A First-in-human Study to Learn How Safe the Study Drug BAY2965501 is, Find the Best Dose (Single Drug & Combination), How it Affects the Body, What Maximum Amount Can be Given, How it Moves Into, Through and Out of the Body, How it Acts on Different Tumors in Participants With Advanced Solid Tumors

PHASE1Active, not recruitingINTERVENTIONAL
Enrollment

284

Participants

Timeline

Start Date

November 4, 2022

Primary Completion Date

June 7, 2027

Study Completion Date

September 9, 2027

Conditions
Advanced Solid Tumors
Interventions
DRUG

BAY2965501

Daily oral application

DRUG

Pembrolizumab

In combination group 200mg as infusion every 3 weeks

DRUG

Platinum-based Chemotherapy

Standard of care doses per tumor type will be administered.

Trial Locations (21)

13620

Seoul National University Bundang Hospital, Seongnam-si

15232

UPMC Hillman Cancer Center, Pittsburgh

28027

Universidad de Navarra - Clinica Universidad de Navarra (CUN) - Madrid, Madrid

28050

The START Center for Cancer Care - Madrid - CIOCC - Hospital Universitario Madrid Sanchinarro - Oncologia, Madrid

31008

Universidad de Navarra - Centro de Investigacion Medica Aplicada (CIMA), Pamplona

80218

Sarah Cannon Research Institute at HCA HealthONE Presbyterian St. Luke's, Denver

100000

Cancer Hospital, Chinese Academy of Medical Sciences, Beijing

310016

Sir Run Run Shaw Hospital, Zhejiang Univ. School of Medicine - Oncology Department, Hangzhou

518172

Cancer Hospital Chinese Academy of Medical Sciences, Shenzhen Center, Shenzhen

Texas

"START , San Antonio"

Unknown

"Antwerp University Hospital , Oncology Department"

"Ghent University Hospital , Drug Research Unit Department"

277-8577

National Cancer Center Hospital East, Kashiwa

03722

Severance Hospital, Yonsei University Health System - Oncology Department, Seoul

135-710

Samsung Medical Center - Oncology Department, Seoul

08023

Hospital Hm Nou Delfos - Oncologia, Barcelona

08035

Hospital Universitari Vall d'Hebron - Institut d'Oncologia - Grupo de Tumores Toracicos y Cancer de Cabeza y Cuello, Barcelona

Oxfordshire

"Oxford University Hospitals NHS Foundation Trust , Churchill Hospital - Oncology"

SM2 5PT

Royal Marsden NHS Trust (Surrey), Sutton

NE7 7DN

Freeman Hospital, Newcastle

SE1 9RT

Guy's and St Thomas' NHS Foundation Trust - Guy's Hospital, London

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Bayer

INDUSTRY

NCT05614102 - A First-in-human Study to Learn How Safe the Study Drug BAY2965501 is, Find the Best Dose (Single Drug & Combination), How it Affects the Body, What Maximum Amount Can be Given, How it Moves Into, Through and Out of the Body, How it Acts on Different Tumors in Participants With Advanced Solid Tumors | Biotech Hunter | Biotech Hunter