Multiple Myeloma Clinical Trial

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

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

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Full 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.

View Eligibility Criteria

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).

Study is for people with:

Multiple Myeloma

Phase:

Phase 1

Estimated Enrollment:

31

Study ID:

NCT03650491

Recruitment Status:

Completed

Sponsor:

Fortis Therapeutics, Inc.

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There are 7 Locations for this study

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UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco California, 94143, United States
University of Colorado Cancer Center
Aurora Colorado, 80045, United States
Winship Cancer Institute, Emory University
Atlanta Georgia, 30322, United States
Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University
Baltimore Maryland, 21231, United States
Karmanos Cancer Institute
Detroit Michigan, 48201, United States
Washington University in St. Louis-Siteman Cancer Center
Saint Louis Missouri, 63310, United States
Icahn School of Medicine at Mt. Sinai
New York New York, 10029, United States

How clear is this clinincal trial information?

Study is for people with:

Multiple Myeloma

Phase:

Phase 1

Estimated Enrollment:

31

Study ID:

NCT03650491

Recruitment Status:

Completed

Sponsor:


Fortis Therapeutics, Inc.

How clear is this clinincal trial information?

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