Trial purpose
Cancer treatment
Tumor type
Multi-Cancer
Age
12 - 99
Clinical summary
Summary
This study will assess how safe and effective a combination of therapies is in patients with locally advanced inoperable or metastatic solid cancers.
The study will enroll approximately 100 adults; a sub-study will enroll approximately 15 adolescents (aged between 12 and 18 years) for a total sample size of approximately 115 participants.
All participants will recieve the same treatment of Naporafenib (200mg) twice daily and Trametinib (1mg) once daily. Both treatments are administered orally as tablets.
Patients with a locally advanced unresectable or metastatic solid tumor cancer that is not responsive to standard therapies, or for which there is no standard therapy, are eligible.
Patients with primary central nervous system (CNS) tumours are not eligible.
Documentation of a RAS Q61X mutation in tumour tissue prior to the first dose of study treatment is required.
Conditions
This trial is treating people with locally advanced unresectable or metastatic RAS Q61X solid tumour malignancies
Eligibility
Inclusion
- Willing and able to provide written informed consent
- Age ≥ 12 years
- A locally advanced or metastatic tumor who has progressed on or for which no standard therapy exists. Patients who are intolerant to standard therapy or who are not a candidate for standard therapy (in the opinion of the Investigator) or who decline standard therapy are also eligible.
- Documentation of a RAS Q61X mutation (tumor tissue or blood) prior to first dose of study treatment as determined locally with an analytically validated assay in a certified testing laboratory.
- Archival tumor tissue collected within 5 years prior to enrollment must be confirmed to be available at the time of Screening, which may be submitted before or after enrollment for exploratory biomarker analysis.
- ECOG performance status 0, 1 or 2
- Presence of at least 1 measurable lesion according to RECIST v1.1
- Able to swallow oral medication.
Exclusion
Exclusion Criteria:
- Prior therapy with an ERK-, MEK-, RAF-, or RAS-inhibitor
- Impairment of GI function or gastrointestinal (GI) disease that may significantly alter the absorption of study treatment (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, small bowel resection)
- History or current evidence of retinal vein occlusion (RVO) or current risk factors for RVO (e.g., uncontrolled glaucoma or ocular hypertension, history of hyperviscosity or hypercoagulability syndrome)
- Corrected QT interval using Fridericia's formula (QTcF) at Screening >450 ms based on triplicate average NOTE: criterion does not apply to patients with a right or left bundle branch block
- LVEF <50%
- All primary CNS tumors
- Symptomatic CNS metastases that are neurologically unstable. Patients with controlled CNS metastases are eligible.
- Patients receiving treatment with medications that are known to be strong inhibitors and/or inducers of cytochrome P450 (CYP)3A; substrates of CYP2C8, CYP2C9, and CYP3A with a narrow therapeutic index and sensitive substrates of CYP3A;
- Are pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the trial
Inclusion
- Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
- Your cancer has not spread to other parts of the body (localised).
- You have been diagnosed with cancer, but have not received any treatment.
- You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
- You are able to swallow medication by mouth.
Exclusion
- You have certain types of non-cancer medical conditions.
- You have had certain treatments, surgical procedures or drugs.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:
Trial sponsor
Erasca, Inc.
Scientific 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
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