Recurrent or Metastatic Cervical CancerPhase 1/2NCT07542717
ASCERV Study: MRG003 Combined With QL1706 in Recurrent or Metastatic Cervical Cancer
A Phase 1/2 study testing Treatment in people with Recurrent or Metastatic Cervical Cancer, run by Second Affiliated Hospital, Zhejiang University, School of Medicine.
Trial summary
This is a single-arm, multicenter, phase II study designed to evaluate the efficacy and safety of MRG003, an anti-EGFR antibody-drug conjugate, in combination with QL1706, a PD-1/CTLA-4 bispecific antibody, in patients with recurrent or metastatic cervical cancer who have failed prior platinum-based therapy. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Recurrent or Metastatic Cervical Cancer
- What is being tested?
- Treatment
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- No sites listed yet
- Study dates
- 10 Apr 2026to 31 Mar 2030
- Phase
- Phase 1/2
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years Histologically confirmed recurrent or metastatic cervical cancer (squamous, adenocarcinoma, or adenosquamous) Progression after ≥1 line of platinum-based therapy At least one measurable lesion per RECIST v1.1 ECOG performance status 0-1 Life expectancy ≥12 weeks Adequate organ function Recovery from prior treatment toxicities (≤ Grade 1) Agreement to use effective contraception Signed informed consent
Who cannot join
- Active malignancy within 5 years (except certain cured cancers) Active CNS metastases Significant cardiovascular disease Uncontrolled comorbidities Active hepatitis B/C or uncontrolled HIV infection Interstitial lung disease or pneumonitis Prior EGFR-targeted therapy Prior T-cell co-stimulatory pathway agents Recent live vaccination Use of strong CYP3A4 inhibitors/inducers Pregnancy or breastfeeding Any condition deemed unsuitable by investigator
About this study
Official title: A Single-Arm, Multicenter, Phase II Study of MRG003 Combined With QL1706 for Second-Line or Later Treatment of Recurrent or Metastatic Cervical Cancer (ASCERV Study)
This is a single-arm, multicenter, phase II study designed to evaluate the efficacy and safety of MRG003, an anti-EGFR antibody-drug conjugate, in combination with QL1706, a PD-1/CTLA-4 bispecific antibody, in patients with recurrent or metastatic cervical cancer who have failed prior platinum-based therapy.
Read the detailed description
Patients with recurrent or metastatic cervical cancer who have progressed after at least one line of platinum-based chemotherapy will receive:
- Conditions
- Recurrent or Metastatic Cervical Cancer
- Being tested
- Treatment
- Keywords
- Metastatic Cervical Cancer, MRG003, QL1706, Second-Line or Later Treatment
- Medical subject headings
- Recurrence, Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TreatmentDrug
MRG003 [Becotatug vedotin, an epidermal growth factor receptor (EGFR)-targeted antibody-drug conjugate (ADC)]: 2.0 mg/kg IV infusion, Day 1, every 3 weeks QL1706 [Iparomlimab and tuvonralimab, a bifunctional anti-programmed death-1/cytotoxic T-lymphocyte antigen-4 antibody]: 5 mg/kg IV infusion, Day 1, every 3 weeks Each treatment cycle is 21 days. Treatment will continue until disease progression, unacceptable toxicity, withdrawal of consent, initiation of new anti-tumor therapy, or death.
