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Advanced Non-Small Cell Lung CancerPhase 1/2NCT05978401

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

A Phase 1/2 study testing GLS-012+GLS-010, GLS-012+GLS-010+pemetrexed+carboplatin and GLS-012+GLS-010+paclitaxel+carboplatin in people with Advanced Non-Small Cell Lung Cancer, run by Guangzhou Gloria Biosciences Co., Ltd. at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Advanced Non-Small Cell Lung Cancer
What is being tested?
GLS-012+GLS-010, GLS-012+GLS-010+pemetrexed+carboplatin and GLS-012+GLS-010+paclitaxel+carboplatin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
152 participants
Where
1 siteChina
Study dates
10 Aug 2023to 1 Apr 2026
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).
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  • 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.

Who cannot join

  • 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);
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  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Shang Hai Pulmonary Hospital

    Shanghai, Shanghai Municipality, 200433

    Caicun Zhou, 021-65115006, caicunzhoudr@163.com

Other trials in China

About this study

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)

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.

Being tested
GLS-012+GLS-010, GLS-012+GLS-010+pemetrexed+carboplatin, GLS-012+GLS-010+paclitaxel+carboplatin

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GLS-012+GLS-010Drug

    Also called LAG3, PD-1

    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-010Drug

    Also called LAG3, PD-1

    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+carboplatinDrug

    Also called LAG3, PD-1, chemotherapy

    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+carboplatinDrug

    Also called LAG3, PD-1, chemotherapy

    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.

Study groups in NCT05978401
Study groupRoleWhat they receive
Phase I Dose-Escalation Stage：GLS-012+GLS-010ExperimentalParticipants will be treated with escalating doses of GLS-010 + GLS-012 to determine the MTD
Receives: Drug: GLS-012+GLS-010
Phase I Expansion Stage：GLS-012+GLS-010ExperimentalParticipants 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.
Receives: Drug: GLS-012+GLS-010
GLS-012+GLS-010+pemetrexed + carboplatinExperimentalParticipants 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.
Receives: Drug: GLS-012+GLS-010+pemetrexed+carboplatin
GLS-012+GLS-010+paclitaxel+carboplatinExperimentalParticipants 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.
Receives: Drug: GLS-012+GLS-010+paclitaxel+carboplatin

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 24 months

  2. Investigator Assessments of Overall Response Rate(ORR)

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

    Measured: 24 months

Secondary outcomes (2)

  1. PFS (progression-free survival)

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

    Measured: 24 months

  2. Disease Control Rate(DCR)

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

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Aug 2023
  2. Study start10 Aug 2023 (estimated)
  3. Primary completion1 Apr 2025 (estimated)
  4. Study completion1 Apr 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Model description
Part1 section is a dose-escalation/expansion study in a single-arm setup； Part2 section sets up a control.
Masking
None (open label)
Enrolment
152 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05978401
Sponsor's protocol ID
GLS-012-21
Status last verified
Aug 2023
First submitted
26 Jul 2023
Last updated
7 Aug 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing GLS-012+GLS-010, GLS-012+GLS-010+pemetrexed+carboplatin and GLS-012+GLS-010+paclitaxel+carboplatin in people with Advanced Non-Small Cell Lung Cancer, run by Guangzhou Gloria Biosciences Co., Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 7 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

DLT/MTD (time frame: 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05978401.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2023.

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