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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05256381
Other study ID # SC104
Secondary ID KEYNOTE-D13AUREL
Status Active, not recruiting
Phase Phase 2
First received
Last updated
Start date June 21, 2022
Est. completion date December 14, 2025

Study information

Verified date September 2023
Source Sotio Biotech Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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Study Design


Intervention

Drug:
Nanrilkefusp Alfa
Subcutaneous (SC) injection.
Pembrolizumab
Intravenous (IV) infusion via peripheral or central venous line.

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Sponsors (2)

Lead Sponsor Collaborator
SOTIO Biotech AG Merck Sharp & Dohme LLC

Countries where clinical trial is conducted

United States,  Belgium,  Czechia,  France,  Georgia,  Hungary,  Italy,  Poland,  Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Objective Response Rate (ORR) According to Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST 1.1) Day 1 up to approximately 3 years
Secondary Number of Participants with a Treatment-emergent Adverse Event (TEAE) Day 1 up to approximately 3 years
Secondary Number of Participants with an Adverse Event of Special Interest (AESI) Day 1 up to approximately 3 years
Secondary Immune ORR (iORR) According to RECIST for immune-based therapeutics (iRECIST) Day 1 up to approximately 3 years
Secondary Best Overall Response (BOR) According to RECIST 1.1 Day 1 up to approximately 3 years
Secondary Immune BOR (iBOR) According to iRECIST Day 1 up to approximately 3 years
Secondary Duration of Response (DoR) According to RECIST 1.1 Day 1 up to approximately 3 years
Secondary Immune DoR (iDoR) According to iRECIST Day 1 up to approximately 3 years
Secondary Clinical Benefit Rate (CBR) According to RECIST 1.1 Day 1 up to approximately 3 years
Secondary Immune CBR (iCBR) According to iRECIST Day 1 up to approximately 3 years
Secondary Progression-free Survival (PFS) According to RECIST 1.1 Day 1 up to approximately 3 years
Secondary Immune PFS (iPFS) According to iRECIST Day 1 up to approximately 3 years
Secondary Time to Response (TtR) According to RECIST 1.1 Day 1 up to approximately 3 years
Secondary Immune TtR (iTtR) According to iRECIST Day 1 up to approximately 3 years
Secondary Metastatic Castration-resistant Prostate Cancer (mCRPC) only: DoR as Assessed According to Prostate Cancer Clinical Trials Working Group 3 (PCWG3)-modified RECIST 1.1 Day 1 up to approximately 3 years
Secondary mCRPC only: CBR as Assessed According to PCWG3-modified RECIST 1.1 Day 1 up to approximately 3 years
Secondary mCRPC only: PFS as Assessed According to PCWG3-modified RECIST 1.1 Day 1 up to approximately 3 years
Secondary mCRPC only: Circulating Tumor Cell (CTC) Count Conversion as Assessed According to PCWG3-modified RECIST 1.1 Day 1 up to approximately 2 years
Secondary mCRPC only: Confirmed Prostate-specific Antigen (PSA) Decline of =50% as Assessed According to PCWG3-modified RECIST 1.1 Day 1 up to approximately 2 years
Secondary mCRPC only: Time to Confirmed PSA Progression as Assessed According to PCWG3-modified RECIST 1.1 Day 1 up to approximately 2 years
Secondary Nanrilkefusp Alfa Concentration Profile at Various Timepoints Cycle 1 Day 1 to Cycle 3 Day 1 (up to approximately 9 weeks, where each cycle is 3 weeks)
Secondary Number of Participants with Anti-drug Antibodies (ADAs) Day 1 up to approximately 2 years
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