Dose expansion of BAY2965501 for Solid Tumors, Advanced Solid Tumors

Phase-Based Progress Estimates
Solid Tumors, Advanced Solid Tumors+1 More
BAY2965501 - Drug
All Sexes
What conditions do you have?

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 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, the degree to which medical problems caused by BAY2965501 can be tolerated (also called tolerability), what maximum amount can be given, and how it moves into, through and out of the body. To answer this, the researchers will look at: the number and severity of medical problems participants have after taking BAY2965501 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 first part, called dose escalation, is done to find the most appropriate dose that can be given in the second part. For this, each participant will receive one of the increasing doses of BAY2965501. They will take BAY2965501 daily by mouth. All participants in the second part, called dose expansion, will receive the most appropriate dose from the first part daily as tablet by mouth. Participants in both parts of the study, will take the study treatment until the tumor gets worse (also known as 'disease progression'), the participants have medical problems, until they leave the study, or until the study is terminated. Each participant will be in the study for several months, including a screening phase of up to 28 days, few months of treatment depending on the participant's benefit, and a follow up phase after the end of treatment. The following approximate numbers of visits to the study site are planned: two during the screening phase, six in the first treatment month, one to three per month in the following periods. Participants in part 2 will be assigned to one of four groups depending on cancer characteristics. Study procedures described below may vary between these groups. During the study, the study team will: take blood and urine samples do physical examinations check vital signs such as blood pressure, heart rate, body temperature examine heart health using ECG (electrocardiogram) check if the participants' cancer has grown and/or spread using CT (computed tomography) or MRI (magnetic resonance imaging) and, if needed, bone scan take tumor samples (if required) The treatment period ends with a visit no later than 7 days after the last BAY2965501 dose. About 30 and 90 days after the last dose and every 12 weeks thereafter, the study team will check the participants' health and any changes in cancer. This follow-up period ends with worsening of the cancer, start of new anti-cancer therapy, or until the participant leaves the study. In addition, the study doctors and their team will contact the participant every 12 weeks to learn about the participant's survival. This ends no later than 12 months after the last participant started treatment or by the end of the study, whichever comes first. If the study participant benefits from treatment, continuation of treatment with BAY2965501 beyond the duration of this study might be possible.

Eligible Conditions
  • Solid Tumors, Advanced Solid Tumors

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

9 Primary · 7 Secondary · Reporting Duration: At 12 months

Approximately 6 months
Disease control rate (DCR)
Duration of response (DOR)
Objective response rate (ORR)
At 12 months
Overall survival (OS) rate
At 6 months
Progression-free survival (PFS) rate
Month 12
Change from baseline in peripheral activation of effector T memory cells as assessed by flow cytometry
Day 21
Number of participants experiencing dose-limiting toxicities (DLTs) at each dose level in the dose escalation part of the study
Day 21
Area under the curve [AUC (0 - 24)] for once daily (QD) dosing of BAY2965501 after single dose in Cycle 1
Area under the curve [AUC(0-12)] for 2 times daily (BID) dosing after single dose in Cycle 1 (if applicable))
Maximum concentration (Cmax) of the respective dosing interval of BAY2965501 after single dose
Day 21
Area under the curve [AUC(0-12)md] for BID dosing of BAY2965501 after multiple dose (if applicable)
Area under the curve [AUC(0-24)md] for QD dosing of BAY2965501 after multiple dose
Maximum concentration (Cmax,md) of the respective dosing interval of BAY2965501 after multiple dose
Day 21
Body Weight Changes
Day 90
Therapeutic procedure
Recommended Phase 2 dose (RP2D) of BAY2965501

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

Dose expansion of BAY2965501
1 of 2
Dose escalation of BAY2965501
1 of 2

Experimental Treatment

179 Total Participants · 2 Treatment Groups

Primary Treatment: Dose expansion of BAY2965501 · No Placebo Group · Phase 1

Dose expansion of BAY2965501
Experimental Group · 1 Intervention: BAY2965501 · Intervention Types: Drug
Dose escalation of BAY2965501
Experimental Group · 1 Intervention: BAY2965501 · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: at 12 months

Who is running the clinical trial?

BayerLead Sponsor
2,140 Previous Clinical Trials
23,767,747 Total Patients Enrolled
9 Trials studying Solid Tumors, Advanced Solid Tumors
4,506 Patients Enrolled for Solid Tumors, Advanced Solid Tumors

Eligibility Criteria

Age 18+ · All Participants · 7 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have measurable disease per RECIST 1.1 as assessed by the local site investigator.
Lesions situated in a previously irradiated area or in an area subjected to locoregional therapy are considered measurable if progression has been demonstrated in such lesions.
You have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
A sample of tumor tissue must be obtained at baseline for all participants.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 28th, 2021

Last Reviewed: November 19th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.