Could an AI-Designed pill take on Hard-to-Treat cancers?

NCT ID NCT06445517

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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

Summary

This early-stage trial is testing an experimental oral drug called ISM8207 in people with advanced solid tumors or relapsed/refractory B-cell lymphoma who have no standard treatment options left. The main goals are to check the drug's safety, tolerability, and how the body processes it, while also looking for any early signs that it might shrink tumors or control the disease. The study is the first time ISM8207 is being given to humans.

What this could mean

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

Active substance
an experimental oral drug called ISM8207
What this could lead to
If safe and effective, ISM8207 could offer a new treatment option for people with advanced solid tumors or B-cell lymphoma who have run out of standard therapies.
What could go wrong
This is a very early, first-in-human trial with only 60 participants, so the drug may prove unsafe or ineffective. Side effects are unknown and could be serious.

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

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 60 people

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

Started

Apr 2024

Expected to finish

Feb 2027

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 years and older

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. Male or female participants with age ≥18 years at the time of signing the informed consent. 2. Advanced solid tumors: Histologically confirmed advanced or metastatic solid tumors who have disease progression after standard therapy, intolerable to standard therapy, or for whom no standard therapy exists. B-cell lymphoma: Histologically confirmed B-cell lymphoma who had received at least one prior line of standard therapy and were relapsed after or refractory to the standard therapy. 3. Have measurable or evaluable lesions in Part 1 and at least one measurable target lesion in Part 2 as defined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria or Lugano 2014. 4. ECOG PS (Eastern Cooperative Oncology Group Performance Status)≤1. 5. Life expectancy of ≥12 weeks as judged by the investigator. 6. Adequate organ function as determined by medical assessment. 7. Capable of providing signed ICF and complying with the requirements and restrictions listed in the ICF and in this study protocol. 8. Female subjects of childbearing potential and male subjects must agree to use an effective method of contraception during the treatment period and for 90 days after the last dose of ISM8207. Exclusion Criteria: 1. Prior treated with other QPCTL, CD47 or SIRPα inhibitors. 2. Burkitt lymphoma/leukemia, plasma cell myeloma, plasmablastic lymphoma. 3. Participation in other therapeutic clinical studies within 28 days or 5 half- lives (whichever is shorter) prior to first dose of study treatment. 4. Anti-tumor therapy (chemotherapy, immunotherapy, targeted therapy, biologic therapy, or other anti-tumor therapy) within 28 days or 5 half-lives, whichever is shorter prior to first dose of study treatment. 5. Previous allogeneic stem cell transplantation or autologous stem cell. transplantation within 3 months prior to first receiving study treatment. 6. Unresolved toxicity of Grade \>1 attributed to any prior therapies (excluding alopecia). 7. Received antitumor steroid therapy within 7 days prior to the first study treatment administration. 8. A serious illness or medical condition(s)

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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

    4 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

    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

  • Beijing Cancer Hospital

    RECRUITING

    Beijing, Beijing Municipality, 100142, China

  • Shanghai Jiao Tong University School of Medicine-Ruijin Hospital

    RECRUITING

    Shanghai, Shanghai Municipality, 200025, China

  • The First Affiliated Hospital of Nanchang University

    RECRUITING

    Nanchang, Jiangxi, China

  • Tianjin Medical University Cancer Institute&Hospital

    RECRUITING

    Tianjin, Tianjin Municipality, China

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