New pill HRS7415 shows promise in early cancer trial
NCT ID NCT05318833
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-phase study tested a new drug called HRS7415 in 38 people with advanced cancers that had spread. The main goals were to check safety, find the right dose, and see if the drug could help control the disease. Researchers monitored side effects and measured drug levels in the blood.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- HRS7415
- What this could lead to
- If it works, this could point toward a new treatment option for advanced cancers that have not responded to other therapies.
- What could go wrong
- This is a very early Phase 1 trial with only 38 participants, so it is primarily testing safety and dosing. The drug may not shrink tumors or may cause side effects.
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
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
38 people
The number who actually took part.
- Started
-
May 2022
- Finished
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Mar 2025
- Lead sponsor
-
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
-
18 to 75 years
- Sex
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Anyone
- Healthy volunteers
-
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. Subjects volunteered to participate in the clinical study, understood the study procedure and was able to sign informed consent in person. 2. 18 to 75 years old, male or female. 3. ECOG Performance Status of 0 or 1. 4. The estimated survival time is ≥12 weeks. 5. Subjects with advanced or metastatic malignancy confirmed by histopathology or cytology. 6. Solid tumor subjects had measurable lesions that met RECIST 1.1 criteria. 7. Adequate hematology and terminal organ function, with vital organ function meeting the upper and lower limits required by the protocol. 8. Male subjects and fertile female subjects must agree to use medically approved contraception during the study period and for 6 months following the study; Fertile female subjects must have a negative serum human chorionic gonadotropin (HCG) test within 7 days prior to initial dosing and must be non-lactation blood pregnancy test must be negative and not lactation. Exclusion Criteria: 1. Subjects plan to receive any other antitumor therapy during the study period. 2. Subjects received chemotherapy, radiotherapy, biotherapy, targeted therapy, or immunotherapy within 4 weeks prior to initial dosing. 3. Major surgery other than diagnosis or biopsy was performed within 4 weeks prior to initial dosing. 4. Received any other investigational drug or treatment that is not on the market within 4 weeks prior to initial dosing. 5. The damage caused by any previous antineoplastic therapy has not recovered to grade ≤1. 6. Imaging diagnosis showed tumor lesion or meningeal metastasis in the brain. 7. Active heart disease in the 6 months prior to initial dosing. 8. Had other malignancies within 5 years prior to first dosing. 9. Subjects with poorly controlled hypertension and a previous history of hypertensive crisis or hypertensive encephalopathy. 10. Having one of several factors affecting oral medication or having active gastrointestinal disease or other medical conditions that may result in significant influence on drug absorption, distribution, metabolism or excretion; 11. Active hepatitis B and C; 12. Serious infections that require intravenous antibiotics, antivirals or antifungals to control; 13. History of immune deficiency or organ transplantation; 14. Comorbidities or any other conditions that, in the investigator's judgment, seriously endanger patient safety or prevent patients from completing the study.
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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
-
Cancer Hospital Affiliated to Shandong First Medical University
Jinan, Shandong, 250021, China
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Other studies related to the condition(s) this trial covers.
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