New cancer drug combo tested in early trial – but study stopped early
NCT ID NCT05904496
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
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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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44 people
The number who actually took part.
- Started
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Jul 2023
- Finished
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Aug 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: * 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.
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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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Hackensack University Medical Center
Hackensack, New Jersey, 07601-1915, United States
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Hospital Universitario Vall Dhebron
Barcelona, 08035, Spain
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Jinan Central Hospital
Jinan, Shandong, 250013, China
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Linear Clinical Research
Nedlands, Western Australia, 6009, Australia
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Md Anderson Cancer Center
Houston, Texas, 77030-3907, United States
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Monash Health
Clayton, Victoria, 3168, Australia
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Next Oncology
San Antonio, Texas, 78229-6028, United States
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Peter Maccallum Cancer Centre
Melbourne, Victoria, 3000, Australia
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Shandong Cancer Hospital
Jinan, Shandong, 250117, China
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Shandong Provincial Hospital
Jinan, Shandong, 250021, China
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Start Madrid Fundacion Jimenez Diaz
Madrid, 28040, Spain
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- First-in-Human trial asks whether HG381 is safe and tolerable in advanced solid tumors
- Custom-Built immune cells take aim at a notorious cancer mutation
- Experimental injection SHR-7787 put to the test against advanced solid tumors
- Experimental biologic AWT020 put to the test in Hard-to-Treat cancers
- Can a pill shrink Hard-to-Treat ovarian tumors?
- Oral drug RVU120 put to the test against advanced solid tumors