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

NCT ID: NCT03908814

Last Updated: 2019-10-31

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 130 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-27
• Study Completion Date: 2022-04-26

Brief 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.

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

Study Design

• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Drug: 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

Group Type: EXPERIMENTAL

Whole Human Anti-PD-L1 Antibody Injection (LDP)

Intervention Type: DRUG

Dose escalation study evaluating six dose levels (0.1, 0.3, 1, 3 , 10and 20 mg/kg) of LDP.

Interventions

Whole Human Anti-PD-L1 Antibody Injection (LDP)

Dose escalation study evaluating six dose levels (0.1, 0.3, 1, 3 , 10and 20 mg/kg) of LDP.

Intervention Type: DRUG

Other Intervention Names

LDP

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai East Hospital

OTHER

Sponsor Role: collaborator

Dragonboat Biopharmaceutical Company Limited

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Li Jin, doctor

Role: STUDY_CHAIR

Shanghai East Hospital

Locations

Dragonboat Biopharmaceutical,Co.,Ltd

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Zhang Xiaolei, doctor

Role: CONTACT

Phone: （86）021-50276381-637

Email: zhangxiaolei@dragonboatbio.com

Wang Qihui, doctor

Role: CONTACT

Phone: 86）021-50276381

Email: Qihui.Wang@dragonboatbio.com

Facility Contacts

ZHANG XIAOLEI, DOCTOR

Role: primary

Other Identifiers

LDP100001

Identifier Type: -

Identifier Source: org_study_id