Clinical trial NCT05978401: Safety, Tolerability, and Efficacy of GLS-012 and GLS-010 in Patients With Advanced Non-Small Cell Lung Cancer
Official title: A Phase I/II Study Evaluating the Safety, Tolerability, and Efficacy of GLS-012 and GLS-010 in Patients With Advanced Non-Small Cell Lung Cancer (Triumph-02)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Advanced Non-Small Cell Lung Cancer
Lead sponsor: Guangzhou Gloria Biosciences Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-08-07
Enrollment: 152
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
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

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 chemotherapy for advanced non-small-cell lung cancer respectively to assess preliminary efficacy at the combination dose.


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.

Primary outcomes:
measure: DLT/MTD
timeFrame: 24 months
measure: Investigator Assessments of Overall Response Rate(ORR)
timeFrame: 24 months
Secondary outcomes:
measure: PFS (progression-free survival)
timeFrame: 24 months
measure: Disease Control Rate(DCR)
timeFrame: 24 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shang Hai Pulmonary Hospital
state: Shanghai
Study officials:
References: