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

Multiple Myeloma Clinical Trial

Official title:

A Phase I Study of FOR46 Administered Every 21 Days in Patients With Relapsed or Refractory Multiple Myeloma (RRMM)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03650491
• Other study ID #: FOR46-002
• Status: Completed
• Phase: Phase 1
• Start date: April 3, 2019
• Est. completion date: January 31, 2022

Study information

• Verified date: July 2022
• Source: Fortis Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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 information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: January 31, 2022
• Est. primary completion date: January 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Multiple Myeloma
• Multiple Myeloma in Relapse
• Multiple Myeloma With Failed Remission
• Neoplasms, Plasma Cell

Intervention

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

Locations

Country	Name	City	State
United States	Winship Cancer Institute, Emory University	Atlanta	Georgia
United States	University of Colorado Cancer Center	Aurora	Colorado
United States	Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University	Baltimore	Maryland
United States	Karmanos Cancer Institute	Detroit	Michigan
United States	Icahn School of Medicine at Mt. Sinai	New York	New York
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

Sponsors (1)

Lead Sponsor	Collaborator
Fortis Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Characterize FOR46 plasma concentration	FOR46 maximum plasma concentration	Through 1 month following last dose
Secondary	Characterize the FOR46 area under the curve	FOR46 area under the plasma concentration-time curve	Through 1 month following last dose
Secondary	Characterize FOR46 elimination	FOR46 elimination half-life	Through 1 month following last dose
Secondary	Antidrug Antibodies	Change from baseline in serum levels of antidrug antibodies	Through 1 month following last dose
Secondary	Duration of response	Assessed by IMWG criteria	From first dose through 6 months following last dose
Secondary	Progression-free survival	Assessed by IMWG criteria	From first dose through 6 months following last dose
Secondary	Time to progression	Assessed by IMWG criteria	From first dose through 6 months following last dose