IDP-121 for Chronic lymphocytic leukemia | B-cell lymphoma | Multiple myeloma

Inclusion criteria

• {"criterion_text":"- Age ≥18 years\n- Performance status (ECOG) ≤ 2\n- Life expectancy ≥3 months\n- Patient is, in the investigator’s opinion, willing and able to comply with the protocol requirements.\n- Patient has given voluntary written informed consent before performance of any studyrelated procedure not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care.\n- Patients diagnosed with chronic lymphocytic leukemia (CLL), B-cell lymphomas, and multiple myeloma (MM) who are ineligible to receive the available treatments.\n- Adequate hematological or biochemical parameters as specified below a. Hemoglobin > 8.0 g/dl (without transfusion support within 7 days) b. 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. c. Absolute neutrophil count (ANC) > 0.75 x109/L (without G-CSF support within 7 days) d. 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) e. 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) f. Total bilirubin: < 2 x the upper limit range. g. Calculated or measured creatinine clearance: >30 mL/min (calculated from the Cockcroft-Gault formula).\n- Left ventricular ejection fraction > 50% or above the Institutional Lower Limit of Normal (LLN), whichever is lower, determined by echocardiogram."}

Exclusion criteria

• {"criterion_text":"- Persistent clinically significant non-hematological toxicity related to previous treatments. The presence of alopecia and NCI-CTC grade <2 symptomatic peripheral neuropathy is allowed.\n- 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).\n- Concomitant anti-tumor therapy within 14 days prior to Day 1 of Cycle 1.\n- Prior allogeneic transplantation in the last 3 months or currently active GVHD with immunosuppressive treatment\n- Limitation of the patient’s ability to comply with the treatment or follow-up protocol.\n- 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”).\n- Pregnant or lactating women; men and women of reproductive potential 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).\n- History of any other neoplastic disease in the last five years (except basal cell carcinoma, skin epithelioma or carcinoma in situ of any site)\n- History of clinically significant hypotension.\n- History of clinically significant allergic or hyper-sensitivity reactions.\n- 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\n- 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\n- Clinically significant or active infection.\n- Significant non-neoplastic liver disease (e.g., cirrhosis, active chronic hepatitis)"}

Primary endpoints

• {"endpoint_text":"- Maximum tolerated dose (MTD): based on the incidence of DLTs observed at the end of Cycle 1 (28 days).","definition_or_measurement_approach":"Based on the incidence of dose-limiting toxicities (DLTs) observed at the end of Cycle 1 (28 days)."}
• {"endpoint_text":"- Recommended phase 2 dose (RP2D): dose used in subsequent Expansion phase. The RP2D will be determined in discussion with the Investigators and the Sponsor based on safety (dose limiting toxicity), PK, PD, and any cumulative toxicity after multiple cycles.","definition_or_measurement_approach":"RP2D determined by assessment of safety (DLTs), pharmacokinetics (PK), pharmacodynamics (PD), and cumulative toxicity after multiple cycles, in discussion between investigators and sponsor."}
• {"endpoint_text":"- Overall response rate (ORR) for CLL, MM and Lymphomas, respectively.","definition_or_measurement_approach":"ORR assessed per disease-specific response criteria/guidelines for CLL, multiple myeloma and B-cell lymphomas."}

Secondary endpoints

• {"endpoint_text":"- Duration of response (DoR), defined as the time from documentation of disease response to disease progression.","definition_or_measurement_approach":"Time from documentation of disease response to disease progression."}
• {"endpoint_text":"- Time to progression (TTP), time from the first treatment day to objective disease progression; does not include deaths.","definition_or_measurement_approach":"Time from first treatment day to objective disease progression; deaths are not counted as events for this endpoint."}
• {"endpoint_text":"- Progression-free survival (PFS) defined as the interval between the first treatment day to the first sign of disease progression or death from any cause.","definition_or_measurement_approach":"Interval from first treatment day to first sign of disease progression or death from any cause."}
• {"endpoint_text":"- Event-free survival (EFS) defined as the interval time between the first treatment day to disease progression, death, or discontinuation of treatment from any cause (e.g., toxicity, patient preference, or initiation of a new treatment without documented progression).","definition_or_measurement_approach":"Interval from first treatment day to disease progression, death, or treatment discontinuation for any cause."}
• {"endpoint_text":"- Overall survival (OS) defined as the interval between the first treatment day to death from any cause.","definition_or_measurement_approach":"Interval from first treatment day to death from any cause."}
• {"endpoint_text":"- Safety endpoints: Vital signs, Physical examination, Hematology, Biochemistry, Urinalysis, Electrocardiograms (ECG), All grades AEs and SAEs","definition_or_measurement_approach":"Safety assessed by monitoring vital signs, physical examinations, laboratory tests (hematology, biochemistry, urinalysis), ECGs, and recording of adverse events (all grades) and serious adverse events."}
• {"endpoint_text":"- Pharmacokinetics parameters: AUClast, Cmax, CL, Css, Ctrough, Ke, t1/2, Tmax, Vd","definition_or_measurement_approach":"Standard PK parameters measured from plasma concentration-time data: AUClast, Cmax, clearance (CL), steady-state concentrations (Css), Ctrough, elimination rate constant (Ke), half-life (t1/2), Tmax, and volume of distribution (Vd)."}

Spain

Earliest CTIS Part Ii Submission Date

08-11-2024

Latest Decision Or Authorization Date

30-12-2024

Processing Time Days

52

Number Of Sites

12

Number Of Participants

62

Primary sponsor

Full Name

Idp Discovery Pharma S.L.

Organisation Type

Pharmaceutical company

Country Of Registered Address

Spain