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

Verified

Overview

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.

SparkCures ID 971
Trial Phase Phase 1
Enrollment 31 Patients
Treatments
Tags
Trial Sponsors
  • Fortis Therapeutics, Inc.
NCT Identifier

NCT03650491

CLOSED

This trial has completed.

Am I Eligible?

The following criteria is a partial list of reasons why patients may or may not be eligible to participate in this clinical trial. Further evaluation with a medical professional will be required to determine full eligibility.

The following criteria is provided for health care professionals.

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
  • 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
  • Clinically significant cardiovascular disease
  • Uncontrolled, clinically significant pulmonary disease
  • Uncontrolled intercurrent illness
  • Requires medications that are strong inhibitors or strong inducers of CYP3A4
  • Prior treatment with an ADC containing Monomethyl auristatin E (MMAE) or Monomethyl auristatin F (MMAF)

US Trial Locations

Please visit the ClinicalTrials.gov page for historical site information.

View Centers
SparkCures Verified

SparkCures is working closely with Fortis Therapeutics, Inc. to provide the most up-to-date information on this clinical trial. Use the button above to add this trial to your list of favorites.

Learn more about how we work with trial sponsors