A Study of Nanrilkefusp Alfa (SOT101) in Combination With Cetuximab to Evaluate the Efficacy and … (NCT05619172) | Clinical Trial Compass
TerminatedPhase 2
A Study of Nanrilkefusp Alfa (SOT101) in Combination With Cetuximab to Evaluate the Efficacy and Safety in Patients With Colorectal Cancer
Stopped: Due to lack of efficacy shown at the time of the interim analysis.
Belgium, France, Spain16 participantsStarted 2022-12-22
Plain-language summary
The primary objective of the study is to estimate the antitumor efficacy of nanrilkefusp alfa (SOT101) in combination with cetuximab in RAS wild-type colorectal cancer.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. ≥18 years of age on the day of signing informed consent
✓. Ability to understand and sign written informed consent to participate in the study
✓. Provides written informed consent for the study
✓. Life expectancy \>6 months
✓. Histologically or cytologically confirmed advanced and/or metastatic colorectal cancer
✓. RAS wild type as confirmed by:
✓. Patients who are relapsed/refractory or intolerant to prior treatment with irinotecan- and oxaliplatin-containing chemotherapy
✓. Have at least one measurable lesion according to RECIST 1.1
Exclusion criteria
✕. Prior exposure to drugs that are agonists of IL-2 or IL-15
✕. Therapy with cetuximab within 3 months prior to ICF signature or patients who had progressive disease as best response to prior cetuximab-containing regimen
✕. Prior systemic anti-cancer therapies, including investigational agents before study entry (ICF signature):
✕.1. Less than 3 weeks or 5 half lives (whichever shorter) for anti-cancer treatments 3.2. Less than 4 weeks from major surgeries and not recovered adequately from the procedure and/or any complications from the surgery
What they're measuring
1
Objective Response Rate According to Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1)
Timeframe: Day 1 up to approximately 1 year 2 months
. Has received more than 4 prior lines of systemic anticancer treatment
✕. Has received prior radiotherapy within 2 weeks of the start of study treatments. A 1-week radiation-free period is permitted for palliative radiation (≤2 weeks of radiotherapy) to non-central nervous system disease. Patients must have recovered from all radiation-related toxicities and not require corticosteroids.
✕. Has received a live or live-attenuated vaccine within 30 days prior to the first dose of study treatments
✕. Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 3 weeks or 5 half lives (whichever longer) before study entry (ICF signature). Patients who have entered the follow-up phase of an investigational study may participate as long as it has been 3 weeks or 5 half lives (whichever longer) after the last dose of the previous investigational agent.