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

ConditionsMultiple Myeloma (MM)Diffuse Large B-Cell Lymphoma, Not Otherwise SpecifiedDouble Hit LymphomaHigh Grade B-Cell Lymphoma, Not Otherwise SpecifiedChronic Lymphocytic Leukemia (CLL)Triple Hit Lymphoma
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorIDP Discovery Pharma S.L.

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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).

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.

Trial design

Design model

Sequential

Treatments tested in this trial

  • 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

Treatment groups

37 Participants
are divided into 2 treatment groups
Group A: Dose Escalation: IDP-121 0.015 Up to 0.70 mg/kgExperimental treatment 1 intervention
Group B: Expansion Phase: IDP-121 at RP2DExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Phase 1: Dose Escalation

Maximum tolerated dose (MTD)

Time frame
Through 1 treatment cycle (each cycle is 28 days)
2

Phase 1: Dose Escalation

Recommended phase 2 dose (RP2D)

Time frame
Through 12 treatment cycles (each cylce is 28 days) or until End of Treatment, whatever occurs first
3

Phase 2: Expansion Phase

Overall Response Rate (ORR)

Time frame
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

1

Phase 2: Expansion Phase

Duration of response (DoR)

Time frame
From disease response to disease progression, up to 12 months
2

Phase 2: Expansion Phase

Time to progression (TTP)

Time frame
From the first treatment day to day of the objective disease progression through study completion, an average of 12 months
3

Phase 2: Expansion Phase

Progression-free survival (PFS)

Time frame
From first treatment day to the first sign of disease progression or death from any cause assessed up to 12 months.
4

Phase 2: Expansion Phase

Event-free survival (EFS)

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

IDP Discovery Pharma S.L.

Lead sponsor

Source ClinicalTrials.gov
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