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This is a multicenter, open-label phase I/II study in patients with advanced cervical cancer designed to evaluate the safety, tolerability, and preliminary efficacy of ZG005 in combination with Gecacitinib ± bevacizumab.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PART 1（phaseⅠ） | Experimental | Part 1 is a dose exploratory study of ZG005 combined with gecaxitinib ± bevacizumab to evaluate the tolerability and safety of the combination regimen |
|
| PART 2（phase II） | Experimental | Part 2 is a dose expansion study to further evaluate the safety and preliminary efficacy of the combination regimen identified in Part 1 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ZG005 | Biological | ZG005 20mg/kg, intravenous infusion(IV), once every 3 weeks (Q3W) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Event (AE) | Up to 2 years | |
| Objective response rate (ORR) | Up to 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yongsheng Chu | Contact | +86-0512-57309965 | chuys@zelgen.com |
| Name | Affiliation | Role |
|---|---|---|
| Jason Wu | Suzhou Zelgen Biopharmaceuticals Co.,Ltd | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhejiang Cancer Hospital | Recruiting | Hangzhou | Zhejiang | 310022 | China |
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| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D000068258 | Bevacizumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| Gecacitinib | Drug | Part 1: Cohort A：Gecacitinib is administered continuously until the end of treatment; Cohort B：Gecacitinib is administered continuously from CnD1 to D14, and discontinued from CnD15 to D21；Part 2：Gecacitinib for dose exploratory stage will commence after the Recommended Phase 2 Dose (RP2D) is determined during the dose escalation stage. |
|
| Bevacizumab | Biological | Bevacizumab 7.5 mg/kg，intravenous infusion(IV), once every 3 weeks (Q3W) |
|
| D009369 |
| Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |