Melanoma Clinical Trial

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

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.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Have measurable disease per Response evaluation criteria in solid tumors version 1.1 (RECIST 1.1) as assessed by the local site investigator.
Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.

Participants with histologically confirmed diagnosis of a solid tumor (specifications for the different parts of the study below) will be enrolled onto this study:

• Dose escalation: All solid cancers, except primary central nervous system cancers

The following tumor types will be recruited to the monotherapy expansion cohorts:

Non-small cell lung cancer (NSCLC)
Gastric/Gastroesophageal Junction (GEJ) adenocarcinoma

The following tumor types will be recruited to the BAY 2965501 and pembrolizumab combination expansion cohorts:

NSCLC: participants with tumors that are TPS score ≥50% PDL-1 high (based on local historical testing) and are eligible for standard of care anti-PD(L)-1 monotherapy in the first line incurable treatment setting.
NSCLC
Gastric/GEJ adenocarcinoma

Exclusion Criteria:

Previous therapy with a DGK inhibitor is prohibited for monotherapy cohorts (participants previously treated with BAY 2965501 or BAY 2862789 must have progressed on that DGK inhibitor (and not discontinued for toxicity) to be eligible for combination).
Has received a prior therapeutic regimen containing an anti-PD-1, anti-PD-L1, or anti PD-L2 agent or an agent directed to another co-stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX 40, CD137) and was discontinued from that treatment due to a Grade 3 or higher infusion-related adverse event (irAE).
Participants with new brain metastases on screening brain MRI/CT. Previously treated brain metastases that are progressive at screening compared to a brain MRI/CT at least 6 weeks earlier are also excluded. Participants with known previously treated brain metastases, which are radiologically stable compared to a CT/MRI scan at least 6 weeks earlier, clinically stable and without the requirement of steroid treatment for at least 14 days prior to the first dose of study treatment may be eligible.
Primary central nervous system malignancy or presence of leptomeningeal disease (i.e., positive cerebrospinal fluid cytology or unequivocal radiological or clinical evidence of leptomeningeal involvement).
Participants with gastrointestinal conditions that may compromise oral absorption such as short bowel syndrome or active tumor-related bowel obstruction with ongoing symptoms compromising absorption over last 6 months.

Study is for people with:

Melanoma

Phase:

Phase 1

Estimated Enrollment:

284

Study ID:

NCT05614102

Recruitment Status:

Recruiting

Sponsor:

Bayer

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There are 20 Locations for this study

See Locations Near You

Sarah Cannon Research Institute at HealthONE
Denver Colorado, 80218, United States
UPMC Hillman Cancer Center
Pittsburgh Pennsylvania, 15232, United States
South Texas Accelerated Research Therapeutics | START San Antonio
San Antonio Texas, 78229, United States
Institut Jules Bordet/Jules Bordet Instituut
Bruxelles , 1070, Belgium
Universitair Ziekenhuis Antwerpen (UZA) - Multidisciplinair Oncologisch Centrum Antwerpen (MOCA)
Edegem , 2650, Belgium
UZ Gent
Gent , 9000, Belgium
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing , 10000, China
National Cancer Center Hospital East
Kashiwa Chiba, 277-8, Japan
Seoul National University Bundang Hospital
Seongnam-si Gyeonggido, 13620, Korea, Republic of
Seoul National University Hospital
Seoul Seoul Teugbyeolsi, 3080, Korea, Republic of
Severance Hospital, Yonsei University Health System
Seoul , 3722, Korea, Republic of
Samsung Medical Center
Seoul , 6351, Korea, Republic of
START Barcelona-Hospital HM Nou Delfos
Barcelona , 08023, Spain
Hospital Universitari Vall d'Hebron - Institut d'Oncologia - Grupo de Tumores Toracicos y Cancer de Cabeza y Cuello
Barcelona , 08035, Spain
Universidad de Navarra - Clinica Universidad de Navarra (CUN) - Madrid
Madrid , 28027, Spain
The START Center for Cancer Care - Madrid - CIOCC - Hospital Universitario Madrid Sanchinarro Location
Madrid , 28050, Spain
Universidad de Navarra - Centro de Investigacion Medica Aplicada (CIMA)
Pamplona , 31008, Spain
Churchill Hospital
Oxford Oxfordshire, OX3 7, United Kingdom
Royal Marsden NHS Trust (Surrey)
Sutton Surrey, SM2 5, United Kingdom
Freeman Hospital
Newcastle Tyne And Wear, NE7 7, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Melanoma

Phase:

Phase 1

Estimated Enrollment:

284

Study ID:

NCT05614102

Recruitment Status:

Recruiting

Sponsor:


Bayer

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.