A Study to Evaluate Safety, Tolerability, and Clinical Activity of Forimtamig-Based Treatment Combinations in Participants with Relapsed or Refractory Multiple Myeloma

Overview

Sponsor-declared trial summary

Key facts

Sponsor

F. Hoffmann-La Roche AG, F. Hoffmann-La Roche AG

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

5 Dec 2023 → 8 Jul 2025

Decision date (initial)

2023-10-20

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

F. Hoffmann La Roche

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety

To evaluate the safety and tolerability of forimtamig when given alone or in combination
To evaluate the preliminary anti-tumor activity of forimtamig when given alone or in combination based on objective response rate (ORR), complete response (CR)/stringent complete response (sCR) rate, rate of very good partial response (VGPR) or better

Secondary objectives 3

1. To evaluate the preliminary anti-tumor activity of forimtamig when given alone or in combination based on progression-free survival (PFS), duration of response (DoR) for participants who achieve a partial response (PR) or better, time to first response, time to best response, Overall survival (OS)
2. To characterize the pharmacokinetics (PK) of forimtamig when given alone or in combination
3. To evaluate the immune response to forimtamig

Conditions and MedDRA coding

Multiple myeloma (MM)

Study design 2 periods

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. Agreement to provide protocol-specific bone marrow biopsy and aspirate samples
2. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
3. Life expectancy of at least 12 weeks
4. Documented diagnosis of MM according to the International Myeloma Working Group (IMWG) diagnostic criteria
5. Evidence of progressive disease based on Investigator’s determination of response by IMWG criteria on or after last dosing regimen
6. Participants with r/r MM who previously received therapy, including an immunomodulatory drugs (IMiDs) and a proteasome inhibitor (PI). Both anti-CD38 naïve and anti-CD38 exposed/refractory participants are allowed

Exclusion criteria 6

1. Pregnant or breastfeeding, or intending to become pregnant during the study or within 3 months after the last dose of forimtamig, tocilizumab, or carfilzomib, or 102 days after the last dose of daratumumab
2. Plasma cell leukemia with circulating plasma cell count = 5% or >500/µL
3. Waldenström’s macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes), or primary amyloid light-chain amyloidosis
4. Participants with current amyloidosis (e.g., positive Congo Red stain or equivalent in tissue biopsy)
5. Participants with myelodysplastic syndrome
6. Participants with (extramedullary) lesions in proximity of vital organs that may develop sudden decompensation/deterioration in the setting of a tumor flare. Participants may be eligible after discussion with the Medical Monitor

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 4

1. 1. Incidence and severity of adverse events (AEs), with severity determined according to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0) and of cytokine release syndrome (CRS) and immune effector cell associated neurotoxicity syndrome (ICANS) according to American Society of Transplantation and Cellular Therapy (ASTCT) Consensus Grading
2. 2. Objective response rate (ORR)
3. 3. Complete response (CR)/stringent complete response (sCR) rate
4. 4. Rate of very good partial response (VGPR) or better

Secondary endpoints 7

1. 1. Progression-free survival (PFS)
2. 2. Duration of response (DoR) for participants who achieve a partial response (PR) or better
3. 3. Time to first response
4. 4. Time to best response
5. 5. Overall survival (OS)
6. 6. To assess the serum concentrations and PK parameters of forimtamig
7. 7. Presence of anti-drug antibodies (ADAs) during the study

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 4

Auxiliary 3

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

F. Hoffmann-La Roche AG

Sponsor organisation

F. Hoffmann-La Roche AG

Address

Grenzacherstrasse 124

City

Basel

Postcode

4058

Country

Switzerland

Scientific contact point

Organisation

F. Hoffmann-La Roche AG

Contact name

Trial Information System - TISL

Public contact point

Organisation

F. Hoffmann-La Roche AG

Contact name

Trial Information System - TISL

Third parties 9

F. Hoffmann-La Roche AG

Sponsor organisation

F. Hoffmann-La Roche AG

Address

Grenzacherstrasse 124

City

Basel

Postcode

4058

Country

Switzerland

Locations

5 EU/EEA countries · 16 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Application history

5 submissions — initial application plus substantial / non-substantial modifications