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Advanced Refractory Solid TumorsPhase 2NCT07712029

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

A Phase 2 study testing Becotatug Vedotin and Pucotenlimab in people with Advanced Refractory Solid Tumors and EGFR Gene Overexpression, run by Tianjin Medical University Second Hospital at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Becotatug Vedotin and Pucotenlimab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32 participants
Where
1 siteChina
Study dates
1 Aug 2026to 31 Dec 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to 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 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).
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  • 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):
  • White blood cell count (WBC) ≥ 3.0 x 10^9/L; absolute neutrophil count (ANC) ≥ 2.0 x 10^9/L.
  • 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.
  • 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.
  • Subjects 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 subjects with partners of childbearing potential, effective medical contraception must be used from the signing of the ICF until 6 months after the last dose.
  • Subjects must voluntarily sign the ICF and be able to comply with the protocol-specified visits and procedures.

Who cannot join

  • 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;
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  • 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:
  • Any investigational drug within 4 weeks before the first dose. B. Last dose of anticancer therapy (including chemotherapy, radiotherapy, targeted therapy, etc.) ≤ 4 weeks before the first dose.
  • Systemic corticosteroids (>10 mg/day prednisone equivalent) or other immunosuppressive agents within 2 weeks before the first dose, except for local inflammation prophylaxis, anti-allergy, or anti-emetic use. Inhaled or topical corticosteroids, and adrenal hormone replacement doses > 10 mg/day prednisone equivalent, are permitted in the absence of active autoimmune disease.
  • Prior anti-cancer vaccine, or live vaccine within 4 weeks before the first dose.
  • Major surgery or severe trauma within 4 weeks before the first dose. F. Concurrent enrollment in another clinical study.
  • 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 limit of detection). Note: Subjects who are HBsAg positive are required to receive anti-HBV therapy during the study treatment period.
  • 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, cachexia, etc.
  • 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 unsuitable for participation.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Haitao Wang, Ph.D. contact

+86-022-88321190

peterrock2000@126.com

Lili Wang, Ph.D. contact

+86-022-88321185

wangliliaigang@163.com

China1 site, 1 recruiting

  • Tianjin Medical Unversity Second Hospital

    Tianjin, Tianjin Municipality, 300211

    Haitao Wang, Ph.D, +86-022-88321190, peterrock2000@126.com

    Lili Wang, Ph.D., +86-022-88321185, wangliliaigang@163.com

    Recruiting

Other trials in China

About this study

Official title: ELEVATE Study: A Phase II Single-Arm Open-Label Single-Center Exploratory Trial of Becotatug Vedotin (MRG003) Plus Pucotenlimab (HX008) in Advanced Refractory Solid Tumors With EGFR-Positive

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.

Read the detailed description

Given the substantial unmet medical need for effective treatment options in patients with advanced refractory solid tumors, and grounded in the synergistic rationale of combining EGFR-targeted therapy with immune checkpoint modulation, the encouraging efficacy and manageable safety profiles observed in early phase studies of Becotatug Vedotin (MRG003) andPucotenlimab (HX008) provide a strong rationale for further investigation. Accordingly, a methodologically rigorous phase II clinical trial is warranted to objectively evaluate the clinical efficacy and safety of this dual regimen specifically in patients with high EGFR expressing advanced refractory solid tumors.

Being tested
Becotatug Vedotin, Pucotenlimab
Keywords
EGFR, EGFR ADC, Becotatug Vedotin, Pucotenlimab

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Becotatug VedotinDrug

    Also called MRG003

    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).

  • PucotenlimabDrug

    Also called HX008

    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.

Study groups in NCT07712029
Study groupRoleWhat they receive
Becotatug Vedotin+PucotenlimabExperimentalIn 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.
Receives: Drug: Becotatug Vedotin; Drug: Pucotenlimab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective Response Rate (ORR)

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

    Measured: Up to approximately 2 years.

Secondary outcomes (6)

  1. Overall Survival(OS)

    Time from start of treatment to death due to any cause.

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

  2. Adverse Events (AEs)

    Number of participants with adverse effects of treatment. Frequency and severity of adverse effects of treatment as assessed by NCI CTCAE.

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

  3. Progression Free Survival(PFS)

    The time from the beginning of the patient's treatment to the disease progression or death for any reason.Based on RECIST criteria v1.1.

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

  4. Radiological Progression-Free Survival(rPFS)

    Progression-free survival (PFS) based on radiographic assessment by the investigator using RECIST version 1.1

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

  5. Disease Control Rate(DCR)

    The disease control rate (DCR), defined as the proportion of patients achieving a best overall response of complete response, partial response, or stable disease, as assessed by the investigator using RECIST v1.1.

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

  6. Duration of Response(DoR)

    Duration of response (DoR) is defined as the time from the first documented objective response (complete response or partial response) until the date of disease progression or death, as assessed by the investigator using RECIST version 1.1.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jul 2026
  2. Study start1 Aug 2026 (estimated)
  3. Primary completion31 Aug 2028 (estimated)
  4. Study completion31 Dec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
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.
Masking
None (open label)
Enrolment
32 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07712029
Sponsor's protocol ID
PAN-CANCER-EGFR-MH
Status last verified
Jul 2026
First submitted
12 Jul 2026
Last updated
17 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Due to the exploratory nature and limited sample size of this phase II study, IPD will not be share.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Becotatug Vedotin and Pucotenlimab in people with Advanced Refractory Solid Tumors and EGFR Gene Overexpression, run by Tianjin Medical University Second Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 17 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Haitao Wang, Ph.D. (+86-022-88321190, peterrock2000@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (ORR) (time frame: Up to approximately 2 years.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07712029.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2026; AzTrials last refreshed its copy on 6 Nov 2026.

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