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)
Verified date | July 2022 |
Source | Fortis Therapeutics, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
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). |
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 |
Lead Sponsor | Collaborator |
---|---|
Fortis Therapeutics, Inc. |
United States,
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 |
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