ASCERV Study: MRG003 Combined With QL1706 in Recurrent or Metastatic Cervical Cancer

Phase 2Not Yet RecruitingNCT07542717

Second Affiliated Hospital, Zhejiang University, School of Medicine41 enrolled

Overview

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:

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Recurrent or Metastatic Cervical Cancer

Interventions

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.

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Objective Response Rate (ORR)

Proportion of patients achieving CR or PR per RECIST v1.1

Time frame: Up to 24 months

Data from ClinicalTrials.gov

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