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

Trial details

Who runs it

Chengdu Cynogen Bio-pharmaceutical Tech. Co., Ltd.

Trial code

NCT07923214

Record updated

2026. november 6.

Original description

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.Read full original descriptionShow less

A Phase I, Open-Label, Multi-Center Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of CG-7321 as Monotherapy or in Combination Therapy in Subjects With Advanced Solid Tumors

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.

Inclusion: 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: 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; 9. Major surgery within 4 weeks before first dose (except minor procedures); 12. Known alcohol or drug dependence; 4. Other active malignancies within 3 years before first dose (except curable tumors treated radically); 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; 10. Known allergy to study drug or excipients; 11. Mental or cognitive impairment affecting study compliance; 5. Primary Central Nervous System（CNS） tumors or CNS metastases that failed local treatment (stable asymptomatic CNS metastases allowed); 13. Pregnant or lactating women; 14. Investigator deems subject unsuitable for study participation.

ClinicalTrials.gov NCT07923214