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Tests treatment safety and results for Cervical Cancer
Official title A Phase II Clinical Study to Evaluate the Efficacy and Safety of HLX43 (Anti-PD-L1 ADC) in Patients With Advanced Gynecological Malignant Tumors
ClinicalTrials.gov ID: NCT06769152
What this study is testing
What is HLX43?
HLX43 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for cervical cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study is being conducted to explore the reasonable dosage and evaluate the efficacy, safety and tolerability of HLX43 (Anti-PD-L1 ADC) in patients with recurrent/metastatic cervical cancer or ovarian cancer failed or intolerance to standard first-line therapy.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75, women only
You may be able to join if
- Volunteer to participate in clinical research; To fully understand and understand this study and to sign the Informed Consent Form (ICF); Willing to...
- The age of signing ICF is ≥ 18 years old and ≤ 75 years old;
- Cohort 1: Metastatic or recurrent cervical cancer including squamous cell, adenocarcinoma or adenosquamous histology confirmed by histopathology or...
- Cohort 1: Previous failure or progression of standard systemic therapy for cervical cancer (For patients with PD-L1 expression positive [CPS≥1], the...
- Within 4 weeks prior to the first administration of the medication, at least one measurable target lesion must be evaluated according to the RECIST...
You likely can't join if
- History of any second malignant tumor within the first 2 years prior to randomization;
- people who are preparing for or have previously received an organ or bone marrow transplant;
- Symptomatic, untreated, or progressively worsening central nervous system (CNS) or leptomeninges metastases;
- After appropriate intervention, uncontrollable pleural effusion, pericardial effusion or ascites still need to be drained frequently;
- Present with grade ≥1 radiation pneumonia as defined by RTOG/EORTC; A history of interstitial lung disease (ILD) or imaging findings during screening...
- people exhibit poorly controlled cardiovascular clinical symptoms or diseases, including but not limited to: (1) NYHA class II or above heart...
See the full eligibility criteria
- Volunteer to participate in clinical research; To fully understand and understand this study and to sign the Informed Consent Form (ICF); Willing to follow and able to complete all test procedures;
- The age of signing ICF is ≥ 18 years old and ≤ 75 years old;
- Cohort 1: Metastatic or recurrent cervical cancer including squamous cell, adenocarcinoma or adenosquamous histology confirmed by histopathology or cytology. Cohort 2: Histologically confirmed high-grade serous ovarian...
- Cohort 1: Previous failure or progression of standard systemic therapy for cervical cancer (For patients with PD-L1 expression positive [CPS≥1], the standard therapy is defined as platinum-based chemotherapy in...
- Within 4 weeks prior to the first administration of the medication, at least one measurable target lesion must be evaluated according to the RECIST v1.1 criteria;
- Tumor tissue should be provided as much as possible for an evaluable PD-L1 expression result at Screening period；
- Before the initial administration of the study drug, there should be at least a 3-week interval or 5 times the half-life of the last cytotoxic chemotherapy, immunotherapy, or biological therapy, whichever is shorter...
- The ECOG physical performance score of 0-1 in the week prior to randomization；
- Expected survival ≥ 3 months；
- Laboratory tests within the previous week confirm adequate organ function (within 14 days prior to the first dose of medication, without receiving interventions such as blood transfusions or granulocyte...
- Female people of childbearing potential must agree to use at least one highly effective method of contraception during the trial and for at least 6 months after the last dose of the study drug. Female people of...
- History of any second malignant tumor within the first 2 years prior to randomization;
- people who are preparing for or have previously received an organ or bone marrow transplant;
- Symptomatic, untreated, or progressively worsening central nervous system (CNS) or leptomeninges metastases;
- After appropriate intervention, uncontrollable pleural effusion, pericardial effusion or ascites still need to be drained frequently;
- Present with grade ≥1 radiation pneumonia as defined by RTOG/EORTC; A history of interstitial lung disease (ILD) or imaging findings during screening that suggest such disease is suspected; Or there are lung diseases...
- people exhibit poorly controlled cardiovascular clinical symptoms or diseases, including but not limited to: (1) NYHA class II or above heart failure, or left ventricular ejection fraction (LVEF) \ 150 mmHg and/or...
- Previous occurrence of adverse events leading to permanent discontinuation of immunotherapy; or A history of ≥ Grade 2 immune-related pneumonia or myocarditis;
- Active or suspected autoimmune disease. Patients with autoimmune-related hypothyroidism who are undergoing thyroid hormone replacement therapy are permitted to participate in the study; patients with controlled Type 1...
- Received systemic corticosteroids (prednisone \>10 mg/day or an equivalent dose of similar drugs) or other immunosuppressive treatments within 14 days prior to the first dose; with the following exceptions: use of...
- Within the 2 weeks prior to randomization, there is the presence of an active systemic infectious disease requiring intravenous antibiotic treatment;
- Live vaccinations or attenuated live vaccinations should not be administered within 4 weeks prior to the initial dosing. Administration of inactivated viral vaccines for seasonal influenza is permitted;
- Used strong inhibitors or strong inducers of CYP2D6 or CYP3A within 2 weeks prior to randomization;
- Known history of severe allergic reactions to macromolecular protein preparations/monoclonal antibodies, or allergy to components of the trial drug formulation; Previously received ADC drugs with topoisomerase I...
- Active tuberculosis;
- Human immunodeficiency virus (HIV) infection;
- Active Hepatitis B or Hepatitis C virus (HBV or HCV) infection or HBV/HCV co-infection;
- Pregnant or lactating women;
- The researcher deems that the subject has any other factors that make them unsuitable for participation in this trial.
The study team makes the final eligibility decision.
Where it's taking place
- Ji'nan, Shandong, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Ji'nan, Shandong, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.