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This study is a randomized, multicenter, Phase Ib/II clinical trial, aimed at evaluating the efficacy and safety of the combination of ZG006 and ZG005 in patients with advanced small cell lung cancer and neuroendocrine carcinoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase Ib: Part1-Dose Escalation | Experimental | This study will employ the traditional "3+3" dose escalation design. Ultimately, two combination dosing cohorts will be selected to enter Part 2, the dose expansion phase, based on a comprehensive evaluation of the safety and pharmacokinetic (PK) data obtained by the investigators and the sponsor. |
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| Phase Ib: Part2-Dose Expansion | Experimental | The safety and pharmacokinetic (PK) data obtained in Part 1 will be used to determine two expansion phase doses of the ZG006 and ZG005 combination. The dose expansion study will further evaluate the efficacy of the two selected combination dosing cohorts in patients with advanced small cell lung cancer and neuroendocrine carcinoma. |
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| Phase II | Experimental | Participants will receive the RP2D of ZG006 in combination with ZG005 identified in Phase Ib of the study. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ZG006 | Drug | ZG006 will be administered as an intravenous (IV) infusion. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Experienced Dose-limiting Toxicity (DLT) | up to 28 days | |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Up to 2 years | |
| Objective Response Rate (ORR) | The objective response rate was defined as the percentage of participants with a confirmed best overall response of complete response (CR) or partial response (PR) based on the modified RECIST v1.1. | Up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Response (DOR) | Up to 2 years | |
| Disease Control Rate (DCR) | Up to 2 years | |
| Progression-free Survival (PFS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hewen Yin | Contact | +86-0512-57309965 | yinhw@zelgen.com |
| Name | Affiliation | Role |
|---|---|---|
| Jason Wu | Suzhou Zelgen Biopharmaceuticals Co.,Ltd | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-sen University Cancer Center | Recruiting | Guanzhou | Guangdong | China |
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| ID | Term |
|---|---|
| D055752 | Small Cell Lung Carcinoma |
| D018278 | Carcinoma, Neuroendocrine |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| ZG005 | Drug | ZG005 will be administered as an intravenous (IV) infusion. |
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| Up to 2 years |
| Overall Survival (OS) | Up to 2 years |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |