Multiple MyelomaPhase 1NCT03650491
A Study of FOR46 in Patients With Relapsed or Refractory Multiple Myeloma (RRMM)
A Phase 1 study testing FOR46 in people with Multiple Myeloma and Multiple Myeloma in Relapse, run by Fortis Therapeutics, Inc. at 7 sites in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma, Multiple Myeloma in Relapse, Multiple Myeloma With Failed Remission
- What is being tested?
- FOR46
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 7 sitesUnited States
- Study dates
- 3 Apr 2019to 31 Jan 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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).
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Winship Cancer Institute, Emory University
Atlanta, Georgia, 30322
University of Colorado Cancer Center
Aurora, Colorado, 80045
Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University
Baltimore, Maryland, 21231
Karmanos Cancer Institute
Detroit, Michigan, 48201
Icahn School of Medicine at Mt. Sinai
New York, New York, 10029
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, 94143
Washington University in St. Louis-Siteman Cancer Center
St Louis, Missouri, 63310
About this study
Official title: A Phase I Study of FOR46 Administered Every 21 Days in Patients With Relapsed or Refractory Multiple Myeloma (RRMM)
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
Read the 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.
- Being tested
- FOR46
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FOR46Drug
FOR46 is an intravenously (IV) administered antibody-drug conjugate (ADC) directed against CD46
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: FOR46 |
| 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. Receives: Drug: FOR46 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events
Number of patients with treatment-related adverse events as assessed by NCI CTCAE v5.0.
Measured: Through 1 month following last dose
Occurrence of dose-limiting toxicities
The severity and incidence of dose-limiting toxicities related to escalating dose levels of FOR46
Measured: Through 1 month following last dose
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
Measured: 6 months
Secondary outcomes (7)
Characterize FOR46 plasma concentration
FOR46 maximum plasma concentration
Measured: Through 1 month following last dose
Characterize the FOR46 area under the curve
FOR46 area under the plasma concentration-time curve
Measured: Through 1 month following last dose
Characterize FOR46 elimination
FOR46 elimination half-life
Measured: Through 1 month following last dose
Antidrug Antibodies
Change from baseline in serum levels of antidrug antibodies
Measured: Through 1 month following last dose
Duration of response
Assessed by IMWG criteria
Measured: From first dose through 6 months following last dose
Progression-free survival
Assessed by IMWG criteria
Measured: From first dose through 6 months following last dose
Time to progression
Assessed by IMWG criteria
Measured: From first dose through 6 months following last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2018
- Study start3 Apr 2019
- Primary completion31 Jan 2022
- Study completion31 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- 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)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fortis Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Andrew Dorr, MD, Study director, Fortis Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03650491
- Sponsor's protocol ID
- FOR46-002
- Status last verified
- Jul 2022
- First submitted
- 21 Aug 2018
- Last updated
- 27 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of FOR46 Administered Every 21 Days in Patients With Relapsed or Refractory Multiple Myeloma (RRMM)
- ClinicalTrials.gov ID
- NCT03650491
- Acronym / sponsor ID
- FOR46-002
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Fortis Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 3 Apr 2019 (actual)
- Primary completion
- 31 Jan 2022 (actual)
- Study completion
- 31 Jan 2022 (actual)
- First posted
- 28 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Experimental: FOR46 (Dose Escalation) | Experimental | Drug: FOR46Eligible 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 | Drug: FOR46Eligible 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FOR46FOR46 is an intravenously (IV) administered antibody-drug conjugate (ADC) directed against CD46 | Drug | Experimental: FOR46 (Dose Escalation), Experimental: FOR46 (Dose Expansion) |
Primary outcome
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.
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
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
7 secondary outcomes
Characterize FOR46 plasma concentration
Time frame: Through 1 month following last dose
Characterize the FOR46 area under the curve
Time frame: Through 1 month following last dose
Characterize FOR46 elimination
Time frame: Through 1 month following last dose
Antidrug Antibodies
Time frame: Through 1 month following last dose
Duration of response
Time frame: From first dose through 6 months following last dose
Progression-free survival
Time frame: From first dose through 6 months following last dose
Time to progression
Time frame: From first dose through 6 months following last dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew Dorr, MD study director
Fortis Therapeutics, Inc.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing FOR46 in people with Multiple Myeloma and Multiple Myeloma in Relapse, run by Fortis Therapeutics, Inc. at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse events (time frame: Through 1 month following last dose). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2022.