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A Study of FOR46 in Patients With Relapsed or Refractory Multiple Myeloma (RRMM) | Clinical Trials | Clareo Health

COMPLETEDPHASE1

A Study of FOR46 in Patients With Relapsed or Refractory Multiple Myeloma (RRMM)

A Phase I Study of FOR46 Administered Every 21 Days in Patients With Relapsed or Refractory Multiple Myeloma (RRMM)

NCT03650491•Fortis Therapeutics, Inc.

Summary

This study will test the safety and efficacy of FOR46 given every 21 days to patients with relapsed or refractory multiple myeloma. The name of the study drug involved in this study is: FOR46 for Injection

Detailed Description

This study is designed to evaluate the safety, tolerability and antitumor activity of FOR46 in patients with relapsed or refractory multiple myeloma. This study will be conducted in two parts: Dose escalation: This part will evaluate increasing doses of FOR46 to identify the maximum tolerated dose (MTD). The first patient enrolled on the study will receive the lowest dose of FOR46. Once this dose is shown to be safe, a second patient will be enrolled at the next higher dose. Patients will continue to be enrolled into either single or multiple patient groups receiving increasing doses until the MTD is reached. Dose expansion: This part of the study will further evaluate the safety, tolerability and antitumor activity of FOR46 at a dose shown to be safe in the dose escalation part of the study.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Male or female ≥ 18 years of age
•Measurable MM that is relapsed or refractory to established therapies with known clinical benefit in RRMM or intolerant of those established MM therapies. Prior lines of therapy must include a proteasome inhibitor (PI), an immunomodulatory imide drug (IMiD) and a CD38-directed therapy in any order of combination.
•ECOG performance status of 0 or 1
•Adequate hematologic, renal and hepatic function
•Females of child-bearing potential must have a negative serum pregnancy test and use a medically acceptable form of contraception
•Male patients with with female partners of childbearing potential must agree to use 2 effective methods of contraception
•Patients must provide signed informed consent

Exclusion Criteria

•Persistent clinically significant toxicities from previous anticancer therapy
•NCI CTCAE Grade ≥ 2 peripheral neuropathy from any etiology or has a genetic disorder that is associated with peripheral neuropathy even without current neuropathic manifestations
•Has received treatment with a stem cell transplant within 12 weeks before administration of patient's first dose of FOR46
•Has had radiation or systemic anticancer therapy within 14 days before first dose of FOR46
•Has received treatment with an investigational drug within 28 days before first dose of FOR46
•Has had a major surgical procedure within 28 days before administration of the patient's first FOR46 dose
•Is breastfeeding
•Clinically significant cardiovascular disease
•Uncontrolled, clinically significant pulmonary disease
•Uncontrolled intercurrent illness
+5 more criteria

Locations (7)

UCSF Helen Diller Family Comprehensive Cancer Center

San Francisco, California, United States

University of Colorado Cancer Center

Aurora, Colorado, United States

Winship Cancer Institute, Emory University

Atlanta, Georgia, United States

Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University

Baltimore, Maryland, United States

Karmanos Cancer Institute

Detroit, Michigan, United States

Washington University in St. Louis-Siteman Cancer Center

St Louis, Missouri, United States

Icahn School of Medicine at Mt. Sinai

New York, New York, United States

Key Dates

Start Date

April 3, 2019

Primary Completion Date

January 31, 2022

Completion Date

January 31, 2022

Last Updated

July 27, 2022

Enrollment

ACTUAL participants

Conditions

Multiple MyelomaMultiple Myeloma in RelapseMultiple Myeloma With Failed Remission

Interventions

FOR46

DRUG

Iberdomide Versus Observation Off Therapy After Idecabtagene Vicleucel CAR-T for Multiple Myeloma

NCT06179888

Multiple Myeloma

View study

RECRUITINGPHASE3

MagnetisMM-32: A Study to Learn About the Study Medicine Called Elranatamab in People With Multiple Myeloma (MM) That Has Come Back After Taking Other Treatments (Including Prior Treatment With an Anti-CD38 Antibody and Lenalidomide)

NCT06152575

Multiple Myeloma

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RECRUITINGPHASE1/PHASE2

A Phase 1b/2 Study of Sonrotoclax (BGB-11417) as Monotherapy and in Various Combinations With Dexamethasone Plus Carfilzomib, Dexamethasone Plus Daratumumab, and Dexamethasone Plus Pomalidomide in Multiple Myeloma

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 27, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study of FOR46 in Patients With Relapsed or Refractory Multiple Myeloma (RRMM)

Inclusion Criteria

Exclusion Criteria

Iberdomide Versus Observation Off Therapy After Idecabtagene Vicleucel CAR-T for Multiple Myeloma

MagnetisMM-32: A Study to Learn About the Study Medicine Called Elranatamab in People With Multiple Myeloma (MM) That Has Come Back After Taking Other Treatments (Including Prior Treatment With an Anti-CD38 Antibody and Lenalidomide)

A Phase 1b/2 Study of Sonrotoclax (BGB-11417) as Monotherapy and in Various Combinations With Dexamethasone Plus Carfilzomib, Dexamethasone Plus Daratumumab, and Dexamethasone Plus Pomalidomide in Multiple Myeloma

A Long-term Study for Participants Previously Treated With Ciltacabtagene Autoleucel

Elranatamab in R/R Multiple Myeloma

Study of ISB 2001 in Relapsed/Refractory Multiple Myeloma (TRIgnite-1)