IDP-023 as a Single Agent and in Combination With Antibody Therapies in Patients With Advanced Hematologic Cancers

NCT06119685 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: Indapta-Trial-1
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 12

Brief Summary

This is an open label, Phase 1/2, first-in-human, multiple ascending dose, and dose-expansion study of IDP-023 administered as a single agent and in combination with or without interleukin-2 (IL-2), and with or without isatuximab, daratumumab or rituximab to evaluate the safety, tolerability and preliminary antitumor activity in patients with advanced hematologic cancers.

Conditions

NHL; Multiple Myeloma; Blood Cancer; Refractory Non-Hodgkin Lymphoma; Relapsed Non-Hodgkin Lymphoma; Refractory Multiple Myeloma; Relapsed Multiple Myeloma

Keywords

Advanced Hematologic Cancers

Outcome Measures

Primary Outcomes (8)

• Incidence of adverse events (AEs) and serious adverse events (SAEs) - (Phase 1)

  Escalation Period

  1 year

• Incidence of dose-limiting toxicities (DLTs) of IDP-023 Monotherapy - (Phase 1)

  Escalation Period

  up to 21 days

• Nature of dose-limiting toxicities (DLTs) of IDP-023 Monotherapy - (Phase 1)

  Escalation Period

  up to 21 days

• Incidence of dose-limiting toxicities (DLTs) of IDP-023 in combination with Isatuximab, Daratumumab or Rituximab - (Phase 1)

  Escalation Period

  up to 35 days

• Nature of dose-limiting toxicities (DLTs) of IDP-023 in combination with Isatuximab, Daratumumab or Rituximab - (Phase 1)

  Escalation Period

  up to 35 days

• Maximum tolerable dose (MTD) or a tolerated dose below MTD - (Phase 1)

  Escalation Period

  1 year

• For MM: Anti-tumor activity by objective response rate (ORR), complete response (CR), stringent complete response (sCR), very good partial response (VGPR), and partial response (PR) - (Phase 2)

  Expansion period

  2 years

• For NHL: Anti-tumor activity by objective response rate (ORR) - (Phase 2)

  Expansion period

  2 years

Secondary Outcomes (5)

• PK (Cmax) of IDP-023 - (Phase 1/2)

  2 years

• PK (AUC) of IDP-023 - (Phase 1/2)

  2 years

• For MM: Anti-tumor activity by objective response rate (ORR), complete response (CR), stringent complete response (sCR), very good partial response (VGPR), and partial response (PR) - (Phase 1)

  1 year

• For NHL: Anti-tumor activity by objective response rate (ORR) - (Phase 1)

  1 year

• Incidence of adverse events (AEs) and serious adverse events (SAEs) - (Phase 2)

  2 years

Study Arms (6)

Phase 1: Single Agent IDP-023 - Single Dose

EXPERIMENTAL

NHL or MM patient treated with a single dose of IDP-023 monotherapy

Drug: IDP-023; Drug: Cyclophosphamide; Drug: Fludarabine; Drug: Mesna

Phase 1: Single Agent IDP-023 - Multiple Doses

EXPERIMENTAL

NHL and MM patients treated with multiple doses of IDP-023 monotherapy

Drug: IDP-023; Drug: Cyclophosphamide; Drug: Fludarabine; Drug: Mesna

Phase 1: Single Agent IDP-023 - Multiple Doses with IL-2

EXPERIMENTAL

NHL and MM patients treated with multiple doses of IDP-023 monotherapy

Drug: IDP-023; Drug: Interleukin-2; Drug: Cyclophosphamide; Drug: Fludarabine; Drug: Mesna

Phase 2: Combination IDP-023 plus rituximab

EXPERIMENTAL

NHL patients treated with multiple doses of IDP-023 in combination with rituximab

Drug: IDP-023; Drug: Rituximab; Drug: Interleukin-2; Drug: Cyclophosphamide; Drug: Fludarabine; Drug: Mesna

Phase 2: Combination IDP-023 plus daratumumab

EXPERIMENTAL

MM patients treated with multiple doses of IDP-023 in combination with daratumumab

Drug: IDP-023; Drug: Daratumumab; Drug: Interleukin-2; Drug: Cyclophosphamide; Drug: Fludarabine; Drug: Mesna

Phase 2: Combination IDP-023 plus isatuximab

EXPERIMENTAL

MM patients treated with multiple doses of IDP-023 in combination with isatuximab

Drug: IDP-023; Drug: Interleukin-2; Drug: Cyclophosphamide; Drug: Fludarabine; Drug: Mesna; Drug: Isatuximab

Interventions

IDP-023 DRUG

NK cell therapy

Phase 1: Single Agent IDP-023 - Multiple Doses; Phase 1: Single Agent IDP-023 - Multiple Doses with IL-2; Phase 1: Single Agent IDP-023 - Single Dose; Phase 2: Combination IDP-023 plus daratumumab; Phase 2: Combination IDP-023 plus isatuximab; Phase 2: Combination IDP-023 plus rituximab

