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This is a multicenter, open-label phase I/II study for the first-line treatment of advanced cervical cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1: Dose Escalation | Experimental | Part 1 is a dose escalation study of ZG005 combined with paclitaxel and platinum-based ± bevacizumab to evaluate the tolerability and safety of the combination regimen |
|
| Part 2: Dose Expansion | Experimental | Part 2 is a dose expansion study to further evaluate the initial efficacy and safety of the combination regimen |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ZG005 Powder for Injection | Drug | ZG005 for dose escalations are set as 10 mg/kg, 15 mg/kg and other doses after discussion, intravenous infusion(IV), once every 3 weeks (Q3W). ZG005 for dose-expansion stage will commence after the Recommended Phase 2 Dose (RP2D) is determined during the dose-escalation stage. |
| Measure | Description | Time Frame |
|---|---|---|
| Dose Limiting Toxicity (DLT) | Up to 2 years | |
| Objective Response Rate (ORR) | ORR was defined as the percentage of the participants in the analysis population who have a Complete Response or a Partial Response. The ORR per RECIST 1.1 as assessed by Investigator is presented. | Up to 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yongsheng Chu | Contact | +8651257309965 | 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 | Zhejiang | Hangzhou | 310022 | China |
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|
|
| Paclitaxel | Drug | IV infusion |
|
| Bevacizumab | Biological | IV infusion |
|
| Cisplatin | Drug | IV infusion |
|
| Carboplatin | Drug | IV infusion |
|
| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| 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 |
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| ID | Term |
|---|---|
| D007267 | Injections |
| D017239 | Paclitaxel |
| D000068258 | Bevacizumab |
| D002945 | Cisplatin |
| D016190 | Carboplatin |
| ID | Term |
|---|---|
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D056831 | Coordination Complexes |
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