Status and phase
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About
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 (in MM subjects only).
Enrollment
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Ages
Volunteers
Inclusion criteria
Be willing and able to provide signed informed consent for the trial.
Age ≥18 years at the time of signed consent.
ECOG Performance Status ≤2.
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
In Phase 2, only subjects with the following indications will be eligible for the appropriate expansion arm:
Have provided archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion (lymph node for NHL subjects, bone marrow aspirate and biopsy for MM subjects) not previously irradiated.
Subjects need to have adequate organ function defined as follows to include:
A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:
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.
Males must refrain from donating sperm while on CFT7455 and for 30 days after discontinuation.
Females must refrain from donating ova while on CFT7455 and for 30 days after discontinuation.
Subjects must refrain from donating blood during study treatment and for 30 days after discontinuation.
Exclusion criteria
Presence of central nervous system (CNS) disease.
Has received prior radiotherapy within 2 weeks of start of study treatment.
Have active pneumonitis.
Have any of the following:
Have received prior CC92480 as the most recent therapy
Subjects with a peripheral neuropathy ≥ Grade 2.
Impaired cardiac function or clinically significant cardiac disease, including any of the following:
VTE occurring within 3 months of the first dose in Cycle 1 onto the study or a subject who is unable or unwilling to undergo protocol required venous thromboembolism prophylaxis.
Known malignancy other than study indication that is progressing or has required treatment within the past three years.
Major surgery within 2 weeks of the first dose of study treatment.
Presence of ≥Grade 2 toxicity (CTCAE v5.0) due to prior cancer therapy.
Initiation of hematopoietic colony-stimulating growth factors (e.g., G-CSF, GMCSF, M-CSF) ≤1 week prior to start of study treatment. An erythroid stimulating agent is allowed if it was initiated at least 2 weeks prior to the first dose of study treatment.
Received live, attenuated vaccine within four weeks of first dose.
Known history of human immunodeficiency virus (HIV) infection. No HIV testing is required unless mandated by local health authority.
Any Subject with a known history or risk of Hepatitis B must be tested for HBV. Subjects will be excluded if there is a reactive Hepatitis B surface antigen (HBS-Ag) or Hepatitis B core antibody (anti-HBc total).
Any Subject with a known history or risk of Hepatitis C must be tested for HCV. 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.
Uncontrolled active systemic infection or any life-threatening illness, medical condition, or organ system dysfunction which, in the investigator's opinion, could compromise the subject's safety or put the study outcomes at undue risk.
Concurrent administration of strong CYP3A modulators.
Is currently participating in, or has participated in, a study of an investigational agent, or has used an investigational treatment within ≤ 5 half-lives or within 4 weeks (whichever is shorter) prior to the first dose of study treatment.
Inability or difficulty swallowing capsules, or tablets (as available), malabsorption syndrome, or any disease or medical condition significantly affecting gastrointestinal function.
Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound results of the study, interfere with the subject's participation for full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
Has a known psychiatric or substance abuse disorder that would interfere with cooperating with requirements of the study.
Is pregnant, breastfeeding, or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 30 days after the last dose of study treatment.
Previously identified hypersensitivity to components of the study treatment or excipients.
Primary purpose
Allocation
Interventional model
Masking
158 participants in 8 patient groups
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Central trial contact
Study Medical officer
Data sourced from clinicaltrials.gov
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