Advanced Malignant Solid Tumors
Conditions
Brief summary
This study aims to evaluate the safety and efficacy of RCZY690 therapy in participants with advanced malignant solid tumors. Participants will receive RCZY690 monotherapy until the end of the study.
Interventions
DRUGRCZY690 Tablets
Oral medication. The patient will continue treatment until unacceptable toxic reactions occur, the disease progresses, or any criteria for leaving the study are met.
DRUGRCZY690 tables
Oral medication. The patient will continue treatment until unacceptable toxic reactions occur, the disease progresses, or any criteria for leaving the study are met.
Sponsors
Rongchang Pharmaceuticals Co., Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Voluntarily participate in this study, sign the informed consent form, and be able to comply with the study protocol. 2. Age between 18 and 75 years inclusive. 3. ECOG performance status of 0 or 1. 4. Expected survival ≥ 12 weeks. 5. At least one measurable target lesion based on imaging assessment per RECIST version 1.1 criteria. 6. Adequate bone marrow, hepatic, renal and coagulation function.
Exclusion criteria
1. Female participants who are pregnant, lactating, or planning to become pregnant. 2. Participants with brain metastases. 3. History of severe bleeding tendency or coagulation dysfunction. 4. Toxicities from prior anti-tumor therapy have not recovered to Grade 1 per NCI-CTCAE version 6.0. 5. Known hypersensitivity or delayed-type allergic reaction to any components of the investigational drug or similar agents. 6. Any condition that impairs the participant's ability to swallow study medication, or conditions judged by the investigator to significantly affect study drug absorption. 7. Participants with acute, chronic or symptomatic infection. 8. Uncontrolled cardiovascular disease. 9. Participants with confirmed or suspected interstitial lung disease (ILD), drug-related pneumonitis or other pulmonary diseases. 10. History of liver cirrhosis (Child-Pugh Class B or C). 11. Active inflammatory bowel disease. 12. Participants with uncontrolled diabetes (HbA1c ≥10%). 13. Arterial or venous thromboembolic events within 6 months prior to the first study drug administration. 14. Pericardial effusion, cardiac tamponade, or third-space effusions (including massive pleural effusion or ascites) that cannot be stably controlled by drainage or other measures as judged by the investigator. 15. Active autoimmune disease requiring systemic therapy within the past 2 years. 16. History of other invasive malignancies within 5 years prior to first dose, or any evidence of residual disease from previously diagnosed malignancy. 17. History of acquired or congenital immunodeficiency disorders, or history of organ transplantation. 18. Past or current poorly controlled psychiatric disorders. 19. Poor compliance, and participants who are expected to be unable to comply with study procedures.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dose-Limiting Toxicity | 24 months |
| Number of subjects with adverse events (AEs) | 24 months |
| Maximum Tolerated Dose and/or Maximum Administered Dose | 24 months |
| Recommended Phase 2 Dose | 24 months |
| Objective Response Rate (ORR) | 24 months |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate | 24 months |
| Adverse Events/Serious Adverse Event | 24 months |
| Disease Control Rate | 24 months |
| Duration of Response | 24 months |
| Progression-Free Survival | 24 months |
| Overall Survival | 24 months |
Countries
China
Contacts
CONTACTHeping Liu
Outcome results
None listed