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Study to Assess the Safety and Tolerability of CFT7455 in Relapsed/Refractory Non-Hodgkin's Lymphoma or Multiple Myeloma

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ClinicalTrials.gov Identifier: NCT04756726
Recruitment Status : Recruiting
First Posted : February 16, 2021
Last Update Posted : April 20, 2022
Sponsor:
Information provided by (Responsible Party):
C4 Therapeutics, Inc.

Brief Summary:
The purpose of this study is to characterize the safety, tolerability, pharmacokinetics, pharmacodynamics, and antitumor activity of CFT7455 administered orally in subjects with Relapsed/Refractory (r/r) Non-Hodgkin's Lymphoma (NHL) or Multiple Myeloma (MM) administered according to different dosing schedules as a single agent and in combination with dexamethasone.

Condition or disease Intervention/treatment Phase
Multiple Myeloma Lymphoma, Non-Hodgkin's Drug: CFT7455 Drug: Dexamethasone Oral Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 158 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1/2 Open-Label Multi-Center Study to Characterize the Safety and Tolerability of CFT7455 in Subjects With Relapsed/Refractory Non-Hodgkin's Lymphoma or Multiple Myeloma
Actual Study Start Date : April 27, 2021
Estimated Primary Completion Date : September 7, 2024
Estimated Study Completion Date : December 7, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Phase 1: Arm A - CFT7455
Participants with r/r NHL or r/r MM will be treated with oral CFT7455 as a single agent administered according to different dosing schedules
Drug: CFT7455
oral CFT7455

Experimental: Phase 1: Arm B1 - CFT7455
Participants with r/r MM will be treated with escalating doses of single agent CFT7455 administered according to different dosing schedules until the determination of maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D)
Drug: CFT7455
oral CFT7455

Experimental: Phase 1: Arm B2 - CFT7455 in combination with dexamethasone
Participants with r/r MM will be treated with oral CFT7455 in combination with a fixed dose of oral dexamethasone in each cohort
Drug: CFT7455
oral CFT7455

Drug: Dexamethasone Oral
oral dexamethasone [ ≤75 years old: 40 mg once per week (QW) on days 1, 8, 15, and 22; >75 Years old: 20 mg QW on days 1, 8, 15, and 22]

Experimental: Phase 1: Arm C - CFT7455
Participants with r/r NHL will be treated with escalating doses of single agent CFT7455 administered according to different dosing schedules in each cohort until determination of MTD/RP2D
Drug: CFT7455
oral CFT7455

Experimental: Phase 2: Arm 1 - CFT7455
Participants with r/r MM will be treated with oral CFT7455
Drug: CFT7455
oral CFT7455

Experimental: Phase 2: Arm 2 - CFT7455 in combination with dexamethasone
Participants with r/r MM treated with oral CFT7455 in combination with oral dexamethasone
Drug: CFT7455
oral CFT7455

Drug: Dexamethasone Oral
oral dexamethasone [ ≤75 years old: 40 mg once per week (QW) on days 1, 8, 15, and 22; >75 Years old: 20 mg QW on days 1, 8, 15, and 22]

Experimental: Phase 2: Arm 3 - CFT7455
Participants with r/r mantle cell lymphoma (MCL) treated with oral CFT7455
Drug: CFT7455
oral CFT7455

Experimental: Phase 2: Arm 4 - CFT7455
Participants with r/r peripheral T-cell lymphoma (PTCL) treated with oral CFT7455
Drug: CFT7455
oral CFT7455




Primary Outcome Measures :
  1. Phase 1: Safety and tolerability of CFT7455 [ Time Frame: Days 1-28 ]
    Percent of subjects with adverse events (AEs) with CFT7455 as a single agent

  2. Phase 1: Safety and tolerability of CFT7455 for CFT7455 in combination with dexamethasone [ Time Frame: Days 1-28 ]
    Percent of subjects with AEs with CFT7455 in combination with dexamethasone

