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

NCT05908409 | Recruiting Phase 1 DMC

• 1 other identifier: IDP-121-1
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 11

Brief 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).

Conditions

Multiple Myeloma (MM); Diffuse Large B-Cell Lymphoma, Not Otherwise Specified; Double Hit Lymphoma; High Grade B-Cell Lymphoma, Not Otherwise Specified; Chronic Lymphocytic Leukemia (CLL); Triple Hit Lymphoma

Outcome Measures

Primary Outcomes (3)

• Phase 1: Dose Escalation

  Maximum tolerated dose (MTD)

  Through 1 treatment cycle (each cycle is 28 days)

• Phase 1: Dose Escalation

  Recommended phase 2 dose (RP2D)

  Through 12 treatment cycles (each cylce is 28 days) or until End of Treatment, whatever occurs first

• Phase 2: Expansion Phase

  Overall Response Rate (ORR)

  Based on iwCLL 20181, IMWG 20162, and the Lugano 20143 criteria for CLL, MM and Lymphomas, respectively; assessed at the end of study (12 months)

Secondary Outcomes (5)

• Phase 2: Expansion Phase

  From disease response to disease progression, up to 12 months

• Phase 2: Expansion Phase

  From the first treatment day to day of the objective disease progression through study completion, an average of 12 months

• Phase 2: Expansion Phase

  From first treatment day to the first sign of disease progression or death from any cause assessed up to 12 months.

• Phase 2: Expansion Phase

  From first treatment day to disease progression, death, or discontinuation of treatment from any cause through study completion, an average of 12 months

• Phase 2: Expansion Phase

  From first treatment day to death from any cause, up to 12 months

Study Arms (2)

Dose Escalation: IDP-121 0.015 Up to 0.70 mg/kg

EXPERIMENTAL

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.

Drug: IDP-121

Expansion Phase: IDP-121 at RP2D

EXPERIMENTAL

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.

Drug: IDP-121

Interventions

IDP-121 DRUG

IDP-121 is a new chemical entity specifically designed to directly target cMyc protein that has demonstrated activity in multiple liquid and solid tumor cell lines and preclinical animal models

Dose Escalation: IDP-121 0.015 Up to 0.70 mg/kg; Expansion Phase: IDP-121 at RP2D

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Persistent clinically significant non-hematological toxicity related to previous treatments. The presence of alopecia and NCI-CTC grade \<2 symptomatic peripheral neuropathy is allowed.
• 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.
• 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
• Other relevant diseases or adverse clinical conditions:
• 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
• Clinically significant or active infection.
• Significant non-neoplastic liver disease (e.g., cirrhosis, active chronic hepatitis)

Sponsors & Collaborators

• IDP Discovery Pharma S.L.: lead

Study Sites (11)

Hospital Universitario Marques de Valdecilla

Santander, Cantabria, 39008, Spain

RECRUITING

Hospital Universitario de Salamanca

Salamanca, Castille and León, 37007, Spain

RECRUITING

Hospital Universitari Vall d'hebron

Barcelona, 08035, Spain

RECRUITING

Hospital Durán i Reynals - ICO L´Hospitalet

Barcelona, Spain

RECRUITING

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

RECRUITING

Hospital Universitario La Paz

Madrid, Spain

RECRUITING

Hospital Universitario Puerta de Hierro

Madrid, Spain

RECRUITING

Hospital Clínico Universitario Virgen de la Arrixaca

Murcia, 30120, Spain

RECRUITING

Hospital Universitario Virgen del Rocio

Seville, Spain

RECRUITING

Hospital de Clinico Universitario de Valencia

Valencia, Spain

RECRUITING

Hospital Universitario Miguel Servet

Zaragoza, Spain

RECRUITING

Related Links

• Sponsor´s web page

MeSH Terms

Conditions

Multiple Myeloma; Lymphoma, Large B-Cell, Diffuse; Leukemia, Lymphocytic, Chronic, B-Cell

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases; Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Lymphatic Diseases; Leukemia, B-Cell; Leukemia, Lymphoid; Leukemia; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Enrique Ocio San Miguel, MD, PhD

  Hospital Universitario Marqués de Valdecilla

  PRINCIPAL INVESTIGATOR

Central Study Contacts

David Molina, PhD

CONTACT

+34669616086; d.molina@idp-pharma.com

Laura Nevola, PhD

CONTACT

+34622540215; l.nevola@idp-pharma.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2023
• First Posted: June 18, 2023
• Study Start: June 5, 2023
• Primary Completion: December 22, 2025
• Study Completion: March 22, 2026
• Last Updated: May 1, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (11)