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Testing a new drug for advanced solid tumors

An Open-label, Phase 1, First-in-human, Dose Escalation and Expansion Study to Evaluate the Safety, Tolerability, Maximum Tolerated or Administered Dose, Pharmacokinetics, Pharmacodynamics, and Tumor Response Profile of the Diacylglycerol Kinase Zeta Inhibitor (DGKzi) BAY 2965501 as Monotherapy, and in Combination, in Participants With Advanced Solid Tumors

Phase 1 Interventional Bayer · NCT05614102

This study is testing a new drug for people with advanced solid tumors, like lung and stomach cancer, to see how safe it is and if it can help fight their cancer, either on its own or with other treatments.

Quick facts

PhasePhase 1
Study typeInterventional
Enrollment284 (estimated)
Ages18 Years and up
SexAll
SponsorBayer Industry-sponsored
Drugs / interventionspembrolizumab, pembrozilumab, chemotherapy, immunotherapy
Locations21 sites (Denver, Colorado and 20 other locations)
Trial IDNCT05614102 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the safety and effectiveness of a new drug, BAY2965501, for patients with advanced solid tumors, including various types of cancer such as lung and stomach cancer. The study will assess how the drug works in the body, its maximum tolerated dose, and its effects when used alone or in combination with other treatments like pembrolizumab and platinum-based chemotherapy. Participants will be closely monitored to determine the drug's safety profile and its potential to activate immune responses against tumors.

Who should consider this trial

Good fit: Ideal candidates include individuals with measurable advanced solid tumors and an ECOG performance status of 0 to 1.

Not a fit: Patients with primary central nervous system cancers or those who do not meet the inclusion criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new immunotherapy option for patients with advanced solid tumors that are difficult to treat with existing therapies.

How similar studies have performed: Other studies have shown promise with similar immunotherapy approaches, indicating potential for success in this novel treatment.

Eligibility criteria

Show full inclusion / exclusion 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 (for monotherapy or BAY 2965501 and pembrolizumab combination cohorts): All solid cancers, except primary central nervous system cancers •Dose escalation (for BAY 2965501 with pembrolizumab and platinum-based regimen combination cohorts): All solid cancers, except primary central nervous system cancers, (including Non-small cell lung cancer (NSCLC), head and neck squamous cell cancer (HNSCC), cervical, endometrial, triple negative breast cancer) that are eligible for standard of care platinum-based regimen and for whom this trial is a reasonable option for them.
* The following tumor types may be recruited to the monotherapy expansion cohorts:

  o Non-small cell lung cancer (NSCLC)
* The following tumor types may be recruited to the BAY 2965501 and pembrolizumab combination expansion cohorts:

  * NSCLC: participants who are treatment-naïve in the incurable disease setting.
  * NSCLC: Participants with metastatic NSCLC (confirmed histologically or cytologically)
  * Gastric/GEJ adenocarcinoma
* other tumor types may be explored based on emerging data
* The following tumor types will be recruited to the BAY 2965501 and pembrolizumab with platinum-based regimen combination expansion cohorts:

  * All solid cancers, except primary central nervous system cancers (including NSCLC, HNSCC, cervical, endometrial, triple negative breast cancer), that are eligible for standard of care platinum-based regimen

Exclusion Criteria:

* Previous therapy with a DGK inhibitor other than BAY 2965501 or BAY 2862789 is prohibited. Participants previously treated with BAY 2965501 or BAY 2862789 must have progressed on that DGK inhibitor (given as monotherapy and not have discontinued for toxicity) to be eligible for the combination of BAY 2965501 and pembrolizumab cohorts only.
* 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 4 weeks earlier are also excluded. Participants with known previously treated brain metastases, which are radiologically stable compared to a CT/MRI scan at least 4 weeks earlier, clinically stable and without the requirement of steroid treatment for at least 14 days prior to the first dose of study treatment
* 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.

Where this trial is running

Denver, Colorado and 20 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 TumorsSolid tumorsNon-small cell lung cancerNSCLCGastroesophageal junction adenocarcinomaGEJ adenocarcinomaRenal cell carcinomaRCC
Last reviewed 2026-06-09 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.