Inobrodib, Pomalidomide and Dexamethasone in Relapsed or Refractory Multiple Myeloma (DoMMino-1)

CellCentric

Status and phase

Begins enrollment in 3 months

Phase 2

Conditions

Multiple Myeloma in Relapse

Multiple Myeloma Refractory

Treatments

Drug: Inobrodib

Drug: Dexamethasone

Drug: Pomalidomide

Study type

Interventional

Funder types

Industry

Identifiers

NCT07096778

2025-522549-24-00 (EU Trial (CTIS) Number)

1012518 (Other Identifier)

CCS1477-04

Details and patient eligibility

About

The purpose of this study is to learn more about the anti-cancer activity of inobrodib, when given in combination with pomalidomide and dexamethasone, in patients with multiple myeloma that has come back following treatment and which no longer responds to available therapies. The study treatment will not be compared to any other treatment and patients will know what treatment they are receiving. This study will also further explore the side effects of inobrodib in combination with these other medicines.

Full description

This is a Phase II, open-label, multicenter study to evaluate the efficacy and safety of inobrodib in combination with pomalidomide and dexamethasone (InoPd) in patients with relapsed and refractory multiple myeloma (RRMM).

Patients must be 18 years or older and be refractory to least one proteosome inhibitor (PI), one anti-CD38 monoclonal antibody (mAb) and pomalidomide. Patients must also be previously treated with an approved targeted immunotherapy (e.g., B-cell maturation antigen [BCMA], chimeric antigen receptor therapy [CAR-T], BCMA or G Protein-Coupled Receptor Class C Group 5 Member D [GPRC5D], T-cell engagers [TCEs], BCMA antibody drug conjugate [ADC]).

Approximately 100 patients will be treated with 40 mg of inobrodib administered orally twice daily (b.i.d.) 4 days on / 3 days off for each 28-day cycle. Pomalidomide and dexamethasone will be administered as per standard of care (SoC), i.e., with a starting dose of 4 mg orally once daily on Day 1 to 21 of each 28-day cycle for pomalidomide, and 40 mg orally once daily on Days 1, 8, 15 and 22 for each 28-day cycle for dexamethasone. Study treatment should be continued until disease progression, initiation of new anticancer therapy, unacceptable toxicity or the patient meets any criteria for withdrawal from the study.

The primary objective is to assess the efficacy of InoPd in terms of objective response rate (ORR) based on International Myeloma Working Group (IMWG) criteria and assessed by Independent Review Committee (IRC).

Enrollment

100 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Male or female ≥18 years of age
Prior diagnosis of MM as defined according to IMWG criteria and relapsed or refractory to the last line of therapy
Eastern Co-operative Oncology Group (ECOG) performance status of 0 to 2
Adequate hematological, renal and hepatic function
Willingness to use highly effective contraceptive measures (if sexually active) with all sexual partners

Exclusion criteria

Use of any investigational agent, chemotherapy, immunotherapy or anticancer agent from a previous clinical study within 14 days or 5 half-lives of first dose of study treatment, whichever is shortest; any antibody based therapy within 30 days
Prior treatment with p300/CBP bromodomain inhibitors
Known or suspected severe allergies to any active or inactive ingredients in the study medications (inobrodib, pomalidomide, dexamethasone) or any prior immunomodulatory drug (lenalidomide, thalidomide)
Treatment with medicines or herbal supplements or foods (e.g. strong CYP3A4 inducers or inhibitors) that would interfere with treatment
Major surgery within 4 weeks of the first dose of study treatment
Live vaccine within 4 weeks of study treatment
Active or unresolved adverse events
Active malignancies (progressing or requiring change in treatment) in the last 24 months other than multiple myeloma
Female patients who are pregnant or breast-feeding at any time during the study
Any illness or medical history that would impact safety or compliance with study requirements or impact ability to interpret study data