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AzTrials

Solid TumorsPhase 1NCT05167071

HBM4003 Combine With Toripalimab in Patients With Advanced NEN and Other Solid Tumors Study

A Phase 1 study testing HBM4003, Toripalimab and Tislelizumab in people with Solid Tumors and Neuroendocrine Tumors, run by Harbour BioMed (Guangzhou) Co. Ltd. at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

To select RP2D/MTD of HBM4003 in combination with Toripalimab in dose confirmation part(Part 1) and use the RP2D in dose expansion part (Part 2) to evaluate the safety, tolerability, PK/PD and preliminary efficacy of in patients with advanced NEN and other solid tumors Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Solid Tumors, Neuroendocrine Tumors, CRC
What is being tested?
HBM4003, Toripalimab and Tislelizumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
53 participants
Where
1 siteChina
Study dates
28 Dec 2021to 30 Jun 2026
Phase
Phase 1
Are there results?
Not yet: the study is under way

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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
  • Patients for Part 1: patients histopathologically diagnosed with advanced or recurrent solid tumors.
  • For arm A and B of Part 2 in the study, Patients with non- functional metastatic neuroendocrine tumor confirmed by histopathology.
  • For arm F of Part 2 in the study, Patients with metastatic colorectal adenocarcinoma diagnosed by histopathology.
  • Patients must be able to provide archived tumor tissues after latest treatment or fresh tumor tissues and relevant pathology report.
  • Patients whose estimated survival time is more than 3 months.
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  • Patients with at least one measurable lesion at baseline according to RECIST (Version 1.1). The lesion had not previously received surgery, radiotherapy and/or local treatment.
  • Patients with Eastern Cooperative Oncology Group(ECOG) performance status score ≤1.
  • Every woman or man with potential fertility needs to use an effective contraceptive method during the study, up to within 3 months after last drug administration.
  • Willing and able to comply with study-specified visits schedule, treatment plan, laboratory examination and other study procedures.

Who cannot join

  • Patients who are simultaneously participating in another clinical 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 or Toripalimab or Tislelizumab or its excipients.
  • Previous and concomitant drugs or treatments to be excluded like:
  • Anti-CTLA4 drug;
  • For part 1, anti-PD1 anti-PDL1 or anti-PDL2 treatment was received within 8 weeks prior to the start of the study;
  • For part 2, patients received anti-PD1, anti-PDL1 or anti-PDL2 treatment during the relapse or metastasis stage, and the time from the last treatment is short than 12 months before the first dose;
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  • Received other antitumor treatment (including chemotherapy, radiation, targeted therapy, or biotherapy), antitumor vaccine, chinese herbal medicine or proprietary medicine with anti-tumor effect, Immunosuppressant or glucocorticoid, Transfusion of PLT or RBC prior to initiation of study treatment;
  • live attenuated vaccine was received before study administration or planned during the study period.
  • Insufficient recovery from previous treatments.
  • Diseases that may affect the efficacy and safety of the investigational product, including but not limited to active infection, active autoimmune disease or autoimmune disease, primary immunodeficiency disease, any clinically significant cardiovascular disease, severe pulmonary insufficiency, organ transplantation, etc.
  • A history of other malignant diseases within 5 years before the first dose.
  • Symptomatic, active, or urgent treatment-requiring central nervous system (CNS) metastasis with imaging evidence (based on CT or MRI assessment).
  • Subjects with pleural effusion, pericardial effusion, or ascites that could not be stabilized by repeated drainage or other methods were determined by investigator.
  • Patients 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.).
  • 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

1 site in 1 country.

China1 site

  • Beijing Cancer Hospital

    Beijing

Other trials in China

About this study

Official title: An Open-Label, Phase 1 Clinical Study to Evaluate the Safety, Tolerability, PK/PD and Preliminary Efficacy of HBM4003 in Combination With Toripalimab/ Tislelizumab in Patients With Advanced NEN and Other Solid Tumors

To select RP2D/MTD of HBM4003 in combination with Toripalimab in dose confirmation part(Part 1) and use the RP2D in dose expansion part (Part 2) to evaluate the safety, tolerability, PK/PD and preliminary efficacy of in patients with advanced NEN and other solid tumors

Read the detailed description

Subjects will be treated with HBM4003 in combination with Toripalimab for up to 2 years or until confirmed disease progression, unacceptable tolerability or treatment discontinuation through withdrawal of consent occurs, whichever happens first.

This trial consists of:

  • A screening period: 28 days
  • A treatment period: no longer than 2 years (Part 1 dose escalation study or Part 2 dose expansion)
  • A post-treatment follow-up period, including 28 days and 84 days after the last dose of study drug;
  • Survival follow-up.
Being tested
HBM4003, Toripalimab, Tislelizumab
Medical subject headings
Neuroendocrine Tumors

What participants receive

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

  • HBM4003Drug

    Also called Porustobart

    Subjects will be treated with HBM4003 on Day 1 during each 21-day cycle.

  • ToripalimabDrug

    Subjects will be treated with Toripalimab on Day 1 during each 21-day cycle.

  • TislelizumabDrug

    Subjects will be treated with Tislelizumab on Day 1 during each 21-day cycle.

Study groups in NCT05167071
Study groupRoleWhat they receive
HBM4003(dose 1) and ToripalimabExperimentalArm A: HBM4003(dose 1) combined with Toripalimab in patients with advanced NEN
Receives: Drug: HBM4003; Drug: Toripalimab
HBM4003(dose 2) and ToripalimabExperimentalArm B: HBM4003(dose 2) combined with Toripalimab in patients with advanced NEN
Receives: Drug: HBM4003; Drug: Toripalimab
HBM4003 and TislelizumabExperimentalArm F: HBM4003(dose 1) combined with Tislelizumab in patients with advanced CRC
Receives: Drug: HBM4003; Drug: Tislelizumab

What is being measured

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

  1. Part 1: DLT

    Number of subjects with DLT in each dose cohort within 1 cycle (21 days) after the first drug administration

    Measured: approximate 21 days

  2. Part 1: MTD

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

    Measured: approximate 21 days

  3. Part 1: RP2D

    The recommended phase 2 dose (RP2D) of HBM4003 combined with Toripalimab

    Measured: approximate 21 days

  4. Part 2: ORR

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

    Measured: maximum 2 years

Timeline

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

  1. First posted22 Dec 2021
  2. Study start28 Dec 2021
  3. Primary completion30 Sep 2025 (estimated)
  4. Study completion30 Jun 2026 (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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
53 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05167071
Sponsor's protocol ID
4003.6
Status last verified
Apr 2025
First submitted
8 Dec 2021
Last updated
27 Apr 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Zhang P, Chen K, Yang J, Song L, Zheng F, Luo R, He Y, Li F, Yang D, Cao N, Tao X, Shen L, Lu M. Efficacy and safety of HBM4003 combined with toripalimab in refractory neuroendocrine neoplasms: a multicenter, phase II study. EClinicalMedicine. 2025 Jun 3;84:103249. doi: 10.1016/j.eclinm.2025.103249. eCollection 2025 Jun.

    PubMed 40521168

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing HBM4003, Toripalimab and Tislelizumab in people with Solid Tumors and Neuroendocrine Tumors, run by Harbour BioMed (Guangzhou) Co. Ltd. at 1 site in China.

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

Who may be eligible to take part?

The sponsor lists 10 inclusion and 15 exclusion criteria. 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: under way, not looking for participants, as of the sponsor's last update on 27 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

This study is still under way. Results are not available in the source record yet.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part 1: DLT (time frame: approximate 21 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 NCT05167071, 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 27 Apr 2025.

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