Status:
NOT_YET_RECRUITING
Safety, Tolerability, and Efficacy of GLS-012 and GLS-010 in Patients With Advanced Non-Small Cell Lung Cancer
Lead Sponsor:
Guangzhou Gloria Biosciences Co., Ltd.
Conditions:
Advanced Non-Small Cell Lung Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
PHASE2
Brief Summary
This is a multicenter, open Phase I/II study. The trial consists of two parts, Part1 is a dose-escalation/expansion study, Part2 is a combination of GLS-010 and GLS-010+GLS-012 with standard chemother...
Eligibility Criteria
Inclusion
- Subjects enroll in the study and sign the Informed Consent Form (ICF);
- Aged ≥18 years and ≤75 years;
- histologically or cytologically confirmed advanced non-small cell lung cancer without driver genes (diagnostic criteria refer to AJCC 8th edition of squamous or non-squamous non-small cell lung cancer);
- Subjects with an Eastern Cooperative Oncology Group (ECOG) score of 0 \~1 for physical status;
- expected survival ≥ 12 weeks;
- Subjects with measurable lesions (at least 1 extracranial lesion) according to the Solid Tumor Evaluation Criteria (RECIST v1.1).
- Subjects provide formalin-fixed, paraffin-embedded tumor tissue blocks or unstained tumor specimen sections (at least 6), either archived or freshly obtained within 5 years prior to the first study treatment (freshly obtained is preferred);
- Organ function meets the following criteria:
- Adequate bone marrow reserve (not acceptable for corrective therapy with hematologic products or cell growth factors administered within 14 days prior to first study dose): absolute neutrophil count ≥ 1.5 x 109/L, platelet count ≥ 90 x 109/L, and hemoglobin ≥ 9 g/dL;
- Liver: serum albumin ≥ 3.0 g/dL; total bilirubin ≤ 1.5 times the Upper Limit of Normal (ULN), and ALT and AST ≤ 3 times the ULN (or AST and ALT ≤ 5 × ULN for patients with known liver metastases);
- Renal: blood creatinine ≤ 1.25 times ULN;
- Heart: left ventricular ejection fraction (LVEF) ≥ 50%.
- Subjects of childbearing potential must be using highly effective contraception during the study and for at least 6 months after the last dose; female subjects of childbearing potential must have a negative blood pregnancy test within 3 days prior to study enrollment.
Exclusion
- Severe immunotherapy-related toxicity during prior treatment with anti-ICIs;
- Prior grade ≥ 3 irAE on immunotherapy and who have not recovered to grade ≤ 1 from the last adverse reaction to antineoplastic therapy;
- With primary or secondary immunodeficiency；
- Any active, known or suspected autoimmune disease;
- Known CNS metastases ;
- Prior severe allergic reactions to large protein preparations/monoclonal antibodies (CTCAE V5.0 classification ≥ grade 4);
- Previous treatment with anti-LAG-3 antibodies;
- Other malignant tumors within 5 years prior to screening, except cured cervical carcinoma in situ and cured basal cell carcinoma of the skin;
- Have uncontrolled cardiac clinical symptoms or disease；
- Subjects have received a live attenuated vaccine (except inactivated viral seasonal influenza vaccine and novel coronavirus vaccine) within 4 weeks prior to the first dose and who will not receive intranasally administered live attenuated influenza vaccine;
- Pregnant or nursing females；
- Poorly compliant or otherwise unsuitable for participation in this study.
Key Trial Info
Start Date :
August 10 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2026
Estimated Enrollment :
152 Patients enrolled
Trial Details
Trial ID
NCT05978401
Start Date
August 10 2023
End Date
April 1 2026
Last Update
August 7 2023
Active Locations (1)
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1
Shang Hai Pulmonary Hospital
Shanghai, Shanghai Municipality, China, 200433