A Phase 1/2 Study of IDP-121 in Patients With Relapsed/Refractory Hematologic Malignancies

A vizsgálat adatai

Ki végzi

IDP Discovery Pharma S.L.

Azonosító

NCT05908409

A regiszteradat frissítve

2025. május 1.

Eredeti leírás

The main aims of this 2-part study are:A teljes eredeti leírásKevesebb

A Phase 1/2 Multicenter, Open-label, Dose-escalation Study of IDP-121 in Patients With Relapsed/Refractory Hematologic Malignancies (CASSANDRA)

The main aims of this 2-part study are:

* Phase I: To determine the maximum tolerated dose (MTD) and the recommended phase 2 dose (RP2D) of IDP-121 in patients with multiple myeloma (MM), diffuse large B cell lymphoma not otherwise specified (DLBCL-NOS), high-grade B cell lymphoma with double or triple hit rearrangement (HGBL-DH/TH) and HGBL-NOS, and chronic lymphocytic leukemia (CLL). * Phase II: To evaluate the overall response rate (ORR), duration of response (DoR), time to progression (TTP), progression-free survival (PFS), event-free survival (EFS) and Overall survival (OS), in patients with MM, DLBCL-NOS, HGBL-DH/TH, HGBL-NOS or CLL treated with IDP-121 at the recommended Phase 2 Dose (RP2D).

Bevonási feltételek: Age ≥18 years; Performance status (ECOG) ≤ 2; Life expectancy ≥3 months; Patient is, in the investigator's opinion, willing and able to comply with the protocol requirements; Patient has given voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care; Patients diagnosed with chronic lymphocytic leukemia (CLL), B-cell lymphomas, and multiple myeloma (MM) who are ineligible to reveive the available treatments; Adequate hematological or biochemical parameters as specified below; Hemoglobin > 8.0 g/dl (without transfusion support within 7 days); Platelets count > 75 x109/L (without transfusional support within 7 days). In patients with bone marrow infiltration, the platelets count may be ≥50 x109/L; Absolute neutrophil count (ANC) > 0.75 x109/L (without G-CSF support within 7 days); Aspartate transaminase (AST): <2.5 x the upper limit range (in patients with no liver metastases or <5 x ULN in patients with liver metastases); Alanine transaminase (ALT): < 2.5 x the upper limit range (in patients with no liver metastases or <5 x ULN in patients with liver metastases); Total bilirubin: < 2 x the upper limit range; Calculated or measured creatinine clearance: >30 mL/min (calculated from the Cockcroft-Gault formula); Left ventricular ejection fraction > 50% or above the Institutional Lower Limit of Normal (LLN), whichever is lower, determined by echocardiogram.

Kizáró feltételek: Persistent clinically significant non-hematological toxicity related to previous treatments. The presence of alopecia and NCI-CTC grade <2 symptomatic peripheral neuropathy is allowed; Other relevant diseases or adverse clinical conditions:; Congestive heart failure or angina pectoris, myocardial infarction within 12 months before inclusion in the study; Uncontrolled arterial hypertension or cardiac arrhythmias (i.e., requiring a change in medication within the last 3 months or hospital admission within the past 6 months); History of significant neurological or psychiatric disorders; The patient is known to be human immunodeficiency virus (HIV) positive, unless the patient is on antiviral therapy with HIV RNA levels <50 copies/mL; Hepatitis B surface antigen-positive or active hepatitis C infection, unless treated with undetectable hepatitis B DNA or hepatitis C RNA levels; or active CMV infection (IgM positive); Concomitant anti-tumor therapy within 14 days prior to Day 1 of Cycle 1; Prior allogeneic transplantation in the last 3 months or currently active GVHD with immunosuppressive treatment; If a COVID-19 vaccine is administered, it should be done >72 hours prior to study treatment initiation or after the completion of the dose-limiting toxicity (DLT) period (if patient is participating in the dose-escalation phase"); History of any other neoplastic disease in the last five years (except basal cell carcinoma, skin epithelioma or carcinoma in situ of any site); History of clinically significant hypotension; History of clinically significant allergic or hyper-sensitivity reactions; History or known clinically significant vascular disease or known high risk of vascular disease (as assessed by the treating physician) including (but not limited to):; Thromboembolism; Peripheral arterial disease; Vasculitis; Clinically significant or active infection; Significant non-neoplastic liver disease (e.g., cirrhosis, active chronic hepatitis); Pregnant or lactating women; men and women of reproductive potential* (as defined in the Appendix 2) who are not using effective contraceptive methods (combined hormonal contraception associated with inhibition of ovulation; progestogen-only hormonal contraception associated with inhibition of ovulation, intrauterine device, intrauterine hormone-releasing system, bilateral tubal occlusion, vasectomised partner, sexual abstinenence); *A woman is considered of childbearing potential (WOCBP), i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile. A man is considered fertile after puberty unless permanently sterile by bilateral orchidectomy; Limitation of the patient's ability to comply with the treatment or follow-up protocol.

ClinicalTrials.gov NCT05908409