A Study Evaluating the Safety Tolerance and Anti-tumor Activity of a Study Drug in Subjects With Advanced Solid Tumors

  • End date
    Feb 20, 2022
  • participants needed
  • sponsor
    Harbour BioMed US Ltd.
Updated on 20 January 2020
Primary Contact
Macquarie University, 2 Technology Place (1.3 mi away) Contact
+1 other location
serum pregnancy test
solid tumour


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.

Treatment HBM4003
Clinical Study IdentifierNCT04135261
SponsorHarbour BioMed US Ltd.
Last Modified on20 January 2020

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Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have Advanced Solid Tumor?
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
CTLA-4 antibody within 6 weeks of study drug administration
Any PD-1 or PD-L1 or Programmed cell death protein ligand 2 (PDL2)-directed antibody within 4 weeks of study drug administration
Any other anticancer therapy within 2 weeks of the start of the study
Anti-tumor vaccines within 3 months prior to study drug administration
Live vaccine within 4 weeks prior to study drug administration or planned live vaccine during study period
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
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
Any traditional anti-tumor herbal medications
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
Known brain metastases or other central nervous system metastases that is either symptomatic or untreated, that requires concurrent treatment
Active infection requiring treatment of antibiotics within 14 days prior to first dose of study drug
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
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
Known primary immunodeficiency
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
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