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Phase II Study of Becotatug Vedotin Plus Pucotenlimab for Advanced Refractory Solid Tumors With EGFR-Positive

NCT07712029 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2026-07-17

No results posted yet for this study

Summary

This phase II trial evaluates the combination of Becotatug Vedotin (MRG003), an EGFR-targeting ADC, and Pucotenlimab (HX008), a PD-1 inhibitor, in patients with high EGFR expressing advanced refractory solid tumors. The study is designed to assess clinical efficacy and safety, building on a strong synergistic rationale and promising early-phase data.

Conditions

  • Advanced Refractory Solid Tumors
  • EGFR Gene Overexpression

Interventions

DRUG

Becotatug Vedotin

Becotatug Vedotin will be given at a dose of 2.0 mg/kg via intravenous infusion on Day 1 of every 3 week cycle (Q3W).

DRUG

Pucotenlimab

Pucotenlimab will be administered intravenously at 3.0 mg/kg (or as a flat dose of 200 mg) also on Day 1 of each Q3W cycle.

Sponsors & Collaborators

  • Lepu Biopharma Co., Ltd.

    collaborator INDUSTRY

  • Tianjin Medical University Second Hospital

    lead OTHER

Principal Investigators

  • Haitao Wang, Ph.D. · Tianjin Medical University Second Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-01
Primary Completion
2028-08-31
Completion
2028-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07712029 on ClinicalTrials.gov