A Study to Learn How Safe the Study Drug BAY 2416964 (AhR Inhibitor) in Combination With the Treatment Pembrolizumab is, How This Combination Affects the Body, the Maximum Amount That Can be Given, How it Moves Into, Through and Out of the Body and Its Action Against Advanced Solid Cancers in Adults

PHASE1TerminatedINTERVENTIONAL
Enrollment

47

Participants

Timeline

Start Date

August 30, 2021

Primary Completion Date

June 28, 2024

Study Completion Date

January 20, 2025

Conditions
Advanced Solid Tumors
Interventions
DRUG

BAY2416964

Oral, twice or three times daily

DRUG

BAY2416964

The highest dose determined safe in combination with pembrolizumab in the dose escalation part or a lower dose. More than one dose may be explored in the dose expansion.

DRUG

Pembrolizumab

Administered as a dose of 200 mg using a 30-minute IV infusion every 3 weeks

Trial Locations (14)

20089

Humanitas Mirasole S.p.A. - Oncologia Medica ed Ematologia, Rozzano

20133

Fondazione IRCCS Istituto Nazionale dei Tumori - S. C. Oncologia Medica 1, Milan

20141

Istituto Europeo di Oncologia s.r.l - Sviluppo di nuovi farmaci per Terapie Innovative, Milan

20162

ASST Grande Ospedale Metropolitano Niguarda, Milan

22031

Virginia Cancer Specialists, PC, Fairfax

32701

Florida Cancer Specialists, Altamonte Springs

34232

Florida Cancer Specialists & Research Institute, Sarasota

37203

Sarah Cannon Research Institute, Nashville

48202

Brigette Harris Cancer Pavilion at Henry Ford Cancer Center - Detroit, Detroit

78705

Texas Oncology- Austin Midtown, Austin

80131

IRCCS Istituto Nazionale Tumori Fondazione Pascale - S. C. Sperimentazioni Cliniche, Napoli

119074

National University Hospital Medical Centre, Singapore

BT12 7AB

Belfast City Hospital, Belfast

NE7 7DN

Freeman Hospital, Newcastle

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Bayer

INDUSTRY