Phase II Study of Becotatug Vedotin Plus Pucotenlimab for Advanced Refractory Solid Tumors With EGFR-Positive

NCT07712029 | Recruiting Phase 2 DMC

• 1 other identifier: PAN-CANCER-EGFR-MH
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Advanced Refractory Solid Tumors; EGFR Gene Overexpression

Keywords

EGFR; EGFR ADC; Becotatug Vedotin; Pucotenlimab

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate (ORR)

  Objective Response Rate (ORR) assessed according to the evaluation criteria for the efficacy of solid tumors (RECIST v1.1).

  Up to approximately 2 years.

Secondary Outcomes (6)

• Overall Survival(OS)

  From treatment administration up to a maximum duration of 24 months.

• Adverse Events (AEs)

  From treatment administration up to a maximum duration of 24 months.

• Progression Free Survival(PFS)

  From treatment administration up to a maximum duration of 24 months.

• Radiological Progression-Free Survival(rPFS)

  From treatment administration up to a maximum duration of 24 months.

• Disease Control Rate(DCR)

  From treatment administration up to a maximum duration of 24 months.

Other Outcomes (1)

• EGFR Expression Level and Efficacy Correlation

  From treatment administration up to a maximum duration of 24 months.

Study Arms (1)

Becotatug Vedotin+Pucotenlimab

EXPERIMENTAL

In this study, Becotatug Vedotin will be given at a dose of 2.0 mg/kg via intravenous infusion on Day 1 of every 3 week cycle (Q3W). Pucotenlimab will be administered intravenously at 3.0 mg/kg (or as a flat dose of 200 mg) also on Day 1 of each Q3W cycle.

Drug: Becotatug Vedotin; Drug: Pucotenlimab

Interventions

Becotatug Vedotin DRUG

Becotatug Vedotin will be given at a dose of 2.0 mg/kg via intravenous infusion on Day 1 of every 3 week cycle (Q3W).

Also known as: MRG003

Becotatug Vedotin+Pucotenlimab

Pucotenlimab DRUG

Pucotenlimab will be administered intravenously at 3.0 mg/kg (or as a flat dose of 200 mg) also on Day 1 of each Q3W cycle.

Also known as: HX008

Becotatug Vedotin+Pucotenlimab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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 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.
• 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):
• A. White blood cell count (WBC) ≥ 3.0 x 10\^9/L; absolute neutrophil count (ANC) ≥ 2.0 x 10\^9/L.
• B. Hemoglobin (HB) ≥90 g/L. C. Platelet count ≥ 100x10\^9/L. D. Serum albumin ≥ 2.8 g/dL. E. Total bilirubin ≤1.5 x upper limit of normal (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3.0 x ULN.
• F. Serum creatinine ≤ 1.5 x ULN or creatinine clearance \> 60 mL/min. G. Activated partial thromboplastin time (APTT) and international normalized ratio (INR) ≤ 1.5 x ULN (subjects receiving stable doses of anticoagulants, such as low-molecular-weight heparin or warfarin, with INR within the expected therapeutic range for the anticoagulant, are eligible for screening).
• 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.

You may not qualify if:

• 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 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.
• 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:

Sponsors & Collaborators

• Tianjin Medical University Second Hospital: lead
• Lepu Biopharma Co., Ltd.: collaborator

Study Sites (1)

Tianjin Medical Unversity Second Hospital

Tianjin, Tianjin Municipality, 300211, China

RECRUITING

Study Officials

• Haitao Wang, Ph.D.

  Tianjin Medical University Second Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Haitao Wang, Ph.D.

CONTACT

+86-022-88321190; peterrock2000@126.com

Lili Wang, Ph.D.

CONTACT

+86-022-88321185; wangliliaigang@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study will employ Simon's two-stage design. The expected response rate in the experimental arm is 0.3, and the null (historical control) response rate is 0.1. With a one-sided alpha of 0.0471 and a beta of 0.1949, the calculated total sample size for this single-arm trial is 29, with 10 patients to be enrolled in the first stage. If the number of responders in the first stage is ≤1, the study will be terminated early for futility. If the number of responders exceeds 1, enrollment will continue into the second stage. After completion of the second stage, if the total number of responders is greater than 5, the experimental regimen will be deemed effective. Accounting for a 10% dropout rate, the study plans to enroll a total of 32 patients.

Study Record Dates

• First Submitted: July 12, 2026
• First Posted: July 17, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): August 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: July 17, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)