CClinicalTrials.gg
Sign In
Status unknownNCT04727164Updated Jan 29, 2021

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

A Phase 1 interventional study of HBM4003 and Triprilimab in Solid Tumors, sponsored by Harbour BioMed (Guangzhou) Co. Ltd.. Status unknown. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-01-29.

Sponsored by Harbour BioMed (Guangzhou) Co. Ltd. · Phase 1, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jan 2021), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 1
Study type
Interventional
Enrollment
61
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

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.

Read the detailed description

An open-label Phase 1 study to evaluate the safety, tolerability, PK/PD and preliminary efficacy of HBM4003 combined with toripalimab in patients with advanced melanoma and other solid tumors.

The study is composed of two part, part 1 will be approximately 31subjects and Part 2 will be approximately 30 subjects.

02

Conditions studied

  • Solid Tumors
03

In context

Lead sponsor

Harbour BioMed (Guangzhou) Co. Ltd. is the lead sponsor of 14 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Main inclusion/exclusion criteria:

Main inclusion criteria

  1. 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.
  2. For Part 1 of the study, patients histopathologically diagnosed with advanced or recurrent solid tumors
  3. 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.
  4. Subjects must be able to provide fresh or archived tumor tissues .
  5. Patients whose estimated survival time is more than 3 months.
  6. Patients with at least one measurable lesion at baseline according to RECIST (Version 1.1).
  7. Patients with Eastern Cooperative Oncology Group (ECOG) performance status score ≤ 1.
  8. Patients whose organ function must meet the study requirements:
  9. Every woman or man with potential fertility needs to use an effective contraceptive method.

Main exclusion criteria

  1. 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.
  2. 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.
  3. Previous and concomitant drugs or treatments to be excluded like CTLA4, PD-1,PD-L1.
  4. Insufficient recovery from previous treatments:
  5. Diseases that may affect the efficacy and safety of the investigational product.
  6. A history of other malignant diseases within 5 years before the first dose.
  7. Symptomatic, active, or urgent treatment-requiring central nervous system (CNS) metastasis with imaging evidence (based on CT or MRI assessment).
  8. Subjects with pleural effusion, pericardial effusion, or ascites
  9. Subjects who the investigator believes may have other factors that will affect the efficacy or safety evaluation of this study (e.g., mental disorders, alcoholism, drug use, etc.).
  10. Women who are pregnant or breastfeeding, or who plan to become pregnant during the study period and within 3 months after the last administration of the investigational product.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
61 participants (estimated)

Study arms

  • Experimental
    HBM4003+Toripalimap

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

    Drug: HBM4003 and Triprilimab

Interventions

  • DrugHBM4003 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.

    Also known as: HBM4003

06

What researchers measure

Primary outcomes

  1. Prat 1 :MTD

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

    Time frame: approximate 42 days

  2. Prat 1 :RP2D

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

    Time frame: approximate 42 days

  3. 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).

    Time frame: approximate 42 days

  4. Part 2:ORR

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

    Time frame: maximum 3 years

Secondary outcomes

  1. Part 1:ORR

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

    Time frame: maximum 3 years

  2. Part 1:Disease Control Rate，DCR

    Including complete response (CR),partial response (PR) and disease stability (SD)

    Time frame: maximum 3 years

  3. Part 1:Duration of Response, DOR

    Calculate the duration from the first confirmed CR or PR to the date of disease progression or death (for any reason)

    Time frame: maximum 3 years

  4. Part 1:Duration of Disease Control, DDC

    For subjects with Cr, PR or SD, the duration from the time of initial administration to the date of disease progression or death (for any reason) was calculated

    Time frame: maximum 3 years

  5. Cmax (Maximum serum concentration)

    Cmax

    Time frame: maximum 3 years

  6. Tmax (Time to reach maximum serum concentration)

    Tmax

    Time frame: maximum 3 years

  7. AUC0-last

    AUC0-last

    Time frame: maximum 3 years

  8. AUC0-tau (Area under the serum concentration versus time curve from time zero to the dosing interval tau

    AUC0-tau

    Time frame: maximum 3 years

  9. The immunogenicity of HBM4003 and Triprilimab

    Including the incidence of ADA positive. For ADA positive patients, the incidence of neutralizing antibody (NAB) was analyzed.

    Time frame: maximum 3 years

  10. Part 2:DCR

    Proportion of patients with CR, PR and SD

    Time frame: maximum 3 years

  11. Part 2:DOR

    Calculate the duration from the first confirmed CR or PR to the date of disease progression or death (for any reason)

    Time frame: maximum 3 years

  12. Part 2:DDC

    For subjects with Cr, PR or SD, the duration from the time of initial administration to the date of disease progression or death (for any reason) was calculated

    Time frame: maximum 3 years

  13. Prat 2:OS

    The length of time from the beginning of treatment to the death of the subject (for any reason)

    Time frame: maximum 3 years

  14. Part 2:PFS

    The length of time from the beginning of treatment to the onset of disease progression or (for any reason) death;

    Time frame: maximum 3 years

  15. Prat 2:The immunogenicity of HBM4003 and Triprilimab

    Including the incidence of ADA positive. For ADA positive patients, the incidence of neutralizing antibody (NAB) was analyzed.

    Time frame: maximum 3 years

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 29, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04727164
Lead sponsor
Harbour BioMed (Guangzhou) Co. Ltd.
Responsible party
Sponsor
First posted
Jan 27, 2021
Start date
Feb 28, 2021 (estimated)
Primary completion
Nov 2023 (estimated)
Completion
Nov 2023 (estimated)
Last update
Jan 29, 2021

Study contacts

Wangnan ZHOU, Master
Contact
wangnan.zhou@harbourbiomed.com
+13810905733
Peter ZHAO
Contact
peter.zhao@harbourbiomed.com
+8617601647910
JUN GUO, DOCTOR
principal investigator · Peking University Cancer Hospital & Institute

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies from this sponsor

Harbour BioMed (Guangzhou) Co. Ltd.

Start the discussion