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

NCT03650491 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: FOR46-002
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 7

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

Conditions

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

Outcome Measures

Primary Outcomes (3)

• Incidence of adverse events

  Number of patients with treatment-related adverse events as assessed by NCI CTCAE v5.0.

  Through 1 month following last dose

• Occurrence of dose-limiting toxicities

  The severity and incidence of dose-limiting toxicities related to escalating dose levels of FOR46

  Through 1 month following last dose

• Disease response

  Overall response rate of FOR46, defined as all responses greater than or equal to a partial response, complete response, stringent complete response, or minimal residual disease negativity

  6 months

Secondary Outcomes (7)

• Characterize FOR46 plasma concentration

  Through 1 month following last dose

• Characterize the FOR46 area under the curve

  Through 1 month following last dose

• Characterize FOR46 elimination

  Through 1 month following last dose

• Antidrug Antibodies

  Through 1 month following last dose

• Duration of response

  From first dose through 6 months following last dose

Study Arms (2)

Experimental: FOR46 (Dose Escalation)

EXPERIMENTAL

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.

Drug: FOR46

Experimental: FOR46 (Dose Expansion)

EXPERIMENTAL

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.

Drug: FOR46

Interventions

FOR46 DRUG

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

Experimental: FOR46 (Dose Escalation); Experimental: FOR46 (Dose Expansion)

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Fortis Therapeutics, Inc.: lead

Study Sites (7)

UCSF Helen Diller Family Comprehensive Cancer Center

San Francisco, California, 94143, United States

Location

University of Colorado Cancer Center

Aurora, Colorado, 80045, United States

Location

Winship Cancer Institute, Emory University

Atlanta, Georgia, 30322, United States

Location

Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University

Baltimore, Maryland, 21231, United States

Location

Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

Location

Washington University in St. Louis-Siteman Cancer Center

St Louis, Missouri, 63310, United States

Location

Icahn School of Medicine at Mt. Sinai

New York, New York, 10029, United States

Location

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Andrew Dorr, MD

  Fortis Therapeutics, Inc.

  STUDY DIRECTOR

Study Design

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

Model Details: Following completion of the dose escalation phase of the study and determination of a recommended phase 2 dose, patients will be enrolled into a dose expansion cohort.

Study Record Dates

• First Submitted: August 21, 2018
• First Posted: August 28, 2018
• Study Start: April 3, 2019
• Primary Completion: January 31, 2022
• Study Completion: January 31, 2022
• Last Updated: July 27, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (7)