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Oligo-metastatic CancerPhase 3NCT07481799

Efficacy and Safety of SBRT Combined With Becotatug Vedotin (MRG003) in EGFR-Positive Metastatic Tumor Patients With Oligometastases

A Phase 3 study testing Becotatug Vedotin and SBRT in people with Oligo-metastatic Cancer, run by Ming-Yuan Chen at 2 sites 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
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Trial summary

The combination of local consolidative therapy for oligometastases with systemic therapy offers the potential for clinical cure and significantly prolongs survival in a subset of patients with advanced metastatic disease. However, a considerable proportion of patients still do not benefit from this approach. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Oligo-metastatic Cancer
What is being tested?
Becotatug Vedotin and SBRT
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
2 sitesChina
Study dates
6 Feb 2026to 28 Feb 2030
Phase
Phase 3
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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age: 18 to 75 years (inclusive), male or female.
  • Patients with histologically or cytologically confirmed recurrent or metastatic solid tumors who are not amenable to curative surgery.
  • Oligometastatic lesions detected on imaging (biopsy of metastatic tissue is preferred but not mandatory). The total number of metastatic lesions must be <=5.
  • The primary tumor has been treated radically and is controlled.
  • Subjects must provide tumor tissue samples for EGFR testing of the primary tumor or metastatic lesions:
  • Sample requirements: Neutral formalin-fixed, paraffin-embedded (FFPE) tissue blocks or 10 unstained tumor tissue or cytology slides. Both fresh and archival samples are acceptable, with fresh samples preferred. Subjects unable to provide freshly obtained tissue may provide archival tumor tissue samples collected within 2 years prior to informed consent. For subjects unable to provide tumor tissue samples meeting the above requirements, enrollment is subject to confirmation after discussion with the Sponsor.
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  • All metastatic lesions are deemed amenable to SBRT (Stereotactic Body Radiation Therapy) by multidisciplinary team (MDT) consultation.
  • For patients whose metastatic lesions have received prior local therapy (e.g., surgery, radiofrequency ablation, radiotherapy):
  • If the treated metastatic lesion is controlled on imaging, the patient is eligible, and SBRT is not required for that specific site.
  • If the treated metastatic lesion is not controlled on imaging:
  • If the prior therapy was surgery and the site is amenable to SBRT, the patient is eligible;
  • If the prior therapy was radiotherapy or RFA, the patient is ineligible.
  • Maximum diameter of brain metastases <= 3 cm.
  • Maximum diameter of extra-cranial metastases <= 5 cm.
  • For bone metastases, the criterion may be extended to a maximum diameter of 6 cm (e.g., ribs, scapula, pelvis) if the investigator deems treatment safe.
  • ECOG performance status of 0-1.
  • Life expectancy >= 6 months.

