New drug combo shows promise for Hard-to-Treat cancers
NCT ID NCT07256782
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a new drug called QLC5508, given with other anti-cancer medicines, for people with advanced solid tumors that have stopped responding to standard treatments. The goal is to find the safest dose and see if the combination can shrink tumors. About 444 adults will take part in this early-phase trial.
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 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 444 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2025
- Expected to finish
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May 2028
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: * At least 18 years of age at screening; * Histologically or cytologically confirmed advanced solid tumors: Dose escalation part will enroll participants who have progressed on or are intolerant to available standard therapies. Dose expansion part will enroll participants who have not received prior treatment for advanced/metastatic diseases. * At least one measurable target lesion according to RECIST v1.1 * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0\~1 * Life expectancy ≥12 weeks * Female or male participants should be willing to use appropriate contraceptive measures throughout the study; * Female participants should have a negative blood pregnancy test within 7 days prior to the first dose or have evidence of non-childbearing potential; * A signed written Informed Consent Form Exclusion Criteria: * . Received or undergoing any of the following treatment: 1. Previous or current treatment with B7-H3 targeted therapy 2. Previous or current treatment with topoisomerase I inhibitors 3. Previous treatment with cytotoxic chemotherapy, investigational agents, traditional Chinese medicine with an anti-tumor indication and antitumor drugs within 14 days prior to the first dose 4. Previous treatment with macromolecular antitumor drugs within 28 days prior to the first dose f. Radiotherapy with a limited field of radiation within 2 weeks prior to the first dose; or more than 30% of the bone marrow irradiation, or large-scale radiotherapy within 4 weeks prior to the first dose e. Pleural effusion or ascites requiring clinical intervention; or presence of pericardial effusion f. Major surgery within 4 weeks prior to the first dose g. Brain metastases; leptomeningeal or brainstem metastases; or spinal cord compression * Unresolved AEs ≥ Grade 2 (CTCAE v5.0) from prior therapy except for alopecia and residual neuropathy * Previous or concurrent primary malignancies * Inadequate bone marrow reserve or organ dysfunction * Evidence of cardiovascular risk * Evidence of current severe or uncontrolled systemic diseases * Severe infection within 4 weeks prior to the first dose; or uncontrolled active infection at screening * Known or suspected interstitial lung disease; or other moderate to severe pulmonary diseases that significantly impair respiratory function and may interfere with the detection or management of drug-related pulmonary toxicity * High risk of gastrointestinal or abdominal bleeding 10. Gastrointestinal diseases of clinical significance within 3 months prior to the first dose * History of severe neuropathy or mental disorders * History of severe hypersensitivity reaction, severe infusion reaction or idiosyncrasy to drugs chemically related to QLC5508 or any of the components of QLC5508 * Unlikely to comply with study procedures and requirements in the opinion of the investigator * Any disease or condition that, in the opinion of the investigator, would compromise participant safety or interfere with study assessments
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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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Shanghai East Hospital
RECRUITINGShanghai, 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