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Solid TumorPhase 1NCT04866485

A Study to Evaluate Safety, Tolerability, PK/PD and Preliminary Efficacy of HBM4003 Combined With Anti-PD-1 Antibody

A Phase 1 study testing HBM4003 and pembrolizumab in people with Solid Tumor, 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 The sponsor has not verified this record for over two years, so it may be out of date.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

This is an open-label, multi-center phase 1 study. The trial, consisting of Part 1a dose confirmation and Part 1b dose expansion, is designed to evaluate the safety, tolerability, PK/PD and preliminary efficacy of HBM4003 in combination with pembrolizumab in patients with advanced NSCLC and other solid tumors. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Solid Tumor
What is being tested?
HBM4003 and pembrolizumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
66 participants
Where
No sites listed yet
Study dates
14 Jun 2021to Feb 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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female patients ≥18 years old at the time of signing the informed consent and ≤ 75 years old at the time of enrollment.
  • Patients for Part 1a: patients diagnosed with advanced or recurrent solid tumors.
  • Patients for Part 1b: patients diagnosed with metastatic NSCLC and confirmed with negative tumor PD-L1 expression (TPS<1%).
  • Patients for Part 1b dose expansion study: have never received systemic therapies as primary therapy for advanced or metastatic diseases.
  • Patients must be able to provide fresh tumor tissues or archived tumor tissues.
  • 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).
  • Patients with Eastern Cooperative Oncology Group (ECOG) performance status score ≤ 1.
  • Patients whose organ function must meet the study requirements.
  • Males or females with childbearing potential need to use an effective contraceptive method.
  • Willing and able to comply with study-specified visits schedule, treatment plan, laboratory examination and other study procedures.

Who cannot join

  • NSCLC patients with EGFR-sensitive mutations or an ALK translocation based on diagnosis results.
  • 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 medical history of severe allergic diseases, a history of severe drug allergies, and are known or suspected allergy to macromolecular protein preparations or HBM4003 or pembrolizumab excipients.
  • Previous and concomitant drugs or treatments to be excluded like CTLA4, PD-1,PD-L1.
  • Insufficient completely recovery from previous treatments.
  • Diseases that may affect the efficacy and safety of the investigational product.
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  • A history of other malignant diseases within 5 years before the first dose.
  • Active brain metastasis or leptomeningeal metastasis during screening or previous with imaging evidence (based on CT or MRI assessment).
  • Patients who have received palliative radiotherapy for non-central nervous system lesions within 2 weeks before the first dose.
  • Patients who have received more than 30 Gy of lung radiation therapy within 6 months before the first dose.
  • A history of interstitial lung disease or non-infectious pneumonia.
  • Patients with pleural effusion, pericardial effusion, or ascites.
  • Patients that may have other conditions that affect the efficacy or safety evaluation of this study (such as mental disorder, alcoholism, drug abuse, etc.) .
  • Women who are pregnant or breastfeeding, or who plan to become pregnant during the study period and within 3 months after the last dose of study drug.

Trial locations and contacts

No sites are listed yet.

Xi LIU contact

+8618616529165

hbm4003public@harbourbiomed.com

Peter ZHAO contact

+8617601647910

hbm4003public@harbourbiomed.com

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 Anti-PD-1 Monoclonal Antibody in Patients With Advanced NSCLC and Other Solid Tumors

This is an open-label, multi-center phase 1 study. The trial, consisting of Part 1a dose confirmation and Part 1b dose expansion, is designed to evaluate the safety, tolerability, PK/PD and preliminary efficacy of HBM4003 in combination with pembrolizumab in patients with advanced NSCLC and other solid tumors.

Read the detailed description

subjects will be treated with HBM4003 in combination with pembrolizumab 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:
  • Part 1a dose confirmation study
  • Part 1b dose expansion study
  • A post-treatment follow-up period, including
  • A safety follow-up period: 28 days after the last dose of study drug;
  • Post-treatment follow-up visit: day 84 after the last dose of study drug;
  • Survival follow-up.
Conditions
Solid Tumor
Being tested
HBM4003 and pembrolizumab

What participants receive

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

  • HBM4003 and pembrolizumabDrug

    Also called HBM4003

    Subjects will be treated with HBM4003 and pembrolizumab on Day 1 during each 21-day cycles.

