Clinical Trial in Chinese Patients of Elapsed/Metastatic/Unresectable Alveolar Soft Part Sarcoma(GB226)

NCT03623581 | Unknown Phase 2

• 1 other identifier: Gxplore-005
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a single-arm, phase 2 trial of Geptanolimab in patients with initially unresectable, recurrent or metastatic ASPS. The study aims to study the activity of Geptanolimab assessed per RECIST 1.1 and iRECIST criteria, and safety profile.

Conditions

Alveolar Soft Part Sarcoma

Keywords

ASPS

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate, ORR

  To evaluate the efficacy of GB226 as defined by objective response rate in patients with ASPS.

  up to 52 weeks

Secondary Outcomes (12)

• Progression-free survival, PFS

  up to 52 weeks

• Duration of response, DOR

  up to 52 weeks

• Disease Control Rate，DCR

  up to 52 weeks

• Overall survival, OS

  up to 52 weeks

• Incidence and severity of adverse events

  up to 52 weeks

Study Arms (1)

GB226 3mg/kg every 2 weeks

EXPERIMENTAL

Geptanolimab Injection, 3mg/kg every 2 weeks

Biological: GB226

Interventions

GB226 BIOLOGICAL

3mg/kg treat every 2 weeks

Also known as: Recombinant humanized anti-PD-1 monoclonal antibody injection, Geptanolimab

GB226 3mg/kg every 2 weeks

Eligibility Criteria

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

You may qualify if:

• The subjects can be enrolled only all the following criteria are met:
• Sign the informed consent form;
• Aged 18\~75 years old, males or females;
• ECOG score of 0-1;
• The expected survival is 3 months or longer;
• Histologically or cytologically confirmed relapsed or metastatic or unresectable alveolar soft part sarcoma (ASPS);
• There is at least one measurable lesion, which is defined as lesion accurately measured in one dimension (RECIST1.1: the longest diameter of non-lymph node lesions≥10mm, the shortest diameter of lymph node lesions ≥15mm);
• The previous treatment is completed ≥4 weeks or ≥5 half-lives of the previous therapeutic agents (whichever is shorter) before administration (at least 1 week interval between previous treatment and study enrollment); washout with nitrosoureas, mitomycin C, RANKL inhibitor for at least 6 weeks; previous radiotherapy must be performed at least 4 weeks ago; the previous monoclonal antibody treatment must be performed at least 6 weeks ago;
• If the patients received more than 350mg/m2 cumulative dose of adriamycin, echocardiography should be performed and left ventricular ejection fraction (LVEF) ≥50%;
• Absolute neutrophil count ≥1.5×109/L, platelet ≥100×109/L, hemoglobin (Hb) ≥80g/L;
• Total bilirubin ≤1.5xULN (≤3xULN is allowed for known Gilbert disease), AST/ALT≤3xULN (AST and/or ALT≤5xULN is allowed for patients with hepatic metastasis), ALP≤2.5xULN (≤5xULN is allowed for patients with hepatic metastasis or bone metastasis);
• The creatinine clearance ≥ 50mL/min/1.73m2 (calculated based on Cockcroft-Gault formula) or Cr≤1.5xULN;
• Female subjects who are confirmed not pregnant within 72 hours before administration; female and male patients of child-bearing potential should agree to adopt adequate contraceptive methods before enrollment, during study period and 6 months after the last dose;
• Lactating women should agree to stop breastfeeding during the study period;
• Agree to provide archived tumor tissue specimens or fresh tissue specimens;

You may not qualify if:

• The subjects cannot be enrolled should any of or several conditions occur:
• Subjects who received anti-PD-1 or anti-PD-L1 monoclonal antibody or targeted drugs of relevant pathways;
• Subjects who are known to be allergic to PD-1 monoclonal antibody or any of its excipients, or subjects who are known to have medical history of allergic diseases or serious allergic constitution;
• Subjects who received CTLA-4 antibody;
• Subjects who have other malignant tumor diseases other than tumor treated in this study, excluding cured malignant tumors which did not relapse within 3 years before enrollment, completely resected basal cell and squamous cell skin cancer, any type of in situ carcinoma which is completely resected;
• Active central nervous system (CNS) metastasis (regardless of whether any treatment is received), including symptomatic brain metastasis or meningeal metastasis or spinal cord compression etc.; excluding asymptomatic brain metastasis (no progression within at least 4 weeks after radiotherapy and/or no neurological symptom or sign after surgical resection, treatment with dexamethasone or mannitol is not necessary);
• Uncontrolled pleural effusion, pericardial effusion or ascites requiring repeated drainage;
• The toxicity of previous treatment still \> grade 1 (CTCAEV4.03 criteria), excluding alopecia and neurotoxicity;
• Subjects who have history of psychiatric disorders;
• Subjects who have medical history of drug addiction or drug abuse;
• Subjects with medical history of idiopathic pulmonary fibrosis or idiopathic pneumonitis, or patients who previously received radiotherapy for large size of lungs;
• Patients with complications requiring treatment with immunosuppressive drugs or systemic or local corticosteroids at the immunosuppressive doses (prednisone \> 10mg/day or equivalent dose of similar agents);
• Medical history of autoimmune diseases, including but not limited to systemic lupus erythematosus, psoriasis, rheumatoid arthritis, inflammatory gastrointestinal disorders, Hashimoto's thyroiditis etc. The following should be excluded: type I diabetes mellitus, hypothyroidism which can be controlled by hormone replacement therapies only, skin diseases requiring no systemic treatment (e.g., vitiligo, psoriasis), controlled celiac disease, or diseases which may not occur without stimulating factors;
• Subjects who previously or currently have active tuberculosis;
• Subjects with active infection requiring systemic treatment;

Sponsors & Collaborators

• Genor Biopharma Co., Ltd.: lead

Study Sites (1)

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100021, China

RECRUITING

MeSH Terms

Conditions

Sarcoma, Alveolar Soft Part

Condition Hierarchy (Ancestors)

Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Sarcoma

Study Officials

• Yuankai Shi, Doctor

  Study Principal Investigator Cancer Hospital Chinese Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shawn Yu, Master

CONTACT

86-010-65260820; shawn.yu@genorbio.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2018
• First Posted: August 9, 2018
• Study Start: September 6, 2018
• Primary Completion: August 1, 2021
• Study Completion: December 30, 2022
• Last Updated: March 3, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)