cmax after single and multiple dose administration of YZJ-5053

    Measured: single dose: predose, 0.5、1、2、4、6、8、12、24、48、72 hours post-dose. multiple dose: predose on days 1、3、4、5、6, and 0.5、1、2、4、6、8、12 hours post-dose on day 5

  3. Terminal half-life (t1/2) of YZJ-5053

    Terminal half-life (t1/2) after single and multiple dose administration of YZJ-5053

    Measured: single dose: predose, 0.5、1、2、4、6、8、12、24、48、72 hours post-dose. multiple dose: predose on days 1、3、4、5、6, and 0.5、1、2、4、6、8、12 hours post-dose on day 5

  4. Area under the plasma concentration-time curve (AUC) of YZJ-5053

    Area under the plasma concentration versus time curve after single and multiple dose administration of YZJ-5053

    Measured: single dose: predose, 0.5、1、2、4、6、8、12、24、48、72 hours post-dose. multiple dose: predose on days 1、3、4、5、6, and 0.5、1、2、4、6、8、12 hours post-dose on day 5

  5. apparent clearance following oral administration for YZJ-5053

    To characterise the pharmacokinetics (PK) after single and multiple dose administration of YZJ-5053

    Measured: single dose: predose, 0.5、1、2、4、6、8、12、24、48、72 hours post-dose. multiple dose: predose on days 1、3、4、5、6, and 0.5、1、2、4、6、8、12 hours post-dose on day 5

  6. apparent volume of distribution for YZJ-5053

    To characterise the PK after single and multiple dose administration of YZJ-5053

    Measured: single dose: predose, 0.5、1、2、4、6、8、12、24、48、72 hours post-dose. multiple dose: predose on days 1、3、4、5、6, and 0.5、1、2、4、6、8、12 hours post-dose on day 5

  7. Objective Response Rate (ORR) as defined by Investigator-assessed Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

    For solid tumors, this will be determined per RECIST v1.1 guidelines

    Measured: Evaluate every 6 weeks (±1 week) until study completion, an average of 1 year

  8. Disease control rate (DCR) as defined by Investigator-assessed RECIST v1.1

    For solid tumors, this will be determined per RECIST v1.1 guidelines

    Measured: Evaluate every 6 weeks (±1 week) until study completion, an average of 1 year

  9. Duration Of Response (DOR) as defined by Investigator-assessed RECIST v1.1

    For solid tumors, this will be determined per RECIST v1.1 guidelines

    Measured: Evaluate every 6 weeks (±1 week) until study completion, an average of 1 year

  10. Progression-free Survival (PFS) as defined by Investigator-assessed RECIST v1.1

    For solid tumors, this will be determined per RECIST v1.1 guidelines

    Measured: Evaluate every 6 weeks (±1 week) until study completion, an average of 1 year

Timeline

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

  1. First posted17 Jan 2024
  2. Study start11 Aug 2023
  3. Primary completion28 Apr 2025
  4. Study completion9 Jul 2025

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
Model description
Dose escalation and dose expansion
Masking
None (open label)
Enrolment
14 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06209385
Sponsor's protocol ID
YZJ-5053-1-01
Status last verified
Jun 2026
First submitted
17 Dec 2023
Last updated
1 Jul 2026
Results posted
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 YZJ-5053 tablets in people with Solid Tumor, run by Shanghai Haiyan Pharmaceutical Technology Co., Ltd. at 4 sites 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 11 inclusion and 19 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 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites 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?

Determination of Maximum Tolerated Dose (MTD) of YZJ-5053 (time frame: 21days as a cycle). 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 NCT06209385.

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 1 Jul 2026.

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