Clinical trial NCT03650491: A Study of FOR46 in Patients With Relapsed or Refractory Multiple Myeloma (RRMM)
Official title: A Phase I Study of FOR46 Administered Every 21 Days in Patients With Relapsed or Refractory Multiple Myeloma (RRMM)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Multiple Myeloma
Multiple Myeloma in Relapse
Multiple Myeloma With Failed Remission
Lead sponsor: Fortis Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2018-08-28
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

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).

Primary outcomes:
measure: Incidence of adverse events
timeFrame: Through 1 month following last dose
measure: Occurrence of dose-limiting toxicities
timeFrame: Through 1 month following last dose
measure: Disease response
timeFrame: 6 months
Secondary outcomes:
measure: Characterize FOR46 plasma concentration
timeFrame: Through 1 month following last dose
measure: Characterize the FOR46 area under the curve
timeFrame: Through 1 month following last dose
measure: Characterize FOR46 elimination
timeFrame: Through 1 month following last dose
measure: Antidrug Antibodies
timeFrame: Through 1 month following last dose
measure: Duration of response
timeFrame: From first dose through 6 months following last dose
measure: Progression-free survival
timeFrame: From first dose through 6 months following last dose
measure: Time to progression
timeFrame: From first dose through 6 months following last dose
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: UCSF Helen Diller Family Comprehensive Cancer Center
state: California
city: Aurora
country: United States
facility: University of Colorado Cancer Center
state: Colorado
city: Atlanta
country: United States
facility: Winship Cancer Institute, Emory University
state: Georgia
city: Baltimore
country: United States
facility: Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University
state: Maryland
city: Detroit
country: United States
facility: Karmanos Cancer Institute
state: Michigan
city: Saint Louis
country: United States
facility: Washington University in St. Louis-Siteman Cancer Center
state: Missouri
city: New York
country: United States
facility: Icahn School of Medicine at Mt. Sinai
state: New York
Study officials:
affiliation: Fortis Therapeutics, Inc.
name: Andrew Dorr, MD
role: STUDY_DIRECTOR
References: