Recurrent Cervical CancerPhase 2NCT07172217
The Efficacy and Safety RC48 Plus QL1706 in Second-Line Treatment of HER2-Expressing Recurrent CC
A Phase 2 study testing RC48 and QL1706 in people with Recurrent Cervical Cancer, run by Qilu Hospital of Shandong University at 1 site in China.
Trial summary
This is a single-arm study. The efficacy and safety of Disitamab Vedotin combined with Apalutamide and Toripalimab in the second-line treatment of HER2-expressing recurrent cervical cancer are evaluated based on the following indicators: Primary evaluation indicator: Objective Response Rate (ORR) Secondary evaluation… Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Recurrent Cervical Cancer
- What is being tested?
- RC48 and QL1706
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2025to 31 Dec 2028
- 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
- Voluntarily enroll in the study and sign a written informed consent form;
- Female patients aged 18 to 75 years (inclusive);
- Histologically or cytologically confirmed primary cervical squamous cell carcinoma, adenocarcinoma, adenosquamous carcinoma, or small cell (neuroendocrine) cervical cancer;
- Progressive disease or recurrent disease after first-line treatment for recurrent cervical cancer;
- Subjects can provide tumor specimens (paraffin blocks, formalin-fixed paraffin-embedded [FFPE] sections, or fresh tissue sections) from the primary or metastatic site for HER2 detection, with HER2 immunohistochemistry (IHC) test results of IHC 1+, 2+, or 3+ (previous test results confirmed by the investigator are also acceptable);
- Presence of at least one evaluable lesion (per RECIST 1.1 criteria);
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- Expected survival time ≥ 6 months;
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0 to 1;
- For female patients of childbearing potential (i.e., premenopausal or not surgically sterilized), the serum pregnancy test result within 7 days before the first administration of the study drug must be negative; and reliable contraceptive measures must be used during the study drug administration period and within 60 days after the last dose;
- Normal function of major organs, meeting the following criteria:
- Left ventricular ejection fraction (LVEF) ≥ 50%; Hemoglobin (Hb) ≥ 9 g/dL; Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L; Platelets (PLT) ≥ 100 × 10⁹/L; Serum total bilirubin (TBIL) ≤ 1.5 × upper limit of normal (ULN); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN in the absence of liver metastasis, and ALT and AST ≤ 5 × ULN in the presence of liver metastasis; Serum creatinine (Scr) ≤ 1.5 × ULN, or creatinine clearance (CrCl) ≥ 40 mL/min calculated by the Cockcroft-Gault formula.
Who cannot join
- History of malignant tumors other than cervical cancer, except for the following two situations:
- Patients who have received potentially curative treatment and have no evidence of the disease for 5 years;
- Basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, cervical carcinoma in situ, and other carcinoma in situ that have been successfully treated with resection;
- Previous allogeneic stem cell or solid organ transplantation;
- Previous systemic anti-tumor therapy (including traditional Chinese medicine with anti-tumor indications) completed less than 4 weeks before the first administration of the study drug, or patients whose adverse events caused by previous treatment have not recovered to ≤ Grade 1 according to the Common Terminology Criteria for Adverse Events (CTCAE) (except for alopecia and pigmentation);
- Vaccination with live vaccines within 4 weeks before the start of study drug administration, or planned receipt of any vaccines (except COVID-19 vaccines) during the study period;
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- Previous or current history of congenital or acquired immunodeficiency diseases;
- Previous treatment with other antibody-drug conjugates (ADCs);
- Patients with known or suspected history of allergy to recombinant humanized anti-HER2 monoclonal antibody-MMAE conjugates and anti-PD-1 drugs of the same class, or history of hypersensitivity to chimeric/humanized antibodies or fusion proteins, or allergy to the excipients of the study drug;
- Other significant clinical and laboratory abnormalities that the investigator deems may affect safety evaluation, such as uncontrolled diabetes mellitus, chronic kidney disease, peripheral neuropathy of Grade 2 or higher (per CTCAE V5.0), abnormal thyroid function, etc.;
- Heart failure of New York Heart Association (NYHA) Class 3 or higher;
- Severe infection in active stage or with poor clinical control; active infections include:
- Positive for human immunodeficiency virus (HIV) (HIV1/2 antibodies);
- Active hepatitis B (positive for hepatitis B surface antigen [HBsAg], or hepatitis B virus deoxyribonucleic acid [HBV DNA] > 2000 IU/ml with abnormal liver function);
- Active hepatitis C (positive for hepatitis C virus [HCV] antibodies, or HCV ribonucleic acid [HCV RNA] ≥ 10³ copies/ml with abnormal liver function);
- Active tuberculosis;
- Other uncontrolled active infections (Grade > 2 per CTCAE V5.0); Unrecovered from surgery (e.g., presence of unhealed surgical incisions or severe postoperative complications);
- Other circumstances deemed unsuitable for enrollment by the investigator.
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
Qilu Hospital of Shandong University
Ji'an, Shandong, 250000
Ying Zhao, 18560081925, ericdareway@163.com
About this study
Official title: Clinical Study on the Efficacy and Safety of Disitamab Vedotin Combined With Iparomlimab and Tuvonralimab in the Second-Line Treatment of HER2-Expressing Recurrent Cervical Cancer
This is a single-arm study. The efficacy and safety of Disitamab Vedotin combined with Apalutamide and Toripalimab in the second-line treatment of HER2-expressing recurrent cervical cancer are evaluated based on the following indicators:
Primary evaluation indicator: Objective Response Rate (ORR)
Secondary evaluation indicators:
Efficacy-related indicators: Progression-Free Survival (PFS), Disease Control Rate (DCR), Duration of Response (DOR), Overall Survival (including median Overall Survival [mOS] and 1-year, 2-year, 3-year Overall Survival rates) Safety-related indicators: Adverse Events (AEs) and Serious Adverse Events (SAEs).
Read the detailed description
This study is a multicenter, open-label, single-arm, exploratory trial. It enrolls 33 participants with recurrent cervical cancer who have HER2 expression (IHC 1+, 2+, or 3+). After eligible participants are enrolled, they will receive treatment with RC48 (dose: 2.5mg/kg, Q3W, intravenous infusion) in combination with QL1706 (dose: 5mg/kg, Q3W, intravenous infusion), with a treatment window of ±3 days. During the study, safety assessment and efficacy assessment will be conducted.
Safety Assessment For participants who have received at least one dose of the study drug, the safety assessment will start from the administration of the study drug. It will be performed before each drug administration, assessed once every 3 weeks (with a window of ±3 days), and continue until 30 days after the last dose of the study drug or the initiation of new anti-tumor treatment.
Efficacy Assessment Tumor assessment will be conducted in accordance with the Response Evaluation Criteria in Solid Tumors (RECIST v1.1). Starting from the administration of the study drug, assessments will be performed once every 6 weeks (with a window of ±3 days) until the occurrence of intolerable toxicity or radiologically confirmed disease progression.
For participants who experience disease progression or start other anti-tumor treatments, survival follow-up will be conducted once every 3 months (with a window of ±14 days) from the date of confirmation. Information on the participants' subsequent anti-tumor treatment and survival status will be collected until the participant's death, withdrawal of informed consent, loss to follow-up, study termination, whichever occurs first.
- Conditions
- Recurrent Cervical Cancer
- Being tested
- RC48, QL1706
- Keywords
- RC48;QL1706;HER2-Expressing;Recidivation; Cervical Cancer
- 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.
RC48Drug
Disitamab Vedotin (RC48) : 2.5 mg/kg, administered once every 3 weeks (Q3w), via intravenous infusion on Day 1 of each treatment cycle
QL1706Drug
Drug: QL1706 Iparomlimab and Tuvonralimab (QL1706) : 5 mg/kg in total, administered once every 3 weeks (Q3w), via intravenous infusion on Day 1 of each treatment cycle
| Study group | Role | What they receive |
|---|---|---|
| RC48 and QL1706 | Experimental | Not described Receives: Drug: RC48; Drug: QL1706 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR)
The proportion of subjects with complete response (CR) and partial response (PR) according RESIST 1.1 in total subjects.
Measured: 6 months after the last subject participating in
Secondary outcomes (4)
Progression-Free Survival
The time elapsed from the enrollment date to the first occurrence of either tumor progression or death from any cause.
Measured: Approximately 1 years after last participant enrollment.
disease control rate (DCR)
The proportion of subjects with complete response (CR) and partial response (PR) and stable disease(SD) in total subjects
Measured: Approximately 1 years after last participant enrollment.
duration of response (DOR)
The time from the date for first documented response of complete response (CR) or partial response (PR) to the date of first documented of disease progression or death, whichever occurs first.
Measured: The time from the start of treatment to the first observation of response (Complete Response [CR] or Partial Response [PR]) that is ultimately confirmed (typically via a subsequent reassessment at least 4 weeks later, per RECIST criteria).
overall survival (OS)
The time from the starting date of study drug to the date of death due to any cause.
Measured: Approximately 1 years after last participant enrollment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2025
- Study start1 Oct 2025 (estimated)
- Primary completion28 Feb 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Cervical CancerStudies of the same condition, open and under way.
- More trials run by Qilu Hospital of Shandong UniversityThe 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
- 33 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qilu Hospital of Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Li Peng, Qilu Hospital of Shandong University
- Investigators
- Peng Li, Principal investigator, Qilu Hospital of Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07172217
- Sponsor's protocol ID
- KYLL-202503-017-1
- Status last verified
- Sep 2025
- First submitted
- 28 Aug 2025
- Last updated
- 15 Sep 2025
- 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 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study on the Efficacy and Safety of Disitamab Vedotin Combined With Iparomlimab and Tuvonralimab in the Second-Line Treatment of HER2-Expressing Recurrent Cervical Cancer
- ClinicalTrials.gov ID
- NCT07172217
- Acronym / sponsor ID
- KYLL-202503-017-1
- Conditions
- Recurrent Cervical Cancer
- Keywords
- RC48;QL1706;HER2-Expressing;Recidivation; Cervical Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 33 participants (estimated)
- Lead sponsor
- Qilu Hospital of Shandong UniversityUniversity, hospital or other
- Study start
- 1 Oct 2025 (estimated)
- Primary completion
- 28 Feb 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 15 Sep 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.
This is a single-arm study. The efficacy and safety of Disitamab Vedotin combined with Apalutamide and Toripalimab in the second-line treatment of HER2-expressing recurrent cervical cancer are evaluated based on the following indicators:
Primary evaluation indicator: Objective Response Rate (ORR)
Secondary evaluation indicators:
Efficacy-related indicators: Progression-Free Survival (PFS), Disease Control Rate (DCR), Duration of Response (DOR), Overall Survival (including median Overall Survival [mOS] and 1-year, 2-year, 3-year Overall Survival rates) Safety-related indicators: Adverse Events (AEs) and Serious Adverse Events (SAEs).
Detailed description
This study is a multicenter, open-label, single-arm, exploratory trial. It enrolls 33 participants with recurrent cervical cancer who have HER2 expression (IHC 1+, 2+, or 3+). After eligible participants are enrolled, they will receive treatment with RC48 (dose: 2.5mg/kg, Q3W, intravenous infusion) in combination with QL1706 (dose: 5mg/kg, Q3W, intravenous infusion), with a treatment window of ±3 days. During the study, safety assessment and efficacy assessment will be conducted.
Safety Assessment For participants who have received at least one dose of the study drug, the safety assessment will start from the administration of the study drug. It will be performed before each drug administration, assessed once every 3 weeks (with a window of ±3 days), and continue until 30 days after the last dose of the study drug or the initiation of new anti-tumor treatment.
Efficacy Assessment Tumor assessment will be conducted in accordance with the Response Evaluation Criteria in Solid Tumors (RECIST v1.1). Starting from the administration of the study drug, assessments will be performed once every 6 weeks (with a window of ±3 days) until the occurrence of intolerable toxicity or radiologically confirmed disease progression.
For participants who experience disease progression or start other anti-tumor treatments, survival follow-up will be conducted once every 3 months (with a window of ±14 days) from the date of confirmation. Information on the participants' subsequent anti-tumor treatment and survival status will be collected until the participant's death, withdrawal of informed consent, loss to follow-up, study termination, whichever occurs first.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RC48 and QL1706 | Experimental | Drug: RC48, Drug: QL1706 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Voluntarily enroll in the study and sign a written informed consent form;
- Female patients aged 18 to 75 years (inclusive);
- Histologically or cytologically confirmed primary cervical squamous cell carcinoma, adenocarcinoma, adenosquamous carcinoma, or small cell (neuroendocrine) cervical cancer;
- Progressive disease or recurrent disease after first-line treatment for recurrent cervical cancer;
- Subjects can provide tumor specimens (paraffin blocks, formalin-fixed paraffin-embedded [FFPE] sections, or fresh tissue sections) from the primary or metastatic site for HER2 detection, with HER2 immunohistochemistry (IHC) test results of IHC 1+, 2+, or 3+ (previous test results confirmed by the investigator are also acceptable);
Key exclusion criteria (18 listed)
- History of malignant tumors other than cervical cancer, except for the following two situations:
- Previous allogeneic stem cell or solid organ transplantation;
- Previous systemic anti-tumor therapy (including traditional Chinese medicine with anti-tumor indications) completed less than 4 weeks before the first administration of the study drug, or patients whose adverse events caused by previous treatment have not recovered to ≤ Grade 1 according to the Common Terminology Criteria for Adverse Events (CTCAE) (except for alopecia and pigmentation);
- Vaccination with live vaccines within 4 weeks before the start of study drug administration, or planned receipt of any vaccines (except COVID-19 vaccines) during the study period;
- Previous or current history of congenital or acquired immunodeficiency diseases;
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 |
|---|---|---|
| RC48Disitamab Vedotin (RC48) : 2.5 mg/kg, administered once every 3 weeks (Q3w), via intravenous infusion on Day 1 of each treatment cycle | Drug | RC48 and QL1706 |
| QL1706Drug: QL1706 Iparomlimab and Tuvonralimab (QL1706) : 5 mg/kg in total, administered once every 3 weeks (Q3w), via intravenous infusion on Day 1 of each treatment cycle | Drug | RC48 and QL1706 |
Primary outcome
Objective Response Rate (ORR)
Time frame: 6 months after the last subject participating in
The proportion of subjects with complete response (CR) and partial response (PR) according RESIST 1.1 in total subjects.
4 secondary outcomes
Progression-Free Survival
Time frame: Approximately 1 years after last participant enrollment.
disease control rate (DCR)
Time frame: Approximately 1 years after last participant enrollment.
duration of response (DOR)
Time frame: The time from the start of treatment to the first observation of response (Complete Response [CR] or Partial Response [PR]) that is ultimately confirmed (typically via a subsequent reassessment at least 4 weeks later, per RECIST criteria).
overall survival (OS)
Time frame: Approximately 1 years after last participant enrollment.
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 15 Sep 2025.
- 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.
Peng Li principal investigator
Qilu Hospital of Shandong University
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 RC48 and QL1706 in people with Recurrent Cervical Cancer, run by Qilu Hospital of Shandong University 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 11 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: opening soon, as of the sponsor's last update on 15 Sep 2025. 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 Ying Zhao (18560081925, ericdareway@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (ORR) (time frame: 6 months after the last subject participating in). 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 15 Sep 2025.