A Phase 3 interventional study of JSKN033 and Docetaxel in Recurrent or Metastatic Cervical Cancer, sponsored by Jiangsu Alphamab Biopharmaceuticals Co., Ltd. Not yet recruiting at 2 sites in China. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-01.
Sponsored by Jiangsu Alphamab Biopharmaceuticals Co., Ltd (part of Alphamab Oncology) · Phase 3, Interventional, and Treatment
This study is a randomized, open-label, controlled, phase III study to evaluate the efficacy and safety of JSKN033 versus investigator's choice of chemotherapy in patients with recurrent or metastatic cervical cancer who have failed platinum-based chemotherapy and PD-1/L1 inhibitor therapy.
2,366 studies on the registry are indexed under Uterine Cervical Neoplasms; 677 are open to participants now.
This study's planned enrollment of 368 is above the median of 100 across 1,738 interventional studies indexed under Uterine Cervical Neoplasms.
Browse Uterine Cervical Neoplasms studies →Jiangsu Alphamab Biopharmaceuticals Co., Ltd is the lead sponsor of 38 studies on the registry; 16 are open to participants now.
Compared within Uterine Cervical Neoplasms, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Recurrence. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CTCAE grade
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
JSKN033
Drug: JSKN033
Investigator's Choice of Chemotherapy: Docetaxel, Topotecan, Gemcitabine or Pemetrexed.
Drug: Docetaxel · Drug: Topotecan · Drug: Gemcitabine (GEM) · Drug: Pemetrexed
JSKN033 should be administered subcutaneously
Docetaxel
Topotecan
Gemcitabine
Pemetrexed
Progression-free Survival (PFS) assessed by Blinded Independent Review Committee (BIRC) as per RECIST 1.1
PFS was defined as the time from randomization until the date of progressive disease or death, whichever occurred first
Time frame: Up to approximately 27 months
Overall Survival (OS)
OS was defined as the time from randomization until the date of death from any cause
Time frame: Up to approximately 27 months
Overall Response Rate (ORR) evaluated by BIRC as per RECIST 1.1
ORR was defined as the proportion of subjects achieving Complete Response (CR) or Partial Response (PR)
Time frame: Up to approximately 27 months
Duration of Response (DoR) evaluated by BIRC as per RECIST 1.1
DOR was defined as the time from CR/PR to PD or death from any cause, whichever occurs first
Time frame: Up to approximately 27 months
Disease Control Rate (DCR) evaluated by BIRC as per RECIST 1.1
DCR was defined as the proportion of subjects whose best overall response is CR, PR, or Stable Disease (SD)
Time frame: Up to approximately 27 months
PFS evaluated by the Investigator as per RECIST 1.1
PFS was defined as the time from randomization until the date of progressive disease or death, whichever occurred first
Time frame: Up to approximately 27 months
ORR evaluated by the Investigator as per RECIST 1.1
ORR was defined as the proportion of subjects achieving Complete Response (CR) or Partial Response (PR)
Time frame: Up to approximately 27 months
DoR evaluated by the Investigator as per RECIST 1.1
DOR was defined as the time from CR/PR to PD or death from any cause, whichever occurs first
Time frame: Up to approximately 27 months
DCR evaluated by the Investigator as per RECIST 1.1
DCR was defined as the proportion of subjects whose best overall response is CR, PR, or Stable Disease (SD)
Time frame: Up to approximately 27 months
Number and Severity of Treatment-emergent Adverse Events (TEAEs)
The incidence and severity of TEAEs and TRAEs (Treatment-related Adverse Events, graded according to NCI CTCAE 5.0), Serious AEs (SAEs), laboratory tests, etc.
Time frame: Up to approximately 27 months
Patient-reported Quality of Life-European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)
Patient-reported quality-of-life assessments using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30). All scores are transformed to a 0-100 scale. Higher scores represent better function/global quality-of-life status for functional and global health scales, and worse symptom burden for symptom scales.
Time frame: Up to approximately 27 months
Patient-reported Quality of Life- European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Cervical Cancer 24 (EORTC QLQ-CX24)
Patient-reported quality-of-life assessments using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Cervical Cancer 24 (EORTC QLQ-CX24). All scores are transformed to a 0-100 scale; higher scores indicate worse outcomes for symptom scales, except for sexual activity and sexual enjoyment items where higher scores indicate better outcomes.
Time frame: Up to approximately 27 months
Plasma Concentrations of JSKN003
Measurement of plasma concentrations of JSKN003.
Time frame: Up to approximately 27 months
Plasma Concentration of Total Antibody
Measurement of plasma concentration of total antibody.
Time frame: Up to approximately 27 months
Plasma Concentration of Free Payload
Measurement of plasma concentration of free payload.
Time frame: Up to approximately 27 months
Plasma Concentration of Envotumab
Measurement of plasma concentration of envotumab.
Time frame: Up to approximately 27 months
Incidence and Titer of Anti-Drug Antibodies
Assessment of the incidence and titer of anti-drug antibodies, as applicable.
Time frame: Up to approximately 27 months
Incidence and Titer of Neutralizing Antibodies
Assessment of the incidence and titer of neutralizing antibodies, as applicable.
Time frame: Up to approximately 27 months
Plan to share: Undecided
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This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: JSKN033
Jiangsu Alphamab Biopharmaceuticals Co., Ltd →