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New cancer drug shows promise in early trial

NCT ID NCT05858164

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

45 people

The number who actually took part.

Started

Aug 2023

Finished

Sep 2025

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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

  • AdventHealth medical Group Oncology Research at Celebration

    Celebration, Florida, 34747, United States

  • Asan Medical Center | Oncology

    Seoul, 05505, South Korea

  • Brigette Harris Cancer Pavilion at Henry Ford Cancer Center - Detroit

    Detroit, Michigan, 48202, United States

  • Chungbuk National University Hospital | Hematology and Oncology

    Chungcheongbuk-do, North Chungcheong, 28644, South Korea

  • Gyeongsang National University Hospital | Oncology

    Jinju, Gyeongsangnam-do, 52727, South Korea

  • Hadassah Hebrew University Hospital Ein Kerem

    Jerusalem, 9112001, Israel

  • Hospital Universitari Vall D Hebron | Oncologia

    Barcelona, 08035, Spain

  • Hospital Universitario Virgen De La Victoria | Oncologia

    Málaga, 29010, Spain

  • Jilin Cancer Hospital

    Changchun, Jilin, 130000, China

  • Princess Alexandra Hospital Australia

    Woolloongabba, Queensland, 4102, Australia

  • START | San Antonio

    San Antonio, Texas, 78229, United States

  • Seoul National University Hospital | Oncology

    Jongno -Gu, Seoul, 03080, South Korea

  • Seoul St Mary's Hospital | Oncology

    Seoul, 06591, South Korea

  • Tel- Aviv Sourasky Medical Center - Nephrology

    Tel Aviv, 6423906, Israel

  • The Kinghorn Cancer Centre - Medical Oncology Department

    Darlinghurst, New South Wales, 2010, Australia

  • Tongji Hosp. of Tongji Med Coll, Huazhong Uni of Sci & Tech.

    Wuhan, Hubei, 430030, China

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