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

NCT07083323 | Recruiting Phase 1

• 1 other identifier: HY0005-101
• Study Type: interventional
• Target: 262
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Advanced Solid Tumor

Outcome Measures

Primary Outcomes (3)

• 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).

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

• 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.

  Up to 2 years.

• 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.

  Up to 2 years.

Secondary Outcomes (8)

• Part 1, Peak Plasma Concentration (Cmax)

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

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

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

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

  Up to 2 years.

• Part 1, Objective Response Rate (ORR)

  Up to 2 years.

• Part 2, Duration Of Response (DOR)

  Up to 2 years.

Study Arms (2)

Part 1, the single-agent dose escalation of HY05350 for injection.

EXPERIMENTAL

Drug: HY05350 for injection

Part 2, dose expansion. The recommended dose will be established from the Dose Escalation part.

EXPERIMENTAL

Drug: HY05350 for injection

Interventions

HY05350 for injection DRUG

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.

Part 1, the single-agent dose escalation of HY05350 for injection.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Sichuan Huiyu Pharmaceutical Co., Ltd: lead
• Peking University Cancer Hospital & Institute: collaborator

Study Sites (1)

Peking University Cancer Hospital

Beijing, Beijing Municipality, 100142, China

RECRUITING

MeSH Terms

Interventions

Injections

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Chun Wan

  Peking University Cancer Hospital & Institute

  STUDY DIRECTOR

Central Study Contacts

Chun Wan

CONTACT

028-86021875; chun.wan3717@huiyupharma.com

Lin Shen

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2025
• First Posted: July 24, 2025
• Study Start: July 22, 2025
• Primary Completion (Estimated): March 31, 2028
• Study Completion (Estimated): March 31, 2028
• Last Updated: November 25, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)