A Phase I Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Anti-PD-1 Antibody (HLX10) in Combination With Avastin Biosimilar (HLX04) in Patients With Advanced Solid Tumors

NCT ID: NCT03757936

Last Updated: 2019-05-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-27
• Study Completion Date: 2020-12-27

Brief Summary

This is a single-center, open-label, dose-escalation Phase I clinical trial to evaluate the safety and the tolerability of HLX10-HLX04 combination therapy in patients with advanced solid tumors after failure of standard of care.

Conditions

Solid Tumor

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

HLX04+HLX10

HLX10, at three dose levels (1, 3, 10 mg/kg), to be intravenously injected once every two weeks; HLX04, at a fixed dose of 5 mg/kg, intravenously injected once every two weeks; Study drugs given in combination for up to 2 years or until the disease gets worse, whichever comes first.

Group Type: EXPERIMENTAL

HLX04

Intervention Type: DRUG

Recombinant Anti-VEGF Humanized Monoclonal Antibody Injection

HLX10

Intervention Type: DRUG

Recombinant Anti-PD-1 Humanized Monoclonal Antibody Injection

Interventions

HLX04

Recombinant Anti-VEGF Humanized Monoclonal Antibody Injection

Intervention Type: DRUG

HLX10

Recombinant Anti-PD-1 Humanized Monoclonal Antibody Injection

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Age ≥18 years, male or female

2. Patient with histologically or cytologically confirmed advanced malignant solid tumors who have failed standard of care, or has no standard-of-care therapy or are not suitable for standard of care at the present stage;

3. Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1；

4. Life expectancy greater than 3 months;

5. Patient must have at least one measurable tumor lesion as defined by RECIST v1.1; the lesion concerned must not be a bone metastasis if only one target lesion is present;

6. Has adequate organ functions;

7. If the subject is a patient with hepatocellular carcinoma, Child-Pugh classification must be A.

8. A qualified patient (male or female) of childbearing potential must agree to use reliable contraceptive methods (hormonal, or barrier method or abstinence) for the course of the study and through at least 6 months after the last dose; a female patient of childbearing potential must have negative blood pregnancy test within 7 days prior to enrollment;

9. The subject must give his/her informed consent to this study prior to the trial, and voluntarily sign a written informed consent form.

Exclusion Criteria

1. Histopathological confirmed head and neck cancer or squamous-cell lung cancer, or bleeding tendency in the tumor lesion judged by the investigator;

2. Has received antitumor therapy like radiotherapy, chemotherapy, targeted therapy, endocrinal therapy or immunotherapy, or other clinical study drug therapy within 4 months prior to the initial drug administration;

3. Has received a surgical operation on major viscera or experienced apparent trauma within 4 weeks from the initial drug administration, or experienced subcutaneous venous access device implantation within 7 days;

4. The adverse reactions which occurred in the previous antitumor treatment were not recovered to ≤ grade 1 based on CTCAE 4.03 assessment (except for hair loss);

5. Evidences of metastatic lesion in the patient's central nervous system;

6. Previously experienced ≥ grade 3 immune-related adverse event during immunotherapy;

7. Active, or history of autoimmune disease which may relapse (for example, systemic lupus erythematosus, rheumatoid arthritis, vasculitis, etc.);

8. Currently having or have had interstitial lung disease;

9. Uncontrollable active infection(s);

10. History of immunodeficiency, including HIV antibody positive;

11. Known active hepatitis B; or hepatitis C virus infections;

12. Has bleeding tendency;

13. History of severe cardiovascular diseases;

14. Known gastrointestinal diseases as follows:

Gastrointestinal perforation, abdominal fistula or abdominal abscess within 6 months before signing the informed consent; History of poorly controlled or recurrent inflammatory bowel disease; Active peptic ulcers, or > moderate esophageal varices;

15. Known hypersensitivity to Bevacizumab, or other anti-PD-1, anti-PD-L1 monoclonal antibody agents;

16. Pregnant or breastfeeding female.

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

Sponsors

Shanghai Henlius Biotech

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Shanghai East Hospital

Shanghai, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Joanne Wang

Role: CONTACT

Joanne_wang@henlius.com

+86-021-33395800-6024

Facility Contacts

Jin Li, MD

Role: primary

lijin@csco.org.cn

Other Identifiers

HLX10HLX04-001

Identifier Type: -

Identifier Source: org_study_id