Cervical CarcinomaPhase 1/2NCT06241235
Study of ZG005 in Combination With Paclitaxel＋Platinum-based ± Bevacizumab in Patients With Advanced Cervical Carcinoma
A Phase 1/2 study testing ZG005 Powder for Injection, Paclitaxel and Bevacizumab in people with Cervical Carcinoma, run by Suzhou Zelgen Biopharmaceuticals Co.,Ltd at 1 site in China.
Trial summary
This is a multicenter, open-label phase I/II study for the first-line treatment of advanced cervical cancer. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Cervical Carcinoma
- What is being tested?
- ZG005 Powder for Injection, Paclitaxel and Bevacizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteChina
- Study dates
- 27 Mar 2024to May 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 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Fully understand the study and voluntarily sign the informed consent form.
- Female 18-70 years of age;
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or
- Life expectancy ≥ 3 months.
Who cannot join
- Patients were deemed unsuitable for participating in the study by the investigator for any reasons.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhejiang Cancer Hospital
Zhejiang, Hangzhou, 310022
Hanmei Lou
About this study
Official title: A Phase I/II Study to Evaluate Safety and Pharmacokinetics and Initial Efficacy of ZG005 in Combination With Paclitaxel Plus Cisplatin/Carboplatin ± Bevacizumab in Patients With Advanced Cervical Carcinoma
This is a multicenter, open-label phase I/II study for the first-line treatment of advanced cervical cancer.
- Conditions
- Cervical Carcinoma
- Being tested
- ZG005 Powder for Injection, Paclitaxel, Bevacizumab, Cisplatin, Carboplatin
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZG005 Powder for InjectionDrug
Also called ZG005
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.
PaclitaxelDrug
IV infusion
BevacizumabBiological
IV infusion
CisplatinDrug
IV infusion
CarboplatinDrug
IV infusion
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: ZG005 Powder for Injection; Drug: Paclitaxel; Biological: Bevacizumab; Drug: Cisplatin; Drug: Carboplatin |
| Part 2: Dose Expansion | Experimental | Part 2 is a dose expansion study to further evaluate the initial efficacy and safety of the combination regimen Receives: Drug: ZG005 Powder for Injection; Drug: Paclitaxel; Biological: Bevacizumab; Drug: Cisplatin; Drug: Carboplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose Limiting Toxicity (DLT)
Measured: 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.
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2024
- Study start27 Mar 2024
- Primary completionMay 2026 (estimated)
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical CarcinomaStudies of the same condition, open and under way.
- More trials run by Suzhou Zelgen Biopharmaceuticals Co.,LtdThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Suzhou Zelgen Biopharmaceuticals Co.,Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jason Wu, Study chair, Suzhou Zelgen Biopharmaceuticals Co.,Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06241235
- Sponsor's protocol ID
- ZG005-003
- Status last verified
- Mar 2024
- First submitted
- 26 Jan 2024
- Last updated
- 2 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Study to Evaluate Safety and Pharmacokinetics and Initial Efficacy of ZG005 in Combination With Paclitaxel Plus Cisplatin/Carboplatin ± Bevacizumab in Patients With Advanced Cervical Carcinoma
- ClinicalTrials.gov ID
- NCT06241235
- Acronym / sponsor ID
- ZG005-003
- Conditions
- Cervical Carcinoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Suzhou Zelgen Biopharmaceuticals Co.,LtdIndustry (pharma, biotech, devices)
- Study start
- 27 Mar 2024 (actual)
- Primary completion
- May 2026 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 5 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multicenter, open-label phase I/II study for the first-line treatment of advanced cervical cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part 1: Dose Escalation | Experimental | Drug: ZG005 Powder for Injection, Drug: Paclitaxel, Biological: Bevacizumab, Drug: Cisplatin, Drug: CarboplatinPart 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 | Drug: ZG005 Powder for Injection, Drug: Paclitaxel, Biological: Bevacizumab, Drug: Cisplatin, Drug: CarboplatinPart 2 is a dose expansion study to further evaluate the initial efficacy and safety of the combination regimen |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Fully understand the study and voluntarily sign the informed consent form.
- Female 18-70 years of age;
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or
- Life expectancy ≥ 3 months.
Key exclusion criteria (1 listed)
- Patients were deemed unsuitable for participating in the study by the investigator for any reasons.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ZG005 Powder for InjectionAlso: ZG005ZG005 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. | Drug | Part 1: Dose Escalation, Part 2: Dose Expansion |
| PaclitaxelIV infusion | Drug | Part 1: Dose Escalation, Part 2: Dose Expansion |
| BevacizumabIV infusion | Biological | Part 1: Dose Escalation, Part 2: Dose Expansion |
| CisplatinIV infusion | Drug | Part 1: Dose Escalation, Part 2: Dose Expansion |
| CarboplatinIV infusion | Drug | Part 1: Dose Escalation, Part 2: Dose Expansion |
Primary outcome
Dose Limiting Toxicity (DLT)
Time frame: Up to 2 years
Objective Response Rate (ORR)
Time frame: Up to 2 years
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jason Wu study chair
Suzhou Zelgen Biopharmaceuticals Co.,Ltd
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing ZG005 Powder for Injection, Paclitaxel and Bevacizumab in people with Cervical Carcinoma, run by Suzhou Zelgen Biopharmaceuticals 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 4 inclusion and 1 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 2 Apr 2024. 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?
Contact Yongsheng Chu (+8651257309965, chuys@zelgen.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose Limiting Toxicity (DLT) (time frame: Up to 2 years). 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?
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 2 Apr 2024.