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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase I Dose-Escalation Stage:GLS-012+GLS-010 | Experimental | Participants will be treated with escalating doses of GLS-010 + GLS-012 to determine the MTD |
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| Phase I Expansion Stage:GLS-012+GLS-010 | Experimental | 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. |
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| GLS-012+GLS-010+pemetrexed + carboplatin | Experimental | 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. |
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| GLS-012+GLS-010+paclitaxel+carboplatin | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GLS-012+GLS-010 | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Investigator Assessments of Overall Response Rate(ORR) | RECIST v1.1 will be used to determine ORR by investigator | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| PFS (progression-free survival) | RECIST v1.1 will be used to determine PFS by investigator | 24 months |
| Disease Control Rate(DCR) | RECIST v1.1 will be used to determine DCR by investigator |
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Inclusion Criteria:
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).
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:
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:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shang Hai Pulmonary Hospital | Shanghai | Shanghai Municipality | 200433 | China |
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Part1 section is a dose-escalation/expansion study in a single-arm setup; Part2 section sets up a control.
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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.
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| GLS-012+GLS-010 | Drug | 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. |
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| GLS-012+GLS-010+pemetrexed+carboplatin | Drug | 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. |
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| GLS-012+GLS-010+paclitaxel+carboplatin | Drug | 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. |
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| 24 months |
| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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