Cervical CancerPhase 2NCT06769152
A Phase II Clinical Study to Evaluate the Efficacy and Safety of HLX43 (Anti-PD-L1 ADC) in Patients With Advanced Gynecological Malignant Tumors
A Phase 2 study testing HLX43 in people with Cervical Cancer and Ovarian Cancer, run by Shanghai Henlius Biotech at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Cervical Cancer, Ovarian Cancer
- What is being tested?
- HLX43
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 190 participants
- Where
- 1 siteChina
- Study dates
- 20 Feb 2025to 5 Jun 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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, fallopian tube, or primary peritoneal cancer.
- 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 combination with immune checkpoint inhibitor (ICI) therapy; for patients with PD-L1 expression negative [CPS<1], the standard therapy is defined as platinum-based chemotherapy), or intolerability toxicity (CTCAE≥3 adverse events), or contraindications to standard therapy.
- Cohort 2: Ovarian cancer patients with platinum-resistant disease: If the patient has previously received only first-line platinum-based chemotherapy, platinum resistance is defined as having received at least 4 cycles of platinum-based chemotherapy, with the tumor showing a response to platinum-based chemotherapy (best tumor assessment being complete remission/partial remission), and the time from the last platinum-based chemotherapy to tumor progression being >3 months and ≤6 months. If the patient has previously received multiple lines of platinum-based chemotherapy, platinum resistance is defined as disease progression occurring during the last line of platinum-based chemotherapy treatment or within 6 months after the last platinum-based chemotherapy.
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- 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. There should be at least a 2-week interval from the previous small molecule targeted therapy, at least a 1-week interval from traditional Chinese medicine treatment with antitumor indications or minor surgery. Additionally, treatment-related adverse events (AEs) should have recovered to NCI-CTCAE grade ≤ 1 (except for grade 2 peripheral neurotoxicity and alopecia)；
- 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 colony-stimulating factor)；
- Female subjects 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 subjects of childbearing potential must have a negative pregnancy test within 7 days prior to enrollment.
Who cannot join
- History of any second malignant tumor within the first 2 years prior to randomization;
- Subjects 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 leading to clinical severe respiratory impairment;
- Subjects 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) < 50%; (2) unstable angina; (3) myocardial infarction or cerebrovascular accident within the last 6 months (excluding lacunar infarction, minor ischemic stroke, or transient ischemic attack); (4) uncontrolled arrhythmias (including QTc interval ≥ 450 ms for males, ≥ 470 ms for females) (QTc interval calculated by Fridericia's formula); (5) poorly controlled hypertension (systolic blood pressure > 150 mmHg and/or diastolic blood pressure > 100 mmHg despite active treatment);
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- 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 diabetes mellitus receiving insulin therapy are also allowed to participate in the study;
- 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 topical, ophthalmic, intra-articular, intranasal, and inhaled corticosteroids; short-term use of corticosteroids for prophylactic treatment during situations such as the use of contrast agents;
- 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 inhibitors as toxins.
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shandong Cancer Hospital
Ji'nan, Shandong
Jinming Yu, Dr., Shandong Cancer Hospital, sdyujinming@126.com
Jinming Yu, Dr.
About this study
Official title: A Phase II Clinical Study to Evaluate the Efficacy and Safety of HLX43 (Anti-PD-L1 ADC) in Patients With Recurrent/Metastatic Gynecological Malignant Tumors Failed or Intolerance to Standard First-Line Therapy
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.
Read the detailed description
This study is an open-label phase II clinical study to explore the reasonable dosage and evaluate the efficacy, safety and tolerability of HLX43 (Anti-PD-L1 ADC) in patients with recurrent/metastatic cervical or ovarian cancer failed or intolerance to standard first-line therapy.
In this study, eligible subjects will be randomized at 1:1:1 ratio, and the patients will be administered with HLX43 at different doses via intravenous infusion.
- Conditions
- Cervical Cancer, Ovarian Cancer
- Being tested
- HLX43
- Medical subject headings
- Uterine Cervical Neoplasms, Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HLX43Drug
HLX43 is an anti-PD-L1 monoclonal antibody conjugated with a novel high potency DNA topoisomerase I (topo I) inhibitor, with a drug-antibody-ratio (DAR) of 8.
| Study group | Role | What they receive |
|---|---|---|
| HLX43 2.0mg/kg | Experimental | every 3 weeks (Q3W) Receives: Drug: HLX43 |
| HLX43 2.5mg/kg | Experimental | every 3 weeks (Q3W) Receives: Drug: HLX43 |
| HLX43 3.0mg/kg | Experimental | every 3 weeks (Q3W) Receives: Drug: HLX43 |
| HLX43 3.0mg/kg loading dose | Experimental | every 3 weeks (Q3W) Receives: Drug: HLX43 |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR
Objective response rate (ORR) (assessed by INV according to the RECIST v1.1 criteria)
Measured: up to 24 week
PFS
Defined as the time (in months) from randomization to the first confirmed and documented progressive disease or death (whichever occurs first) as assessed by INV according to the RECIST v1.1 criteria.
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 14 months
Secondary outcomes (4)
ORR
Objective response rate (ORR) (assessed by the IRRC according to the RECIST v1.1 criteria)
Measured: up to 24 weeks
PFS
Defined as the time (in months) from randomization to the first confirmed and documented progressive disease or death (whichever occurs first) as assessed by the IRRC according to the RECIST v1.1 criteria.
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 14 months
OS
Overall Survival
Measured: From randomization to death from any cause (up to approximately 36 months)
Incidence and severity of adverse events (AEs)
severity determined according to National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] Version [v] 5.0
Measured: time from the date of the first dose of study drug until the date of death from any cause, assessed up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2025
- Study start20 Feb 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion5 Jun 2027 (estimated)
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 Shanghai Henlius BiotechThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 190 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Henlius Biotech
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jinming Yu, Dr., Principal investigator, Shandong Cancer Hospital and Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06769152
- Sponsor's protocol ID
- HLX43-CC201
- Status last verified
- Apr 2026
- First submitted
- 7 Jan 2025
- Last updated
- 22 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Clinical Study to Evaluate the Efficacy and Safety of HLX43 (Anti-PD-L1 ADC) in Patients With Recurrent/Metastatic Gynecological Malignant Tumors Failed or Intolerance to Standard First-Line Therapy
- ClinicalTrials.gov ID
- NCT06769152
- Acronym / sponsor ID
- HLX43-CC201
- Conditions
- Cervical Cancer, Ovarian Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 190 participants (estimated)
- Lead sponsor
- Shanghai Henlius BiotechIndustry (pharma, biotech, devices)
- Study start
- 20 Feb 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 5 Jun 2027 (estimated)
- First posted
- 10 Jan 2025 (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.
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.
Detailed description
This study is an open-label phase II clinical study to explore the reasonable dosage and evaluate the efficacy, safety and tolerability of HLX43 (Anti-PD-L1 ADC) in patients with recurrent/metastatic cervical or ovarian cancer failed or intolerance to standard first-line therapy.
In this study, eligible subjects will be randomized at 1:1:1 ratio, and the patients will be administered with HLX43 at different doses via intravenous infusion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| HLX43 2.0mg/kg | Experimental | Drug: HLX43every 3 weeks (Q3W) |
| HLX43 2.5mg/kg | Experimental | Drug: HLX43every 3 weeks (Q3W) |
| HLX43 3.0mg/kg | Experimental | Drug: HLX43every 3 weeks (Q3W) |
| HLX43 3.0mg/kg loading dose | Experimental | Drug: HLX43every 3 weeks (Q3W) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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, fallopian tube, or primary peritoneal cancer.
- 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 combination with immune checkpoint inhibitor (ICI) therapy; for patients with PD-L1 expression negative [CPS<1], the standard therapy is defined as platinum-based chemotherapy), or intolerability toxicity (CTCAE≥3 adverse events), or contraindications to standard therapy.
Key exclusion criteria (18 listed)
- History of any second malignant tumor within the first 2 years prior to randomization;
- Subjects 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 leading to clinical severe respiratory impairment;
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 |
|---|---|---|
| HLX43HLX43 is an anti-PD-L1 monoclonal antibody conjugated with a novel high potency DNA topoisomerase I (topo I) inhibitor, with a drug-antibody-ratio (DAR) of 8. | Drug | HLX43 2.0mg/kg, HLX43 2.5mg/kg, HLX43 3.0mg/kg, HLX43 3.0mg/kg loading dose |
Primary outcome
ORR
Time frame: up to 24 week
Objective response rate (ORR) (assessed by INV according to the RECIST v1.1 criteria)
PFS
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 14 months
Defined as the time (in months) from randomization to the first confirmed and documented progressive disease or death (whichever occurs first) as assessed by INV according to the RECIST v1.1 criteria.
4 secondary outcomes
ORR
Time frame: up to 24 weeks
PFS
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 14 months
OS
Time frame: From randomization to death from any cause (up to approximately 36 months)
Incidence and severity of adverse events (AEs)
Time frame: time from the date of the first dose of study drug until the date of death from any cause, assessed up to 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2026.
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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.
Jinming Yu, Dr. principal investigator
Shandong Cancer Hospital and Institute
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 HLX43 in people with Cervical Cancer and Ovarian Cancer, run by Shanghai Henlius Biotech 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 13 inclusion and 18 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: looking for participants now, as of the sponsor's last update on 22 Apr 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jinming Yu, Dr. (0531-67626971, sdyujinming@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ORR (time frame: up to 24 week). 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 22 Apr 2026.