New pill QLS-1304 enters human testing for advanced cancers
NCT ID NCT06823609
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early-stage trial tests an experimental drug called QLS-1304 in 180 adults with advanced solid tumors that have not responded to standard treatments. The main goals are to check the drug's safety, find the right dose, and get a first look at whether it can shrink tumors. Participants take QLS-1304 tablets, and the study is currently recruiting.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- QLS-1304 tablet
- What this could lead to
- If it works, this could point toward a new treatment option for people with advanced solid tumors who have run out of standard therapies.
- What could go wrong
- This is an early Phase 1 trial focused on safety and dosing, so it is too soon to know if QLS-1304 will be effective. Side effects are unknown, and many early-stage cancer drugs do not advance to later trials.
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 180 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2025
- Expected to finish
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Dec 2027
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: * Volunteer to participate in this study, sign an informed consent form and have good compliance; * Age ≥ 18 years old, Male or female * ECOG score: 0-1 * Expected survival ≥ 12 weeks * Local recurrent or metastatic advanced malignant solid tumor confirmed by histopathology or cytopathology; * Failed to standard treatment or has no standard treatment scheme; * Baseline presence of at least one evaluable lesion according to the RECIST v1.1; * The functional level of important organs is basically normal, meeting the requirements of the scheme * Female subjects with fertility and male subjects must agree to use highly effective contraception during the study treatment period and within 180 days after the last medication; * Female subjects with fertility must have a negative serum HCG test within 7 days before the first medication in the study, and must be in non lactation. * Volunteer to participate in this clinical trial, willing and able to follow the procedures related to clinical visits and research, understand the research procedures, and have signed informed consent Exclusion Criteria: * 1\. Subjects have received live or attenuated live vaccines within 4 weeks before the first use of the investigational drug. * Subjects have undergone major organ surgery within 4 weeks before the first use of the investigational drug. * Subjects require long-term or high-dose use of non-steroidal drugs. * Subjects have not recovered from adverse events (AEs) caused by previous anti-tumor treatment to ≤ grade 1. * Subjects have a known or suspected severe allergy to theinvestigational drug or any of its components Subjects have other active malignant tumors within 5 years before the first use of the investigational drug. * Subjects have brain metastases and/or carcinomatous meningitis or leptomeningeal disease. * Subjects have active tuberculosis, radiation pneumonitis, drug-induced pneumonitis, pulmonary fibrosis, or other diseases, symptoms, or signs of severe lung function impairment. * Subjects are unable to swallow tablets or had gastrointestinal abnormalities that the investigator assessed as potentially affecting drug absorption. * Subjects have a history of severe cardiovascular or cerebrovascular disease within 6 months before the first use of the investigational drug. * Subjects have a hypertension medial history that blood is not well controlled despite treatment with multiple antihypertension drugs.
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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.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Fudan University Cancer Hospital
RECRUITINGShanghai, China
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