Melanoma Clinical Trial
A Study to Characterize the Safety, Tolerability, and Preliminary Efficacy of CFT1946 as Monotherapy and in Combination With Trametinib in Subjects With BRAF V600 Mutant Solid Tumors
The purpose of this study is to evaluate the safety and tolerability of CFT1946 as well as to determine the maximum tolerated dose (MTD) and/or the recommended Phase 2 dose (RP2D) of CFT1946 as monotherapy (Arm A) and in combination with trametinib (CFT1946 + trametinib; Arm B).
Subject (or legally authorized representative, where applicable) is willing and able to provide signed informed consent and can follow protocol requirements
Subject is ≥18 years of age at time of informed consent
Eastern Cooperative Oncology Group performance status of 0 or 1
Subject has documented evidence of a BRAF V600 mutation obtained from tumor tissue or liquid biopsy: (other protocol conditions may apply)
Subject must have received ≥1 prior line of SoC therapy for their unresectable locally advanced or metastatic disease with disease progression on or after last prior treatment. Prior regimens for these subjects vary by indication and investigational arm, but must have included the following:
Melanoma or NSCLC (Phase 1 and Phase 2 Arms A1 and B1): Prior receipt of a BRAF inhibitor and an immune checkpoint inhibitor (any sequence or combination). Prior (neo)adjuvant immunotherapy may be acceptable.
CRC: Receipt of a systemic chemotherapy-based regimen per SoC for unresectable locally advanced or metastatic disease, and previous treatment with BRAF inhibitor in combination with an EGFR monoclonal antibody. Subjects with documented MSI-H or dMMR CRC must have received prior immunotherapy. Subjects with MSS disease must have received at least 2 prior treatments. Subjects who received neo(adjuvant) chemotherapy regimens may be eligible.
ATC: Subjects must have received SoC therapy options including BRAF inhibitor if available and of benefit to the subject
Other BRAF V600 mutant solid tumors (non-CNS): Subjects must have received SoC therapy options per their Investigator's best judgment, including BRAF inhibitor if available and of benefit to the subject
Subject has measurable disease per RECIST v1.1
Adequate bone marrow, liver, renal, and cardiac function
A female subject may be eligible if not pregnant, planning a pregnancy, not breast feeding, a women of non-child bearing potential or a WOCBP willing to comply with protocol conditions relating to the use contraception, ova or blood donation and pregnancy testing prior to the first dose
A male subject must agree to comply with protocol conditions relating to the use of contraception, sperm and blood donation
Subject can safely swallow a tablet or pill
Other protocol defined exclusion criteria may apply
Subject has had major surgery within 21 days prior to the planned first dose. Minor surgery is permitted within 21 days prior to enrollment
Subject with CNS involvement (primary tumor or metastatic disease), except if clinically stable, have no evidence of new or enlarging brain metastases and are on stable or tapering doses of steroids for at least 7 days prior to first dose. Subjects with untreated brain metastases may be eligible to enter without prior radiation therapy.
Subject with known malignancy other than trial indication that is progressing or has required treatment within the past 3 years, except for conditions that have undergone potentially curative therapy
Subject with history of thromboembolic or cerebrovascular events ≤6 months as defined in the protocol
Subject with impaired cardiac function or clinically significant cardiac disease, as defined in the protocol
Subject with history of uncontrolled diabetes mellitus (only for subjects who will receive CFT1946 + trametinib)
Subject with history or current evidence of retinal vein occlusion (RVO), chorioretinopathy, or current risk factors for RVO (only for subjects who will receive CFT1946 + trametinib)
Subject has received live, attenuated vaccine within 28 days prior to first dose administration
Subject has history of pneumonitis or interstitial lung disease
Subject has history of uveitis
Subject has known human immunodeficiency virus (HIV) infection (with exceptions)
Subject has history of or known HBV or active HCV infection
Subject has concurrent administration of strong CYP3A4/5 inhibitors and inducers, including any herbal medications/supplements
Subject has presence of Grade ≥2 toxicity due to prior cancer therapy, excepting alopecia and hypothyroidism requiring thyroid replacement therapy
Subject has initiation or receipt of the following ≤7 days prior to first dose administration: Hematopoietic colony-stimulating growth factors, transfusion of packed red blood cells (pRBC), and transfusion of platelets
Subject is pregnant, breastfeeding, or expecting to conceive or father children any time during the study
Other protocol defined exclusion criteria may apply
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There are 13 Locations for this study
Sarasota Florida, 34232, United States More Info
Boston Massachusetts, 02215, United States More Info
Saint Louis Missouri, 63110, United States More Info
New York New York, 10021, United States More Info
Nashville Tennessee, 37203, United States More Info
Houston Texas, 77030, United States More Info
Fairfax Virginia, 22031, United States More Info
Bordeaux Cedex , 33076, France More Info
Lyon , 69008, France More Info
Barcelona , 08023, Spain More Info
Barcelona , 08035, Spain More Info
Madrid , 28040, Spain More Info
Valencia , 46010, Spain More Info
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