A Phase 1/2a Study Investigating TAK-079 Administered Subcutaneously in Patients With Relapsed/Refractory Multiple Myeloma

Verified

Overview

The purpose of this study is to assess the safety and tolerability, maximum tolerated dose (MTD)/recommended phase 2 dose of TAK-079 monotherapy and when combined with a backbone regimen of pomalidomide and dexamethasone (PomDex) in Phase 1, and to provide a preliminary evaluation of the clinical activity of TAK-079 monotherapy in Phase 2a in participants with relapsed/refractory multiple myeloma.

The information from the study may be used to:

  • To develop a better understanding of how people’s genetic makeup and cell proteins affects the safety and effectiveness of TAK-079
  • To generate information needed for research, development and regulatory approval of TAK-079 and diagnostic tests related to diseases or conditions that TAK-079 might treat

How many people will take part in the study?

It is planned that 24 patients with multiple myeloma will take part in Phase 1, and 18 patients will take part in Phase 2. The study is being carried out at multiple sites in the United States.

How Long Will I Be In the Study?

You can continue receiving TAK-079 unless your disease worsens or you experience unacceptable side effects or withdraw due to other reasons not listed. You will be followed for 30 (+/-7) days after your last dose of TAK-079 or right before the start of any subsequent anticancer therapy. If you discontinue treatment for any other reason then you will be followed every 4 weeks from end of treatment until progressive disease, consent withdrawal, or others reasons the study would end.

What Will Happen During the Study?

Phase 1 (dose escalation):

In Phase 1 of the study, patients will start receiving low doses of TAK-079. The lowest dose has already been given in healthy individuals. If that dose is well tolerated, the study will enroll the next group of 3 patients who will receive a little higher dose of TAK-079, and if that dose is well tolerated, the next group will receive the next higher dose, and so on until the best dose for TAK-079 is reached. There will be 6 planned dose levels for Phase I. However, if a certain level of toxicity is observed, the recommendation is to stop increasing doses.

Phase 2 (dose expansion):

In Phase 2 of the study, patients will receive the dose of TAK-079 found to be safe and well tolerated during the during the first phase of the study to check specifically the activity of TAK -079 against your disease. However, during this phase of the study, toxicity will be monitored as well. If a certain grade of toxicity has been seen observed, no more patients will be accepted to enter this study until further investigation. Only after further investigation has shown that continuation of the study is safe, the study will be re-opened again and new patients will be accepted again.

How Will Treatment Be Administered?

You will receive the study drug, TAK 079 by subcutaneous (under your skin) injections given every 30 minutes until the full scheduled dose has been administered.

You will receive TAK-079 at weekly intervals for 8 weeks. If you do not have any severe side effects, your cancer does not get worse, and your study doctor feels that you would continue to benefit from treatment with TAK 079, you will continue to receive treatments every 2 weeks for 16 weeks, and then once every 4 weeks unless your disease worsens or you experience unacceptable side effects.

SparkCures ID 946
Trial Phase Phase 1/2
Enrollment 100 Patients
Treatments
Trial Sponsors
  • Takeda Oncology
NCT Identifier

NCT03439280

Am I Eligible?

The following criteria is a partial list of reasons why patients may or may not be eligible to participate in this clinical trial. Further evaluation with a medical professional will be required to determine full eligibility.

  • Are at least 18 years old
  • Have relapsed or refractory multiple myeloma
  • Have been treated with at least three prior lines of multiple myeloma therapy including a proteasome inhibitor, an immunomodulatory agent, an alkylating agent, and steroids OR 2 lines of prior therapy if one of the lines included a combination of a proteasome inhibitor and an immunomodulatory agent
  • Have not received allogeneic stem cell transplant.
  • Prior treatment with an anti-CD38 antibody is allowed; details should be discussed with your doctor

The following criteria is provided for health care professionals.

e

Inclusion Criteria:

