Advanced TumorsPhase 1NCT03908814

Phase I Clinical Trial of Human Anti-PD-L1 Antibody Injection (LDP) in Patients With Advanced Malignant Tumors

A Phase 1 study testing Whole Human Anti-PD-L1 Antibody Injection (LDP) in people with Advanced Tumors, run by Dragonboat Biopharmaceutical Company Limited at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This is a phase I, open-label, multiple-dose, dose-escalation study to evaluate the safety, tolerability, pharmacokinetics and anti-tumor activity of LDP in subjects with advanced malignant tumors. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Advanced Tumors
What is being tested?: Whole Human Anti-PD-L1 Antibody Injection (LDP)
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 66 participants
Where: 1 siteChina
Study dates: 27 Apr 2019to 10 Apr 2023
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Age ≥ 18 (inclusive), regardless of gender
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;
The estimated survival time is more than 3 months.
At least one assessable tumor lesion (solid tumors according to RECIST 1.1, lymphoma according to Lugano 2014);
ECOG physical strength score 0-1;
Enough organ function:

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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;
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;
Prior to the trial, the subject shall have informed consent to the study and voluntarily sign a written form of informed consent;

Who cannot join

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；
Major organ surgery (excluding puncture biopsy) or significant trauma occurred within 4 weeks before the first administration.
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).
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;
Those who have previously received treatment with PD-1 or PD-L1 inhibitors;
In the past, immune-related adverse events (> grade 3) have occurred in immunotherapy (irAE, see Appendix 5)；

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Patients with active or recurrent autoimmune diseases (such as systemic lupus erythematosus, rheumatoid arthritis, vasculitis, etc.)；
Current or previous patients with interstitial lung disease;
Uncontrolled active infections;
History of immunodeficiency, including positive HIV antibody test；
Patients with active hepatitis B (HBV titer higher than detection limit) ; hepatitis C virus infection;
Those with a history of serious cardiovascular disease;
Patients with other serious systemic disease history who are judged to be unsuitable for clinical trials;
Alcohol or drug dependence is known;
Mental disorder or poor compliance;
Pregnant or lactating women;
Acceptance of live attenuated vaccine within 4 weeks before the first administration or during the study period is planned.
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.

Trial locations and contacts

1 site in 1 country.

China1 site

Dragonboat Biopharmaceutical,Co.,Ltd
Shanghai, Shanghai Municipality

Other trials in China

About this study

Official title: Phase I Clinical Trial to Evaluate the Safety, Tolerance and Pharmacokinetics of Human Anti-PD-L1 Monoclonal Antibody Injection (LDP) in Patients With Advanced Malignant Tumors

This is a phase I, open-label, multiple-dose, dose-escalation study to evaluate the safety, tolerability, pharmacokinetics and anti-tumor activity of LDP in subjects with advanced malignant tumors.

Read the detailed description

This trial is an open, dose escalation phase I clinical trial study of patients with advanced cancer who have failed standard treatment. The trial is divided into a dose escalation phase and an expansion phase.

Approximately 130 patients will be enrolled in this trial. The dose-increasing phase is about 30 cases, and the expansion stage is about 100 cases.

Conditions: Advanced Tumors
Being tested: Whole Human Anti-PD-L1 Antibody Injection (LDP)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Whole Human Anti-PD-L1 Antibody Injection (LDP)Drug
Also called LDP
Dose escalation study evaluating six dose levels (0.1, 0.3, 1, 3 , 10and 20 mg/kg) of LDP.

