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

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ClinicalTrials.gov Identifier: NCT03650491
Recruitment Status : Not yet recruiting
First Posted : August 28, 2018
Last Update Posted : August 28, 2018
Sponsor:
Information provided by (Responsible Party):
Fortis Therapeutics, Inc.

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
Multiple Myeloma Multiple Myeloma in Relapse Multiple Myeloma With Failed Remission Drug: FOR46 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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 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.
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)
Estimated Study Start Date : November 2018
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : April 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

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




Primary Outcome Measures :
  1. Incidence of adverse events [ Time Frame: 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 [ Time Frame: Through 1 month following last dose ]
    The severity and incidence of dose-limiting toxicities related to escalating dose levels of FOR46

  3. Disease response [ Time Frame: 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 [ Time Frame: Through 1 month following last dose ]
    FOR46 maximum plasma concentration

  2. Characterize the FOR46 area under the curve [ Time Frame: Through 1 month following last dose ]
    FOR46 area under the plasma concentration-time curve

  3. Characterize FOR46 elimination [ Time Frame: Through 1 month following last dose ]
    FOR46 elimination half-life

  4. Antidrug Antibodies [ Time Frame: Through 1 month following last dose ]
    Change from baseline in serum levels of antidrug antibodies

  5. Duration of response [ Time Frame: From first dose through 6 months following last dose ]
    Assessed by IMWG criteria

  6. Progression-free survival [ Time Frame: From first dose through 6 months following last dose ]
    Assessed by IMWG criteria

  7. Time to progression [ Time Frame: From first dose through 6 months following last dose ]
    Assessed by IMWG criteria



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  • 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
  • Clinically significant cardiovascular disease
  • Uncontrolled, clinically significant pulmonary disease
  • Uncontrolled intercurrent illness
  • Requires medications that are strong inhibitors or strong inducers of CYP3A4

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03650491


Contacts
Contact: Andrew Dorr, MD 858-504-1453 adorr414@me.com
Contact: Kimberly Marshall, BSN 301-762-6100 ext 108 kmarshall@rrdintl.com

Sponsors and Collaborators
Fortis Therapeutics, Inc.
Investigators
Study Director: Andrew Dorr, MD Fortis Therapeutics, Inc.

Responsible Party: Fortis Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT03650491     History of Changes
Other Study ID Numbers: FOR46-002
First Posted: August 28, 2018    Key Record Dates
Last Update Posted: August 28, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases