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

Status: Recruiting
Location: See all (11) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY

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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care.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.

Locations
Other Locations
Spain
Hospital Durán i Reynals - ICO L´Hospitalet
RECRUITING
Barcelona
Hospital Universitari Vall d'hebron
RECRUITING
Barcelona
Hospital Universitario 12 de Octubre
RECRUITING
Madrid
Hospital Universitario La Paz
RECRUITING
Madrid
Hospital Universitario Puerta de Hierro
RECRUITING
Madrid
Hospital Clínico Universitario Virgen de la Arrixaca
RECRUITING
Murcia
Hospital Universitario de Salamanca
RECRUITING
Salamanca
Hospital Universitario Marques de Valdecilla
RECRUITING
Santander
Hospital Universitario Virgen del Rocio
RECRUITING
Seville
Hospital de Clinico Universitario de Valencia
RECRUITING
Valencia
Hospital Universitario Miguel Servet
RECRUITING
Zaragoza
Contact Information
Primary
David Molina, PhD
d.molina@idp-pharma.com
+34669616086
Backup
Laura Nevola, PhD
l.nevola@idp-pharma.com
+34622540215
Time Frame
Start Date: 2023-06-05
Estimated Completion Date: 2026-03-22
Participants
Target number of participants: 37
Treatments
Experimental: Dose Escalation: IDP-121 0.015 Up to 0.70 mg/kg
IDP-121 will be administered as a 4-hours i.v. infusion twice a week (3 weeks on, 1 week off) on days 1, 4, 8, 11, 15 and 18 in 28-day treatment (a Cycle) (Table 4). A minimum interval of 3 days and no more than 5 days between dosing is allowed.~Patients can receive IDP-121 until disease progression, unacceptable toxicity or any other discontinuation criteria are met, or for a maximum treatment period of 1 year, whichever occurs first. Patients at the RP2D may enter the expansion phase.
Experimental: Expansion Phase: IDP-121 at RP2D
Additional 17 patients will be enrolled for treatment at the RP2D level to further study safety and evaluate efficacy. DP-121 will be administered as a 4-hours i.v. infusion twice a week (3 weeks on, 1 week off) on days 1, 4, 8, 11, 15 and 18 in 28-day treatment Patients can receive IDP-121 until disease progression, unacceptable toxicity or any other discontinuation criteria are met, or for a maximum treatment period of 1 year, whichever occurs first.
Sponsors
Leads: IDP Discovery Pharma S.L.

This content was sourced from clinicaltrials.gov

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