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New treatment option for Advanced Refractory Solid Tumors
Official title Phase II Study of Becotatug Vedotin Plus Pucotenlimab for Advanced Refractory Solid Tumors With EGFR-Positive
ClinicalTrials.gov ID: NCT07712029
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 advanced refractory solid tumors.
Also referred to as MRG003.
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
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age≥18 years at the time of signing the informed consent form (ICF).
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 within 7 days prior to the first dose. ECOG 2 is allowable if it is solely...
- Life expectancy≥ 12 weeks.
- Histologically or cytologically confirmed locally advanced or metastatic solid tumors that have failed standard therapy (progressive disease or...
- Documentation of EGFR expression status is required for enrollment. If not available, the subject must provide adequate fresh or archival tumor...
You likely can't join if
- Presence of uncontrolled serious medical conditions, including severe cardiac disease, cerebrovascular disease, uncontrolled diabetes, uncontrolled...
- History of allergy or hypersensitivity to any component of monoclonal antibody-based agents, or known allergic constitution.
- Uncontrolled cardiac symptoms or diseases, such as:
- New York Heart Association (NYHA) Class ≥ II heart failure, or left ventricular ejection fraction (LVEF) \< 50% on echocardiography;
- Unstable angina;
- Myocardial infarction within 1 year;
See the full eligibility criteria
Who can join
- Age≥18 years at the time of signing the informed consent form (ICF).
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 within 7 days prior to the first dose. ECOG 2 is allowable if it is solely attributable to tumor progression, as judged by the investigator.
- Life expectancy≥ 12 weeks.
- Histologically or cytologically confirmed locally advanced or metastatic solid tumors that have failed standard therapy (progressive disease or intolerance to prior treatment), or for whom standard therapy is currently...
- Documentation of EGFR expression status is required for enrollment. If not available, the subject must provide adequate fresh or archival tumor tissue samples for EGFR testing. If adequate tumor specimens cannot be...
- EGFR expression positive (2+ or 3+) as determined by immunohistochemistry (IHC).
- At least one measurable lesion per RECIST version 1.1.
- Adequate organ function, as defined by the following criteria (no blood components, cell growth factors, leukopoiesis agents, thrombopoiesis agents, or anemia-correcting drugs are allowed within 14 days prior to the...
- No contraindications to chemotherapy, targeted therapy, or immunotherapy.
- No history of immune-related diseases.
- No uncontrolled pneumonia or pulmonary infection.
- Females of childbearing potential must agree to use effective contraception during the trial; a serum or urine pregnancy test must be negative within 72 hours before the start of chemotherapy.
- people must be compliant, able to undergo treatment and follow-up, and willing to comply with the study requirements as specified in the protocol.
- For male people with partners of childbearing potential, effective medical contraception must be used from the signing of the ICF until 6 months after the last dose.
- people must voluntarily sign the ICF and be able to comply with the protocol-specified visits and procedures.
What rules you out
- Presence of uncontrolled serious medical conditions, including severe cardiac disease, cerebrovascular disease, uncontrolled diabetes, uncontrolled hypertension, uncontrolled infection, active peptic ulcer, etc.
- History of allergy or hypersensitivity to any component of monoclonal antibody-based agents, or known allergic constitution.
- Uncontrolled cardiac symptoms or diseases, such as:
- New York Heart Association (NYHA) Class ≥ II heart failure, or left ventricular ejection fraction (LVEF) \< 50% on echocardiography;
- Unstable angina;
- Myocardial infarction within 1 year;
- Clinically significant supraventricular or ventricular arrhythmias requiring intervention (including QTc interval≥470 ms).
- Severe infection (CTC AE \> Grade 2) within 4 weeks before the first dose, such as severe pneumonia requiring hospitalization, bacteremia, infectious complications, etc.; evidence of active pulmonary inflammation on...
- Unexplained fever \> 38.5 ℃ during screening or before the first dose (people with tumor fever, as judged by the investigator, may be enrolled).
- Active autoimmune disease or history of autoimmune disease (e.g., interstitial pneumonia, colitis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism, including but not limited to these)...
- History of immunodeficiency, including HIV-positive status, other acquired or congenital immunodeficiency diseases, or history of organ transplantation or allogeneic bone marrow transplantation.
- Untreated chronic hepatitis B, or hepatitis B virus (HBV) DNA \> 500 IU/mL, or active hepatitis C virus (HCV) infection. people with inactive hepatitis B surface antigen (HBsAg) carriers, treated and stabilized...
- History of interstitial lung disease (excluding radiation pneumonitis that has not been treated with corticosteroids) or non-infectious pneumonitis.
- Active pulmonary tuberculosis infection by history or CT findings, or history of active tuberculosis within 1 year before enrollment, or history of active tuberculosis more than 1 year ago without adequate treatment.
- Prior receipt of any of the following treatments: A. Any investigational drug within 4 weeks before the first dose. B. Last dose of anticancer therapy (including chemotherapy, radiotherapy, targeted therapy, etc.) ≤ 4...
- Dementia, altered mental status, or any psychiatric condition that would interfere with understanding or providing informed consent or completing questionnaires.
- History of allergy or hypersensitivity to any component of the study treatments.
- Known history of allogeneic organ or allogeneic hematopoietic stem cell transplantation.
- Active hepatitis B (HBsAg positive, requiring HBV-DNA testing; HBV-DNA≥500 IU/mL or above the lower limit of detection, whichever is higher) or active hepatitis C (HCV antibody positive with HCV-RNA above the lower...
- Positive HIV test or history of acquired immunodeficiency syndrome (AIDS); known active syphilis infection.
- Major surgery within 4 weeks before the first dose, or anticipated to require major surgery during the study period.
- Rapid deterioration of clinical condition during the screening period (e.g., significant changes in performance status).
- Local or systemic disease not caused by malignancy, or disease/symptoms secondary to the tumor, that would pose a higher medical risk or introduce uncertainty in survival assessment, such as leukemoid reaction...
- Any condition that, in the investigator's opinion, would interfere with evaluation of the study drug, compromise subject safety, or confound interpretation of study results, or any other condition rendering the subject...
The study team makes the final eligibility decision.
Where it's taking place
- Tianjin, Tianjin Municipality, 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, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tianjin, Tianjin Municipality, 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.