Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

New cancer drug combo tested in early trial – but study stopped early

NCT ID NCT05904496

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
The trial has finished. Results may not be published yet.
Stopped early This study
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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This early-phase trial tested a new drug called BGB-30813, either alone or combined with the immunotherapy tislelizumab, in 44 people with advanced solid tumors that had not responded to standard treatments. The main goals were to check safety, find the right dose, and see if the drugs shrank tumors. However, the study was terminated early, so results are limited.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
BGB-30813 (a DGKζ inhibitor) and tislelizumab (an immunotherapy drug)
What this could lead to
If it works, this could lead to a new treatment option for people with advanced solid tumors that have not responded to other therapies.
What could go wrong
This was a very early (phase 1) trial, so safety and effectiveness are not yet known. The trial was terminated early, meaning results may be limited.

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

44 people

The number who actually took part.

Started

Jul 2023

Finished

Aug 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: * Phase 1a (Dose Escalation): * Participants with histologically or cytologically confirmed advanced, metastatic, and unresectable solid tumors who have previously received available standard systemic therapy or for whom treatment is not available or not tolerated and who have not received any prior therapy targeting diacylglycerol kinase (DGK) * Eligible tumor types are immune sensitive solid tumors such as non-small cell lung cancer (NSCLC), head neck squamous cell cancer (HNSCC), small cell lung cancer, hepatocellular carcinoma, esophageal cancer, gastric or gastroesophageal carcinoma, nasopharyngeal carcinoma, triple-negative breast cancer, urothelial carcinoma, renal cell carcinoma, cervical cancer, endometrial carcinoma, cutaneous squamous cell carcinoma, melanoma, Merkel cell carcinoma, mesothelioma, microsatellite instability (MSI)-high, tumor mutation burden (TMB)-high, or mismatch repair deficient solid tumors * Prior checkpoint inhibitor (CPI) therapy is allowed * Phase 1b (Dose Expansion): * Participants with selected advanced or metastatic solid tumors including NSCLC, HNSCC, and additional potential tumor types to be defined based on emerging data * ≥ 1 measurable lesion per RECIST v1.1 * Eastern Cooperative Group Oncology Performance (ECOG) Performance Status score ≤ 1 * Females of childbearing potential must be willing to use a highly effective method of birth control for the duration of the study * Adequate organ function as indicated by the following laboratory values up to first dose of study treatment: Hemoglobin≥ 90 grams per liter (g/L), Absolute neutrophil count ≥ 1.5 x 109/L , Serum total bilirubin ≤ 1.5 x upper limit of normal (ULN) (\< 3 x ULN for participants with Gilbert syndrome ), aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN Exclusion Criteria: * Previous therapy targeting DGK * Active leptomeningeal disease or uncontrolled symptomatic central nervous system (CNS) metastasis * Active autoimmune diseases or history of autoimmune diseases that may relapse * Any active malignancy ≤ 2 years before the first dose of study treatment except for the specific cancer under investigation in this study and any locally recurring cancer that has been treated with curative intent * Systemic anticancer therapy, including chemotherapy ≤ 21 days or 5 half-lives (whichever is shorter) before the first dose of study drugs * ≥ Grade 3 immune-mediated adverse events on prior immuno-oncology agent (anti-PD-1 or anti-CTLA4 antibodies or other experimental drugs) Note: Other protocol-defined Inclusion/Exclusion criteria may apply.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Advanced solid tumor are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

neoplasm Squamous Cell Carcinoma of Head and Neck

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601-1915, United States

  • Hospital Universitario Vall Dhebron

    Barcelona, 08035, Spain

  • Jinan Central Hospital

    Jinan, Shandong, 250013, China

  • Linear Clinical Research

    Nedlands, Western Australia, 6009, Australia

  • Md Anderson Cancer Center

    Houston, Texas, 77030-3907, United States

  • Monash Health

    Clayton, Victoria, 3168, Australia

  • Next Oncology

    San Antonio, Texas, 78229-6028, United States

  • Peter Maccallum Cancer Centre

    Melbourne, Victoria, 3000, Australia

  • Shandong Cancer Hospital

    Jinan, Shandong, 250117, China

  • Shandong Provincial Hospital

    Jinan, Shandong, 250021, China

  • Start Madrid Fundacion Jimenez Diaz

    Madrid, 28040, Spain

More trials for these conditions

Other studies related to the condition(s) this trial covers.