A Study of Imvotamab Monotherapy and in Combination in Subjects With Relapsed/Refractory Non-Hodgkin Lymphoma

NCT04082936 | Terminated Phase 1 DMC FDA Drug

• 1 other identifier: IGM-2323-001
• Study Type: interventional
• Target: 97
• Locations: 7 countries
• Sites: 26

Brief Summary

This is a Phase 1/2 study of imvotamab in adult subjects with relapsed or refractory B-cell Non-Hodgkin Lymphoma. This study will consist of a dose-escalation stage, a combination stage, and a randomized dose-expansion stage where subjects will be enrolled into indication-specific expansion cohorts. imvotamab will be administered intravenously (IV). Additional CD20-positive NHL histologies (e.g. MZL and MCL), may be allowed with Medical Monitor approval during the Dose-Escalation Phase of the study.

Conditions

Non-Hodgkin Lymphoma; Follicular Lymphoma; DLBCL; Mantle Cell Lymphoma; Marginal Zone Lymphoma

Keywords

Lymphoma; Non-Hodgkin Lymphoma; DLBCL; Follicular Lymphoma; relapsed or refractory

Outcome Measures

Primary Outcomes (2)

• Overall Frequency of Adverse Events

  Percentage of Adverse Events

  Baseline through approximately 30 days after last study treatment

• Overall Response Rate (ORR)

  Percentage of measurable disease in subjects who have achieved either complete response (CR) or partial response (PR)

  Baseline up to 5 years

Secondary Outcomes (2)

• Objective Response Rate (ORR)

  Baseline up to 5 years

• Duration of Response (DOR)

  Baseline up to 5 years

Study Arms (6)

Phase 1a (Dose Escalation)

EXPERIMENTAL

Subjects will receive imvotamab via intravenous (IV) infusion weekly. No longer enrolling.

Drug: imvotamab

Phase 1a (Q3W)

EXPERIMENTAL

Subjects will receive imvotamab via intravenous (IV) infusion every 3 weeks. No longer enrolling.

Drug: imvotamab

Phase 1a (Prior bi-specific)

EXPERIMENTAL

Subjects treated with prior bi-specifics will receive imvotamab via IV infusion weekly. No longer enrolling.

Drug: imvotamab

Phase 2 (DLBCL)

EXPERIMENTAL

DLBCL subjects will receive imvotamab via IV infusion at a dose and schedule to be determined after reviewing all available response and safety data. No longer enrolling.

Drug: imvotamab

Phase 2 (FL)

EXPERIMENTAL

FL subjects will receive imvotamab via IV infusion at a dose and schedule to be determined after reviewing all available response and safety data. No longer enrolling.

Drug: imvotamab

Phase 1b (Combination)

EXPERIMENTAL

Subjects will receive imvotamab via IV infusion weekly and loncastuximab tesirine via IV infusion every 3 weeks.

Drug: imvotamab

Interventions

imvotamab DRUG

Subjects with r/r B-cell NHL will receive IGM-2323 via IV infusion.

Phase 1a (Dose Escalation); Phase 1a (Prior bi-specific); Phase 1a (Q3W); Phase 1b (Combination); Phase 2 (DLBCL); Phase 2 (FL)

Eligibility Criteria

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

You may qualify if:

• \> 18 years of age: ECOG PS 0 or 1
• Relapsed or Refractory Follicular Lymphoma (FL), and Diffuse Large B-cell Lymphoma (DLBCL), Mantle cell Lymphoma (MCL), Marginal Zone Lymphoma (MZL) in dose escalation
• Relapsed or refractory to at least two prior systemic treatment regimens (must include anti-CD20 chemo-immunotherapy regimen). FL/MZL may be enrolled with a least 2 prior systemic regimens which must include an anti-CD20, without the need for a prior chemotherapy regimen)
• At least one bi-dimensionally measurable lesion (\>1.5cm in it's longest dimension by computerized tomography (CT scan)
• Good organ function
• Not eligible for autologous stem cell transplant (DLBCL subjects), due to chemoresistant disease, medically unfit (organ function), or unwilling.

You may not qualify if:

• Prior allogeneic transplant
• ASCT within 100 days prior to the first imvotamab administration.
• Lack of response to prior treatment with CAR-T therapy, subjects with less than 3 months from prior CAR-T therapy to first dose of imvotamab, and prior CAR-T therapy only allowed with Medical Monitor approval.
• Concurrent serious co-morbidities that could limit patients full participation and compliance.
• Prior CD-targeting bispecific antibodies.
• Prior loncastuximab tesirine.

Sponsors & Collaborators

• IGM Biosciences, Inc.: lead
• ADC Therapeutics S.A.: collaborator

Study Sites (26)

City of Hope

Duarte, California, 91010, United States

Location

Moffitt Cancer Center

Tampa, Florida, 33612, United States

Location

Norton Cancer Institute

Louisville, Kentucky, 40202, United States

Location

Dana Farber Cancer Institute (DFCI)

Boston, Massachusetts, 02215, United States

Location

NYU

New York, New York, 10016, United States

Location

MSKCC

New York, New York, 10065, United States

Location

Tennessee Oncology

Nashville, Tennessee, 37203, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Fred Hutch

Seattle, Washington, 98109, United States

Location

Monash Health

Clayton, Victoria, 3168, Australia

Location

St. Vincent's Hospital Melbourne

Fitzroy, Victoria, 3065, Australia

Location

Linear Clinical Resaerch

Nedlands, Western Australia, 6009, Australia

Location

Fakultní nemocnice Královské Vinohrady

Prague, Czechia

Location

CHU de Poitiers

Poitiers, 86000, France

Location

Gustave Roussy

Villejuif, France

Location

ASST Papa Giovanni XXIII

Bergamo, BG, Italy

Location

Fondazione Policlinico Universitario Agostino Gemelli

Roma, RM, Italy

Location

Azienda Ospedaliero Universitaria di Bologna-Ematologia Bologna

Bologna, 40138, Italy

Location

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Samsung Medical Center

Seoul, 06351, South Korea

Location

Hospital Santa Creu i Sant Pau

Barcelona, 08025, Spain

Location

Hospital Del Mar

Barcelona, 8003, Spain

Location

Hospital de la Santa Creu i Sant Pau

Barcelona, Spain

Location

Institut Catala d'Oncologia

Barcelona, Spain

Location

START-Madrid: Fundacion Jimenez Diaz

Madrid, 28040, Spain

Location

START-Madrid: Centro Integral Oncologico Clara Campal

Madrid, 28050, Spain

Location

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin; Lymphoma, Follicular; Lymphoma, Mantle-Cell; Lymphoma, B-Cell, Marginal Zone; Lymphoma; Recurrence

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Lymphoma, B-Cell; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• IGM Biosciences

  IGM Biosciences, Inc.

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: September 4, 2019
• First Posted: September 10, 2019
• Study Start: September 30, 2019
• Primary Completion: February 16, 2024
• Study Completion: February 22, 2024
• Last Updated: July 24, 2024

Record last verified: 2024-07

Locations

CZ (1); FR (2); AU (3); IT (3); KR (2); US (9); ES (6)