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Monoclonal Antibodies
BAY3375968 + 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 approximately 60 months
Awards & highlights
Study Summary
This trial is studying a new way to treat people with advanced solid tumors by using immunotherapy with PD-1/PD-L1 inhibitors and an antibody that binds to a protein called CCR8.
Who is the study for?
This trial is for adults with advanced solid tumors that have spread and are not curable with existing treatments. Participants must be physically capable of daily activities (ECOG PS 0 or 1), have functioning organs, agree to use contraception if applicable, and not be pregnant or breastfeeding. They should have tried all other effective treatments without success.Check my eligibility
What is being tested?
The study tests BAY3375968 alone and combined with Pembrolizumab in two parts: dose escalation to find the safest high dose, then dose expansion at this best dose focusing on lung, breast, head/neck cancer, and melanoma. It measures safety, tolerability, how the body processes the drug, optimal dosing levels, and anti-cancer effects.See study design
What are the potential side effects?
Potential side effects include typical reactions from immunotherapy such as fatigue; skin reactions; digestive issues like nausea or diarrhea; potential immune-related problems affecting lungs or liver; infusion-related symptoms; changes in blood counts leading to increased infection risk.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ approximately 60 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 60 months
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 concentration-time curve (AUC) of BAY3375968
Maximum tolerated dose (MTD) or Maximum administered dose (MAD)
Number of participants experiencing dose-limiting toxicity (DLTs) at each dose level in the dose-escalation part of the study
+3 moreSecondary outcome measures
Fold change in intratumor CD8+ T cell/Treg ratio (as measured by IHC [Immunohistochemistry]) in on-treatment compared with baseline tumor biopsies
Fold change in serum IFN (Interferon)-γ (as measured by immune-based assay) in on-treatment compared with baseline serum samples
Objective response rate (ORR)
+1 moreSide effects data
From 2024 Phase 2 trial • 57 Patients • NCT0300418321%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Pneumonia
7%
Kidney Injury and/or Infection
7%
Dyspnea
7%
Weight Loss
5%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
5%
Intractable pain, back pain, hip pain
5%
Activated partial thromboplastin time prolonged
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Thrombocytopenia
2%
Respiratory failure
2%
Skin rash
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm
Trial Design
4Treatment groups
Experimental Treatment
Group I: Dose expansion - Arm 2BExperimental Treatment2 Interventions
Disease-specific combination expansion with separate cohorts in 4 ICI-relapsed tumor types (NSCLC, TNBC, HNSCC, and melanoma)
Group II: Dose expansion - Arm 2AExperimental Treatment1 Intervention
BAY3375968 monotherapy-mode-of-action (monotherapy-MoA) expansion in subjects with one of the following tumor types: NSCLC (PD-L1 tumor proportion score [TPS] ≥50%), TNBC (PD-L1 combined positive score [CPS] ≥10), HNSCC (PD-L1 CPS ≥20), or melanoma (no PD-L1 cut-off). The tumors should have primary (ICI-refractory) or secondary (ICI-relapsed) resistance to prior ICI-therapy. The final decision on the enrolled tumor type is at the discretion of the Sponsor.
Group III: Dose escalation - Arm 1BExperimental Treatment2 Interventions
Dose escalation of BAY 3375968 in combination with pembrolizumab
Group IV: Dose escalation - Arm 1AExperimental Treatment1 Intervention
Dose escalation of BAY3375968 as monotherapy
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 2
~2010
Find a Location
Who is running the clinical trial?
BayerLead Sponsor
2,240 Previous Clinical Trials
25,332,507 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I've tried or can't tolerate all known beneficial treatments.My cancer originated in my brain or spinal cord.I have been treated for an autoimmune disease in the last 2 years.I have not had major surgery in the last 4 weeks.I have another cancer that is getting worse or was treated in the last 3 years.I have had lung inflammation not caused by infection that needed steroids.I have not had lung radiation over 30 Gy in the last 6 months.I have an immune system disorder or am on high-dose steroids.I have been diagnosed with TNBC, NSCLC, HNSCC, or melanoma.My lung cancer diagnosis was confirmed through lab tests.I am HIV-positive with a history of Kaposi sarcoma or Castleman Disease.My cancer is advanced or has spread and confirmed by lab tests.I have a history of severe heart failure.I have been treated with a CCR8 depleting antibody before.My kidney and liver are working well.I have new or worsening brain metastases or leptomeningeal disease.I am able to understand and sign the consent form.I have no lasting side effects from cancer treatment, except for hair loss or skin color changes.I stopped a previous cancer treatment due to severe side effects.I have a serious illness or had an organ transplant that needs ongoing treatment.I am not pregnant, breastfeeding, or able to become pregnant.I am fully active or have some restrictions but can still care for myself.I agree to use birth control if I can have children and am sexually active.
Research Study Groups:
This trial has the following groups:- Group 1: Dose escalation - Arm 1B
- Group 2: Dose expansion - Arm 2A
- Group 3: Dose expansion - Arm 2B
- Group 4: Dose escalation - Arm 1A
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is enrollment for this research endeavor still available?
"This clinical trial is still recruiting participants, as indicated by the information on clinicaltrials.gov. The research was uploaded to the website in October of 2022 with a subsequent update made in November of that year."
Answered by AI
Has the FDA granted a license for BAY3375968?
"Limited efficacy and safety data supporting BAY3375968 led to a score of 1 on our team's rating scale. This indicates that it is in the initial phase of clinical trials."
Answered by AI
What is the current participant intake for this research endeavor?
"Affirmative. According to clinicaltrials.gov, this trial is actively looking for participants and was initially uploaded on October 11th 2022 before being updated on November 14th of the same year. 270 people are needed from 4 distinct sites in order to reach completion."
Answered by AI
In how many regions is this clinical test being conducted?
"This trial is taking place at 4 different sites, including the University of Chicago in Chicago, Princess Margaret Cancer Centre in Toronto, and Ohio State University in Columbus. Additionally, there are other locations that have been selected for this study."
Answered by AI
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