Description:
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
Title
- 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)
Clinical Trial IDs
- ORG STUDY ID:
FOR46-002
- NCT ID:
NCT03650491
Conditions
- Multiple Myeloma
- Multiple Myeloma in Relapse
- Multiple Myeloma With Failed Remission
Interventions
Drug | Synonyms | Arms |
---|
FOR46 | | Experimental: FOR46 (Dose Escalation) |
Purpose
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.
Trial Arms
Name | Type | Description | Interventions |
---|
Experimental: FOR46 (Dose Escalation) | Experimental | 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. | |
Experimental: FOR46 (Dose Expansion) | Experimental | 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. | |
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).
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Incidence of adverse events |
Time Frame: | Through 1 month following last dose |
Safety Issue: | |
Description: | Number of patients with treatment-related adverse events as assessed by NCI CTCAE v5.0. |
Secondary Outcome Measures
Measure: | Characterize FOR46 plasma concentration |
Time Frame: | Through 1 month following last dose |
Safety Issue: | |
Description: | FOR46 maximum plasma concentration |
Measure: | Characterize the FOR46 area under the curve |
Time Frame: | Through 1 month following last dose |
Safety Issue: | |
Description: | FOR46 area under the plasma concentration-time curve |
Measure: | Characterize FOR46 elimination |
Time Frame: | Through 1 month following last dose |
Safety Issue: | |
Description: | FOR46 elimination half-life |
Measure: | Antidrug Antibodies |
Time Frame: | Through 1 month following last dose |
Safety Issue: | |
Description: | Change from baseline in serum levels of antidrug antibodies |
Measure: | Duration of response |
Time Frame: | From first dose through 6 months following last dose |
Safety Issue: | |
Description: | Assessed by IMWG criteria |
Measure: | Progression-free survival |
Time Frame: | From first dose through 6 months following last dose |
Safety Issue: | |
Description: | Assessed by IMWG criteria |
Measure: | Time to progression |
Time Frame: | From first dose through 6 months following last dose |
Safety Issue: | |
Description: | Assessed by IMWG criteria |
Details
Phase: | Phase 1 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Fortis Therapeutics, Inc. |
Last Updated
August 17, 2021