Safety, Tolerability, and Efficacy of GLS-012 and GLS-010 in Patients With Advanced Non-Small Cell Lung Cancer

Advanced Non-Small Cell Lung Cancer Clinical Trial

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)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05978401
• Other study ID #: GLS-012-21
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• Start date: August 10, 2023
• Est. completion date: April 1, 2026

Study information

• Verified date: August 2023
• Source: Guangzhou Gloria Biosciences Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 152
• Est. completion date: April 1, 2026
• Est. primary completion date: April 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Advanced Non-Small Cell Lung Cancer
• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms

Intervention

Drug:
• GLS-012+GLS-010
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.
• GLS-012+GLS-010
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.
• GLS-012+GLS-010+pemetrexed+carboplatin
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.
• GLS-012+GLS-010+paclitaxel+carboplatin
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.

Locations

Country	Name	City	State
China	Shang Hai Pulmonary Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Guangzhou Gloria Biosciences Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	DLT/MTD	To evaluate GLS-012 in combination with GLS-010 dose-limiting toxicity (DLT)/maximum tolerated dose (MTD) in patients with advanced non-small cell lung cancer	24 months
Primary	Investigator Assessments of Overall Response Rate(ORR)	RECIST v1.1 will be used to determine ORR by investigator	24 months
Secondary	PFS (progression-free survival)	RECIST v1.1 will be used to determine PFS by investigator	24 months
Secondary	Disease Control Rate(DCR)	RECIST v1.1 will be used to determine DCR by investigator	24 months