Who cannot join

  • History of severe hypersensitivity to any component of monoclonal antibodies.
  • The investigator's choice of systemic therapy regimen contains taxanes (or other microtubule inhibitors) .
  • Severe infection within 4 weeks prior to the start of study treatment; or active infection of CTCAE Grade>=2 requiring systemic antibiotic treatment within 2 weeks prior to the first dose.
  • Received anti-tumor therapy such as chemotherapy, biotherapy, targeted therapy, immunotherapy, or other investigational drugs within 4 weeks prior to the first dose of study drug or investigator's choice of systemic therapy and SBRT; Exceptions:
  • The interval between the last dose of oral fluorouracil or small molecule targeted drugs and the first dose of study treatment is > 2 weeks or 5 half-lives (whichever is shorter);
  • The interval between the last dose of Traditional Chinese Medicine (TCM) with anti-tumor indications and the first dose of study treatment is > 2 weeks;
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  • The interval between the completion of prior radioactive seed implantation and the first dose of study treatment is > 4 weeks or 5 half-lives of the seeds (whichever is shorter); the interval between the completion of Tumor Treating Fields and the first dose of study treatment is < 7 days.
  • Received treatment with strong CYP3A4 or CYP2D6 inhibitors or inducers, or P-gp inhibitors within 5 half-lives prior to the first dose.
  • Prior treatment with EGFR ADCs, or prior treatment with ADCs containing microtubule inhibitors.
  • History of interstitial lung disease, such as idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or radiation pneumonitis requiring steroid treatment; or imaging at screening suggests suspected ILD or ILD cannot be excluded (subjects with radiation pneumonitis limited solely to the radiation field may participate); or presence of respiratory failure, severe asthma, severe chronic obstructive pulmonary disease (COPD), or other pulmonary diseases severely affecting lung function; or prior pneumonectomy.
  • Clinical or radiological evidence of spinal cord compression, or tumor distance to the spinal cord < 3 mm.
  • Grade >= 2 coronary heart disease, arrhythmia (including QTc interval prolongation > 450 ms for males, > 470 ms for females), or cardiac insufficiency.
  • Patients with brain metastases requiring surgical decompression.
  • Patients with malignant effusions.
  • patients with concomitant malignancies.
  • Dementia or seizures.
  • Comorbidities requiring chronic use of immunosuppressive medication, or systemic or local corticosteroids at immunosuppressive doses, or receipt of high-dose corticosteroids within 4 weeks prior to enrollment.
  • Active pulmonary tuberculosis, currently undergoing anti-tuberculosis treatment, or having received such treatment within 1 year prior to screening.
  • Presence of any active autoimmune disease or history of autoimmune disease (including but not limited to: interstitial pneumonitis, uveitis, enteritis, hepatitis, hypophysitis, nephritis, hyperthyroidism, hypothyroidism). Patients with vitiligo or childhood asthma that has completely resolved without need for intervention in adulthood are eligible; patients with asthma requiring bronchodilators for medical intervention are excluded.
  • HIV positive; HBsAg positive with detectable HBV DNA >= 1000 copies/ml); positive blood screening for chronic Hepatitis C (HCV antibody positive). Vaccination with any anti-infective vaccine (e.g., influenza, varicella) within 4 weeks prior to enrollment.
  • Positive pregnancy test in women of childbearing potential, or breastfeeding women.
  • Other patients considered unsuitable for inclusion by the investigator.

Trial locations and contacts

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

Mingyuan Chen contact

+86 18124188280

chmingy@mail.sysu.edu.cn

Xiaoting Cai contact

+86 15602268126

caixiaoting17@163.com

China2 sites, 2 recruiting

  • The Fifth Affiliated Hospital,Sun Yat-sen University

    Zhuhai, Guangdong, 519099

    Rui You, 13580439820, your5@mail.sysu.edu.cn

    Not yet recruiting

  • The Fifth Affiliated Hospital,Sun Yat-sen University

    Zhuhai, Guangdong, 519099

    You Rui, 13580439820, your5@mail.sysu.edu.cn

    Recruiting

Other trials in China

About this study

Official title: Phase 3 Clinical Study on the Efficacy and Safety of SBRT Combined With Becotatug Vedotin (MRG003) in EGFR-Positive Metastatic Tumor Patients With Oligometastases

The combination of local consolidative therapy for oligometastases with systemic therapy offers the potential for clinical cure and significantly prolongs survival in a subset of patients with advanced metastatic disease. However, a considerable proportion of patients still do not benefit from this approach.

Becotatug vedotin (MRG003) is an antibody-drug conjugate that carries the payload monomethyl auristatin E (MMAE), a microtubule inhibitor. MMAE has been shown to effectively enhance radiosensitivity in various preclinical tumor models, including head and neck squamous cell carcinoma, liver cancer, gastric cancer, pancreatic cancer, and lung cancer. Furthermore, multiple clinical studies have demonstrated the promising therapeutic potential of vicetuximab in EGFR-positive solid tumors.

