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

Part of paid clinical trials in Whittier, California.

Sponsor
SOTIO Biotech AG
Study ID
NCT05256381
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Nanrilkefusp Alfa — DRUG
    Subcutaneous (SC) injection.
  • Pembrolizumab — DRUG
    Intravenous (IV) infusion via peripheral or central venous line.

Study Details

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

Key Dates

Start date
Jun 21, 2022
Status verified
Nov 2025
Primary completion
Aug 31, 2024
Completion
Nov 29, 2024

Study Design

Enrollment
166 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Nanrilkefusp Alfa and Pembrolizumab
    Participants will be treated with 12 μg/kg of nanrilkefusp alfa on Day 1, Day 2, Day 8, and Day 9 of each 3-week cycle in combination with 200 mg pembrolizumab on Day 1 of each 3-week cycle.

Primary Outcome Measure

Percentage of Patients With Objective Response Rate According to Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1) [ Time Frame: Day 1 up to approximately 2 years and 2 months ]

Locations (2)

FacilityCityStateZIP
Innovative Clinical Research InstituteWhittierCalifornia90603
University of Pittsburg Medical Center (UPMC) Hillman Cancer CenterPittsburghPennsylvania15232

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Innovative Clinical Research Institute· Whittier, CAUniversity of Pittsburg Medical Center (UPMC) Hillman Cancer Center· Pittsburgh, PA

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