Back to resultsA Study of FOR46 in Patients With Relapsed or Refractory Multiple Myeloma (RRMM)
Primary Purpose
Multiple Myeloma, Multiple Myeloma in Relapse, Multiple Myeloma With Failed Remission
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
FOR46
Sponsored by
About this trial
This is an interventional treatment trial for Multiple Myeloma
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).
Sites / Locations
- UCSF Helen Diller Family Comprehensive Cancer Center
- University of Colorado Cancer Center
- Winship Cancer Institute, Emory University
- Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University
- Karmanos Cancer Institute
- Washington University in St. Louis-Siteman Cancer Center
- Icahn School of Medicine at Mt. Sinai
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Experimental: FOR46 (Dose Escalation)
Experimental: FOR46 (Dose Expansion)
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Incidence of adverse events
Number of patients with treatment-related adverse events as assessed by NCI CTCAE v5.0.
Occurrence of dose-limiting toxicities
The severity and incidence of dose-limiting toxicities related to escalating dose levels of FOR46
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
Secondary Outcome Measures
Characterize FOR46 plasma concentration
FOR46 maximum plasma concentration
Characterize the FOR46 area under the curve
FOR46 area under the plasma concentration-time curve
Characterize FOR46 elimination
FOR46 elimination half-life
Antidrug Antibodies
Change from baseline in serum levels of antidrug antibodies
Duration of response
Assessed by IMWG criteria
Progression-free survival
Assessed by IMWG criteria
Time to progression
Assessed by IMWG criteria
Full Information
NCT ID
NCT03650491
First Posted
August 21, 2018
Last Updated
July 25, 2022
Sponsor
Fortis Therapeutics, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT03650491
Brief Title
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
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
April 3, 2019 (Actual)
Primary Completion Date
January 31, 2022 (Actual)
Study Completion Date
January 31, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fortis Therapeutics, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma, Multiple Myeloma in Relapse, Multiple Myeloma With Failed Remission
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
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.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
31 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental: FOR46 (Dose Escalation)
Arm Type
Experimental
Arm Description
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.
Arm Title
Experimental: FOR46 (Dose Expansion)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
FOR46
Intervention Description
FOR46 is an intravenously (IV) administered antibody-drug conjugate (ADC) directed against CD46
Primary Outcome Measure Information:
Title
Incidence of adverse events
Description
Number of patients with treatment-related adverse events as assessed by NCI CTCAE v5.0.
Time Frame
Through 1 month following last dose
Title
Occurrence of dose-limiting toxicities
Description
The severity and incidence of dose-limiting toxicities related to escalating dose levels of FOR46
Time Frame
Through 1 month following last dose
Title
Disease response
Description
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
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Characterize FOR46 plasma concentration
Description
FOR46 maximum plasma concentration
Time Frame
Through 1 month following last dose
Title
Characterize the FOR46 area under the curve
Description
FOR46 area under the plasma concentration-time curve
Time Frame
Through 1 month following last dose
Title
Characterize FOR46 elimination
Description
FOR46 elimination half-life
Time Frame
Through 1 month following last dose
Title
Antidrug Antibodies
Description
Change from baseline in serum levels of antidrug antibodies
Time Frame
Through 1 month following last dose
Title
Duration of response
Description
Assessed by IMWG criteria
Time Frame
From first dose through 6 months following last dose
Title
Progression-free survival
Description
Assessed by IMWG criteria
Time Frame
From first dose through 6 months following last dose
Title
Time to progression
Description
Assessed by IMWG criteria
Time Frame
From first dose through 6 months following last dose
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew Dorr, MD
Organizational Affiliation
Fortis Therapeutics, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
UCSF Helen Diller Family Comprehensive Cancer Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
University of Colorado Cancer Center
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Winship Cancer Institute, Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21231
Country
United States
Facility Name
Karmanos Cancer Institute
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Washington University in St. Louis-Siteman Cancer Center
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63310
Country
United States
Facility Name
Icahn School of Medicine at Mt. Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Study of FOR46 in Patients With Relapsed or Refractory Multiple Myeloma (RRMM)
We'll reach out to this number within 24 hrs