Rituximab DRUG

Anti-CD20 antibody therapy

Also known as: Rituxan

Phase 2: Combination IDP-023 plus rituximab

Daratumumab DRUG

Anti-CD38 antibody therapy

Also known as: Darzalex

Phase 2: Combination IDP-023 plus daratumumab

Interleukin-2 DRUG

Immune cytokine

Also known as: Proleukin

Phase 1: Single Agent IDP-023 - Multiple Doses with IL-2; Phase 2: Combination IDP-023 plus daratumumab; Phase 2: Combination IDP-023 plus isatuximab; Phase 2: Combination IDP-023 plus rituximab

Cyclophosphamide DRUG

Lymphodepleting chemotherapy

Phase 1: Single Agent IDP-023 - Multiple Doses; Phase 1: Single Agent IDP-023 - Multiple Doses with IL-2; Phase 1: Single Agent IDP-023 - Single Dose; Phase 2: Combination IDP-023 plus daratumumab; Phase 2: Combination IDP-023 plus isatuximab; Phase 2: Combination IDP-023 plus rituximab

Fludarabine DRUG

Lymphodepleting chemotherapy

Phase 1: Single Agent IDP-023 - Multiple Doses; Phase 1: Single Agent IDP-023 - Multiple Doses with IL-2; Phase 1: Single Agent IDP-023 - Single Dose; Phase 2: Combination IDP-023 plus daratumumab; Phase 2: Combination IDP-023 plus isatuximab; Phase 2: Combination IDP-023 plus rituximab

Mesna DRUG

Chemoprotectant

Phase 1: Single Agent IDP-023 - Multiple Doses; Phase 1: Single Agent IDP-023 - Multiple Doses with IL-2; Phase 1: Single Agent IDP-023 - Single Dose; Phase 2: Combination IDP-023 plus daratumumab; Phase 2: Combination IDP-023 plus isatuximab; Phase 2: Combination IDP-023 plus rituximab

Isatuximab DRUG

Anti-CD38 antibody therapy

Also known as: Sarclisa

Phase 2: Combination IDP-023 plus isatuximab

Eligibility Criteria

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

You may qualify if:

• For MM patients: Documented diagnosis of MM requiring systemic therapy and relapsed and/or refractory (R/R) disease after ≥ 3 prior lines of therapy.
• For NHL patients: R/R disease and failed ≥ 2 lines of systemic chemotherapy.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Life expectancy of greater than 12 weeks per the Investigator.

You may not qualify if:

• Impaired cardiac function or history of clinical significant cardiac disease.
• Human immunodeficiency virus (HIV) infection, active hepatitis B infection, or hepatitis C infection.
• Active SARS-CoV-2 infection.
• Has untreated central nervous system, epidural tumor metastasis, or brain metastasis.

Sponsors & Collaborators

• Indapta Therapeutics, INC.: lead

Study Sites (12)

Valkyrie Clinical Trials

Los Angeles, California, 90670, United States

RECRUITING

Florida Cancer Specialists and Research Institute - Lake Mary Cancer Center

Lake Mary, Florida, 32746, United States

WITHDRAWN

Emory University Hospital

Atlanta, Georgia, 30322, United States

RECRUITING

University of Minnesota

Minneapolis, Minnesota, 55455, United States

RECRUITING

NYP/Weill Cornell Medical Center

New York, New York, 10065, United States

WITHDRAWN

Atrium Health Wake Forest Baptist

Winston-Salem, North Carolina, 27157, United States

RECRUITING

University Hospitals Cleveland

Cleveland, Ohio, 44106, United States

RECRUITING

Providence Cancer Institute Franz Clinic

Portland, Oregon, 97213, United States

WITHDRAWN

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

RECRUITING

SCRI Oncology Partners

Nashville, Tennessee, 37203, United States

RECRUITING

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

NEXT Oncology Virginia

Fairfax, Virginia, 22031, United States

RECRUITING

MeSH Terms

Conditions

Multiple Myeloma; Hematologic Neoplasms; Lymphoma, Non-Hodgkin

Interventions

Rituximab; daratumumab; Interleukin-2; aldesleukin; Cyclophosphamide; fludarabine; Mesna; isatuximab

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; Neoplasms by Site; Lymphoma; Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Interleukins; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Lymphokines; Biological Factors; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Alkanesulfonates; Alkanesulfonic Acids; Alkanes; Hydrocarbons, Acyclic; Sulfhydryl Compounds; Sulfur Compounds; Sulfonic Acids; Sulfur Acids

Study Officials

• Indapta Therapeutics, Inc.

  Indapta Therapeutics, INC.

  STUDY DIRECTOR

Central Study Contacts

Indapta Therapeutics, Inc.

CONTACT

TRIALS@INDAPTA.COM

Study Design

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

Model Details: Multiple ascending dose, and dose-expansion study of IDP-023 administered as a single agent and in combination with or without interleukin-2 (IL-2), and with or without isatuximab, daratumumab or rituximab.

Study Record Dates

• First Submitted: October 22, 2023
• First Posted: November 7, 2023
• Study Start: October 25, 2023
• Primary Completion: December 30, 2025
• Study Completion (Estimated): December 31, 2029
• Last Updated: June 3, 2025

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (12)