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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.
Patients with recurrent or metastatic cervical cancer who have progressed after at least one line of platinum-based chemotherapy will receive:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Treatment | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | Proportion of patients achieving CR or PR per RECIST v1.1 | Up to 24 months |
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Inclusion Criteria:
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
Exclusion Criteria:
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
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| ID | Term |
|---|---|
| D012008 | Recurrence |
| D002583 | Uterine Cervical Neoplasms |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014594 | Uterine Neoplasms |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
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|
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |