New drug YL202 targets tough cancers in latest trial
NCT ID NCT07202364
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This phase 2 trial tests a new drug called YL202 in about 100 people with advanced solid tumors, including lung, colorectal, and cervical cancers. The drug is given through an IV and aims to shrink tumors or stop them from growing. Researchers will check how well it works and monitor for side effects.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- YL202 (a drug given by IV infusion)
- What this could lead to
- If successful, this could point toward a new treatment option for people with advanced solid tumors that have not responded to other therapies.
- What could go wrong
- This is an early-phase trial with only 100 participants, so results may not apply to everyone. The drug may cause side effects or fail to shrink tumors.
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 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 100 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2025
- Expected to finish
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Feb 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: * Subjects must meet all the following criteria to be included in the study: 1. Subjects who are aware of relevant study information prior to the start of the study, and voluntarily sign and date on the informed consent form (ICF). 2. Subjects aged ≥18 years at the time of giving informed consent 3. Body mass index (BMI) within the range of 18 to 32 kg/m2. 4. Subjects with histologically or cytologically confirmed non-Sq NSCLC/CRC/CC or other advanced solid tumor, and had received 1-2 lines of systemic therapy in the advanced/metastatic setting 5. There is at least one extracranial measurable lesion as the target lesion per the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. 6. Archived or fresh tumor tissue samples are available. 7. Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0 or 1. 8. The function of organs and bone marrow meets the requirements within 7 days prior to the first dose 9. Female subjects of childbearing potential must agree to adopt highly effective contraceptive measures from screening throughout the study period and within at least 6 months after the last dose of the investigational product. Male subjects must agree to adopt highly effective contraceptive measures from screening throughout the study period and within at least 6 months after the last dose of the investigational product. 10. Expected survival ≥3 months. 11. Be capable of and willing to comply with the visits and procedures stipulated in the study protocol. Exclusion criteria * Subjects who meet any of the following criteria should be excluded from the study: 1. Prior drug therapy targeting HER3 2. Previously intolerant to topoisomerase I inhibitors or ADC therapy composed of topoisomerase I inhibitors). 3. Are participating in another clinical study, unless it is an observational (non-interventional) clinical study or in the follow-up period of an interventional study. 4. The washout period from the previous anti-tumor therapy is insufficient prior to the first dose of the investigational product. 5. Patients who received major surgery (excluding diagnostic surgery) within 4 weeks prior to the first dose of the investigational product or those who are expected to receive major surgery during the study. 6. Prior treatment with allogeneic bone marrow transplantation or solid organ transplantation. 7. Prior treatment with systemic steroids (prednisone \>10 mg/day or equivalent) or other immunosuppressive treatment within 2 weeks prior to the first dose of the investigational product. 8. Patients who received any live vaccine within 4 weeks prior to the first dose of the investigational product or those who plan to receive live vaccine during the study period. 9. Meningeal metastasis or cancerous meningitis. 10. Brain metastasis or spinal cord compression. 11. Patients with uncontrolled or clinically significant cardiovascular diseases. 12. Clinically significant complicated pulmonary disorders. 13. Medical history of hepatic encephalopathy within 6 months prior to the first dose. 14. Subjects with active or chronic corneal disorders, or other active eye disorders requiring continuous treatment, or any clinically significant corneal disorders that preclude adequate monitoring of drug-induced keratopathy. 15. Diagnosed with Gilbert's syndrome. 16. Significantly symptomatic or unstable pleural effusion, peritoneal effusion, and pericardial effusion, or those requiring repeated drainage. 17. Medical history of gastrointestinal perforation and/or fistula within 6 months prior to the first dose, or active gastric and duodenal ulcers, ulcerative colitis, or other gastrointestinal diseases that may cause hemorrhage or perforation in the opinion of the investigator. 18. Serious infection prior to the first dose (National Cancer Institute-Common Terminology Criteria for Adverse Events \[NCI CTCAE\] v5.0 grade ≥3), 19. Patients with severe coagulopathy or other diseases with evident risk of bleeding. 20. Patients with uncontrolled diabetes mellitus. 21. Human immunodeficiency virus (HIV) infection; positive syphilis antibody and a positive titer result. 22. Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection. 23. Medical history of any other primary malignancies within 5 years prior to the first dose of the investigational product, except fully resected non-melanoma skin cancer, cured in-situ disease, or other cured solid tumors. 24. Unresolved toxicity of previous anti-tumor therapy, 25. History of severe hypersensitivity to inactive ingredients in the drug substance (DS) and drug product (DP) or other monoclonal antibodies. 26. Lactating women, or women who are confirmed pregnant via a pregnancy test within 3 days prior to the first dose. 27. Have any diseases, medical conditions, organ system dysfunction, or social conditions that may interfere with the subject ability to sign the ICF, adversely affect the subject ability to cooperate and participate in the study, or affect the interpretation of study results, including but not limited to mental illness or substance/alcohol abuse, in the opinion of the investigator.
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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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Hunan Provincial Tumor Hospital
RECRUITINGChangsha, Hunan, 410006, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- A multicenter, Dose-Escalation and expansion phase I/IIa clinical study to evaluate the safety, tolerability, pharmacokinetic characteristics, immunogenicity, and preliminary efficacy of SGT003 in patients with advanced solid tumors
- Ivosidenib plus mFOLFOXIRI and celecoxib as a treatment for BRAF-targeted therapy-refractory BRAF V600E-mutant colorectal cancer patients: a phase II study
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