Based on this background, we plan to conduct a clinical study evaluating the combination of stereotactic body radiotherapy (SBRT) for oligometastases with investigator-selected systemic therapy and Becotatug vedotin (MRG003) in patients with EGFR-positive oligometastatic tumors.

Being tested
Becotatug Vedotin, SBRT, Systemic Therapy/Standard of Care
Keywords
EGFR-postive oligo-metastatic cancer, SBRT, MMAE, Becotatug vedotin

What participants receive

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

  • Becotatug VedotinDrug

    Becotatug vedotin was administered intravenously at a dose of 2.0 mg/kg every 3 weeks (Q3W).

  • SBRTRadiation

    All oligometastatic lesions will be treated with SBRT with curative intent. Radiation doses are determined based on published clinical studies

  • Systemic Therapy/Standard of CareDrug

    Systemic therapy /Standard of Care will be determined at the investigator's discretion, in accordance with clinical guidelines and individual patient characteristics.

Study groups in NCT07481799
Study groupRoleWhat they receive
Becotatug vedotin plus SBRT and systemic therapy armExperimentalFor patients in the experimental group receives Becotatug vedotin plus SBRT and systemic therapy.
Receives: Drug: Becotatug Vedotin; Radiation: SBRT; Drug: Systemic Therapy/Standard of Care
SBRT and systemic therapy armActive comparatorFor patients in the control group receives SBRT and systemic therapy.
Receives: Radiation: SBRT; Drug: Systemic Therapy/Standard of Care

What is being measured

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

  1. Progression-free Survival (PFS)

    Defined as time from randomization to loco-regional or distant metastasis relapse or death from any cause, whichever occurred first.

    Measured: 1 year

Secondary outcomes (7)

  1. Overall Survival (OS)

    Defined as the time interval from randomization to death due to any cause.

    Measured: 1 year

  2. Objective Response Rate (ORR)

    Defined as the proportion of patients whose tumors shrink to complete response (CR) or partial response (PR) and remain for a certain period of time according to RECIST 1.1.

    Measured: 3 months after SBRT

  3. Disease Control Rate (DCR)

    Defined as the proportion of patients whose tumors shrink to complete response (CR), partial response (PR) or stable disease (SD) and remain for a certain period of time according to RECIST 1.1.

    Measured: 3 months after SBRT

  4. Duration of Response (DoR)

    Defined as the time from the first documented Complete Response (CR) or Partial Response (PR) to the first documented disease progression (PD) or death from any cause in patients with an objective response

    Measured: 1 year

  5. Health related quality of Life

    The quality of life was evaluated by referring to the European EORTC Quality of Life Questionnaire Core 30 (QLQ-C30, version 3.0) . The scores range from 0 to 100, with higher scores indicating a better quality of life outcome and lower scores indicating worse symptoms or functions.

    Measured: Baseline, after every two cycles of systemic therapy, before SBRT, after SBRT, and at each follow-up.

  6. Incidence of treatment related acute complications

    The proportion of patients with treatment related acute complications according to NCI-CTC5.0 criteria and RTOG criteria.

    Measured: During systemic therapy and up to three months after SBRT

  7. Incidence of treatment related late complications

    The proportion of patients with treatment related late complications according to NCI-CTC5.0 criteria and RTOG criteria.

    Measured: More than three months after SBRT

Timeline

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

  1. First posted19 Mar 2026
  2. Study start6 Feb 2026
  3. Primary completion28 Feb 2029 (estimated)
  4. Study completion28 Feb 2030 (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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07481799
Sponsor's protocol ID
ZDWY.FSZLK.008
Status last verified
Feb 2026
First submitted
15 Mar 2026
Last updated
2 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Becotatug Vedotin and SBRT in people with Oligo-metastatic Cancer, run by Ming-Yuan Chen at 2 sites 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 17 inclusion and 22 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 2 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 Mingyuan Chen (+86 18124188280, chmingy@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free Survival (PFS) (time frame: 1 year). 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 NCT07481799.

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 2 Apr 2026.

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