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Advanced Solid TumorPhase 1/2NCT07083323

A Phase I/II Study of HY05350 in Mesothelin(MSLN)-Positive Advanced Solid Tumors

A Phase 1/2 study testing HY05350 for injection in people with Advanced Solid Tumor, run by Sichuan Huiyu Pharmaceutical Co., Ltd at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This is a multicenter, open-label Phase I/II clinical study to evaluate the safety, tolerability, pharmacokinetic characteristics and preliminary clinical efficacy of HY05350 for injection in patients with MSLN-positive advanced solid tumors. Read more about this study

Who is it for?
Ages 18 to 75 yearsHealthy volunteers can take part
Conditions the study is for
Advanced Solid Tumor
What is being tested?
HY05350 for injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
262 participants
Where
1 siteChina
Study dates
22 Jul 2025to 31 Mar 2028
Phase
Phase 1/2
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
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Aged ≥18 years and ≤75 years at the time of signing the informed consent form, regardless of gender.
  • Investigator-assessed expected survival period ≥3 months.
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1.
  • Patients with cytologically or pathologically confirmed advanced solid tumors who have failed standard treatment.
  • Subjects enrolled in the dose escalation stage must have evaluable tumor lesions, and subjects enrolled in the dose expansion stage must have at least one measurable tumor lesion (based on RECIST 1.1).
  • Participant must have adequate main organ function.
  • Agree to provide archived pathological tissues or fresh biopsy tumor tissues for detection of related markers such as MSLN and Programmed cell death ligand 1 (PD-L1) expression levels, and MSLN expression is positive.
  • Female subjects of childbearing potential must have a negative serum pregnancy test within 7 days before the first drug administration, and be willing to use effective contraceptive methods to prevent pregnancy and have no plans to donate eggs during the study period and for 6 months after the last drug administration. Male subjects must agree to have no plans to donate sperm and use effective contraceptive methods during the study period and for 6 months after the last drug administration. Postmenopausal women must have been amenorrheic for at least 12 months to be considered non-childbearing.

Who cannot join

  • Received radiotherapy, chemotherapy, endocrine therapy, biological therapy, immunotherapy and other anti-tumor therapies within 4 weeks before the first drug administration.
  • Received other investigational drugs or participated in interventional medical device studies within 4 weeks before the first drug administration.
  • Had received or planned to receive live/attenuated vaccines or mRNA vaccines within 4 weeks before screening.
  • Pregnant or lactating women.
  • Subjects with adverse events caused by previous anti-tumor therapy that remained > Grade 1 (based on CTCAE 5.0) before the first drug administration.
  • Subjects with a history of ≥ Grade 3 immune-related adverse events or who discontinued immunotherapy due to irAE of any grade.
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  • Subjects with primary central nervous system (CNS) tumors, symptomatic CNS metastases, meningeal metastases, or a history of epilepsy are excluded.
  • Subjects who underwent major surgery on vital organs (excluding biopsy) within 4 weeks before the first drug administration, experienced significant trauma, or require major elective surgery during the trial.
  • Subjects with a history of tissue or organ transplantation.
  • Subjects who had severe infections within 4 weeks before the first drug administration.
  • Positive human immunodeficiency virus test.
  • Active hepatitis B, untreated chronic hepatitis B, or chronic hepatitis B that is treated but uncontrolled.
  • Subjects with active Hepatitis C virus(HCV) infection;
  • Positive treponema pallidum antibody and confirmed positive by diagnostic test;
  • Subjects with untreated or ongoing tuberculosis.
  • Known severe allergic history, or known allergic reactions to macromolecular protein preparations/antibodies or any component of the investigational drug.
  • History of active autoimmune diseases or a history of autoimmune diseases with potential for recurrence.
  • Subjects who received systemic glucocorticoids or other immunosuppressants within 14 days before the first drug administration.
  • History of non-infectious pneumonia requiring glucocorticoid treatment or current interstitial lung disease.
  • History of severe cardiovascular and cerebrovascular diseases.
  • Subjects with thrombosis or bleeding risk.
  • Known history of psychoactive substance abuse or drug use that is considered to affect study compliance.
  • Except for the tumor enrolled in the study, subjects with other active malignant tumors within 1 year before the first drug administration.
  • Uncontrolled pleural effusion, pericardial effusion, or ascites requiring drainage.
  • Subjects deemed unsuitable for participation by the investigator.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Chun Wan contact

028-86021875

chun.wan3717@huiyupharma.com

Lin Shen contact

China1 site, 1 recruiting

  • Peking University Cancer Hospital

    Beijing, Beijing Municipality, 100142

    Lin Shen

    Recruiting

Other trials in China

About this study

Official title: A Multicenter, Open-label Phase I/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Preliminary Clinical Efficacy of HY05350 for Injection in Patients With MSLN-positive Advanced Solid Tumors

This is a multicenter, open-label Phase I/II clinical study to evaluate the safety, tolerability, pharmacokinetic characteristics and preliminary clinical efficacy of HY05350 for injection in patients with MSLN-positive advanced solid tumors.

