CFT1946-1101
A Phase 1/2 Open-Label Multicenter Trial to Characterize the Safety, Tolerability, and Preliminary Efficacy of CFT1946 as Monotherapy and Combination Therapy in Subjects With BRAF V600 Mutant Solid Tumors
REKRUTIERUNG IN DEUTSCHLAND GEPLANT FÜR Q4/2024-Q1/2025
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) or Cetuximab (CFT1946 + cetuximab; Arm C).
Klinische Settings
Indikation: Malignes Melanom
Therapiesituation: inoperable fortgeschritten, höhere Therapielinie
Einschlusskriterien
- 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)
- for more please visit clinicalTrial.gov
Ausschlusskriterien
- 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
- for more please visit clinicalTrial.gov
Links
An der Studie beteiligte Zentren
Zentrum
Hauttumorzentrum am Westdeutschen Tumorzentrum
Universitätsmedizin Essen Hufelandstraße 55
45147 Essen
Deutschland
Kontakt
Herr Prof. Dr. Dirk Schadendorf Hautklinik.Studienzentrum@uk-essen.de
Zentrum
Hautkrebszentrum am LMU Klinikum
Klinik und Poliklinik für Dermatologie und Allergologie - LMU Klinikum Frauenlobstr. 9-11
80337 München
Deutschland
Kontakt
Frau Prof. Dr. Lucie Heinzerling lucie.heinzerling@med.uni-muenchen.de