A Phase 1/2, First-in-Human, Multicenter, Open-Label, Dose Escalation and Dose-Expansion Study assessing safety and tolerability of Single-Agent ISB 1442 in Patients with Relapsed/Refractory Multiple Myeloma

Ichnos Sciences SA0 个研究点目标入组 121 人开始时间: 2022年6月17日最近更新: 2022年6月27日

适应症

试验速览

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•1. Male or female patients aged 18 years or older.
•2. Willing and able to provide written informed consent.
•3. Patients with pathologically confirmed and measurable multiple myeloma (MM) who have progressed on or after standard therapy.
•4. Patients must have received: a proteosome inhibitor (PI), a immune modulator (IMiD), and an anti-CD38 therapies either in combination or as a single agent; and must not be candidates for regimens known to provide clinical benefit.
•5. Body weight more than 40.0 kg.
•6. Patients must have adequate hematologic and organ function laboratory values.
•7. Left ventricular ejection fraction (LVEF) more than 45% as assessed by echocardiogram (ECHO) or multiple gated acquisition (MUGA) scan.
•8. Have a negative serum pregnancy test result at screening for women of childbearing potential.
•9. Must agree to acceptable contraception.

•1. Cannot have diagnosis of primary amyloidosis, Waldenström’s disease, smoldering multiple myeloma, POEMS syndrome, myelodysplastic syndrome, or myeloproliferative syndrome.
•2. Cannot have prior treatment or radiation within 14 days before first dose of study drug.
•3. Cannot have autologous stem cell transplantation within 12 weeks of first dose of study drug.
•4. Cannot have other investigation agent, live vaccine, or major surgery within 4 weeks of first dose of study drug.
•5. Cannot have known history of human immunodeficiency virus (HIV) infection or any other relevant congenital or acquired immunodeficiency.
•6. Cannot have history of allogeneic tissue or solid organ transplant.
•7. Cannot have history of any of congestive heart failure, unstable angina, myocardial infarction, unstable symptomatic ischemic heart disease, uncontrolled hypertension despite appropriate medical therapy, symptomatic cardiac arrhythmias, pulmonary embolism or any other serious cardiac condition within 6 months of first dose of study drug.

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