Study groups in NCT03908814
Study group	Role	What they receive
Drug: LDP	Experimental	This is a dose-escalation trial, all participants will receive treatment with LDP. Participants enrolled in this trial may receive one of the following doses dependent upon time of enrolment into the study. Cohort 1: 0.1 mg/kg Cohort 2: 0.3 mg/kg Cohort 3: 1 mg/kg Cohort 4: 3 mg/kg Cohort 5: 10 mg/kg Cohort 6: 10 mg/kg Receives: Drug: Whole Human Anti-PD-L1 Antibody Injection (LDP)

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of participants with dose limiting toxicity (DLT)
An DLT is defined as a ≥Grade 3 drug-related adverse event occurring within the first cycle (28 days) of dosing (excluding tumor flare causing local pain at sites of known or suspected tumor, localized rash, or a transient ≤Grade 3 infusion reaction) using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE).
Measured: At the end of Cycle 1 (28 days).
Maximum tolerable dose (MTD)
MTD refers to the highest dose which can satisfy the first cycle of the same dose group and the proportion of DLT occurring is less than 1/3 in the incremental dose stage. The dose of MTD required confirmation by 6 subjects.
Measured: At the end of Cycle 1 (28 days).

Secondary outcomes (8)

Pharmacokinetic parameters: Observed Maximum Serum Concentration (Cmax) of LDP After Infusion
Pharmacokinetic parameters Cmax for LDP
Measured: Up to 22 Days
Pharmacokinetic Parameters: Area Under the Serum Concentration-time Curve From Time Zero to the Last Sampling Time (AUC0-t) After Infusion AUC(0-t) for LDP
AUC(0-t) for LDP
Measured: Up to 22 Days
Pharmacokinetic parameters: Area Under the Serum Concentration-time Curve From Time Zero to Infinity (AUC0-00) After Infusion Pharmacokinetic parameters: AUC(0-00) for LDP
Pharmacokinetic parameters: AUC(0-00) for LDP
Measured: Up to 22 Days
Pharmacokinetic parameters: Apparent Terminal Half-life (t1/2) of LDP After Infusion
Pharmacokinetic parameters T1/2 for LDP
Measured: Up to 22 Days
Immunogenicity indicators: Number of participants with positive anti-drug antibodies (ADA)
Immunogenicity indicators: Number of participants with positive anti-drug
Measured: Up to 176 Days
Immunogenicity indicators: Number of participants with positive neutralizing antibodies
Immunogenicity indicators: Number of participants with positive neutralizing antibodies
Measured: Up to 176 Days
Objective response rate (ORR)
The ORR is defined as the proportion of subjects with confirmed CR or confirmed PR, based on RECIST Version 1.1.
Measured: From first dose of LDP through 21 days after last dose of LDP up to 2 years.
Progression-free survival (PFS)
Progression-free survival is defined as the time from the start of treatment with LDP until the first documentation of disease progression or death due to any cause, whichever occurs first.
Measured: From first dose of LDP through 21 days after last dose of LDP up to 2 years.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

27 Apr 201910 Apr 2023

First posted9 Apr 2019
Study start27 Apr 2019
Primary completion10 Apr 2023
Study completion10 Apr 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Advanced TumorsStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Sequential
Masking: None (open label)
Enrolment: 66 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03908814
Sponsor's protocol ID: LDP100001
Status last verified: Apr 2023
First submitted: 8 Apr 2019
Last updated: 6 Jul 2026
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Advanced Tumors trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase I Clinical Trial to Evaluate the Safety, Tolerance and Pharmacokinetics of Human Anti-PD-L1 Monoclonal Antibody Injection (LDP) in Patients With Advanced Malignant Tumors
ClinicalTrials.gov ID: NCT03908814
Acronym / sponsor ID: LDP100001
Conditions: Advanced Tumors
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 66 participants (actual)
Lead sponsor: Dragonboat Biopharmaceutical Company LimitedIndustry (pharma, biotech, devices)
Collaborators: Shanghai East Hospital
Study start: 27 Apr 2019 (actual)
Primary completion: 10 Apr 2023 (actual)
Study completion: 10 Apr 2023 (actual)
First posted: 9 Apr 2019 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This is a phase I, open-label, multiple-dose, dose-escalation study to evaluate the safety, tolerability, pharmacokinetics and anti-tumor activity of LDP in subjects with advanced malignant tumors.

