Actively Recruiting
Phase I Study of Becotatug Vedotin for Safety and Efficacy in EGFR-Positive Pediatric Relapsed/Refractory or Metastatic Solid Tumors
Led by Sun Yat-sen University · Updated on 2026-05-13
51
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Phase I Study of Becotatug Vedotin for Safety and Efficacy in EGFR-Positive Pediatric Relapsed/Refractory or Metastatic Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient or legal guardian provides informed consent and understands the study
- Age between 2 and 18 years at consent
- Estimated life expectancy of at least 3 months
- Histologically confirmed relapsed, refractory, or metastatic EGFR-positive solid tumor in specified subtypes
- Tumor measurable by CT or MRI according to RECIST v1.1 criteria
- ECOG performance status of 0, 1, or 2
- Adequate bone marrow function with specified blood counts
- Adequate liver and kidney function within defined laboratory limits
- Prior progression after platinum-based chemotherapy and PD-1/PD-L1 therapy for certain carcinomas
You will not qualify if you...
- Known hypersensitivity to Becotatug Vedotin or its components
- Presence of symptomatic central nervous system metastases
- History of other primary cancers except for specified exceptions in remission
- Clinically significant liver disease including positive hepatitis C or active hepatitis B
- Known HIV infection
- Severe eye conditions such as severe dry eye syndrome or exposure keratitis
- Severe or uncontrolled systemic diseases like interstitial lung disease or active autoimmune disease requiring immunosuppression
- Significant cardiac disease including congestive heart failure, uncontrolled arrhythmias, or prolonged QTc interval
- Recent systemic antitumor therapy or major surgery within 3 weeks before study drug
- Planned surgery during the study period
- History of severe skin toxicity from prior EGFR therapy or ongoing chronic skin disease requiring systemic treatment
- Any other medical condition that increases risk or impairs ability to complete the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060
Actively Recruiting
Research Team
Y
Yizhuo Zhang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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