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

NCT ID: NCT03650491

Last Updated: 2022-07-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-03
• Study Completion Date: 2022-01-31

Brief 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.

Conditions

Multiple Myeloma; Multiple Myeloma in Relapse; Multiple Myeloma With Failed Remission

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental: FOR46 (Dose Escalation)

Eligible patients will receive FOR46 administered as an IV infusion every 21 days. Patients will be enrolled into escalating dose levels during the Dose Escalation period of the study.

Group Type: EXPERIMENTAL

FOR46

Intervention Type: DRUG

FOR46 is an intravenously (IV) administered antibody-drug conjugate (ADC) directed against CD46

Experimental: FOR46 (Dose Expansion)

Eligible patients will receive FOR46 administered as an IV infusion every 21 days. Patients will receive the maximum tolerated dose during the Dose Expansion period of the study.

Group Type: EXPERIMENTAL

FOR46

Intervention Type: DRUG

FOR46 is an intravenously (IV) administered antibody-drug conjugate (ADC) directed against CD46

Interventions

FOR46

FOR46 is an intravenously (IV) administered antibody-drug conjugate (ADC) directed against CD46

Intervention Type: DRUG

Eligibility Criteria

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
• Has known positive status for HIV or either active/chronic hepatitis B/C
• Requires anticoagulation with warfarin or direct thrombin inhibitor; a washout of 7 days before the administration of a patient's first FOR46 dose is required for patients removed from these treatments
• Requires medications that are strong inhibitors or strong inducers of CYP3A4
• Has a history of episodic atrial fibrillation or flutter; patients with chronic atrial fibrillation are not excluded.
• Prior treatment with an ADC containing Monomethyl auristatin E (MMAE) or Monomethyl auristatin F (MMAF).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fortis Therapeutics, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Andrew Dorr, MD

Role: STUDY_DIRECTOR

Fortis Therapeutics, Inc.

Locations

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

Countries

United States

Other Identifiers

FOR46-002

Identifier Type: -

Identifier Source: org_study_id