What side effects are associated with this type of intervention?

Common side effects of immunotherapies for solid tumors, such as those involving T-cell activation like BAY2965501, include fatigue, fever, chills, nausea, joint pain, and headache. Severe but less common side effects can include immune-related adverse events such as pneumonitis, colitis, hepatitis, endocrinopathies, and nephritis, which result from the immune system attacking normal organs and tissues.

What prior FDA approvals exist?

The FDA has approved several immunotherapies for the treatment of solid tumors that work by activating T-cells. Pembrolizumab, an anti-PD-1 antibody, is approved for various cancers including non-small cell lung cancer and melanoma. Ipilimumab, an anti-CTLA-4 antibody, is approved for metastatic melanoma. These drugs enhance the immune system's ability to fight cancer by blocking inhibitory pathways in T-cells, similar to the investigational drug BAY2965501, which is a T-cell enzyme blocker aimed at activating T-cells for immunotherapy.

What other types of research exist?

Promising alternatives to BAY2965501 for solid tumor patients include pembrolizumab and nivolumab, which are PD-1 inhibitors that have shown efficacy in various solid tumors. Additionally, combination therapies such as nivolumab plus ipilimumab (a CTLA-4 inhibitor) have demonstrated improved outcomes in some patients. Other novel agents like dostarlimab, another PD-1 inhibitor, and avelumab, a PD-L1 inhibitor, are also being explored in clinical trials for their potential benefits in treating solid tumors.

← Back to Search

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 at 6 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug called BAY2965501, alone or with pembrolizumab, for people with advanced cancers that are hard to treat. The drug helps the immune system fight cancer by activating certain immune cells. Researchers aim to find the safest and most effective dose and see how well it works against tumors. Pembrolizumab has shown efficacy in treating various cancers, including melanoma, cervical cancer, and head and neck cancer.

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.

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.

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 ~ at 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

Disease control rate (DCR)

Duration of response (DOR)

Objective response rate (ORR)

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

6Treatment 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 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 expansion of BAY 2965501 + pembrolizumab + platinum-based regimenExperimental Treatment1 Intervention

Participants with selected (to be decided by the sponsor) advanced solid tumors will be recruited in a dose expansion cohort of BAY 2965501 with pembrolizumab and platinum-based regimen.

Group IV: 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 in combination with 200mg pembrolizumab every 3 weeks.

Group V: Dose escalation of BAY2965501Experimental Treatment1 Intervention

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

Group VI: Dose escalation of BAY 2965501 + pembrolizumab + platinum-based regimenExperimental Treatment1 Intervention

The starting dose of BAY 2965501 with pembrolizumab for this combination will be no higher than one dose level below that shown to be safe in BAY 2965501 and pembrolizumab dose escalation. The doses of platinum-based regimen will be as per standard of care and given for a maximum of 6 cycles, in line with the current labeled dose. The dose of pembrolizumab will be 200 mg every 3 weeks, in line with the current labeled dose.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Platinum-based Chemotherapy

2017

Completed Early Phase 1

~570

Pembrolizumab

2017

Completed Phase 3

~3130

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for solid tumors, particularly those similar to BAY2965501, involve immunotherapies that activate the body's immune system to target and destroy cancer cells. BAY2965501 works by blocking an enzyme in T-cells, thereby activating these immune cells to enhance their anti-cancer effects. This is crucial for solid tumor patients as it leverages the body's natural defense mechanisms to fight cancer, potentially leading to more effective and targeted treatments. Other common immunotherapies include checkpoint inhibitors like pembrolizumab, which block proteins that inhibit T-cell activity, thus allowing T-cells to attack cancer cells more effectively. These treatments are significant because they offer a promising alternative to traditional therapies, which may be less effective for advanced solid tumors.