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NCT05614102 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of Advanced Solid Tumors, sponsored by Bayer.

Active
Registry status
Phase 1
Development phase
284
Enrollment target
20
Study locations

NCT05614102 is a Phase 1 study of Advanced Solid Tumors that is active but no longer recruiting, run by Bayer. The registered enrollment target is 284 participants, above the 197-participant average among 144 other Advanced Solid Tumors trials with a reported enrollment target (44% higher). The trial reports 20 study locations across 12 states.

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The verdict

NCT05614102, a Phase 1 study of Advanced Solid Tumors, is active but no longer recruiting, sponsored by Bayer.

ACTIVE NOT RECRUITING
Registry status
Phase 1
Development phase
284 participants
Enrollment target
20
Study locations

Study Summary

Researchers are looking for a better way to treat people who have advanced solid tumors. Advanced solid tumors are types of cancer that may have spread to nearby tissue, lymph nodes, and/or to distant parts of the body and that are unlikely to be cured or controlled with currently available treatments. This study focuses on certain types of skin cancer, kidney cancer, stomach cancer, and lung cancer. The study treatment BAY2965501 is currently under development as monotherapy or in combination for the treatment of people with advanced solid tumors. BAY2965501 blocks an enzyme in T-cells to activate them. T-cells are a type of immune cell that are known to have an anti-cancer effect and BAY2965501 is a potential new immunotherapy. The main purpose of this first-in-human study is to learn: • how safe different doses of BAY2965501 are when given as a single drug or in combination, • the degree to which medical problems caused by BAY2965501 when given as a single drug or in combination, can be tolerated (also called tolerability), • what maximum amount can be given as a single drug or in combination, and • how it moves into, through and out of the body as a single drug or in combination. To answer this, researchers will look at: • the number and severity of medical problems participants have after taking BAY2965501 as a single drug or in combination for each dose level. These medical problems are also referred to as adverse events. • the (average) total level of BAY2965501 in the blood (also called AUC) after intake of single and multiple doses • the (average) highest level of BAY2965501 in the blood (also called Cmax) after intake of single and multiple doses Doctors keep track of all medical problems that participants have during the study, even if they do not think the medical problem might be related to the study treatment. In addition, the researchers want to know if and how the participants' tumors change after taking BAY2965501. The study will have two parts. The

Conditions Studied

Advanced Solid Tumors

Interventions

  • DRUG Pembrolizumab
  • DRUG BAY2965501
  • DRUG Platinum-based Chemotherapy

Study Locations (20)

Other

  • Antwerp University Hospital | Oncology Department - Antwerp
  • Ghent University Hospital | Drug Research Unit Department - Ghent
  • Cancer Hospital, Chinese Academy of Medical Sciences - Beijing
  • Cancer Hospital Chinese Academy of Medical Sciences, Shenzhen Center - Shenzhen
  • Samsung Medical Center - Oncology Department - Seoul
  • Hospital Hm Nou Delfos | Oncologia - Barcelona
  • Hospital Universitari Vall D Hebron | Oncologia - Barcelona
  • Clinica Universidad De Navarra | Oncologia - Madrid
  • Hospital Universitario Hm Sanchinarro | Oncologia - Madrid

Colorado

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

Pennsylvania

  • UPMC Hillman Cancer Center - Pittsburgh

Texas

  • START | San Antonio - San Antonio

Zhejiang

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

Chiba

  • National Cancer Center Hospital East - Kashiwa

Gyeonggido

  • Seoul National University Bundang Hospital - Seongnam-si

Seoul Teugbyeolsi

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

Trial Details

FieldValue
Enrollment Target 284 participants
Start Date 2022-11-04
Est. Completion 2027-09-09
Phase Phase 1

Sponsor

Bayer

591 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05614102

The ClinicalTrials.gov registry entry for NCT05614102 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 284 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 197-participant average among 144 other Advanced Solid Tumors trials with a reported enrollment target (44% higher). The listed sponsor is Bayer, which has 591 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Advanced Solid Tumors appearing as the primary indexed condition, and to 3 interventions - of which Pembrolizumab is the first listed.

NCT05614102 reports 20 study locations spanning 12 distinct geographic areas - top geographies include Other, Colorado, Pennsylvania.

Frequently Asked Questions

What is clinical trial NCT05614102 about?

NCT05614102 is a clinical study titled "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". Researchers are looking for a better way to treat people who have advanced solid tumors. Advanced solid tumors are types of cancer that may have spread to nearby tissue, lymph nodes, and/or to distant parts of the body and that are unlikely to be cured or controlled with currently available treatmen...

What is the current status of trial NCT05614102?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 284 participants. The study started on 2022-11-04. Estimated completion is 2027-09-09.

What conditions does trial NCT05614102 study?

This clinical trial studies the following conditions: Advanced Solid Tumors.

What interventions are being tested in trial NCT05614102?

The interventions under investigation include: Pembrolizumab (DRUG), BAY2965501 (DRUG), Platinum-based Chemotherapy (DRUG).

Who is sponsoring clinical trial NCT05614102?

This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05614102 being conducted?

This trial has 20 study locations across Colorado, Pennsylvania, Texas, Zhejiang, Chiba. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.