NL-OMON50321撤回不适用
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 - HBM4003.1
Harbour BioMed0 个研究点目标入组 7 人开始时间: 待定最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 入组人数
- 7
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 64（—）
入选标准
- •1. Subject with HBV negative will be allowed.
- •a. If the subject has positive HBsAg, he/she should receive appropriate
- •antiviral therapy for hepatitis B virus (HBV) according to institutional
- •standard of care and HBV DNA level must be < 2000 UI/ml.
- •b. Negative HBsAg and positive HBcAb (past HBV), HBV DNA level must be <2000
- •UI/ml and the patient should be monitored for viral re-activation during the
- •2. Subject with positive HCV-Ab should be tested HCV-RNA and could be enrolled
- •if HCVRNA titer is negative and should be monitored during the study.
- •3. Must have at least one measurable lesion at baseline based on Response
- •Evaluation Criteria in Solid Tumors (RECIST) 1.1.
- •4. Must undergo tumor biopsy or provide archived tumor samples at screening.
- •5. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
- •6. Adequate organ and bone marrow function, defined as:
- •a. Absolute neutrophil count *1×109/L, hemoglobin *9 g/dL, and platelet count
- •*50×109/L.
- •b. Adequate liver function defined as
- •* AST and ALT *2.5×upper limit of normal (ULN) and total bilirubin (TBIL)
- •*1.5×ULN;
- •* For subjects with liver metastases, ALT and AST * 5×ULN and TBIL * 2×ULN;
- •* For subjects with Gilbert syndrome, TBIL * 2×ULN.
- •c. Adequate renal function defined as creatinine clearance rate * 45mL/min
- •according to Cockcroft-Gault.
- •7. Subjects of reproductive potential must be willing to use adequate
- •contraception during the course of the study and through 3 months after the
- •last dose of HBM4003.
- •a. Females of childbearing potential may participate, providing they meet the
- •following conditions:
- •* Agree to practice abstinence; and If heterosexually active, agree to use at
- •least 2 highly effective contraceptive methods (oral, injectable, or
- •implantable hormonal contraceptive; tubal ligation; intra-uterine device;
- •barrier contraceptive with spermicide; or vasectomized partner) throughout the
- •study, and for 3 months following the last dose of IP; and
- •* Have a negative serum pregnancy test (sensitivity of at least 25 mIU/mL)
- •within 7 days prior to starting study therapy (note that the screening serum
- •pregnancy test can be used as the test prior to starting study therapy if it is
- •performed within the 7-day timeframe).
- •b. Or must be a female of non-childbearing potential, defined as:
- •* Postmenopausal (i.e., *1 year without any menses) prior to Screening Visit, or
- •* Documented surgically sterile (*1 month prior to Screening Visit).
- •c. Male subjects with a female partner of childbearing potential must agree to
- •* Abstinence or to the use of a physician-approved contraceptive method
- •throughout the course of the study and avoid fathering a child during the
- •course of the study and for 3 months following the last dose of IP.
- •8. Life expectancy of*12 weeks (as determined by the investigator which could
- •be estimated according to the tumor burden, general conditions and function of
- •the organs of the patient)
- •Part 2 (Dose-Expansion Stage):
- •Male or female subject aged *18 years at the time of screening who has signed
- •the ICF prior to the initiation of any study-specific procedures and are
- •willing and able to comply with scheduled visits and other requirements of the
- 另有 2 项未显示
排除标准
- •1. History of severe or not under well controlled allergic diseases, history of
- •severe drug allergy, or are known to be allergic to macromolecular protein
- •preparations or any component of HBM4003
- •2. Subject receiving the following anti-cancer medications or investigational
- •drugs will be excluded:
- •a. Cytotoxic T lymphocyte-associated antigen-4 (CTLA-4) antibody or any CTLA-4
- •bispecific antibody before the first dose of HBM4003;
- •b. Programmed cell death protein 1 (PD-1)/Programmed cell death protein ligand
- •1 (PD-L1)/Programmed cell death protein ligand 2 (PD-L2)-directed antibody
- •within 8 weeks of first dose of HBM4003
- •c. Cancer vaccines within 3 months prior to first dose of HBM4003
- •d. Live vaccine within 4 weeks prior to first dose of HBM4003
- •e. Any other anti-cancer therapy within 2 weeks prior to first dose of HBM4003
- •3. Not yet recovered from surgery or (immune-related) toxicity related with
- •previous treatment
- •* Subject who has had major surgical procedure(s) within 28 days prior to the
- •first dose of HBM4003, or not yet recovered from a previous surgical procedure
- •4. Failed to recover from any immune-related toxicity from prior cancer therapy
- •to * Grade 1 prior to screening for this study
- •5. Concomitant medication or treatment
- •a. 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 for
- •advanced prostate cancers is acceptable. Local treatment of isolated non-target
- •lesions for palliative intent is acceptable
- •b. Any traditional anti-tumor herbal medications (for example, semen coicis and
- •glaucescent fissistigma root are considered to have anti-tumor effect according
- •to the Traditional Chinese Medicine Pharmacopoeia of Chinese Pharmacopoeia);
- •c. 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 IP
- •d. Received treatment with corticosteroids or other immunosuppressive
- •medications within 2 weeks before the first dose of HBM4003
- •6. Have concomitant diseases that may affect the treatment efficacy and safety
- •a. Known brain metastases or other central nervous system metastases that are
- •either symptomatic or untreated that require concurrent treatment, inclusive of
- •but not limited to surgery, radiation, and/or corticosteroids. Subjects with
- •previously treated brain metastases may participate provided they are
- •clinically stable for at least 4 weeks prior to study entry, have no evidence
- •of new or enlarging metastases, and are on a stable dose of steroids of total
- •daily dose of <1.5 mg/kg of dexamethasone
- •b. Active infection that requires treatment with antibiotics within 14 days
- •prior to first dose of HBM4003
- •c. Known history of infection with human immunodeficiency virus or known AIDS
- •d. autoimmune disease, including but not limited to inflammatory bowel disease,
- •autoimmune hepatitis, Guillain-Barré syndrome, demyelinating lesions, extensive
- •dermatitis, immune-related interstitial pneumonia or Grave*s disease requiring
- •antithyroid drugs
- •e. Known primary immunodeficiency
- •f. Clinically significant gastrointestinal disorders
- 另有 1 项未显示
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