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Can a pill shrink advanced tumors? a new drug steps into the spotlight

NCT ID NCT07749703

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 06, 2026 · Last updated Aug 12, 2026 · Updated 3 times

Summary

This early-stage trial is testing an experimental pill called SIM0532 in adults with advanced solid tumors that have not responded to standard treatments. The study is split into two parts: first, to find a safe dose, and then to see if the drug can shrink tumors or slow their growth. Researchers will also measure how the drug moves through the body and how long any benefit lasts.

What this could mean

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

Active substance
SIM0532 tablets
What this could lead to
If successful, this could lead to a new oral treatment option for people with advanced solid tumors that have not responded to other therapies.
What could go wrong
This is an early, first-in-human study, so the drug may not be safe or effective. Side effects are unknown, and the results may not lead to a widely available treatment.

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 346 people

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

Started

Mar 2026

Expected to finish

Jun 2030

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\. Signed the informed consent form prior to performing the specified procedures required by the study. * 2\. Aged ≥18 years. * 3\. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1. * 4\. Expected survival ≥12 weeks. * 5\. Laboratory test results indicating sufficient organ function. * 6\. At least one measurable lesion per RECIST v1.1; Exclusion Criteria: * 1\. A history of other malignant tumors within 2 years. * 2\. With symptomatic central nervous system (CNS) metastases. * 3\. Gastrointestinal diseases that affect drug administration/absorption. * 4\. Known psychiatric disorders or substance abuse that may interfere with the conduct of the study. * 5\. Uncontrolled pleural effusion, pericardial effusion or ascites requiring drainage or medical intervention within 4 weeks. * 6\. Any active infection requiring systemic treatment within 2 weeks. * 7\. A history of non-infectious pneumonia requiring oral or intravenous steroid therapy for recovery, or interstitial lung disease (ILD) or severe obstructive pulmonary disease. * 8\. Previous treatment with RAS-targeting therapies other than RAS (OFF) inhibitors. * 9\. Failure to recover from adverse events (AEs) caused by previous antineoplastic therapy. * 10\. Currently participating in or having participated in a study of other investigational drugs or devices within 4 weeks. * 11\. Major surgery within 4 weeks. * 12\. Previous antineoplastic therapy before the first dose of study treatment should have a certain wash-out period * 13\. Vaccination with any live vaccine within 4 weeks. * 14\. Known human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS). * 15\. Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection; * 16\. A history of clinically significant cardiovascular disease. * 17\. A history of allogeneic organ transplantation or graft-versus-host disease (GVHD). * 18\. Known hypersensitivity to the study drug or any of its excipients. * 19\. Participants who are pregnant or breastfeeding.

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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.

Contacts and locations

Locations

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality, China

  • Shandong Cancer Hospital and Institute

    Jinan, Shandong, China

  • Shanghai Pulmonary Hospital

    Shanghai, Shanghai Municipality, China

  • The First Affiliated Hospital of University of Science and Technology of China

    Hefei, Anhui, China

  • The First Hospital of China Medical University

    Shenyang, Liaoning, China

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.