New combo therapy aims to shrink Hard-to-Treat tumors
NCT ID NCT07272590
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a new drug combination (QLC5513 plus QL1706, with or without platinum chemo) in people with advanced solid tumors that have spread. The goal is to see if the treatment can shrink tumors and to check its safety. About 290 participants will take part, and the study is for those who cannot have surgery or radiation.
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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 290 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Dec 2025
An estimate. Start dates often move.
- Expected to finish
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Aug 2031
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.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Has an eastern cooperative oncology group (ECOG) performance status of 0 to 1. 2. Has adequate organ function. 3. The expected survival period is ≥3 months. 4. Based on the pathological report of the most recent biopsy or other pathological specimens, advanced or metastatic solid tumors confirmed by histology or cytology are not suitable for radical treatments such as surgery and radiotherapy. 5. According to the RECIST v1.1 evaluation criteria, the participants had at least one radiologically measurable lesion. Exclusion Criteria: 1. Prior treatment with TROP2-targeting agents, ADCs with topoisomerase 1 inhibitor (TOP1i) payloads, or other TOP1i drugs. 2. There was symptomatic central nervous system (CNS) metastasis, leptomeningeal metastasis or spinal cord compression caused by metastasis before the first use of the investigational product. 3. Active, uncontrolled bacterial, fungal or viral infections. 4. Radiotherapy with more than 25% of the bone marrow exposed within 4 weeks prior to the first use of the investigational drug; Local radiotherapy (excluding brain radiotherapy) was performed within two weeks before the first use of the investigational drug. 5. Subjects with a history of a second malignant tumor other than the target indication within 5 years prior to signing the informed consent (excluding cured basal cell skin cancer, superficial bladder cancer, carcinoma in situ of the breast, papillary thyroid carcinoma, etc.). 6. Prior to the first dose of the investigational product, all reversible toxicities from prior anti-tumor therapy (excluding alopecia and pigmentation) have not recovered to ≤ Grade 1 (as assessed by CTCAE v5.0), with the exception that peripheral neuropathy must have not recovered to ≤ Grade 2. History of irAEs from prior immune checkpoint inhibitor treatment that required permanent discontinuation of the immune checkpoint inhibitor. 7. Active autoimmune disease that has required systemic treatment in the past 2 years.
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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 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.
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Other studies related to the condition(s) this trial covers.
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