Safety, Tolerability, Pharmacokinetics and Efficacy of SCT-I10A in Patients With Advanced Solid Tumors or Lymphoma

NCT03821363 | Unknown Phase 1

• 1 other identifier: SCT-I10A-X101
• Study Type: interventional
• Target: 206
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of recombinant humanized anti- PD-1 monoclonal antibody（SCT-I10A）in patients with advanced solid tumors or lymphoma treated after failure of standard therapy.

Conditions

Advanced Solid Tumors or Lymphoma

Keywords

Neoplasms; Solid Tumors; Lymphoma; PD-1; SCT-I10A

Outcome Measures

Primary Outcomes (1)

• Safety/Tolerability

  Incidence of adverse events and outlier of laboratory tests, positive rate of immunogenicity

  24 months

Secondary Outcomes (5)

• Objective response rate (ORR)

  24 months

• Duration of response (DOR)

  24 months

• Disease control rate (DCR)

  24 months

• Progression free survival (PFS)

  24 months

• Overall survival (OS)

  24 months

Study Arms (3)

Low dose group

EXPERIMENTAL

SCT-I10A will be administered at a dose of 60mg, Q3W up to 24 months.

Biological: SCT-I10A

Middle dose group

EXPERIMENTAL

SCT-I10A will be administered at a dose of 200mg, Q3W up to 24 months.

Biological: SCT-I10A

High dose group

EXPERIMENTAL

SCT-I10A will be administered at a dose of 600mg, Q3W up to 24 months.

Biological: SCT-I10A

Interventions

SCT-I10A BIOLOGICAL

Experimental: Anti- PD-1 monoclonal antibody（SCT-I10A）

High dose group; Low dose group; Middle dose group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able to provide written informed consent before screening；
• Males or females. Aged 18 to 75 years old;
• Life expectancy≥12 weeks before starting treatment (clinical assessment);
• With an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1;
• Histologically or cytologically confirmed advanced solid tumor or lymphoma;
• Advanced solid tumor or lymphoma with standard treatment failed or no effective therapy;
• According to RECIST 1.1 or Lugano 2014 criteria, patients must have at least one measurable lesion that can be accurately assessed;
• Adequate organ and bone marrow function as defined below:
• Absolute neutrophil count (ANC) greater than/equal to 1.5×l09/L; Platelets greater than/equal to 75×109/L; Hemoglobin greater than/equal to 80g/L; Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) less than/equal to 2.5 times ULN, or less than/equal to 5 times ULN if known liver metastases; Total bilirubin less than/equal to 1.5 times ULN; Serum creatinine less than/equal to 1.5 times ULN or Ccr\>50ml/min; Thyroid stimulating hormone (TSH) hormone levels less than/equal to ULN.

You may not qualify if:

• Patients who are allergic to analogue of SCT-I10A and/or its inactive ingredients;
• Patients have been treated with anti-PD-L1 and anti-PD-1 antibody;
• Patients are currently enrolled in other research devices or in research drugs, or less than 4 weeks from other research drugs or devices;
• Within 4 weeks prior to the first dose of study drug, patients have received anti-tumor drugs (such as chemotherapy, endocrine therapy, targeted therapy, immune therapy, tumor embolization). Within 6 weeks prior to the first dose of study drug, patients have been treated with biological products, nitrosourea or mitomycin C;
• Within 2 weeks prior to the first dose of study drug, patients have received corticosteroids or other immunosuppressive agents;
• Within 4 weeks prior to the first dose of study drug, patients have received live attenuated vaccine (LAV), or who planned to use LAV during the study period;
• Within 4 weeks prior to the first dose of study drug, patients have received major surgery, or had wounds, ulcers or fractures that haven't healed;
• Prior to the first dose of study drug, patients had toxicity due to previous anti-tumor treatment, which hasn't return to Grade 0-1 according to the NCI CTCAEv4.03;
• Patient with cerebrospinal meningitis metastasis or central nervous system metastasis with untreated or uncontrolled with other treatment;
• Patients with an active, known or suspected autoimmune disease or a history of autoimmune disease;
• Patients with a history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;
• Within 6 months prior to study, patients had uncontrolled concurrent diseases, including but not limited to acute myocardial infarction, unstable angina pectoris, stroke, or transient ischemic attack, congestive heart failure (NYHA, greater than II), left ventricular ejection fraction (LVEF) \<50%, and with related heart disease. Patients with chronic or acute disease, psychological or psychiatric disorders, laboratory abnormalities which may affect subject compliance and outcomes in this clinical study;
• Patients with HIV, active hepatitis B (HBV DNA≥104 copies/ml) or active hepatitis C (HCV RNA≥103 copies/ml), etc.;
• Patients who have interstitial lung disease, such as interstitial pneumonia, pulmonary fibrosis, or CT or MRI reminder ILD.
• Patients with clinical symptoms, required clinical intervention or stable time less than 4 weeks of serous cavity effusion (such as pleural effusion and ascites);

Sponsors & Collaborators

• Sinocelltech Ltd.: lead

Study Sites (1)

The Fifth Medical Center of PLA General Hospital

Beijing, Beijing Municipality, 100071, China

RECRUITING

MeSH Terms

Conditions

Lymphoma; Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Central Study Contacts

jianming xu, MD

CONTACT

+8613910866712; jmxu2003@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Groups of participants are assigned to receive interventions based on prior milestones being reached in the study, such as in some dose escalation and adaptive design studies

Study Record Dates

• First Submitted: January 24, 2019
• First Posted: January 29, 2019
• Study Start: December 13, 2018
• Primary Completion: July 1, 2020
• Study Completion: July 1, 2020
• Last Updated: January 29, 2019

Record last verified: 2018-07

Locations

CN (1)