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Trial Title:
Safety, Tolerability, and Efficacy of GLS-012 and GLS-010 in Patients With Advanced Non-Small Cell Lung Cancer
NCT ID:
NCT05978401
Condition:
Advanced Non-Small Cell Lung Cancer
Conditions: Official terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Paclitaxel
Carboplatin
Pemetrexed
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Single Group Assignment
Intervention model description:
Part1 section is a dose-escalation/expansion study in a single-arm setup； Part2 section
sets up a control.
Primary purpose:
Treatment
Masking:
None (Open Label)
Masking description:
Part1 section is a dose-escalation/expansion study in a single-arm setup； Part2 section
sets up a control； All processes do not involve blind settings.
Intervention:
Intervention type:
Drug
Intervention name:
GLS-012+GLS-010
Description:
Two dose levels will be evaluated for GLS-012+GLS-010 administered. GLS-012+GLS-010 will
be given via intravenous (IV) infusion on Day 1 of each 21-day cycle until disease
progression or loss of clinical benefit.
Arm group label:
Phase I Dose-Escalation Stage：GLS-012+GLS-010
Other name:
LAG3
Other name:
PD-1
Intervention type:
Drug
Intervention name:
GLS-012+GLS-010
Description:
Target dose levels will be evaluated for GLS-012+GLS-010 administered. GLS-012+GLS-010
will be given via intravenous (IV) infusion on Day 1 of each 21-day cycle until disease
progression or loss of clinical benefit.
Arm group label:
Phase I Expansion Stage：GLS-012+GLS-010
Other name:
LAG3
Other name:
PD-1
Intervention type:
Drug
Intervention name:
GLS-012+GLS-010+pemetrexed+carboplatin
Description:
GLS-012+GLS-010 will be given via IV infusion on Day 1 of each 21-day cycle in
combination with pemetrexed and carboplatin. Combination treatment will be administered
4~6 cycles.GLS-012+GLS-010/GLS-010 may continue until disease progression or loss of
clinical benefit.
Arm group label:
GLS-012+GLS-010+pemetrexed + carboplatin
Other name:
LAG3
Other name:
PD-1
Other name:
chemotherapy
Intervention type:
Drug
Intervention name:
GLS-012+GLS-010+paclitaxel+carboplatin
Description:
GLS-012+GLS-010 will be given via IV infusion on Day 1 of each 21-day cycle in
combination with paclitaxel and carboplatin. Combination treatment will be administered
4~6 cycles.GLS-012+GLS-010/GLS-010 may continue until disease progression or loss of
clinical benefit.
Arm group label:
GLS-012+GLS-010+paclitaxel+carboplatin
Other name:
LAG3
Other name:
PD-1
Other name:
chemotherapy
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 chemotherapy for advanced non-small-cell lung cancer respectively to assess
preliminary efficacy at the combination dose.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Subjects enroll in the study and sign the Informed Consent Form (ICF);
2. Aged ≥18 years and ≤75 years;
3. 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);
4. Subjects with an Eastern Cooperative Oncology Group (ECOG) score of 0 ~1 for
physical status;
5. expected survival ≥ 12 weeks;
6. Subjects with measurable lesions (at least 1 extracranial lesion) according to the
Solid Tumor Evaluation Criteria (RECIST v1.1).
7. 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);
8. Organ function meets the following criteria:
1. 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;
2. 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);
3. Renal: blood creatinine ≤ 1.25 times ULN;
4. Heart: left ventricular ejection fraction (LVEF) ≥ 50%.
9. 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 Criteria:
1. Severe immunotherapy-related toxicity during prior treatment with anti-ICIs;
2. Prior grade ≥ 3 irAE on immunotherapy and who have not recovered to grade ≤ 1 from
the last adverse reaction to antineoplastic therapy;
3. With primary or secondary immunodeficiency；
4. Any active, known or suspected autoimmune disease;
5. Known CNS metastases ;
6. Prior severe allergic reactions to large protein preparations/monoclonal antibodies
(CTCAE V5.0 classification ≥ grade 4);
7. Previous treatment with anti-LAG-3 antibodies;
8. Other malignant tumors within 5 years prior to screening, except cured cervical
carcinoma in situ and cured basal cell carcinoma of the skin;
9. Have uncontrolled cardiac clinical symptoms or disease；
10. 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;
11. Pregnant or nursing females；
12. Poorly compliant or otherwise unsuitable for participation in this study.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Shang Hai Pulmonary Hospital
Address:
City:
Shanghai
Zip:
200433
Country:
China
Contact:
Last name:
Caicun Zhou
Phone:
021-65115006
Email:
caicunzhoudr@163.com
Start date:
August 10, 2023
Completion date:
April 1, 2026
Lead sponsor:
Agency:
Guangzhou Gloria Biosciences Co., Ltd.
Agency class:
Industry
Source:
Guangzhou Gloria Biosciences Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05978401
