New combo aims to control metastatic cancer in patients with limited spread

NCT ID NCT07481799

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This Phase 3 trial tests whether combining stereotactic body radiotherapy (SBRT) with the drug becotatug vedotin (MRG003) can improve outcomes for patients with EGFR-positive metastatic tumors that have spread to only a few spots (oligometastases). The study will enroll 200 adults aged 18-75. The goal is to see if this approach can delay cancer progression and extend survival.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
becotatug vedotin (MRG003) combined with stereotactic body radiotherapy (SBRT)
What this could lead to
If successful, this combination could offer better control of metastatic cancer and extend survival for patients with limited spread.
What could go wrong
This is still an early Phase 3 trial with 200 participants. The drug may cause side effects, and not all patients may benefit. Results may not apply to all cancer types.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 200 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2026

Expected to finish

Feb 2030

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Age: 18 to 75 years (inclusive), male or female. 2. Patients with histologically or cytologically confirmed recurrent or metastatic solid tumors who are not amenable to curative surgery. 3. Oligometastatic lesions detected on imaging (biopsy of metastatic tissue is preferred but not mandatory). The total number of metastatic lesions must be \<=5. 4. The primary tumor has been treated radically and is controlled. 5. Subjects must provide tumor tissue samples for EGFR testing of the primary tumor or metastatic lesions: a) 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. 6. All metastatic lesions are deemed amenable to SBRT (Stereotactic Body Radiation Therapy) by multidisciplinary team (MDT) consultation. 7. For patients whose metastatic lesions have received prior local therapy (e.g., surgery, radiofrequency ablation, radiotherapy): 1. If the treated metastatic lesion is controlled on imaging, the patient is eligible, and SBRT is not required for that specific site. 2. If the treated metastatic lesion is not controlled on imaging: 1. If the prior therapy was surgery and the site is amenable to SBRT, the patient is eligible; 2. If the prior therapy was radiotherapy or RFA, the patient is ineligible. 8. Maximum diameter of brain metastases \<= 3 cm. 9. Maximum diameter of extra-cranial metastases \<= 5 cm. a) 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. 10. ECOG performance status of 0-1. 11. Life expectancy \>= 6 months. Exclusion Criteria: 1. History of severe hypersensitivity to any component of monoclonal antibodies. 2. The investigator's choice of systemic therapy regimen contains taxanes (or other microtubule inhibitors) . 3. 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. 4. 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: 1. 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); 2. 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; 3. 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. 5. Received treatment with strong CYP3A4 or CYP2D6 inhibitors or inducers, or P-gp inhibitors within 5 half-lives prior to the first dose. 6. Prior treatment with EGFR ADCs, or prior treatment with ADCs containing microtubule inhibitors. 7. 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. 8. Clinical or radiological evidence of spinal cord compression, or tumor distance to the spinal cord \< 3 mm. 9. Grade \>= 2 coronary heart disease, arrhythmia (including QTc interval prolongation \> 450 ms for males, \> 470 ms for females), or cardiac insufficiency. 10. Patients with brain metastases requiring surgical decompression. 11. Patients with malignant effusions. 12. patients with concomitant malignancies. 13. Dementia or seizures. 14. 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. 15. Active pulmonary tuberculosis, currently undergoing anti-tuberculosis treatment, or having received such treatment within 1 year prior to screening. 16. 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. 17. 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. 18. Positive pregnancy test in women of childbearing potential, or breastfeeding women. 19. Other patients considered unsuitable for inclusion by the investigator.

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How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

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Contacts and locations

Locations

  • The Fifth Affiliated Hospital,Sun Yat-sen University

    NOT_YET_RECRUITING

    Zhuhai, Guangdong, 519099, China

  • The Fifth Affiliated Hospital,Sun Yat-sen University

    RECRUITING

    Zhuhai, Guangdong, 519099, China