Ireland
--:--IST
Recruiting Phase 1

A Phase I Study of CG-7321 Monotherapy or Combination Therapy in Advanced Solid Tumors

NCT07923214 · tracked via the Priya Life Science China tracker
Sponsor
Chengdu Cynogen Bio-pharmaceutical Tech. Co., Ltd
Phase
Phase 1
Started
2024-07-02
Last updated
2026-11-06

Condition(s) studied

Advanced Solid TumorsBreast CancerOvarian CancerGastric CancerOther Solid Tumors

Investigational drug(s) / intervention(s)

CG-7321

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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * 1\. Voluntary signed informed consent and compliance with protocol requirements * 2\. Age ≥18 years, any gender * 3\. Life expectancy ≥12 weeks * 4\. Eastern Cooperative Oncology Group(ECOG) performance status 0-1 * 5\. For Ia monotherapy dose escalation: patients with cytologically and/or histopathologically confirmed advanced or metastatic solid tumors who have failed, are intolerant to, or have no effective standard treatment, or who refuse standard treatment * 6\. Voluntary provision of tumor tissue specimens (archived within 2 years or fresh tissue) * 7\. At least one measurable lesion per Response Evaluation Criteria in Solid Tumors, version 1.1(RECIST 1.1) * 8\. Prior anticancer treatment-related toxicities resolved to ≤1 grade (except alopecia) * 9\. Adequate organ and bone marrow function * 10\. Negative serum pregnancy test within 7 days before first dose * 11\. Agreement to use effective contraception from ICF signing to ≥6 months after last dose * 12\. No breastfeeding during study and ≥6 months after last dose * 13\. Understanding of study and voluntary written informed consent Exclusion Criteria: * 1\. Anticancer therapy (chemotherapy, targeted therapy, biologics, immunotherapy, radiotherapy) within 4 weeks before first dose, or participation in other interventional clinical studies (observational studies excluded) * 2\. Strong Cytochrome P450 3A4(CYP3A4)inhibitors within 2 weeks before first dose * 3\. Strong Cytochrome P450 2C8(CYP2C8) inhibitors within 2 weeks before first dose * 4\. Other active malignancies within 3 years before first dose (except curable tumors treated radically) * 5\. Primary Central Nervous System(CNS) tumors or CNS metastases that failed local treatment (stable asymptomatic CNS metastases allowed) * 6\. Conditions affecting drug absorption or Pharmacokinetics(PK) parameters (e.g., uncontrolled nausea/vomiting, chronic diarrhea, malabsorption syndrome) * 7\. Uncontrolled or significant cardiovascular disease, * 8\. Active infection requiring systemic therapy within 2 weeks; * 9\. Major surgery within 4 weeks before first dose (except minor procedures) * 10\. Known allergy to study drug or excipients * 11\. Mental or cognitive impairment affecting study compliance * 12\. Known alcohol or drug dependence * 13\. Pregnant or lactating women * 14\. Investigator deems subject unsuitable for study participation

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)

FacilityCityRegionStatus
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
Official registry record

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