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Solid TumorsPhase 1NCT04727164

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

A Phase 1 study testing HBM4003 and Triprilimab in people with Solid Tumors, run by Harbour BioMed (Guangzhou) Co. Ltd..

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Solid Tumors
What is being tested?
HBM4003 and Triprilimab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
61 participants
Where
No sites listed yet
Study dates
28 Feb 2021to Nov 2023
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Trial locations and contacts

No sites are listed yet.

Wangnan ZHOU, Master contact

+13810905733

wangnan.zhou@harbourbiomed.com

Peter ZHAO contact

+8617601647910

peter.zhao@harbourbiomed.com

About this study

Official title: An Open Phase I Study to Evaluate the Safety, Tolerability, PK / PD, and Initial Efficacy of HBM4003 in Combination With Toripalimab in Patients With Advanced Melanoma and Other Solid Tumors

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.

Conditions
Solid Tumors
Being tested
HBM4003 and Triprilimab

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HBM4003 and TriprilimabDrug

    Also called HBM4003

    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.

Study groups in NCT04727164
Study groupRoleWhat they receive
HBM4003+ToripalimapExperimentalHBM4003 combined with toripalimab in patients with advanced melanoma and other solid tumors
Receives: Drug: HBM4003 and Triprilimab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Prat 1 :MTD

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

    Measured: approximate 42 days

  2. Prat 1 :RP2D

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

    Measured: 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).

    Measured: approximate 42 days

  4. Part 2:ORR

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

    Measured: maximum 3 years

Secondary outcomes (15)

  1. Part 1:ORR

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

    Measured: maximum 3 years

  2. Part 1:Disease Control Rate，DCR

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

    Measured: 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)

    Measured: 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

    Measured: maximum 3 years

  5. Cmax (Maximum serum concentration)

    Cmax

    Measured: maximum 3 years

  6. Tmax (Time to reach maximum serum concentration)

    Tmax

    Measured: maximum 3 years

  7. AUC0-last

    AUC0-last

    Measured: maximum 3 years

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

    AUC0-tau

    Measured: 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.

    Measured: maximum 3 years

  10. Part 2:DCR

    Proportion of patients with CR, PR and SD

    Measured: 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)

    Measured: 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

    Measured: 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)

    Measured: 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;

    Measured: 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.

    Measured: maximum 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2021
  2. Study start28 Feb 2021 (estimated)
  3. Primary completionNov 2023 (estimated)
  4. Study completionNov 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
61 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04727164
Sponsor's protocol ID
4003.2
Status last verified
Jan 2021
First submitted
8 Dec 2020
Last updated
29 Jan 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 39366752

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing HBM4003 and Triprilimab in people with Solid Tumors, run by Harbour BioMed (Guangzhou) Co. Ltd..

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 29 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Wangnan ZHOU, Master (+13810905733, wangnan.zhou@harbourbiomed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Prat 1 :MTD (time frame: approximate 42 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04727164, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2021.

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