Phase I Study of Becotatug Vedotin for Safety and Efficacy in EGFR-Positive Pediatric Relapsed/Refractory or Metastatic Solid Tumors

Sponsor
Sun Yat-sen University
Study ID
NCT07584499
Phase
PHASE1
Status
Recruiting
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Conditions

  • Atypical Teratoid/Rhabdoid Tumors
  • Diffuse Intrinsic Pontine Gliomas
  • Head and Neck Squamous Cell Carcinoma (HNSCC) - Recurrent/Metastatic (R/M)
  • Lymphoepithelial Carcinoma
  • Medulloblastoma
  • Nasopharyngeal Carcinoma
  • Neuroblastoma
  • Other EGFR-positive Pediatric Solid Tumors Deemed Eligible by the Investigator
  • Rhabdomyosarcoma
  • Wilms Tumor

Eligibility Criteria

Sex
ALL
Age
2 Years - 18 Years
Healthy Volunteers
Not accepted

Interventions

  • Becotatug Vedotin — DRUG
    Study Drug: Becotatug Vedotin (MRG003) for Injection (lyophilized powder, 20 mg/vial) Route: Intravenous (IV) infusion over 30 minutes to 3 hours Schedule: Every 3 weeks (Q3W) on Day 1 of each 21-day cycle Maximum Treatment Duration: Up to 8 cycles (24 weeks); patients with confirmed clinical benefit (objective response or stable disease) may continue treatment beyond 8 cycles until disease progression, unacceptable toxicity, withdrawal of consent, or study termination

Study Details

There is a significant unmet medical need for effective therapies for pediatric relapsed/refractory solid tumors. EGFR is highly and stably expressed in multiple pediatric solid tumor subtypes, and adult Phase I data of Becotatug Vedotin demonstrated a manageable safety profile and promising antitumor activity in EGFR-positive advanced solid tumors.This is a multicenter, non-randomized, single-arm, open-label Phase I clinical trial sponsored by Sun Yat-sen University Cancer Center (SYSUCC). The trial evaluates the safety, tolerability, pharmacokinetics (PK), immunogenicity, and preliminary efficacy of Becotatug Vedotin-an EGFR-targeted antibody-drug conjugate (ADC)-in pediatric patients with EGFR-positive relapsed/refractory or metastatic solid tumors.

Key Dates

Start date
May 30, 2026
Status verified
May 2026
Primary completion
May 30, 2027
Completion
May 30, 2028

Study Design

Enrollment
51 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Becotatug Vedotin (MRG003) Phase I Dose-Escalation & Expansion in EGFR-Positive Pediatric R/M Solid
    This is a single-arm, open-label study where all enrolled participants receive Becotatug Vedotin (MRG003), a novel EGFR-targeted antibody-drug conjugate (ADC), as monotherapy. Intervention Details Study Drug: Becotatug Vedotin (MRG003) for Injection Route of Administration: Intravenous (IV) infusion over 30 minutes to 3 hours Dosing Schedule: Every 3 weeks (Q3W) on Day 1 of each 21-day cycle Maximum Treatment Duration: Up to 8 cycles (24 weeks) Dose Levels: Ia Dose-Escalation Phase: 4 planned dose levels (1.0, 1.5, 2.0, 2.3 mg/kg) Starting dose: 1.0 mg/kg (modified accelerated titration design, 1 patient per cohort) Subsequent doses: Standard 3+3 design Ib Dose-Expansion Phase: All patients receive the determined Recommended Phase II Dose (RP2D)

Primary Outcome Measure

Incidence of dose-limiting toxicities [ Time Frame: First 21-day treatment cycle (Cycle 1) ]

Central Contacts

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