Terminated PHASE1 INTERVENTIONAL 6-arm NCT04234113

Study of Nanrilkefusp Alfa Alone and With Pembrolizumab in Adult Patients With Advanced/Metastatic Solid Tumors

A Multicenter Open-label Phase 1/1b Study to Evaluate the Safety and Preliminary Efficacy of SO-C101 as Monotherapy and in Combination With Pembrolizumab in Patients With Selected Advanced/Metastatic Solid Tumors

Sponsor: SOTIO Biotech AG

Conditions Anal Cancer Biliary Tract Cancer Bladder Cancer Cervical Cancer Gastric Cancer Head and Neck Squamous Cell Carcinoma Hepatocellular Carcinoma Melanoma Merkel Cell Carcinoma Mesothelioma Microsatellite Instability High Non Small Cell Lung Cancer Ovarian Cancer Renal Cell Carcinoma Skin Squamous Cell Carcinoma Small-cell Lung Cancer Thymic Cancer Thyroid Cancer Triple Negative Breast Cancer

Interventions Nanrilkefusp alfa Pembrolizumab

Updated 15 times since 2020 Last updated: Jan 6, 2025 Started: Jun 13, 2019 Primary completion: Aug 31, 2024 Completion: Nov 27, 2024

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Terminated

Due to lack of efficacy shown at the time of the interim analysis.

Other terminated trials from SOTIO Biotech AG

Colorectal Cancer · Phase PHASE2 · Jun 2024

More terminations from SOTIO Biotech AG

This PHASE1 trial investigates Anal Cancer and Biliary Tract Cancer and is currently terminated or withdrawn. SOTIO Biotech AG leads this study, which shows 15 recorded versions since 2019 — indicating substantial longitudinal coverage. As an oncology study, it adds to the longitudinal record of treatment development for this indication.

Status Flow

Change History

15 versions recorded

Sep 2025 — Present [monthly]

Terminated PHASE1
Feb 2025 — Sep 2025 [monthly]

Terminated PHASE1

Status: Active Not Recruiting → Terminated
Oct 2024 — Feb 2025 [monthly]

Active Not Recruiting PHASE1
Sep 2024 — Oct 2024 [monthly]

Active Not Recruiting PHASE1
Jul 2024 — Sep 2024 [monthly]

Active Not Recruiting PHASE1

▶ Show 10 earlier versions

Apr 2024 — Jul 2024 [monthly]

Active Not Recruiting PHASE1
Oct 2023 — Apr 2024 [monthly]

Active Not Recruiting PHASE1

Status: Recruiting → Active Not Recruiting
Sep 2023 — Oct 2023 [monthly]

Recruiting PHASE1
May 2023 — Sep 2023 [monthly]

Recruiting PHASE1
May 2022 — May 2023 [monthly]

Recruiting PHASE1
Nov 2021 — May 2022 [monthly]

Recruiting PHASE1
May 2021 — Nov 2021 [monthly]

Recruiting PHASE1
Jan 2021 — May 2021 [monthly]

Recruiting PHASE1
Dec 2020 — Jan 2021 [monthly]

Recruiting PHASE1
Feb 2020 — Dec 2020 [monthly]

Recruiting PHASE1

First recorded

Jun 2019

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

SOTIO Biotech AG
SOTIO Biotech a.s.

Data source: Sotio Biotech Inc.

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Barcelona, Spain , Brno, Czechia , Houston, United States , Lyon, France , Madrid, Spain , Marseille, France , New Haven, United States , Paris, France , Pittsburgh, United States , Saint-Herblain, France and 1 more location