| Study group | Role | What they receive |
|---|---|---|
| treatment | Experimental | MRG003 [Becotatug vedotin, an epidermal growth factor receptor (EGFR)-targeted antibody-drug conjugate (ADC)]: 2.0 mg/kg IV infusion, Day 1, every 3 weeks QL1706 [Iparomlimab and tuvonralimab, a bifunctional anti-programmed death-1/cytotoxic T-lymphocyte antigen-4 antibody]: 5 mg/kg IV infusion, Day 1, every 3 weeks Each treatment cycle is 21 days. Treatment will continue until disease progression, unacceptable toxicity, withdrawal of consent, initiation of new anti-tumor therapy, or death. Receives: Drug: Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR)
Proportion of patients achieving CR or PR per RECIST v1.1
Measured: 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 posted21 Apr 2026
- Study start10 Apr 2026 (estimated)
- Primary completion31 Mar 2028 (estimated)
- Study completion31 Mar 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent or Metastatic Cervical CancerStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 41 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07542717
- Sponsor's protocol ID
- ASCERV Study
- Status last verified
- Mar 2026
- First submitted
- 8 Apr 2026
- Last updated
- 21 Apr 2026
- 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 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Arm, Multicenter, Phase II Study of MRG003 Combined With QL1706 for Second-Line or Later Treatment of Recurrent or Metastatic Cervical Cancer (ASCERV Study)
- ClinicalTrials.gov ID
- NCT07542717
- Acronym / sponsor ID
- ASCERV Study
- Conditions
- Recurrent or Metastatic Cervical Cancer
- Keywords
- Metastatic Cervical Cancer, MRG003, QL1706, Second-Line or Later Treatment
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 41 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 10 Apr 2026 (estimated)
- Primary completion
- 31 Mar 2028 (estimated)
- Study completion
- 31 Mar 2030 (estimated)
- First posted
- 21 Apr 2026 (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, multicenter, phase II study designed to evaluate the efficacy and safety of MRG003, an anti-EGFR antibody-drug conjugate, in combination with QL1706, a PD-1/CTLA-4 bispecific antibody, in patients with recurrent or metastatic cervical cancer who have failed prior platinum-based therapy.
Detailed description
Patients with recurrent or metastatic cervical cancer who have progressed after at least one line of platinum-based chemotherapy will receive:
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| treatment | Experimental | Drug: TreatmentMRG003 [Becotatug vedotin, an epidermal growth factor receptor (EGFR)-targeted antibody-drug conjugate (ADC)]: 2.0 mg/kg IV infusion, Day 1, every 3 weeks QL1706 [Iparomlimab and tuvonralimab, a bifunctional anti-programmed death-1/cytotoxic T-lymphocyte antigen-4 antibody]: 5 mg/kg IV infusion, Day 1, every 3 weeks Each treatment cycle is 21 days. Treatment will continue until disease progression, unacceptable toxicity, withdrawal of consent, initiation of new anti-tumor therapy, or death. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Age ≥18 years Histologically confirmed recurrent or metastatic cervical cancer (squamous, adenocarcinoma, or adenosquamous) Progression after ≥1 line of platinum-based therapy At least one measurable lesion per RECIST v1.1 ECOG performance status 0-1 Life expectancy ≥12 weeks Adequate organ function Recovery from prior treatment toxicities (≤ Grade 1) Agreement to use effective contraception Signed informed consent
Key exclusion criteria (1 listed)
- Active malignancy within 5 years (except certain cured cancers) Active CNS metastases Significant cardiovascular disease Uncontrolled comorbidities Active hepatitis B/C or uncontrolled HIV infection Interstitial lung disease or pneumonitis Prior EGFR-targeted therapy Prior T-cell co-stimulatory pathway agents Recent live vaccination Use of strong CYP3A4 inhibitors/inducers Pregnancy or breastfeeding Any condition deemed unsuitable by investigator
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 |
|---|---|---|
| TreatmentMRG003 [Becotatug vedotin, an epidermal growth factor receptor (EGFR)-targeted antibody-drug conjugate (ADC)]: 2.0 mg/kg IV infusion, Day 1, every 3 weeks QL1706 [Iparomlimab and tuvonralimab, a bifunctional anti-programmed death-1/cytotoxic T-lymphocyte antigen-4 antibody]: 5 mg/kg IV infusion, Day 1, every 3 weeks Each treatment cycle is 21 days. Treatment will continue until disease progression, unacceptable toxicity, withdrawal of consent, initiation of new anti-tumor therapy, or death. | Drug | treatment |
Primary outcome
Objective Response Rate (ORR)
Time frame: Up to 24 months
Proportion of patients achieving CR or PR per RECIST v1.1
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 21 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Treatment in people with Recurrent or Metastatic Cervical Cancer, run by Second Affiliated Hospital, Zhejiang University, School of Medicine.
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 1 inclusion and 1 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 21 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
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 Response Rate (ORR) (time frame: Up to 24 months). 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 21 Apr 2026.