A Phase I Study of CG-7321 Monotherapy or Combination Therapy in Advanced Solid Tumors
Condition(s) studied
Investigational drug(s) / intervention(s)
CG-7321: Novel oral cyclin-dependent kinase (CDK) inhibitor. Dose levels: 2mg, 6mg, 12mg, 20mg, 30mg, 40mg, 50mg BID. 28-day cycle.
Study summary
This is a Phase I, open-label, multi-center study to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of CG-7321 capsules as monotherapy or in combination with fulvestrant in subjects with advanced solid tumors.
The study consists of:
* Part Ia (Monotherapy): Dose escalation (accelerated titration followed by 3+3 design) from 2mg to 50mg twice daily (BID), plus dose expansion cohorts in advanced solid tumors including HR+/HER2- breast cancer, ovarian cancer, gastric cancer, and other tumor types.
* Part Ib (Combination Therapy): Dose escalation of CG-7321 combined with fulvestrant in HR+/HER2- advanced breast cancer.
Eligibility
Primary outcome measure(s)
- Dose-Limiting Toxicities (DLTs) — DLT observation period [approximately 28 days]
Number of participants experiencing DLTs during DLT evaluation period. - Maximum Tolerated Dose (MTD) — End of dose escalation phase [approximately 6-12 months]
The highest dose level at which ≤2/6 evaluable subjects experience DLT. - Recommended Phase 2 Dose (RP2D) — End of dose escalation phase [approximately 6-12 months]
The dose level recommended for Phase 2 studies. - Adverse Events (AEs) and SAEs — From first dose to 30 days after last dose [up to approximately 2 years]
Incidence and severity of AEs and SAEs, graded per NCI-CTCAE Version 5.0.
Trial sites (4)
| Facility | City | Region | Status |
|---|---|---|---|
| Fujian Cancer Hospital | Fuzhou | Fujian | Recruiting |
| Zhongshan Hospital of Dalian University | Dalian | Liaoning | Recruiting |
| Fudan University Shanghai Cancer Center | Shanghai | Shanghai Municipality | Recruiting |
| West China Hospital, Sichuan University | Chengdu | Sichuan | Recruiting |
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07923214 on ClinicalTrials.gov ↗ ← All trials in China