Read the detailed description

This study is a multicenter, open-label phase I/II clinical trial divided into two parts: dose escalation part (Part 1) and dose expansion part (Part 2). The main objectives of the first part are to evaluate the safety and tolerability of HY05350 for injection as monotherapy in patients with mesothelin-positive advanced solid tumors, and to explore the Maximum Tolerated Dose (MTD) and determine the Recommended Phase 2 Dose (RP2D) or the recommended dose for subsequent clinical studies. The main objective of the second part is to evaluate the anti-tumor efficacy of HY05350 for injection. The study includes patients with cytologically or pathologically confirmed advanced solid tumors who have failed standard treatment.

Being tested
HY05350 for injection

What participants receive

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

  • HY05350 for injectionDrug

    HY05350 should be administered intravenously at planned dosage, once a week, once every two weeks, or once every three weeks, until disease progression or intolerable toxicity occurs.

  • HY05350 for injectionDrug

    HY05350 should be administered intravenously at recommended dose, once a week, once every two weeks, or once every three weeks, until disease progression or intolerable toxicity occurs.

Study groups in NCT07083323
Study groupRoleWhat they receive
Part 1, the single-agent dose escalation of HY05350 for injection.ExperimentalNot described
Receives: Drug: HY05350 for injection
Part 2, dose expansion. The recommended dose will be established from the Dose Escalation part.ExperimentalNot described
Receives: Drug: HY05350 for injection

What is being measured

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

  1. Part 1, the occurrence of dose limiting toxicity (DLT)

    Measure Description: DLT will be defined using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 or American Society for Transplantation and Cellular Therapy (ASTCT) criteria for Cytokine Release Syndrome (CRS).

    Measured: At the end of Cycle 1 (each cycle is 28 days).

  2. Part 1, Incidence of Treatment-Emergent Adverse Events (TEAE)

    Measure Description: Incidence and severity of TEAE according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.

    Measured: Up to 2 years.

  3. Part 2, Objective Response Rate (ORR)

    Measure Description: The proportion of participants who have a Complete Response (CR) or a Partial Response (PR) based on Response Evaluation Criteria in Solid Tumours (RECIST) Version 1.1.

    Measured: Up to 2 years.

Secondary outcomes (8)

  1. Part 1, Peak Plasma Concentration (Cmax)

    Measure Description: Maximum concentration observed from the pharmacokinetic profile

    Measured: At the end of Cycle 3 (each cycle is 28 days).

  2. Part 1, Area under the plasma concentration versus time curve (AUC)

    Measure Description: Area under the concentration versus time curve calculated using the trapezoidal method.

    Measured: At the end of Cycle 3 (each cycle is 28 days).

  3. Part 1, Assessment of Anti-drug Antibody (ADA)

    Measure Description: Incidence, duration, titer of serum anti-HY05350 antibody (ADA)

    Measured: Up to 2 years.

  4. Part 1, Objective Response Rate (ORR)

    Measure Description: Proportion of participants who have a complete response (CR) or a partial response (PR) determined by Investigator per the Response Evaluation Criteria in Solid Tumours (RECIST) Version 1.1.

    Measured: Up to 2 years.

  5. Part 2, Duration Of Response (DOR)

    Measure Description: Duration Of Response (DOR) is defined as the time from the measurement criteria are first met for complete response (CR) /partial response (PR) (whichever is first recorded) until the first date that recurrent or progressive disease.

    Measured: Up to 2 years.

  6. Part 2, Incidence of Treatment-Emergent Adverse Events (TEAE)

    Measure Description: Incidence and severity of TEAE according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.

    Measured: Up to 2 years.

  7. Part 2, Peak Plasma Concentration (Cmax)

    Measure Description: Maximum concentration observed from the pharmacokinetic profile.

    Measured: At the end of Cycle 3 (each cycle is 28 days).

  8. Part 2, Assessment of Anti-drug Antibody (ADA)

    Measure Description: Incidence, duration, titer of serum anti-HY05350 antibody (ADA).

    Measured: Up to 2 years.

Timeline

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

  1. First posted24 Jul 2025
  2. Study start22 Jul 2025
  3. Primary completion31 Mar 2028 (estimated)
  4. Study completion31 Mar 2028 (estimated)

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 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
262 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07083323
Sponsor's protocol ID
HY0005-101
Status last verified
Nov 2025
First submitted
6 Jul 2025
Last updated
25 Nov 2025
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 1/2 study testing HY05350 for injection in people with Advanced Solid Tumor, run by Sichuan Huiyu Pharmaceutical 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 8 inclusion and 25 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 25 Nov 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 combined 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.

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 Chun Wan (028-86021875, chun.wan3717@huiyupharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part 1, the occurrence of dose limiting toxicity (DLT) (time frame: At the end of Cycle 1 (each cycle is 28 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?

On the ClinicalTrials.gov record for NCT07083323.

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 25 Nov 2025.

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