CG-7321: a first-in-human test in advanced solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase I, open-label, multicenter study to determine the safety, tolerability, pharmacokinetics, and preliminary activity of CG-7321 as a single agent and in combination with fulvestrant. The trial uses a dose-escalation approach to identify the maximum tolerated dose and a recommended Phase II dose, with expansion cohorts to further evaluate safety and early signals of effectiveness in specific tumor types. Part Ia investigates monotherapy across several solid tumors, while Part Ib assesses CG-7321 with fulvestrant in HR+/HER2- advanced breast cancer. Eligible patients include adults with advanced or metastatic solid tumors who have exhausted standard therapies or refuse them.

Why it matters

Who can join: the full rules

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

Where it's running

• Fujian Cancer Hospital
  Fuzhou, Fujian, China Recruiting
• Zhongshan Hospital of Dalian University
  Dalian, Liaoning, China Recruiting
• Fudan University Shanghai Cancer Center
  Shanghai, Shanghai Municipality, China Recruiting
• West China Hospital, Sichuan University
  Chengdu, Sichuan, China Recruiting

Study contacts

• Study coordinator: Ke Lan
• Email: lanke@cynogen.com
• Phone: +86-13982078904

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.