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Testing a new drug for advanced solid tumors

First-in-human Dose-escalation and Expansion Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of the Anti-CCR8 Antibody BAY 3375968 as Monotherapy and in Combination With Pembrolizumab in Participants With Selected Advanced Solid Tumors

Phase 1 Interventional Bayer · NCT05537740

This study is testing a new drug for people with advanced solid tumors to see if it can help them when other treatments haven't worked.

Quick facts

PhasePhase 1
Study typeInterventional
Enrollment354 (estimated)
Ages18 Years and up
SexAll
SponsorBayer Industry-sponsored
Drugs / interventionspembrolizumab, immunotherapy, radiation, prednisone
Locations29 sites (Chicago, Illinois and 28 other locations)
Trial IDNCT05537740 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the safety and effectiveness of BAY3375968, an anti-CCR8 antibody, both alone and in combination with Pembrolizumab, for patients with advanced solid tumors. The study will assess how the drug interacts with the body, including its absorption, distribution, metabolism, and excretion. Participants will be closely monitored to determine the optimal dosage and to understand the drug's impact on the immune system's ability to fight cancer. The trial focuses on patients who have not responded to or are ineligible for existing treatments.

Who should consider this trial

Good fit: Ideal candidates include individuals with advanced or metastatic solid tumors who have exhausted other treatment options.

Not a fit: Patients with early-stage tumors or those who have not yet received standard therapies may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced solid tumors who have limited treatment choices.

How similar studies have performed: Other studies involving immunotherapy and targeting regulatory T cells have shown promise, suggesting potential for success with this novel approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Capable of giving signed informed consent.
* Has received, been intolerant to, or been ineligible for all treatment options proven to confer clinical benefit.
* Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
* Eastern Cooperative Oncology Group (ECOG) Performance status (PS) of 0 or 1.
* Adequate renal and liver function.
* Male individuals and female individuals of childbearing potential who engage in heterosexual intercourse must agree to use methods of contraception.
* Female participants are eligible if they are not pregnant, not breastfeeding or not a Woman of childbearing potential (WOCBP).
* Inclusion criterion for the dose-escalation: Individuals with histologically or cytologically confirmed, advanced or metastatic solid tumors.
* Inclusion criteria for disease-specific combination expansion: Individuals with histologically or cytologically confirmed triple-negative breast cancer (TNBC), non-small cell lung cancer (NSCLC), gastric cancer, melanoma, or head and neck squamous cell carcinoma (HNSCC).
* Inclusion criterion for the monotherapy-MoA expansion: Individuals with histologically or cytologically confirmed NSCLC, TNBC, HNSCC, or melanoma.
* Willingness and medical feasibility (as per Investigator assessment) to undergo paired tumor biopsies with a non-significant risk.

Exclusion Criteria:

* A known additional malignancy that is progressing or has required active treatment within the past 3 years.
* Primary central nervous system malignancy.
* Major surgery ≤ 28 days before start of study treatment.
* Any unresolved toxicity of Grade ≥ 2, not otherwise specified in other eligibility criteria, from previous anticancer treatment, except for alopecia and skin pigmentation.
* Uncontrolled intercurrent illness requiring systemic treatment or solid organ transplant.
* Known hypersensitivity to study treatment or any drugs similar in structure or class, including severe hypersensitivity (≥ Grade 3) to pembrolizumab and/or any of its excipients.
* Any prior immune-related toxicity (Grade 3 or 4) leading to discontinuation of immunotherapy.
* History of congestive heart failure New York Heart Association (NYHA) \>II.
* Medical history of (non-infectious) pneumonitis/interstitial lung disease (ILD), drug-induced ILD, radiation pneumonitis which required steroid treatment, or any evidence of clinically-active pneumonitis/ILD.
* HIV-infection with a history of Kaposi sarcoma and/or Multicentric Castleman Disease.
* Known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study.
* History or current evidence of any condition, therapy, laboratory abnormality, or other circumstance that might confound the results of the study or interfere with the participant's participation for the full duration of the study, such that it is not in the best interest of the participant to participate, in the opinion of the treating Investigator.
* Any other history, condition, therapy, or uncontrolled intercurrent illness which could in the opinion of the Investigator affect compliance with study requirements.
* New brain metastases on screening brain MRI/CT; previously treated brain metastases that are progressive at screening or leptomeningeal disease.
* Prior therapy with a C-C motif chemokine receptor 8 (CCR8) depleting antibody.
* Prior allogeneic tissue/solid organ transplant.
* Radiation therapy to the lung that is \> 30 Gy within 6 months before the start of study treatment.
* Diagnosis of immunodeficiency or current chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent).
* Active autoimmune disease that has required systemic treatment in the past 2 years.

Where this trial is running

Chicago, Illinois and 28 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Advanced Solid TumorsRelapseImmunooncology treatmentNon small cell lung cancerNSCLCHNSCCHead and neck squamous cell carcinomasMelanoma
Last reviewed 2026-06-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.