Can a new drug shrink advanced solid tumors?

NCT ID NCT06417554

What the study statuses mean

This study's is highlighted.

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 24, 2026 · Last updated Aug 25, 2026 · Updated 1 time

Summary

This trial is testing an investigational drug called SHR-A2102, given alone or with other anti-tumor therapies, in people with advanced solid tumors. The goal is to find a safe and effective dose and see how well it shrinks tumors. Participants must be adults with certain types of advanced cancer that have not responded to standard treatment.

What this could mean

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

Active substance
SHR-A2102, an investigational drug, given alone or combined with other anti-tumor therapies
What this could lead to
If successful, this could lead to a new treatment option for people with advanced solid tumors that have not responded to standard therapies.
What could go wrong
This is an early-phase trial, so the drug may not be effective or may cause unexpected side effects. The results are not yet known.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 80 people

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

Started

May 2024

Expected to finish

Dec 2031

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Ages

18 to 80 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. Have the ability to give informed consent, have signed informed and able to comply with the treatment plan to visit the tests and other procedural requirements; 2. The age of signing the informed consent is above 18 years old, regardless of gender; for the SHR-A2102 combined with Disitamab Vedotin cohort, the maximum upper limit was 80 years old 3. The ECOG score is 0 or 1; 4. Expected survival ≥12 weeks 5. Subjects with pathologically confirmed locally advanced unresectable or metastatic solid tumors, stage Ib subjects who have failed standard treatment; Stage II subjects with pathologically confirmed locally advanced unresectable or metastatic solid tumors without systemic antitumor therapy; 6. Provide archived or fresh tumor tissue; 7. At least one measurable lesion according to RECIST v1.1 criteria; 8. Good level of organ function; 9. Male subjects whose partners are women of childbearing age and female subjects who are fertile are required to use highly effective contraceptive methods. Exclusion Criteria: 1. Inadequately treated central nervous system metastases or the presence of uncontrolled or symptomatic active central nervous system metastases; 2. Have previously received antiboy-coupled drugs containing topoisomerase I inhibitors; Stage II was previously treated with PD-1/PD-L1 inhibitors;For the SHR-A2102 combined with Disitamab Vedotin cohort, those who have previously received Disitamab Vedotin treatment or antibody-drug conjugates containing topoisomerase I inhibitors 3. Systemic antitumor therapy was received 4 weeks before the start of the study; 4. Palliative radiotherapy was completed within 14 days before the first dose; Chest radiotherapy \>30 Gy within 6 months prior to initial administration; 5. Toxicity and/or complications of previous antitumor therapy did not return to NCI-CTCAE level ≤1 or exclusion criteria; 6. Systemic immunosuppressive therapy was administered within 14 days prior to the first study; 7. Subjects with known or suspected interstitial pneumonia; 8. ≥ grade 3 immune-related adverse events occurred during previous treatment with immune checkpoint inhibitors were not eligible to be enrolled in the cohort of SHR-A2102 combined with SHR-1316 ; 9. The presence of any active, known, or suspected autoimmune disease; 10. Moderate or severe ascites with clinical symptoms, uncontrolled or moderate or above pleural effusion and pericardial effusion; 11. The presence of clinical cardiac symptoms or diseases that are not well controlled; 12. Any other malignancy diagnosed within the previous 5 years; 13. Subjects who had a severe infection within 28 days prior to the first dose; 14. Active hepatitis B or active hepatitis C; 15. Patients with active tuberculosis infection within 1 year prior to enrollment, or with a history of active tuberculosis infection more than 1 year prior but without formal treatment; 16. History of immune deficiency; 17. Live attenuated vaccines were used within 28 days prior to initial study administration or during the expected study period; 18. Participants who are participating in another clinical study or whose first dose is less than 4 weeks from the end of the previous clinical study (last dose), or five half-lives of the investigational drug, whichever is shorter; 19. Have undergone major surgery other than diagnosis or biopsy within 28 days prior to initial dosing; Minor traumatic surgery within 7 days prior to first dosing; Presence of non-healing wounds or untreated fractures; 20. Severe allergic reactions are known to occur in individuals allergic to any component of SHR-A2102, SHR-1316, Disitamab Vedotin or other monoclonal antibody/fusion protein drugs; 21. Female subjects who are pregnant or plan to become pregnant during the study period; 22. The presence of uncontrolled mental illness and other conditions known to affect the completion of the study process, such as alcohol, drug or substance abuse, and criminal detention; 23. In the investigator's judgment, there are any other circumstances that may increase the risk of participating in the study, interfere with the study results, or make participation in the study inappropriate; 24. Severe dry eye syndrome, active keratitis, corneal ulcers, and other conditions that the researchers have assessed may increase the risk of corneal diseases and are not suitable for participation in this study; 25. ≥ grade 2 peripheral neuropathy.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

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

  1. The places running it

    1 site. 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

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Peking University Cancer Hospital

    RECRUITING

    Beijing, Beijing Municipality, 100142, China

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