SEACRAFT-1
Research type
Research Study
Full title
An open-label study to assess the safety and efficacy of naporafenib (ERAS-254) administered with trametinib in previously treated patients with locally advanced unresectable or metastatic solid tumor malignancies with RAS Q61X mutations [SEACRAFT-1]
IRAS ID
1008403
Contact name
James Davis
Contact email
Sponsor organisation
Erasca, Inc.
Clinicaltrials.gov Identifier
Research summary
SEACRAFT-1 is an open-label study to assess the safety and efficacy of naporafenib administered with trametinib in previously treated patients with locally advanced unresectable or metastatic RAS Q61X solid tumour malignancies.
Dysregulation of the RAS/MAPK pathway is observed in a subset of most solid tumour cancer types. To put this in perspective, it is estimated that approximately 19% of cancer patients will harbour a RAS mutation, which is equivalent to approximately 3.4 million cases per year worldwide.
Naporafenib is an investigational drug that has shown anti-cancer activity in animals and humans by blocking this cell pathway that contributes to cancer formation and progression.
Trametinib is a medication used by itself or in combination with another cancer drug to treat adults with melanoma and some other forms of cancer that have a mutation in another gene in the same pathway that naporafenib targets. It is hoped that that the combination of these drugs may be more effective than either drug given by itself.
The study will enrol a total of approximately 100 adult participants; a sub-study will enrol approximately 15 adolescent patients ≥12 and <18 years for a total sample size of approximately 115. Participants with a locally advanced unresectable or metastatic solid tumour malignancy that is not responsive to standard therapies or for which there is no approved or curative therapy are eligible.
Participants will be asked to come for the screening visit, and then 4 times during the first 28 days (known as a “cycle”), 2 times during the second cycle, and then once during each cycle (every 28 days) after that. Participants will remain in the study for as long as they are tolerating the treatment and receiving benefit.
Naporafenib is to be given by mouth twice a day with trametinib given by mouth once a day, both continuously.
REC name
East of England - Essex Research Ethics Committee
REC reference
23/EE/0243
Date of REC Opinion
6 Dec 2023
REC opinion
Further Information Favourable Opinion