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Not yet recruitingNCT05978401Updated Aug 7, 2023

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

A Phase 1/2 interventional study of GLS-012+GLS-010 and GLS-012+GLS-010 in Advanced Non-Small Cell Lung Cancer, sponsored by Guangzhou Gloria Biosciences Co., Ltd.. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-08-07.

Sponsored by Guangzhou Gloria Biosciences Co., Ltd. · Phase 1/2, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Apr 2025, 1 year 6 months ago, but the record still lists the study as not yet recruiting.
Phase
Phase 1/2
Study type
Interventional
Enrollment
152
Allocation
Non-randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Advanced Non-Small Cell Lung Cancer
03

In context

Lung Neoplasms

7,243 studies on the registry are indexed under Lung Neoplasms; 1,558 are open to participants now.

This study's planned enrollment of 152 is above the median of 60 across 5,296 interventional studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

Guangzhou Gloria Biosciences Co., Ltd. is the lead sponsor of 8 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
152 participants (estimated)

Study arms

  • Experimental
    Phase I Dose-Escalation Stage：GLS-012+GLS-010

    Participants will be treated with escalating doses of GLS-010 + GLS-012 to determine the MTD

    Drug: GLS-012+GLS-010

  • Experimental
    Phase I Expansion Stage：GLS-012+GLS-010

    Participants will be enrolled in the expansion stage to better characterize the safety, tolerability, PK variability, and preliminary efficacy of GLS-012+GLS-010 in Advanced Non-Small Cell Lung Cancer.

    Drug: GLS-012+GLS-010

  • Experimental
    GLS-012+GLS-010+pemetrexed + carboplatin

    Participants will be enrolled in the expansion stage to better characterize the safety, PK variability, and preliminary efficacy of GLS-012+GLS-010+pemetrexed+carboplatin in Advanced Non-Small Cell Lung Cancer.

    Drug: GLS-012+GLS-010+pemetrexed+carboplatin

  • Experimental
    GLS-012+GLS-010+paclitaxel+carboplatin

    Participants will be enrolled in the expansion stage to better characterize the safety, PK variability, and preliminary efficacy of GLS-012+GLS-010+paclitaxel+carboplatin in Advanced Non-Small Cell Lung Cancer.

    Drug: GLS-012+GLS-010+paclitaxel+carboplatin

Interventions

  • DrugGLS-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.

    Also known as: LAG3, PD-1

  • DrugGLS-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.

    Also known as: LAG3, PD-1

  • DrugGLS-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.

    Also known as: LAG3, PD-1, chemotherapy

  • DrugGLS-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.

    Also known as: LAG3, PD-1, chemotherapy

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 24 months

  2. Investigator Assessments of Overall Response Rate(ORR)

    RECIST v1.1 will be used to determine ORR by investigator

    Time frame: 24 months

Secondary outcomes

  1. PFS (progression-free survival)

    RECIST v1.1 will be used to determine PFS by investigator

    Time frame: 24 months

  2. Disease Control Rate(DCR)

    RECIST v1.1 will be used to determine DCR by investigator

    Time frame: 24 months

07

Study locations

1 site
  • Shang Hai Pulmonary Hospital
    Shanghai, Shanghai 200433, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 7, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05978401
Lead sponsor
Guangzhou Gloria Biosciences Co., Ltd.
Responsible party
Sponsor
First posted
Aug 7, 2023
Start date
Aug 10, 2023 (estimated)
Primary completion
Apr 1, 2025 (estimated)
Completion
Apr 1, 2026 (estimated)
Last update
Aug 7, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.

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