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Trial record 1 of 1 for:    HBM4003
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A Study Evaluating the Safety, Tolerance and Anti-tumor Activity of a Study Drug in Subjects With Advanced Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04135261
Recruitment Status : Recruiting
First Posted : October 22, 2019
Last Update Posted : January 13, 2020
Information provided by (Responsible Party):
Harbour BioMed US, Inc.

Brief Summary:
This is a study to evaluate the safety and tolerability of the study drug HBM4003, and to determine the maximum tolerated dose and/or recommended Phase 2 study dose of HBM4003. Participants will receive 3 escalating doses of HBM4003, with the possibility of a fourth, higher dose level following review by a Safety Committee. The study will also look at the anti-tumor activity of HBM4003.

Condition or disease Intervention/treatment Phase
Advanced Solid Tumor Drug: HBM4003 Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1 Open-label, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Anti-tumor Activity of HBM4003 in Subjects With Advanced Solid Tumors
Actual Study Start Date : September 24, 2019
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : February 2022

Arm Intervention/treatment
Experimental: HBM4003
Up to 4 (28 day) cycles of treatment with the potential for a higher dose to be administered in each of cycle 2 and cycle 4.
Drug: HBM4003
Intravenous (IV) administration on days 1, 8, 15 and 22 of a 28-day treatment cycle.

Primary Outcome Measures :
  1. Proportion of subjects with Dose-Limiting Toxicity (DLT) [ Time Frame: From Day 1 until disease progression or Day 28 ]
    Number of subjects who experience DLT events during 28 days after first administration of HBM4003, divided by the number of DLT-evaluable subjects

Secondary Outcome Measures :
  1. Objective Response Rate [ Time Frame: Up to 28 months ]
    Proportion of subjects with best overall response of complete response (CR) or partial response (PR) per RECIST 1.1 and per Response Criteria for Use in Trials Testing Immunotherapeutics (iRECIST)

  2. Duration of response [ Time Frame: Up to 28 months ]
    Time interval from first occurrence of a documented objective response to the time of disease progression, as determined by the Investigator using RECIST 1.1 or death from any cause, whichever comes first.

  3. Disease control rate [ Time Frame: Up to 28 months ]
    Proportion of subjects with a best overall response of complete response (CR), partial response (PR) or stable disease (SD).

  4. Duration of disease control [ Time Frame: Up to 28 months ]
    Time from data of start of treatment to the date of disease progression or death for subjects who had CR or PR or SD during treatment.

  5. Tumor shrinkage (The percentage of patients with tumor shrinkage) [ Time Frame: Up to 28 months ]
    Greatest tumor shrinkage achieved at any follow-up assessment. Measured by radiological (computed tomography [CT]/Magnetic Resonance Imaging [MRI]) scanning until documented radiographic disease progression according to RECIST 1.1, or loss of clinical benefit after disease progression according to RECIST 1.1

  6. Cmax (Maximum serum concentration) [ Time Frame: Up to 28 months ]
  7. Tmax (Time to reach maximum serum concentration) [ Time Frame: Up to 28 months ]

  8. AUC0-tau (Area under the serum concentration versus time curve from time zero to the dosing interval tau [ Time Frame: Up to 28 months ]
  9. AUC0-inf (Area under the serum concentration versus time curve from time zero to infinity [ Time Frame: Up to 28 months ]
  10. t1/2 (Terminal half-life) [ Time Frame: Up to 28 months ]
  11. Clearance (CL) [ Time Frame: Up to 28 months ]
  12. Vss (Volume of distribution at steady state) [ Time Frame: Up to 28 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Signed informed consent form and willingness to comply study requirements.
  • Confirmed advanced solid tumors that have progressed after treatment with standard therapies, or for which no effective standard therapy is available, or the subject refuses or has a contraindication to standard therapy.
  • Adequate organ and bone marrow function.
  • Females of childbearing potential may participate provided they agree to practice abstinence; and, if heterosexually active, agree to use at least 2 highly effective contraceptive methods throughout the study and for 3 months following the last dose of study drug; and have a negative serum pregnancy test.
  • Females of non-childbearing potential must be post-menopausal or have been surgically sterilized.
  • Male subjects with a female partner of childbearing potential must agree to practice abstinence or to use a physician-approved contraceptive method throughout the study and for 3 months following the last does of study drug.