  3. Phase 1: Maximum tolerated dose (MTD) or recommended Phase 2 dose (RP2D) for CFT7455 [ Time Frame: Baseline through 3 months after the last dose of study treatment ]
    Percent of subjects with dose-limiting toxicities (DLTs) with CFT7455 as a single agent

  4. Phase 1: MTD or recommended RP2D for CFT7455 in combination with dexamethasone [ Time Frame: Baseline through 3 months after the last dose of study treatment ]
    Percent of subjects with DLTs with CFT7455 in combination with dexamethasone

  5. Phase 2: Antitumor activity of CFT7455 [ Time Frame: Baseline through 6 months after the last dose of study treatment, or until disease progression, whichever occurs first ]
    Overall Response Rate (ORR) based on Best Overall Response (BOR), Duration of Response (DOR), Clinical Benefit Rate (CBR), and Progression Free Survival (PFS) of CFT7455

  6. Phase 2: Antitumor activity of CFT7455 in combination with dexamethasone [ Time Frame: Baseline through 6 months after the last dose of study treatment, or until disease progression, whichever occurs first ]
    ORR based on BOR, DOR, CBR, and PFS of CFT7455 as a single agent and in combination with dexamethasone in subjects with MM based on International Myeloma Working Group (IMWG) criteria



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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:

  1. Be willing and able to provide signed informed consent for the trial.
  2. Age ≥18 years at the time of signed consent.
  3. Have histologically or cytologically-confirmed NHL or MM that is r/r disease and must not be candidates for regimens known to provide clinical benefit to be eligible for the study.
  4. MM subject must have a documented diagnosis of MM and measurable disease at enrollment. Measurable disease is defined as:

    • M-protein ≥0.5g/dL by Serum Protein Electrophoresis (sPEP) or
    • ≥200mg/24-hour urine collection by Urine Protein Electrophoresis (uPEP) or
    • Serum Free Light Chain (FLC) levels >100 mg/L involved light chain and an abnormal kappa/lambda (κ/λ) ratio in subjects without measurable serum or urine M-protein or
    • For subjects with immunoglobulin class A (IgA), myeloma whose disease can only be reliably measured by quantitative immunoglobulin measurement, a serum IgA level ≥ 0.50g/dL.
  5. Prior treatments for MM subjects must have the following:

    • Received at least 3 prior anti-myeloma regimens including at least 2 consecutive cycles of lenalidomide, pomalidomide, a proteasome inhibitor a glucocorticoid and an anti-CD38 antibody (induction with or without a bone marrow transplant with or without maintenance therapy is considered one regimen).
    • Refractory disease defined as disease that is nonresponsive to therapy (failure to achieve minimal response or development of progressive disease) or disease progression within 60 days from the last dose of their last myeloma therapy.
  6. NHL subjects must have documented diagnosis of NHL and measurable disease defined by measurable disease (consistent with Lugano classification) defined as at least one lesion that can be accurately measured in at least two dimensions with PET-CT, documented within 4 weeks of their projected cycle one day one (C1D1) visit. Minimum measurement must be >15 mm in the longest diameter.
  7. NHL subjects must have received the following regarding prior therapy:

    • Peripheral T-cell Lymphoma: At least one prior line containing alkylator-based chemotherapy. Note: For subjects with Anaplastic Large Cell Lymphoma (ALCL), the subject must also have received CD30 antibody therapy.
    • Mantle Cell Lymphoma: ≥2 lines of therapy, including CD20 antibody and alkylator chemotherapy, and a Bruton's tyrosine kinase (BTK) inhibitor.
    • Follicular Lymphoma: ≥2 lines of therapy, including CD20 antibody therapy and alkylator chemotherapy.
    • Diffuse Large B-cell Lymphoma: ≥2 lines of therapy, including prior CD20 antibody therapy, and has received prior autologous bone marrow transplant (or is ineligible for bone marrow transplant).
    • Other NHL: Subjects must have been treated with all standard of care therapies available to the subject which, in the assessment of the investigator, may be beneficial to the subject.
  8. A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:

    • A woman of non-childbearing potential (i.e., physiologically incapable of becoming pregnant) defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea [in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) > 40 MIU/mL and estradiol < 40 pg/mL (<147 pmol/L) must be obtained].
    • Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the contraception methods specified in the study protocol if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of postmenopausal status prior to study enrollment.
    • Agree to having ongoing pregnancy tests during the study and after discontinuation of the study.
  9. A male participant must have either had a prior vasectomy or agree to use a condom during the treatment period and for at least 90 days after the last dose of study treatment.

