TerminatedPhase 2

A Study of SOT101 in Combination With Pembrolizumab to Evaluate the Efficacy and Safety in Patients With Selected Advanced Solid Tumors

Stopped: Due to lack of expected efficacy shown at the time of the interim analysis

United States, Belgium166 participantsStarted 2022-06-21

Plain-language summary

The primary objective of the study is to estimate the antitumor efficacy of nanrilkefusp alfa in combination with pembrolizumab in selected tumors.

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✕. Less than 4 weeks for systemic chemotherapy and immuno-oncology therapies; and for tyrosine kinase inhibitors 4 weeks or 5 half-lives (whichever is shorter).
✕. Less than 4 weeks from major surgeries and not recovered adequately.
✕. Cardiomyopathy, with left ventricular ejection fraction ≤ 50%.
✕. Congestive heart failure of New York Heart Association grade ≥2.
✕. History of clinically significant artery or coronary heart disease.
✕. Prolongation of QTcF \>450 msec .
✕. Clinically significant cardiac arrythmia that cannot be controlled with adequate medication.

Percentage of Patients With Objective Response Rate According to Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1)

Timeframe: Day 1 up to approximately 2 years and 2 months

NCT IDNCT05256381

SponsorSOTIO Biotech AG

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-08-31

Results submitted2025-08-15