New antibody aims to unleash immune system against advanced tumors
NCT ID NCT03908814
First seen Jul 06, 2026 · Last updated Jul 07, 2026 · Updated 1 time
Summary
This early-stage trial tests a new drug called LDP, an antibody that blocks PD-L1, a protein cancers use to hide from the immune system. The study enrolls adults with advanced malignant tumors who have exhausted standard treatments. Researchers are evaluating the drug's safety, tolerability, and how the body processes it at different dose levels.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- LDP (anti-PD-L1 antibody)
- What this could lead to
- If successful, this could lead to a new immunotherapy option for people with advanced cancers that have not responded to standard treatments.
- What could go wrong
- This is an early Phase 1 trial focused on safety and dosing, so it is not yet known if LDP will effectively shrink tumors. Side effects, including immune-related reactions, are possible.
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
-
66 people
The number who actually took part.
- Started
-
Apr 2019
- Finished
-
Apr 2023
- 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 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: 1. Age ≥ 18 (inclusive), regardless of gender 2. Histologically or cytologically confirmed patients with advanced malignant tumors who fail to receive standard treatment or have no standard treatment or are not suitable for standard treatment at this stage; 3. The estimated survival time is more than 3 months. 4. At least one assessable tumor lesion (solid tumors according to RECIST 1.1, lymphoma according to Lugano 2014); 5. ECOG physical strength score 0-1; 6. Enough organ function: Blood routine (no blood transfusion or colony stimulating factor (G-CSF) treatment within 14 days):ANC≥1.5×109 / L, PLT≥75×109 / L, Hb≥80g/L;Liver function: TBIL≤1.5×ULN, ALT≤2.5×ULN, AST≤2.5×ULN (ALT=5×ULN for liver metastasis patients, AST≤5×ULN);Renal function: Cr ≤ 1.5 × ULN, and creatinine clearance \> 50 ml (according to Croft - Gault formula) Coagulation function: activated partial thromboplastin time (APTT) ≤ 1.5 times ULN, prothrombin time (PT) ≤ 1.5 times ULN, international normalized ratio (INR) ≤ 1.5 times ULN; 7. Eligible patients (male and female) with fertility must agree to use reliable methods of contraception (hormone or barrier or abstinence) during the trial period and at least 6 months after the last dose; female patients of childbearing age are selected before the election. The blood or urine pregnancy test within the day must be negative; 8. Prior to the trial, the subject shall have informed consent to the study and voluntarily sign a written form of informed consent; Exclusion Criteria: 1. Received radiotherapy, chemotherapy, targeted therapy, endocrine therapy or immunotherapy within 4 weeks before the first administration, or other unlisted clinical trial drug therapy (mitomycin and nitrosourea are at least 6 weeks from the last administration, oral fluorouracil drugs such as tegiol and capecitabine are at least 2 weeks from the last administration, and small molecule targeted drugs are at the last administration). At least 2 weeks, or at least 5 half-lives, whichever is longer; 2. Major organ surgery (excluding puncture biopsy) or significant trauma occurred within 4 weeks before the first administration. 3. Adverse reactions of antineoplastic therapy in the past have not been restored to CTCAE grade 5.0≤1 (except for hair loss and other adverse reactions that the investigator judges have no safety risk). 4. Brain metastasis, spinal cord compression, cancerous meningitis with clinical symptoms, or other evidence that the metastasis of brain and spinal cord has not yet been controlled, are not suitable for the group judged by the researchers; patients with suspected clinical symptoms of brain or pia mater diseases need to be excluded by CT/MRI examination; 5. Those who have previously received treatment with PD-1 or PD-L1 inhibitors; 6. In the past, immune-related adverse events (\> grade 3) have occurred in immunotherapy (irAE, see Appendix 5); 7. Patients with active or recurrent autoimmune diseases (such as systemic lupus erythematosus, rheumatoid arthritis, vasculitis, etc.); 8. Current or previous patients with interstitial lung disease; 9. Uncontrolled active infections; 10. History of immunodeficiency, including positive HIV antibody test; 11. Patients with active hepatitis B (HBV titer higher than detection limit) ; hepatitis C virus infection; 12. Those with a history of serious cardiovascular disease; 13. Patients with other serious systemic disease history who are judged to be unsuitable for clinical trials; 14. Alcohol or drug dependence is known; 15. Mental disorder or poor compliance; 16. Pregnant or lactating women; 17. Acceptance of live attenuated vaccine within 4 weeks before the first administration or during the study period is planned. 18. Researchers believe that there are any abnormal clinical or laboratory examinations or other reasons in the subjects and that they are not suitable for this clinical study.
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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
-
Dragonboat Biopharmaceutical,Co.,Ltd
Shanghai, Shanghai Municipality, China
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