Can a pill shrink advanced tumors? a new drug steps into the spotlight
NCT ID NCT07749703
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
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 346 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2026
- Expected to finish
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Jun 2030
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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
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Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
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Shandong Cancer Hospital and Institute
Jinan, Shandong, China
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Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, China
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The First Affiliated Hospital of University of Science and Technology of China
Hefei, Anhui, China
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The First Hospital of China Medical University
Shenyang, Liaoning, China
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Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- First-in-Human trial asks whether HG381 is safe and tolerable in advanced solid tumors
- Custom-Built immune cells take aim at a notorious cancer mutation
- Experimental injection SHR-7787 put to the test against advanced solid tumors
- Experimental biologic AWT020 put to the test in Hard-to-Treat cancers
- Can a pill shrink Hard-to-Treat ovarian tumors?
- Oral drug RVU120 put to the test against advanced solid tumors