Study groups in NCT04866485
Study groupRoleWhat they receive
HBM4003+pembrolizumabExperimentalHBM4003 combined with pembrolizumab in subjects with advanced NSCLC and other solid tumors
Receives: Drug: HBM4003 and pembrolizumab

What is being measured

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

  1. Part 1a: Number of subjects with DLT in each dose group within 1 cycles (21 days) after the first drug administration

    DLT observation period was defined as one treatment cycles with a total of 21 days

    Measured: approximate 21 days

  2. Part 1b: ORR

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

    Measured: maximum 2 years

Secondary outcomes (20)

  1. Part 1a: ORR

    including proportions of subjects with complete response (CR) and partial response (PR)

    Measured: maximum 2 years

  2. Part 1a: Disease Control Rate, DCR

    including proportion of subjects with complete response (CR) and partial response (PR) and stable disease (SD)

    Measured: maximum 2 years

  3. Part 1a: 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 2 years

  4. Part 1a: 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 2 years

  5. Cmax

    Peak Plasma Concentration

    Measured: maximum 2 years

  6. Tmax

    Time to reach maximum serum concentration

    Measured: maximum 2 years

  7. AUC0-last

    Area under the plasma concentration versus time curve from time zero to last

    Measured: maximum 2 years

  8. AUC0-tau

    Area under the serum concentration versus time curve from time zero to the dosing interval tau

    Measured: maximum 2 years

  9. UC0-inf

    Area under the serum concentration versus time curve from time zero to infinity

    Measured: maximum 2 years

  10. Vss

    Volume of distribution at steady state

    Measured: maximum 2 years

  11. CL

    Clearance

    Measured: maximum 2 years

  12. t1/2

    Terminal half-life

    Measured: maximum 2 years

  13. Part 1a: Immunogenicity of HBM4003 and pembrolizumab

    including the occurrence of positive anti-drug antibodies (ADA). The occurrence of neutralizing antibodies for subjects with positive ADA

    Measured: maximum 2 years

  14. Part 1b: Number of subjects experiencing at least one treatment-related AE

    Evaluate safety

    Measured: maximum 2 years

  15. Part 1b: DCR

    including proportion of subjects with CR, PR and SD

    Measured: maximum 2 years

  16. Part 1b: DOR

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

    Measured: maximum 2 years

  17. Part 1b: DDC

    for subjects with CR, PR or SD, calculate the duration from the time of initial medication to the day of disease progression or (for any reason) death

    Measured: maximum 2 years

  18. Part 1b: Overall survival (OS)

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

    Measured: maximum 2 years

  19. Part 1b: Progression-free survival (PFS)

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

    Measured: maximum 2 years

  20. Part 1b: Immunogenicity of HBM4003 and pembrolizumab

    including the occurrence of positive anti-drug antibodies (ADA). The occurrence of neutralizing antibodies for subjects with positive ADA.

    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 posted29 Apr 2021
  2. Study start14 Jun 2021 (estimated)
  3. Primary completionFeb 2023 (estimated)
  4. Study completionFeb 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
66 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04866485
Sponsor's protocol ID
4003.3
Status last verified
Apr 2021
First submitted
26 Apr 2021
Last updated
29 Apr 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing HBM4003 and pembrolizumab in people with Solid Tumor, 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?

The sponsor lists 11 inclusion and 14 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: status not confirmed, as of the sponsor's last update on 29 Apr 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 Xi LIU (+8618616529165, hbm4003public@harbourbiomed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part 1a: Number of subjects with DLT in each dose group within 1 cycles (21 days) after the first drug administration (time frame: approximate 21 days). The study lists 2 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 NCT04866485.

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 Apr 2021.

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