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

Sponsor
Fortis Therapeutics, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT03650491
Collaborator
(none)
31
Enrollment
7
Locations
2
Arms
34
Actual Duration (Months)
4.4
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

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

Condition or Disease Intervention/Treatment Phase
Phase 1

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
31 participants
Allocation:
Non-Randomized
Intervention Model:
Sequential Assignment
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.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)
Primary Purpose:
Treatment
Official Title:
A Phase I Study of FOR46 Administered Every 21 Days in Patients With Relapsed or Refractory Multiple Myeloma (RRMM)
Actual Study Start Date :
Apr 3, 2019
Actual Primary Completion Date :
Jan 31, 2022
Actual Study Completion Date :
Jan 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Experimental: FOR46 (Dose Escalation)

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.

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

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.

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

Outcome Measures

Primary Outcome Measures

  1. Incidence of adverse events [Through 1 month following last dose]

    Number of patients with treatment-related adverse events as assessed by NCI CTCAE v5.0.

  2. Occurrence of dose-limiting toxicities [Through 1 month following last dose]

    The severity and incidence of dose-limiting toxicities related to escalating dose levels of FOR46

  3. Disease response [6 months]

    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

  1. Characterize FOR46 plasma concentration [Through 1 month following last dose]

    FOR46 maximum plasma concentration

  2. Characterize the FOR46 area under the curve [Through 1 month following last dose]

    FOR46 area under the plasma concentration-time curve

  3. Characterize FOR46 elimination [Through 1 month following last dose]

    FOR46 elimination half-life

  4. Antidrug Antibodies [Through 1 month following last dose]

    Change from baseline in serum levels of antidrug antibodies

  5. Duration of response [From first dose through 6 months following last dose]

    Assessed by IMWG criteria

  6. Progression-free survival [From first dose through 6 months following last dose]

    Assessed by IMWG criteria

  7. Time to progression [From first dose through 6 months following last dose]

    Assessed by IMWG criteria

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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).

Contacts and Locations

Locations

Site City State Country Postal Code
1 UCSF Helen Diller Family Comprehensive Cancer Center San Francisco California United States 94143
2 University of Colorado Cancer Center Aurora Colorado United States 80045
3 Winship Cancer Institute, Emory University Atlanta Georgia United States 30322
4 Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University Baltimore Maryland United States 21231
5 Karmanos Cancer Institute Detroit Michigan United States 48201
6 Washington University in St. Louis-Siteman Cancer Center Saint Louis Missouri United States 63310
7 Icahn School of Medicine at Mt. Sinai New York New York United States 10029

Sponsors and Collaborators

  • Fortis Therapeutics, Inc.

Investigators

  • Study Director: Andrew Dorr, MD, Fortis Therapeutics, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Fortis Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT03650491
Other Study ID Numbers:
  • FOR46-002
First Posted:
Aug 28, 2018
Last Update Posted:
Jul 27, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell

Study Results

No Results Posted as of Jul 27, 2022