Cervical CancerPhase 2NCT06226350
A Phase Ⅱ Study of F520 in Patients With Cervical Carcinoma
A Phase 2 study testing Recombinant Humanized Anti-PD-1 Monoclonal Antibody Injection in people with Cervical Cancer, run by Shandong New Time Pharmaceutical Co., LTD at 1 site in China.
Trial summary
This study was an open, single-arm, enriched, multicenter Phase II study. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cervical Cancer
- What is being tested?
- Recombinant Humanized Anti-PD-1 Monoclonal Antibody Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteChina
- Study dates
- 4 Mar 2021to 3 Jan 2024
- Phase
- Phase 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women aged 18 years and above;
- Cervical squamous cell carcinoma, adenosquamous cell carcinoma or adenocarcinoma confirmed by histopathology;
- Patients with advanced (stage IVb) cervical cancer that is inoperable and/or radiotherapy-resistant, or patients with persistent, recurrent or metastatic cervical cancer that progresses after first-line or above chemotherapy;
- According to RECIST1.1 criteria, subjects must have at least one measurable target lesion examined by enhanced CT and/or enhanced MRI (non-lymph node diameter ≥10mm, or lymph node lesion diameter ≥15mm);
- Expected survival ≥3 months;
- Those with 0-2 scores on the American Eastern Oncology Collaboration Group (ECOG) scale;
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- Those who agree to provide archived tumor tissue samples or fresh tissue samples;
- The function of vital organs meets the following requirements (drugs with blood components and cell growth factors are not allowed to be used within 14 days before the first administration) :
- Blood routine: Absolute neutrophil count ≥1.5×109/L; Platelet ≥75×109/L; Hemoglobin ≥90g/L; Liver function: TBIL≤1.5×ULN, ALT and AST≤2.5×ULN; If liver metastasis was present, TBIL≤3×ULN, ALT and AST≤5×ULN; Renal function: serum creatinine (Cr) ≤1.5×ULN; Thyroid stimulating hormone (TSH) in the normal range; If TSH is abnormal, free triiodothyronine (FT3) and free thyroxine (FT4) must be normal or abnormal without clinical significance.
- International Normalized ratio (INR) ≤1.5×ULN and activated partial thromboplastin time (APTT) ≤1.5×ULN.
Who cannot join
- Patients with specific pre-existing conditions such as active autoimmune disease, type 1 diabetes, hypothyroidism requiring hormone replacement, and severe mental illness;
- a history of other malignancies within the last 3 years, except locally curable cancers (limited to basal cell or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the breast);
- Patients with central nervous system metastasis with clinical symptoms;
- Previously treated with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibodies or any other antibody or drug targeting T-cell co-stimulation or immune checkpoint pathways;
- Immunosuppressive, systemic or local hormone therapy within 14 days prior to initial administration for immunosuppressive purposes (daily dose equivalent to prednisone \> 10mg of systemic corticosteroid);
- Active infection requiring systemic treatment or unexplained fever during screening or prior to initial dosing \> 38.5℃ (according to the investigators' judgment, patients with fever caused by tumors could be included in the group);
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- Patients receiving systemic tumor therapy with radiotherapy, chemotherapy, hormone therapy, surgery, targeted therapy or antibody drugs within 4 weeks before the first dose; Those who had been treated with monoclonal antibody coupled radionuclides or cytotoxins within 10 weeks prior to initial administration; The toxicity of previous anti-tumor therapy did not return to ≤ grade 1 (except hair loss);
- Those who have had previous organ transplantation or received autologous stem cell transplantation within 3 months before the first administration;
- infected with active tuberculosis;
- suffering from interstitial lung disease (except for interstitial lung disease caused by radiotherapy and chemotherapy and currently asymptomatic);
- Active hepatitis;
- HIV antibody positive;
- have been treated with any other investigational drug/device within 4 weeks prior to initial dosing;
- Have uncontrolled or severe cardiovascular disease, such as New York Heart Association (NYHA) Class II or above congestive heart failure, unstable angina, myocardial infarction and other cardiovascular disease within 6 months before the first dose; Difficult to control hypertension (systolic blood pressure ≥180mmHg and/or diastolic blood pressure ≥100mmHg);
- Those who have a history of drug abuse or alcoholism within 6 months before the first dose;
- Known patients with previous macromolecular protein preparations, or known anti-PD-1 /PD-L1 antibodies;
- Those who received live attenuated vaccine within 4 weeks prior to the first dose (except inactivated influenza vaccines such as injectable seasonal influenza vaccine);
- Pregnant or lactating women, women who planned to become pregnant during the study period and within 6 months after the last dose, and who did not wish to use a medically approved effective contraceptive method (such as an IUD or condom) during the trial period;
- Those who were judged not suitable for inclusion by the researchers.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open, Single-arm, Multicenter Phase II Trial of Efficacy and Safety of F520 Monotherapy in the Treatment of Advanced, Persistent, Recurrent, or Metastatic Cervical Cancer
This study was an open, single-arm, enriched, multicenter Phase II study.