Detailed description

Approximately 130 patients will be enrolled in this trial. The dose-increasing phase is about 30 cases, and the expansion stage is about 100 cases.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Sequential
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Drug: LDP	Experimental	Drug: Whole Human Anti-PD-L1 Antibody Injection (LDP)This is a dose-escalation trial, all participants will receive treatment with LDP. Participants enrolled in this trial may receive one of the following doses dependent upon time of enrolment into the study. Cohort 1: 0.1 mg/kg Cohort 2: 0.3 mg/kg Cohort 3: 1 mg/kg Cohort 4: 3 mg/kg Cohort 5: 10 mg/kg Cohort 6: 10 mg/kg

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

Age ≥ 18 (inclusive), regardless of gender
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;
The estimated survival time is more than 3 months.
At least one assessable tumor lesion (solid tumors according to RECIST 1.1, lymphoma according to Lugano 2014);
ECOG physical strength score 0-1;

Key exclusion criteria (18 listed)

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；
Major organ surgery (excluding puncture biopsy) or significant trauma occurred within 4 weeks before the first administration.
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).
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;
Those who have previously received treatment with PD-1 or PD-L1 inhibitors;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Whole Human Anti-PD-L1 Antibody Injection (LDP)Also: LDPDose escalation study evaluating six dose levels (0.1, 0.3, 1, 3 , 10and 20 mg/kg) of LDP.	Drug	Drug: LDP

Primary outcome

Number of participants with dose limiting toxicity (DLT)
Time frame: At the end of Cycle 1 (28 days).
An DLT is defined as a ≥Grade 3 drug-related adverse event occurring within the first cycle (28 days) of dosing (excluding tumor flare causing local pain at sites of known or suspected tumor, localized rash, or a transient ≤Grade 3 infusion reaction) using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE).
Maximum tolerable dose (MTD)
Time frame: At the end of Cycle 1 (28 days).
MTD refers to the highest dose which can satisfy the first cycle of the same dose group and the proportion of DLT occurring is less than 1/3 in the incremental dose stage. The dose of MTD required confirmation by 6 subjects.

8 secondary outcomes

Pharmacokinetic parameters: Observed Maximum Serum Concentration (Cmax) of LDP After Infusion
Time frame: Up to 22 Days
Pharmacokinetic Parameters: Area Under the Serum Concentration-time Curve From Time Zero to the Last Sampling Time (AUC0-t) After Infusion AUC(0-t) for LDP
Time frame: Up to 22 Days
Pharmacokinetic parameters: Area Under the Serum Concentration-time Curve From Time Zero to Infinity (AUC0-00) After Infusion Pharmacokinetic parameters: AUC(0-00) for LDP
Time frame: Up to 22 Days
Pharmacokinetic parameters: Apparent Terminal Half-life (t1/2) of LDP After Infusion
Time frame: Up to 22 Days
Immunogenicity indicators: Number of participants with positive anti-drug antibodies (ADA)
Time frame: Up to 176 Days
Immunogenicity indicators: Number of participants with positive neutralizing antibodies
Time frame: Up to 176 Days
Objective response rate (ORR)
Time frame: From first dose of LDP through 21 days after last dose of LDP up to 2 years.
Progression-free survival (PFS)
Time frame: From first dose of LDP through 21 days after last dose of LDP up to 2 years.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
Individual participant dataSharing planned: No

Related trials for Advanced Tumors

Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 3
A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)
Carcinoma, Renal Cell
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Li Jin, doctor study chair

Shanghai East Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Whole Human Anti-PD-L1 Antibody Injection (LDP) in people with Advanced Tumors, run by Dragonboat Biopharmaceutical Company Limited at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants with dose limiting toxicity (DLT) (time frame: At the end of Cycle 1 (28 days).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03908814.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2026.