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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04756726
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1/Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

C4 Therapeutics, Inc.
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Multiple Myeloma, Lymphoma, Non-Hodgkin's
Arms & Interventions

Arms

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

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)

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

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

Experimental: Phase 2: Arm 1 - CFT7455

Participants with r/r MM will be treated with 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

Experimental: Phase 2: Arm 3 - CFT7455

Participants with r/r mantle cell lymphoma (MCL) treated with oral CFT7455

Experimental: Phase 2: Arm 4 - CFT7455

Participants with r/r peripheral T-cell lymphoma (PTCL) treated with oral CFT7455

Interventions

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]

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Mayo Clinic, Phoenix, Arizona

Status

Recruiting

Address

Mayo Clinic

Phoenix, Arizona, 85054

University of California-San Francisco, San Francisco, California

Status

Recruiting

Address

University of California-San Francisco

San Francisco, California, 94143

Denver, Colorado

Status

Recruiting

Address

Colorado Blood Cancer Institute (Sarah Cannon Research Institute)

Denver, Colorado, 80218

Mayo Clinic, Jacksonville, Florida

Status

Recruiting

Address

Mayo Clinic

Jacksonville, Florida, 32224

Emory University Hospital, Atlanta, Georgia

Status

Recruiting

Address

Emory University Hospital

Atlanta, Georgia, 30322

Massachusetts General Hospital, Boston, Massachusetts

Status

Recruiting

Address

Massachusetts General Hospital

Boston, Massachusetts, 02114

Dana-Farber Cancer Institute, Boston, Massachusetts

Status

Recruiting

Address

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215

Mayo Clinic, Rochester, Minnesota

Status

Recruiting

Address

Mayo Clinic

Rochester, Minnesota, 55905

Saint Louis, Missouri

Status

Recruiting

Address

Washington University School of St. Louis

Saint Louis, Missouri, 63110

Mt Sinai Medical Center, New York, New York

Status

Recruiting

Address

Mt Sinai Medical Center

New York, New York, 10029

Memorial Sloan Kettering Cancer Center, New York, New York

Status

Recruiting

Address

Memorial Sloan Kettering Cancer Center

New York, New York, 10065

Nashville, Tennessee

Status

Recruiting

Address

Tennessee Oncology (Sarah Cannon Research Institute)

Nashville, Tennessee, 37203

Medical College of Wisconsin, Milwaukee, Wisconsin

Status

Recruiting

Address

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226