Read the detailed description
The trial was divided into screening period, treatment period and follow-up period. Participants entered the screening period after signing informed consent and met the inclusion criteria. Subjects who did not meet the exclusion criteria were treated with F520 monotherapy, intravenously, at 3mg/kg every 3 weeks until disease progression or intolerable toxicity or withdrawal for other reasons, for a maximum of 2 years.
- Conditions
- Cervical Cancer
- Being tested
- Recombinant Humanized Anti-PD-1 Monoclonal Antibody Injection
- 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.
Recombinant Humanized Anti-PD-1 Monoclonal Antibody InjectionDrug
F520,IV, 3mg/kg every 3 weeks, for up to 2 years until disease progression, intolerable toxic reactions, or termination of treatment for other reasons.
| Study group | Role | What they receive |
|---|---|---|
| F520 monotherapy | Experimental | Not described Receives: Drug: Recombinant Humanized Anti-PD-1 Monoclonal Antibody Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective tumor response rate (ORR) assessed by RECIST1.1
CR+PR
Measured: approximately 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2024
- Study start4 Mar 2021
- Primary completion5 Dec 2023
- Study completion3 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- More trials run by Shandong New Time Pharmaceutical 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shandong New Time Pharmaceutical Co., LTD
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- QI ZHOU, MD, Principal investigator, Chongqing University Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06226350
- Sponsor's protocol ID
- NTP-F520-005
- Status last verified
- Jan 2024
- First submitted
- 17 Jan 2024
- Last updated
- 26 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open, Single-arm, Multicenter Phase II Trial of Efficacy and Safety of F520 Monotherapy in the Treatment of Advanced, Persistent, Recurrent, or Metastatic Cervical Cancer
- ClinicalTrials.gov ID
- NCT06226350
- Acronym / sponsor ID
- NTP-F520-005
- Conditions
- Cervical Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Shandong New Time Pharmaceutical Co., LTDIndustry (pharma, biotech, devices)
- Study start
- 4 Mar 2021 (actual)
- Primary completion
- 5 Dec 2023 (actual)
- Study completion
- 3 Jan 2024 (actual)
- First posted
- 26 Jan 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 study was an open, single-arm, enriched, multicenter Phase II study.
Detailed description
The trial was divided into screening period, treatment period and follow-up period. Participants entered the screening period after signing informed consent and met the inclusion criteria. Subjects who did not meet the exclusion criteria were treated with F520 monotherapy, intravenously, at 3mg/kg every 3 weeks until disease progression or intolerable toxicity or withdrawal for other reasons, for a maximum of 2 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| F520 monotherapy | Experimental | Drug: Recombinant Humanized Anti-PD-1 Monoclonal Antibody Injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Women aged 18 years and above;
- Cervical squamous cell carcinoma, adenosquamous cell carcinoma or adenocarcinoma confirmed by histopathology;
- Patients with advanced (stage IVb) cervical cancer that is inoperable and/or radiotherapy-resistant, or patients with persistent, recurrent or metastatic cervical cancer that progresses after first-line or above chemotherapy;
- According to RECIST1.1 criteria, subjects must have at least one measurable target lesion examined by enhanced CT and/or enhanced MRI (non-lymph node diameter ≥10mm, or lymph node lesion diameter ≥15mm);
- Expected survival ≥3 months;
Key exclusion criteria (19 listed)
- Patients with specific pre-existing conditions such as active autoimmune disease, type 1 diabetes, hypothyroidism requiring hormone replacement, and severe mental illness;
- a history of other malignancies within the last 3 years, except locally curable cancers (limited to basal cell or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the breast);
- Patients with central nervous system metastasis with clinical symptoms;
- Previously treated with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibodies or any other antibody or drug targeting T-cell co-stimulation or immune checkpoint pathways;
- Immunosuppressive, systemic or local hormone therapy within 14 days prior to initial administration for immunosuppressive purposes (daily dose equivalent to prednisone \> 10mg of systemic corticosteroid);
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 |
|---|---|---|
| Recombinant Humanized Anti-PD-1 Monoclonal Antibody InjectionF520,IV, 3mg/kg every 3 weeks, for up to 2 years until disease progression, intolerable toxic reactions, or termination of treatment for other reasons. | Drug | F520 monotherapy |
Primary outcome
Objective tumor response rate (ORR) assessed by RECIST1.1
Time frame: approximately 2 years
CR+PR
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2024.
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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.
QI ZHOU, MD principal investigator
Chongqing University Cancer Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Recombinant Humanized Anti-PD-1 Monoclonal Antibody Injection in people with Cervical Cancer, run by Shandong New Time Pharmaceutical 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 10 inclusion and 19 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: finished, as of the sponsor's last update on 26 Jan 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 phase mean?
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective tumor response rate (ORR) assessed by RECIST1.1 (time frame: approximately 2 years). 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 26 Jan 2024.