New cancer drug shows promise in early trial
NCT ID NCT05858164
First seen Jun 27, 2026 · Last updated Aug 12, 2026 · Updated 2 times
Summary
This early-phase study tested a new drug called BAY 2862789 in 45 people with advanced solid tumors, including non-small cell lung cancer. The drug works by activating immune cells to fight cancer. The main goals were to check safety, find the best dose, and see how the drug moves through the body. Participants took the drug until their cancer worsened or side effects became too severe.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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45 people
The number who actually took part.
- Started
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Aug 2023
- Finished
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Sep 2025
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Capable of giving signed informed consent * Be ≥18 years of age on day of signing informed consent. * Have measurable disease per Response Evaluation Criteria in Solid Tumours 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 a histologically confirmed diagnosis of a solid tumor that have exhausted available treatments known to be beneficial for this tumor type or for whom these treatments are not acceptable and for whom this trial is a reasonable option for them, will be enrolled onto this study. Appropriate molecular profiling of tumors should have been performed according to local national guidelines prior to trial entry. Specifications for the different parts of the study are below: \-- Dose escalation: All solid cancers, except primary central nervous system cancers. * Provision of archival tumor sample at baseline is mandatory for all participants in escalation, and expansion cohorts. * Participants must be willing to undergo mandatory paired biopsies of tumor (pre- and on- treatment). * Have adequate organ function. * Agree to use contraception during the treatment period and for at least 6 months after the last dose of study treatment. Exclusion Criteria: * Had an allogeneic tissue/solid organ transplant. * Previous therapy with a diacylglycerol kinase (DGK) inhibitor * Has received a prior therapeutic regimen containing an anti-programmed cell death protein 1 (anti-PD-1), anti-programmed death-ligand 1 (anti-PD-L1), or anti-programmed cell death 1 ligand 2 (anti PD-L2) agent or an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., cytotoxic T-lymphocyte-associated protein 4 (CTLA-4), OX 40, CD137) and was discontinued from that treatment regimen due to a Grade 3 or higher immune related adverse event (irAE) or any toxicity that was life-threatening. * Has received prior systemic anti-cancer therapy including investigational agents within 4 weeks or 5 half-lives, whatever is shorter, prior to treatment. Growth factor treatments such as granulocyte colony-stimulating factor (G-CSF) must have been discontinued 4 weeks prior to entering the study. * Participants must have recovered from previous radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. * Participants cannot have had a blood transfusion within 2 weeks of starting therapy. * Has received a live vaccine within 30 days prior to the first dose of study drug. * Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment. * Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug. * Has a known additional malignancy that is progressing or has required active treatment within the past 3 years. * Participants with new brain metastases on screening brain magnetic resonance imaging/computed tomography (MRI/CT). * Primary central nervous system malignancy or presence of leptomeningeal disease. * 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. * Has an active autoimmune disease including inflammatory bowel disease that has required systemic treatment in past 2 years. * Current pneumonitis / interstitial lung disease. * Has an active infection requiring systemic therapy.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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AdventHealth medical Group Oncology Research at Celebration
Celebration, Florida, 34747, United States
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Asan Medical Center | Oncology
Seoul, 05505, South Korea
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Brigette Harris Cancer Pavilion at Henry Ford Cancer Center - Detroit
Detroit, Michigan, 48202, United States
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Chungbuk National University Hospital | Hematology and Oncology
Chungcheongbuk-do, North Chungcheong, 28644, South Korea
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Gyeongsang National University Hospital | Oncology
Jinju, Gyeongsangnam-do, 52727, South Korea
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Hadassah Hebrew University Hospital Ein Kerem
Jerusalem, 9112001, Israel
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Hospital Universitari Vall D Hebron | Oncologia
Barcelona, 08035, Spain
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Hospital Universitario Virgen De La Victoria | Oncologia
Málaga, 29010, Spain
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Jilin Cancer Hospital
Changchun, Jilin, 130000, China
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Princess Alexandra Hospital Australia
Woolloongabba, Queensland, 4102, Australia
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START | San Antonio
San Antonio, Texas, 78229, United States
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Seoul National University Hospital | Oncology
Jongno -Gu, Seoul, 03080, South Korea
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Seoul St Mary's Hospital | Oncology
Seoul, 06591, South Korea
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Tel- Aviv Sourasky Medical Center - Nephrology
Tel Aviv, 6423906, Israel
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The Kinghorn Cancer Centre - Medical Oncology Department
Darlinghurst, New South Wales, 2010, Australia
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Tongji Hosp. of Tongji Med Coll, Huazhong Uni of Sci & Tech.
Wuhan, Hubei, 430030, China
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Other studies related to the condition(s) this trial covers.
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