A Study of FOR46 in Patients With Relapsed or Refractory Multiple Myeloma (RRMM)
- Conditions
- Multiple MyelomaMultiple Myeloma With Failed RemissionMultiple Myeloma in Relapse
- Interventions
- Registration Number
- NCT03650491
- Lead Sponsor
- Fortis Therapeutics, Inc.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 31
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Experimental: FOR46 (Dose Expansion) FOR46 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. Experimental: FOR46 (Dose Escalation) FOR46 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.
- Primary Outcome Measures
Name Time Method Occurrence of dose-limiting toxicities Through 1 month following last dose The severity and incidence of dose-limiting toxicities related to escalating dose levels of FOR46
Disease response 6 months 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
Incidence of adverse events Through 1 month following last dose Number of patients with treatment-related adverse events as assessed by NCI CTCAE v5.0.
- Secondary Outcome Measures
Name Time Method Antidrug Antibodies Through 1 month following last dose Change from baseline in serum levels of antidrug antibodies
Progression-free survival From first dose through 6 months following last dose Assessed by IMWG criteria
Characterize FOR46 elimination Through 1 month following last dose FOR46 elimination half-life
Duration of response From first dose through 6 months following last dose Assessed by IMWG criteria
Characterize the FOR46 area under the curve Through 1 month following last dose FOR46 area under the plasma concentration-time curve
Time to progression From first dose through 6 months following last dose Assessed by IMWG criteria
Characterize FOR46 plasma concentration Through 1 month following last dose FOR46 maximum plasma concentration
Trial Locations
- Locations (7)
Icahn School of Medicine at Mt. Sinai
🇺🇸New York, New York, United States
Karmanos Cancer Institute
🇺🇸Detroit, Michigan, United States
University of Colorado Cancer Center
🇺🇸Aurora, Colorado, United States
Washington University in St. Louis-Siteman Cancer Center
🇺🇸Saint Louis, Missouri, United States
UCSF Helen Diller Family Comprehensive Cancer Center
🇺🇸San Francisco, California, United States
Winship Cancer Institute, Emory University
🇺🇸Atlanta, Georgia, United States
Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University
🇺🇸Baltimore, Maryland, United States