  1. Eastern Cooperative Oncology Group (ECOG) performance status of <=2.
  2. Has received previous myeloma-specific therapy.
  3. In the Combination Cohort (TAK-079-PomDex) only must be able to take concurrent prophylactic anticoagulation per standard clinical practice as directed by the investigator and the Pomalyst product information.
  4. Documentation of RRMM as defined by the International Myeloma Working Group (IMWG) criteria.
  5. For Participants with MM, measurable disease defined as one of the following:
    • Serum M-protein ≥ 0.5 g/dL (≥ 5 gram per liter [g/L]).
    • Urine M-protein ≥ 200 mg/24 hours.
    • In participants without measurable M-protein in serum protein electrophoresis (SPEP) or urine protein electrophoresis (UPEP), a serum FLC assay result with involved FLC level ≥ 10 mg/dL (≥ 100 milligram per liter [mg/L]), provided serum FLC ratio is abnormal.
  6. Prior therapy should meet all the following criteria:

    Participants in the dose Escalation Cohort (escalation phase) and participants in the dose Confirmation Cohort;

    • Should be previously treated with at least a proteasome inhibitor (PI), an immunomodulatory drug (IMiD), and a steroid. Note: Participants who have had a previous autologous stem cell transplant will have additionally been exposed to an alkylating agent; however, participant who have not had a previous autologous stem cell transplant may not have been exposed to an alkylating agent per standard practice.
    • Should be refractory or intolerant to at least 1 PI and at least 1 IMiD.
    • Should either have received ≥ 3 prior lines of therapy or should have received at least 2 prior lines of therapy if one of those lines included a combination of PI and IMiD.
    • In phase 1, previous exposure to an anti-CD38 agent, as a single agent or in combination, is allowed but is not required. (Participants in the dose Escalation Cohort).
    • In phase 1 dose Confirmation Cohort, cohorts of participants that are refractory at any time to at least 1 anti-CD38 agent or who are anti-CD38 naïve will be enrolled.

    Participants in the Combination Cohort (TAK-079 added to PomDex cohort only):

    • Have undergone prior therapy with > 2 prior anti-myeloma therapies (line of therapy defined below).
    • Has either relapsed or relapsed and refractory disease. Should have progressed on or within 60 days of completing the last anti-myeloma therapy (refractory defined below).
  7. In the phase 2a portion of the study, up to 2 cohorts of participants with RRMM may be enrolled: 1 that is refractory to at least 1 anti-CD38 monoclonal antibody (mAb) therapy at any time during treatment and 1 that is naïve to daratumumab.

Note: Refractory is defined as at least a 25% increase in M-protein (response of stable disease during prior therapy) or PD during treatment or within 60 days after last dose of prior therapy.

Exclusion Criteria:

  1. Sensory or motor neuropathy of National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Grade ≥ 3.
  2. Have received allogeneic stem cell transplant.
  3. Have received anti-CD38 antibody therapy and do not fulfill a 180-day washout period before receiving TAK-079.
  4. Not recovered from adverse reactions to prior myeloma treatment or procedures (chemotherapy, immunotherapy, radiation therapy) to NCI CTCAE Grade ≤ 1 or baseline, excluding alopecia.
  5. Clinical signs of central nervous system (CNS) involvement of MM.
  6. Active chronic hepatitis B virus (HBV) or hepatitis C virus (HCV) infection, active HIV, or cytomegalovirus (CMV) infection.
  7. POEMS (polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy and skin changes) syndrome, monoclonal gammopathy of unknown significance, smoldering myeloma, solitary plasmacytoma, amyloidosis, Waldenström macroglobulinemia, or IgM myeloma.
  8. Positive Coombs tests at screening.
  9. For participants in the Combination Cohort (TAK-079-PomDex) only: participant has previously received pomalidomide or has hypersensitivity to thalidomide or lenalidomide.

US Trial Locations

Accepting Patients

The following is a listing of trial locations that are open and accepting patients.

California
Missouri
Siteman Cancer Center - Washington University Medical Campus
New York
Mount Sinai Hospital - Tisch Cancer Institute
Weill Cornell Medicine -
Oregon
Texas
MD Anderson Cancer Center - The University of Texas
Wisconsin
Medical College of Wisconsin - Froedtert Hospital

Resources

Travel Assistance May Be Available
Travel Assistance May Be Available

Travel assistance may be available for this trial. Please contact SparkCures for more details.

SparkCures Verified

SparkCures is working closely with Takeda Oncology to provide the most up-to-date information on this clinical trial. Use the button above to add this trial to your list of favorites.

Learn more about how we work with trial sponsors