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Study Investigating Safety,Tolerability,Pharmacokinetics and Antitumor Activities of HBM4003 Combine With Toripalimab

NCT04727164 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 61

Last updated 2021-01-29

No results posted yet for this study

Summary

HBM4003 in combination with Toripalimab. The expected duration of treatment for each subject will vary according to the number of cycles completed; the number of cycles will depend on whether the subject benefits from the treatment. The study consists of a 4-week screening period, a 21-day treatment cycle (repeatable, depending on the presence/absence of clinical benefit), EOT visit after discontinuation of treatment, and 2 follow-up visits 28 days (± 2 days) and 84 days (± 5 days) after the last study medication.

Conditions

Interventions

DRUG

HBM4003 and Triprilimab

Subjects will be treated with HBM4003 on Day 1 Cycle 1 and be treated with HBM4003 and Triprilimab during each 21-day cycles from Cycle 2 in part 1.Subjects will be treated with HBM4003 and Triprilimab on Day 1 during each 21-day cycle in part 2.

Sponsors & Collaborators

  • Harbour BioMed (Guangzhou) Co. Ltd.

    lead INDUSTRY

Principal Investigators

  • JUN GUO, DOCTOR · Peking University Cancer Hospital & Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-28
Primary Completion
2023-11-30
Completion
2023-11-30

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04727164 on ClinicalTrials.gov