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Tests treatment safety and results for Head and Neck Squamous Cell Carcinoma (HNSCC) -...
Official title Phase I Study of Becotatug Vedotin for Safety and Efficacy in EGFR-Positive Pediatric Relapsed/Refractory or Metastatic Solid Tumors
ClinicalTrials.gov ID: NCT07584499
What this study is testing
What is Becotatug Vedotin?
Becotatug Vedotin is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for head and neck squamous cell carcinoma (hnscc) - recurrent/metastatic (r/m).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 1: an early, usually small safety study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 2 to 18
You may be able to join if
- All participants must meet all of the following criteria to be eligible for enrollment:
- Informed Consent: The patient (and/or legal guardian, as age-appropriate) fully understands the study, voluntarily agrees to participate, and signs a...
- Age: 2 to 18 years old at the time of consent. Life Expectancy: Estimated overall survival of at least 3 months.
- Histologically Confirmed Disease: Pathologically confirmed relapsed/refractory or metastatic EGFR-positive solid tumor, belonging to one of the...
- Head and neck squamous cell carcinoma, nasopharyngeal carcinoma, or lymphoepithelial carcinoma that progressed during or after at least one line of...
You likely can't join if
- Participants will be excluded from the study if they meet any of the following criteria:
- Hypersensitivity: Known hypersensitivity to any component of Becotatug Vedotin (MRG003) or its excipients.
- Symptomatic CNS Metastases: Presence of symptomatic central nervous system (CNS) metastases.
- Prior Malignancies: History of other primary malignant tumors, except for:
- Locally excised basal cell or squamous cell carcinoma of the skin Cervical carcinoma in situ Any prior malignancy that has been in complete remission...
- Significant Liver Disease: Clinically significant liver disease, including:
See the full eligibility criteria
- All participants must meet all of the following criteria to be eligible for enrollment:
- Informed Consent: The patient (and/or legal guardian, as age-appropriate) fully understands the study, voluntarily agrees to participate, and signs a written informed consent form (ICF). A separate biomarker consent...
- Age: 2 to 18 years old at the time of consent. Life Expectancy: Estimated overall survival of at least 3 months.
- Histologically Confirmed Disease: Pathologically confirmed relapsed/refractory or metastatic EGFR-positive solid tumor, belonging to one of the following subtypes:
- Head and neck squamous cell carcinoma, nasopharyngeal carcinoma, or lymphoepithelial carcinoma that progressed during or after at least one line of platinum-based chemotherapy and PD-1/PD-L1 inhibitor therapy...
- Performance Status: Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2.
- Adequate Bone Marrow Function:
- Absolute neutrophil count (ANC) ≥1.5 × 10⁹/L Platelet count ≥75 × 10⁹/L Hemoglobin ≥80 g/L Exception for patients with bone marrow involvement: ANC ≥1.0 × 10⁹/L, platelets ≥50 × 10⁹/L, hemoglobin ≥75 g/L
- Adequate Hepatic and Renal Function:
- Serum creatinine ≤1.5 × upper limit of normal (ULN) Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 × ULN Total bilirubin ≤1.5 × ULN Exception for patients with liver involvement: AST/ALT ≤5 ×...
- Participants will be excluded from the study if they meet any of the following criteria:
- Hypersensitivity: Known hypersensitivity to any component of Becotatug Vedotin (MRG003) or its excipients.
- Symptomatic CNS Metastases: Presence of symptomatic central nervous system (CNS) metastases.
- Prior Malignancies: History of other primary malignant tumors, except for:
- Locally excised basal cell or squamous cell carcinoma of the skin Cervical carcinoma in situ Any prior malignancy that has been in complete remission for ≥3 years without treatment Note: Melanoma (any stage) is...
- Significant Liver Disease: Clinically significant liver disease, including:
- Positive hepatitis C virus (HCV) antibody Chronic active hepatitis B (HBV DNA \>20,000 IU/mL) HIV Infection: Known human immunodeficiency virus (HIV) infection. Severe Ocular Abnormalities: History of severe...
- Uncontrolled Systemic Diseases: Severe or uncontrolled medical conditions, including:
- Interstitial lung disease or pneumonitis Active autoimmune diseases requiring systemic immunosuppressive therapy
- Cardiac Disease: Clinically significant cardiac dysfunction or cardiac disease, including:
- Congestive heart failure (New York Heart Association Class ≥II) Uncontrolled arrhythmias QTc interval prolongation \>450 ms (males) or \>470 ms (females) Recent Antitumor Therapy: Received any systemic antitumor therapy...
- Recent Major Surgery: Underwent major surgical procedure within 3 weeks prior to the first dose of study drug.
- Planned Surgery: Planned surgical procedure during the study period, or any surgery deemed necessary by the investigator.
- Prior EGFR Therapy Toxicity: History of severe skin toxicity caused by prior EGFR-targeted therapy, or chronic skin disease requiring ongoing oral or intravenous treatment.
- Other Significant Risks: Any other concurrent medical condition that, in the investigator's judgment, would increase the risk of toxicity or compromise the patient's ability to complete the study.
The study team makes the final eligibility decision.
Where it's taking place
- Guangzhou, Guangdong, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 2 years to 18 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Guangzhou, Guangdong, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.