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Enzyme Inhibitor

BAY2965501 + Pembrolizumab for Advanced Cancer

Phase 1

Recruiting

Research Sponsored by Bayer

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months

Awards & highlights

Study Summary

This trial will test an experimental drug to treat advanced solid tumors in people. The drug works by activating T-cells and the study will look at safety, tolerability, and how it moves in/out of the body.

Who is the study for?

This trial is for adults with advanced solid tumors, including specific types of skin, kidney, stomach, and lung cancers. Participants must have a confirmed diagnosis, measurable disease per RECIST 1.1 criteria, adequate organ function, and an ECOG status of 0 to 1. They cannot have had certain recent treatments or severe infusion reactions to similar drugs in the past.Check my eligibility

What is being tested?

The study tests BAY2965501 alone or combined with pembrolizumab on different tumor types. It aims to find safe doses and understand how the drug affects the body and cancer cells. The trial has two parts: dose escalation to determine appropriate dosing levels and dose expansion where those doses are given more broadly.See study design

What are the potential side effects?

Potential side effects may include typical immune-related adverse events such as inflammation in various organs due to T-cell activation by BAY2965501 or pembrolizumab. These can range from mild symptoms like fatigue to more serious conditions affecting heart rhythm or causing pneumonitis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Area under the curve [AUC (0 - 24)] of the respective dosing interval of BAY 2965501 after single-dose and multiple-dose

Maximum Tolerated Dose (MTD)/ Maximum Administered Dose (MAD): Number of participants experiencing dose-limiting toxicities (DLTs) at each dose level in the dose escalation part of the study

Maximum concentration (Cmax) of the respective dosing interval of BAY2965501 after single dose and multiple-dose

+2 more

Secondary outcome measures

Body Weight Changes

Change from baseline in peripheral activation of effector T memory cells as assessed by flow cytometry

Disease control rate (DCR)

+4 more

Trial Design

4Treatment groups

Experimental Treatment

Group I: Dose expansion of BAY2965501 +pembrolizumabExperimental Treatment1 Intervention

For expansion part, specific tumor types are recruited (non-small cell lung cancer (NSCLC) and gastric/gastroesophageal junction (GEJ) adenocarcinoma). BAY2965501 will be taken daily in combination with 200mg pembrolizumab every 3 weeks.

Group II: Dose expansion of BAY2965501Experimental Treatment1 Intervention

For expansion part, specific tumor types are recruited (non-small cell lung cancer (NSCLC) and gastric/gastroesophageal junction (GEJ) adenocarcinoma).

Group III: Dose escalation of BAY2965501+pembrolizumabExperimental Treatment1 Intervention

For escalation part different dose levels of BAY2965501 are planned in combination with 200mg pembrolizumab. BAY2965501 will be taken daily in combination with 200mg pembrolizumab every 3 weeks.

Group IV: Dose escalation of BAY2965501Experimental Treatment1 Intervention

For escalation part, different dose levels of BAY2965501 are planned.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pembrolizumab

2017

Completed Phase 2

~2010

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

BayerLead Sponsor

2,240 Previous Clinical Trials

25,332,493 Total Patients Enrolled

Media Library

BAY2965501 (Enzyme Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05614102 — Phase 1

Solid Tumors Research Study Groups: Dose expansion of BAY2965501 +pembrolizumab, Dose escalation of BAY2965501+pembrolizumab, Dose expansion of BAY2965501, Dose escalation of BAY2965501

Solid Tumors Clinical Trial 2023: BAY2965501 Highlights & Side Effects. Trial Name: NCT05614102 — Phase 1

BAY2965501 (Enzyme Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05614102 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what degree is the enlargement of BAY2965501 dosage hazardous for participants?

"Our safety assessment of Dose Expansion of BAY2965501 yielded a score of 1, given that this is an initial phase trial which has not yet produced enough data to ascertain efficacy or guarantee the drug's security."

Answered by AI

How many participants are currently receiving treatment in this experiment?

"Affirmative. Records hosted on clinicaltrials.gov demonstrate that this research is actively searching for volunteers, and was initially posted on November 4th 2022 before being amended on the 10th of November. The study intends to recruit 179 participants from two distinct medical centres."

Answered by AI

Are volunteers being welcomed to participate in this scientific study presently?

"As per data hosted on clinicaltrials.gov, this medical trial is currently seeking volunteers. The study was initially launched on November 4th 2022 and has since been revised on the 10th of the same month."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2022. "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". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05614102.