Phase II Study of Becotatug Vedotin Plus Pucotenlimab for Advanced Refractory Solid Tumors With E… (NCT07712029) | Clinical Trial Compass
RecruitingPhase 2
Phase II Study of Becotatug Vedotin Plus Pucotenlimab for Advanced Refractory Solid Tumors With EGFR-Positive
China32 participantsStarted 2026-08-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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 not applicable or unavailable. There is no limit on the number of prior lines of therapy.
. 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 provided, a repeat biopsy may be performed if deemed feasible and safe by the investigator and after obtaining the subject's consent; however, repeat biopsy is not mandatory. In cases where repeat biopsy is not feasible or the subject refuses, eligibility must be jointly confirmed by the investigator and the sponsor.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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 first dose):
Exclusion criteria
. 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:
. 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 baseline chest imaging; signs or symptoms of infection or need for oral or intravenous antibiotics (excluding prophylactic antibiotics) within 2 weeks before the first dose.
. Unexplained fever \> 38.5 ℃ during screening or before the first dose (subjects 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). Exceptions include: autoimmune-mediated hypothyroidism treated with stable doses of thyroid-replacement hormones; type 1 diabetes mellitus controlled with stable insulin; vitiligo; or childhood asthma/allergy that has resolved and requires no intervention in adulthood.
. 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. Subjects with inactive hepatitis B surface antigen (HBsAg) carriers, treated and stabilized hepatitis B (HBV DNA \< 500 IU/mL), or cured hepatitis C may be enrolled.