A Phase 1/2 Open-label, Multicenter, Dose Escalation and Dose Expansion Study of the Safety, Tolerability, and Pharmacokinetics of HPN217 in Patients with Relapsed/Refractory Multiple Myeloma

Harpoon Therapeutics, Inc.0 个研究点目标入组 114 人开始时间: 2020年5月15日最近更新: 2021年12月21日

适应症

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方: Harpoon Therapeutics, Inc.
入组人数: 114

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

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研究设计

研究类型: Interventional clinical trial of medicinal product

入排标准

性别: All

入选标准

•1. Able to read, understand and provide written informed consent.
•2. Patients =18 years of age at the time of signing informed consent.
•3. Documented RRMM for which no standard therapy options are
•anticipated to result in a durable remission. Relapse defined as
•progressive disease after initial response (minimal response [MR] or
•better) to previous treatment, more than 60 days after cessation of last
•treatment. Refractory disease defined as <25% reduction in M-protein or
•progression of disease during treatment or within 60 days after
•cessation of treatment.
•4. Received at least 3 prior therapies (including proteasome inhibitor,
•immune-modulatory drug, and an anti-CD38 antibody; patients should
•not be a candidate for or be intolerant of all established therapies known to provide clinical benefit in multiple myeloma).
•5. Measurable disease defined as at least one of the following:
•a. Serum M-protein =0.5 g/dL
•b. Urine M-protein =200 mg/24 hours
•c. Serum free light chain (FLC) assay: Involved FLC level =10 mg/dL (=
•100 mg/L) and an abnormal serum FLC ratio (<0.26 or >1.65)
•6. Eastern Cooperative Oncology Group (ECOG) performance status =2.
•7. Adequate hematologic status, including:
•a. ANC =1000 cells/µL
•b. Platelet count =50,000/µL (without transfusions)
•c. Hemoglobin =8 g/dL
•Note: To meet all above hematological criteria (Inclusion Criteria 7a
•through 7c), transfusions and supportive therapy (e.g., granulocyte colony stimulating factors) may be administered prior to Screening.
•However, in all such instances, levels of the relevant parameters (for which the patient was transfused) must be allowed to stabilize for at least 72 hours after
•dosing/infusion, after which Screening labs may be redrawn.
•8. Adequate renal function, including:
•a. Calculated creatinine clearance =30 mL/min using the formula of Cockcroft and Gault
•9. Adequate liver function, including:
•a. Total bilirubin =1.5 × upper limit of normal (ULN), regardless of direct bilirubin
•b. Aspartate and alanine aminotransferase (AST and ALT) =3.0 × ULN (= 5.0× ULN if due to myeloma involvement)
•c. Alkaline phosphatase =3.0× ULN (=5.0× ULN if due to myeloma involvement)
•10. Serum calcium (corrected for albumin) at or below the ULN range; patient may enroll with hypercalcemia at Screening if hypercalcemia resolves with standard treatment by Cycle 1 Day 1, prior to study therapy initiation.
•11. Resolved acute effects of any prior therapy to baseline severity or CTCAE version 5.0 Grade =1.
•12. Willing to complete all scheduled visits and assessments at the institution administering therapy.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 100
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 14

排除标准

•1. Plasma cell leukemia; non-secretory myeloma (e.g., solitary plasmacytoma)
•2. Patients with only extramedullary relapse of multiple myeloma who do not meet Inclusion Criterion 5 for measurable disease.
•3. POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin changes)
•4. Waldenstrom's macroglobulinemia
•5. Localized radiation therapy to disease site(s) within 2 weeks of treatment
•6. Prior autologous peripheral stem cell transplant or prior autologous bone marrow transplantation within <90 days of the start of study
•7. Prior allogeneic stem cell transplantation or solid organ transplantation within 12 months of Screening. However, any patient receiving immunosuppressive medication will be excluded
•8. Prior corticosteroid use within <2 weeks of treatment, with the exception of topical or temporary use (=20 mg/day for no more than 5 days total), which may be allowed after approval by the CRO Medical Monitor
•9. Known central nervous system involvement by multiple myeloma
•10. Untreated spinal cord compression
•11. Concurrent treatment with anti-TNFa therapies, or other immune
•suppressive drugs within the 2 weeks prior to Screening
•12. History of clinically significant cardiovascular disease, unstable angina pectoris, recent myocardial infarction, congestive heart failure, uncontrolled cardiac arrhythmia, history of cerebral vascular accident, transient ischemic attack, or other co-morbid condition that in the opinion of the investigator would compromise the patient's safety or interfere with the evaluation of the safety of HPN217. Participants with cardiovascular disease that is stable for at least 6 months while on
•treatment may be enrolled after documenting evaluation and approval of trial participation by a cardiologist.
•13. Known congestive heart failure (New York Heart Association Class 3)
•14. History of any thromboembolic event within 3 months prior to first dose of HPN217
•15. Active infectious disease requiring treatment within 2 weeks of Screening
•16. Active or chronic hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) infection
•17. Clinically active or chronic liver disease, including liver cirrhosis of Child-Pugh class C
•18. Other malignancy within 3 years of Screening (except basal cell or squamous cell carcinoma of the skin or carcinoma in situ treated with curative therapy)
•19. Last anticancer treatment within 2 weeks of scheduled dosing (or 5 half-lives of drug, whichever is shorter)
•20. Major surgery within 4 weeks of scheduled dosing
•21. Pulmonary, hematologic, renal, hepatic, gastrointestinal, neurological or psychiatric disease that would limit compliance with study requirements
•22. Any serious underlying medical or psychiatric condition (e.g., alcohol or drug abuse), dementia or altered mental status or any issue that would impair the ability of the patient to understand informed consent or that in the opinion of the Investigator would contraindicate the patient's participation in the study or confound the results of the study
•23. Known hypersensitivity, allergies, or intolerance to immunoglobulins, or to any excipient contained in HPN217 (see Investigator's Brochure)
•24. Treatment with another investigational drug within 4 weeks before start of study treatment or concomitantly with this study
•25. Patient has unresolved AEs =Grade 2 (National Cancer Institute [NCI] CTCAE version 5.0) except for:
•a. Alopecia
•b. Known peripheral neuropathy (peripheral neuropathy =Grade

研究者

发起方

Harpoon Therapeutics, Inc.

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