Exclusion Criteria:

  1. Presence of central nervous system (CNS) disease.
  2. Has received prior radiotherapy within 2 weeks of start of study treatment.
  3. Have active pneumonitis.
  4. Have any of the following:

    • Non-secretory or oligosecretory MM
    • Plasma cell leukemia
    • Systemic light chain amyloidosis
    • Polyneuropathy, Organomegaly, Endocrinopathy, Monoclonal gammopathy, and Skin changes (POEMS) Syndrome
    • Lymphoblastic lymphoma
    • Mycosis fungoides
    • Sezary syndrome
    • Primary cutaneous T-cell lymphomas
    • Primary CNS lymphoma
    • B-cell or T-cell prolymphocytic leukemia
  5. Subjects with a peripheral neuropathy ≥ Grade 2.
  6. Known malignancy other than study indication that is progressing or has required treatment within the past three years.
  7. Received live, attenuated vaccine within four weeks of first dose.
  8. Known history of human immunodeficiency virus (HIV) infection. No HIV testing is required unless mandated by local health authority.
  9. Subjects with positive test for Hepatitis B surface (HBS-Ag) or Hepatitis B core (HBc) antigen.
  10. Subjects with positive test for hepatitis C (HCV) infection are excluded regardless of viral load. If hepatitis C antibody test is positive, a confirmatory test should be performed. If the test is negative, subject is eligible for this trial.
  11. Concurrent administration of strong CYP3A modulators.
  12. Is pregnant, breastfeeding, or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of study treatment.
  13. Subjects on proton pump inhibitors (PPIs). The last dose of PPIs must be administered seven days prior to administration of study drug. Antacids are acceptable when administered in a staggered dosing manner with CFT7455.

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): NCT04756726


Contacts
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Contact: Chief Medical officer (617) 231-0700 clinicaltrials@C4therapeutics.com

Locations
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United States, Arizona
Mayo Clinic Recruiting
Phoenix, Arizona, United States, 85054
United States, California
University of California-San Francisco Recruiting
San Francisco, California, United States, 94143
United States, Colorado
Colorado Blood Cancer Institute (Sarah Cannon Research Institute) Recruiting
Denver, Colorado, United States, 80218
United States, Florida
Mayo Clinic Recruiting
Jacksonville, Florida, United States, 32224
United States, Georgia
Emory University Hospital Recruiting
Atlanta, Georgia, United States, 30322
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Dana-Farber Cancer Institute Not yet recruiting
Boston, Massachusetts, United States, 02215
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
United States, Missouri
Washington University School of St. Louis Recruiting
Saint Louis, Missouri, United States, 63110
United States, New York
Mt Sinai Medical Center Recruiting
New York, New York, United States, 10029
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
United States, North Carolina
Levine Cancer Institute - Charlotte Not yet recruiting
Charlotte, North Carolina, United States, 28204
United States, Tennessee
Tennessee Oncology (Sarah Cannon Research Institute) Recruiting
Nashville, Tennessee, United States, 37203
United States, Wisconsin
Medical College of Wisconsin Not yet recruiting
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
C4 Therapeutics, Inc.
Investigators
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Study Director: Adam Crystal, MD C4 Therapeutics, Inc.
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Responsible Party: C4 Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT04756726    
Other Study ID Numbers: CFT7455-1101
First Posted: February 16, 2021    Key Record Dates
Last Update Posted: April 20, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by C4 Therapeutics, Inc.:
Multiple Myeloma
Lymphoma, Non-Hodgkin's
CFT7455
Relapsed
Refractory
Additional relevant MeSH terms:
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Lymphoma
Multiple Myeloma
Neoplasms, Plasma Cell
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Dexamethasone
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents