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

NCT04727164 | Unknown Phase 1

• 1 other identifier: 4003.2
• Study Type: interventional
• Target: 61
• Locations: 0 countries
• Sites: N/A

Brief 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

Solid Tumors

Outcome Measures

Primary Outcomes (4)

• Prat 1 :MTD

  The maximum tolerated dose (MTD) of HBM4003 combined with toripalimab

  approximate 42 days

• Prat 1 :RP2D

  Recommended Phase 2 dose (RP2D) of HBM4003 combined with toripalimab

  approximate 42 days

• Part 1:Number of subjects with DLT in each dose group within 2 cycles (42 days) after the first trial administration

  DLT observation period was defined as two treatment cycles with a total of 42 days,including 21 days in the first cycle (HBM4003 single drug treatment cycle) and 21 days in the second cycle (HBM4003 combined with triprilimab treatment cycle).

  approximate 42 days

• Part 2:ORR

  Proportion of patients with complete response (CR) and partial response (PR)

  maximum 3 years

Secondary Outcomes (15)

• Part 1:ORR

  maximum 3 years

• Part 1:Disease Control Rate，DCR

  maximum 3 years

• Part 1:Duration of Response, DOR

  maximum 3 years

• Part 1:Duration of Disease Control, DDC

  maximum 3 years

• Cmax (Maximum serum concentration)

  maximum 3 years

Study Arms (1)

HBM4003+Toripalimap

EXPERIMENTAL

HBM4003 combined with toripalimab in patients with advanced melanoma and other solid tumors

Drug: HBM4003 and Triprilimab

Interventions

HBM4003 and Triprilimab DRUG

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.

Also known as: HBM4003

HBM4003+Toripalimap

Eligibility Criteria

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

You may not qualify if:

• Males or females aged ≥ 18 years at the time of signing the informed consent form. For Part 1 of this study, the subjects should be ≤ 75 years of age.
• For Part 1 of the study, patients histopathologically diagnosed with advanced or recurrent solid tumors
• For Part 2 of the study, patients with locally advanced or metastatic melanoma who had been pathologically confirmed and could not be surgically removed were enrolled.
• Subjects must be able to provide fresh or archived tumor tissues .
• Patients whose estimated survival time is more than 3 months.
• Patients with at least one measurable lesion at baseline according to RECIST (Version 1.1).
• Patients with Eastern Cooperative Oncology Group (ECOG) performance status score ≤ 1.
• Patients whose organ function must meet the study requirements:
• Every woman or man with potential fertility needs to use an effective contraceptive method.
• Patients who are simultaneously participating in another clinical study, unless the study is an observational (non-interventional) clinical study or the patient is already in the survival follow-up period of the interventional study.
• Patients with a history of severe allergic diseases, a history of severe drug allergies, and known or suspected allergy to macromolecular protein preparations or HBM4003 excipients or toripalimab excipients.
• Previous and concomitant drugs or treatments to be excluded like CTLA4, PD-1,PD-L1.
• Insufficient recovery from previous treatments:
• Diseases that may affect the efficacy and safety of the investigational product.
• A history of other malignant diseases within 5 years before the first dose.

Sponsors & Collaborators

• Harbour BioMed (Guangzhou) Co. Ltd.: lead

Related Publications (1)

• Tang B, Chen Y, Jiang Y, Fang M, Gao Q, Ren X, Yao L, Huang G, Chen J, Zhang X, Li R, Zhao S, Gao M, Luo R, Qi M, Li F, Zheng F, Lee M, Tao X, Duan R, Guo J, Chi Z, Cui C. Toripalimab in combination with HBM4003, an anti-CTLA-4 heavy chain-only antibody, in advanced melanoma and other solid tumors: an open-label phase I trial. J Immunother Cancer. 2024 Oct 4;12(10):e009662. doi: 10.1136/jitc-2024-009662.

  PMID: 39366752 DERIVED

Study Officials

• JUN GUO, DOCTOR

  Peking University Cancer Hospital & Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wangnan ZHOU, Master

CONTACT

+13810905733; wangnan.zhou@harbourbiomed.com

Peter ZHAO

CONTACT

+8617601647910; peter.zhao@harbourbiomed.com

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: December 8, 2020
• First Posted: January 27, 2021
• Study Start: February 28, 2021
• Primary Completion: November 1, 2023
• Study Completion: November 1, 2023
• Last Updated: January 29, 2021

Record last verified: 2021-01