A Phase I Clinical Study of HLX53 in Advanced/Metastatic Solid Tumors

NCT05394168 | Active Not Recruiting Phase 1 DMC

• 1 other identifier: HLX53-FIH101
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

This phase I, first-in-human, open-label clinical study will evaluate the safety, tolerability, pharmacokinetic characteristics and preliminary efficacy of HLX53 (an anti-TIGIT Fc fusion protein) in patients with advanced/metastatic solid tumors.

Conditions

Advanced/Metastatic Solid Tumors

Outcome Measures

Primary Outcomes (4)

• Adverse event

  Incidence and severity of adverse events graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0 for patients receiving study drug.

  Through study completion, assessed up to 2 years.

• Incidence of DLT

  Ratio of the number of patients with DLT events in each dose group to the number of patients in the dose group during the DLT evaluation period.

  Up to 3 weeks.

• MTD

  The maximum tolerated dose (MTD) of HLX53

  Up to 3 weeks

• RP2D

  The recommended phase II dose (RP2D) of HLX53

  Through study completion, assessed up to 2 years.

Secondary Outcomes (8)

• Cmax

  From baseline to 30 days after the last administration, assessed up to 7 months

• Tmax

  From baseline to 30 days after the last administration, assessed up to 7 months

• t1/2

  From baseline to 30 days after the last administration, assessed up to 7 months

• TIGIT Receptor Occupancy

  From baseline to 30 days after the last administration，assessed up to 7 months

• ADA

  From baseline to 30 days after the last administration，assessed up to 7 months

Study Arms (1)

HLX53

EXPERIMENTAL

an anti-TIGIT Fc fusion protein

Biological: HLX53

Interventions

HLX53 BIOLOGICAL

There are 5 preset dose groups, namely 30mg/QW, 150mg/QW, 400mg/QW, 1000mg/Q3W and 2000mg/Q3W, administered by intravenous infusion.

HLX53

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Voluntary participation in clinical studies, full understanding of the trial, and signing of informed consent, willingness to follow and ability to complete the study in accordance with the requirements of the trial protocol.
• histologically or cytologically confirmed advanced/metastatic solid tumors or lymphoma, failure of standard therapy, or no standard therapy.
• Age ≥ 18 years and ≤ 75 years at the time of informed consent.
• Eastern Cooperative Oncology Group (ECOG) score 0 or 1.
• At least one measurable lesion according to RECISTv1.1 or 2014 Lugano (lymphoma) response evaluation criteria.
• Life expectancy of more than three months.
• Adequate hematological function.
• Adequate liver function.
• Adequate renal function
• Adequate cardiac function.
• Male and female subjects of childbearing potential must agree to use at least 1 highly effective method of contraception during the trial and for at least 6 months after the last dose of study drug.

You may not qualify if:

• Known history of serious allergy to the components of HLX53 or to any monoclonal antibody.
• Prior treatment with anti-TIGIT or antibody to the relevant target CD155, CD112, or CD113.
• Unresolved toxicity after prior antineoplastic therapy, i.e., not resolved to baseline, Grade 0-1 per NCI-CTCAE 5.0 (except alopecia).
• Coexisting unstable or controlled medical conditions.
• Spinal cord compression with clinical symptoms.
• Prior allogeneic bone marrow transplant or solid organ transplant.
• History of primary immunodeficiency.
• History of eczema or asthma that cannot be controlled by topical corticosteroids.
• History of any second malignancy within 2 years, except for curatively treated early malignancies (carcinoma in situ or stage I tumors) such as non-melanoma skin cancer, carcinoma in situ of the cervix, localized prostate cancer, ductal carcinoma in situ of the breast, papillary thyroid cancer.
• Vaccination with a live attenuated vaccine within 4 weeks prior to the first dos.e
• Use of immunosuppressive drugs within 2 weeks prior to initial administration.
• Received major surgery, anti-tumor therapy (chemotherapy, radiotherapy, targeted therapy, immunotherapy or biological therapy) within 4 weeks prior to the first dose.
• Known to have active infectious disease such as active HBV, HCV infection.
• History of human immunodeficiency virus (HIV) infection.
• Pregnancy or lactation.

Sponsors & Collaborators

• Shanghai Henlius Biotech: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, China

Location

Study Officials

• Jian Zhang

  Fudan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2022
• First Posted: May 27, 2022
• Study Start: December 9, 2022
• Primary Completion: December 4, 2024
• Study Completion: March 4, 2025
• Last Updated: April 1, 2024

Record last verified: 2024-03

Locations

CN (1)