Exclusion Criteria:

  • Participation in another clinical study at the same time.
  • History of severe allergic diseases, history of severe drug allergy, or are known to be allergic to macromolecular protein preparations or any component of the study drug.
  • Receipt of anticancer medications or investigational drugs within the following intervals before the first administration of the study drug:

    1. CTLA-4 antibody within 6 weeks of study drug administration;
    2. Any PD-1 or PD-L1 or Programmed cell death protein ligand 2 (PDL2)-directed antibody within 4 weeks of study drug administration;
    3. Any other anticancer therapy within 2 weeks of the start of the study;
    4. Anti-tumor vaccines within 3 months prior to study drug administration;
    5. Live vaccine within 4 weeks prior to study drug administration or planned live vaccine during study period;
    6. Corticosteroids (>10 mg daily prednisone equivalent) or other immunosuppressive medications within 2 weeks of study drug administration; Nasal spray, inhalation, topical corticosteroids or physiological doses of systemic corticosteroids are not included.
  • Major surgical procedure(s) within 28 days prior to first dose of study drug.
  • Failure to recover from any immune-related toxicity from prior cancer therapy, or any other toxicity related to previous anticancer treatment, with the exception of alopecia.
  • Combination medication or treatments to be excluded:

    1. Any concurrent chemotherapy, radiotherapy, immunotherapy, or biological therapy for cancer treatment. Concurrent use of hormones on a stable dose for non-cancer related conditions is acceptable. Androgen deprivation therapy (ADT) for advanced prostate cancers is acceptable. Local treatment of isolated non-target lesions for palliative intent is acceptable;
    2. Any traditional anti-tumor herbal medications;
    3. Receipt of red blood cells or platelets infusion, granulocyte colony stimulating factor (G-CSF) or granulocyte monocyte colony stimulating factor (GM-CSF) within 1 week of the first dose of study drug.
  • Have other diseases that may affect the effectiveness and safety of the study drug, such as:

    1. Known brain metastases or other central nervous system metastases that is either symptomatic or untreated, that requires concurrent treatment;
    2. Active infection requiring treatment of antibiotics within 14 days prior to first dose of study drug;
    3. Known history of infection of human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS), human T lymphotropic virus 1, hepatitis B virus, or active hepatitis C virus;
    4. Active known or suspected autoimmune disease or a history of autoimmune disease, including but not limited to inflammatory bowel disease, autoimmune hepatitis, Guillain-Barre syndrome.
    5. Known primary immunodeficiency;
    6. Sever diarrhea, active gastrointestinal bleeding, or a history of Gastrointestinal perforation, acute diverticulitis, intra-abdominal abscess or gastrointestinal obstruction;

    (b) Have received allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation, or have received autologous hematopoietic stem cell transplantation within 3 months prior to the first dose of study drug.

  • Subjects with major cardiovascular disease.
  • History of other uncured malignant diseases, except for non-melanoma skin cancer in situ, superficial bladder cancer, cervical cancer in situ that has been curatively resected, and localized prostate cancer managed by active surveillance.
  • Pregnant or breastfeeding women.

Other protocol-defined inclusion/exclusion criteria may apply.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04135261

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Contact: Maria +86 021-5339-9017
Contact: Alma +86 021-5339-9017

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Australia, New South Wales
St. George Private Hospital, 1 South Street Recruiting
Kogarah, New South Wales, Australia, 2217
Contact: Amanda Idan    +61 02 8594 5785   
Macquarie University, 2 Technology Place Not yet recruiting
Macquarie, New South Wales, Australia, 2109
Australia, Victoria
Monash Health, Monash Medical Centre, 246 Clayton Road Recruiting
Clayton, Victoria, Australia, 3168
Contact: Penny Macquire    +61 03 8572 2429   
The Alfred Hospital, Commercial Road Not yet recruiting
Melbourne, Victoria, Australia, 3004
Sponsors and Collaborators
Harbour BioMed US, Inc.
Additional Information:
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Responsible Party: Harbour BioMed US, Inc. Identifier: NCT04135261    
Other Study ID Numbers: 4003.1
First Posted: October 22, 2019    Key Record Dates
Last Update Posted: January 13, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Data generated by this study will be considered confidential by the Investigator, except to the extent that it is included in a publication. The general strategy regarding publication of the study will be mutually agreed upon by the Investigator and Sponsor. The Sponsor reserves the right to manage the publication of all study results. The Investigator agrees that oral and written communication to third parties of any procedures or results from the study is subject to prior written consent of the Sponsor. Presentation material and/or manuscript(s) for publication will be reviewed by the Sponsor prior to submission for publication. Alterations in the material will only be made in agreement between the Investigator and the Sponsor.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Harbour BioMed US, Inc.:
advanced solid tumors
Additional relevant MeSH terms:
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