This is a Phase I, open-label, multi-center study to measure the safety, tolerability, pharmacokinetics (PK), and preliminary how well it works of CG-7321 capsules as this drug alone or in combination with fulvestrant in subjects with advanced solid tumors. The study consists of: * Part Ia (this drug alone): 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.
Official registry: https://clinicaltrials.gov/study/NCT07923214 · Chengdu Cynogen Bio-pharmaceutical Tech. Co., Ltd. · enrollment listed as 30
Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
If you join, the listed intervention(s) are CG-7321. The registry lists allocation as randomized. This is a Phase I, open-label, multi-center study to measure the safety, tolerability, pharmacokinetics (PK), and preliminary how well it works of CG-7321 capsules as this drug alone or in combination with fulvestrant in subjects with advanced solid tumors.
They plan to enroll about 30 people at 4 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.
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
Interventions: CG-7321
Primary outcome (registry wording): Dose-Limiting Toxicities (DLTs)
Ke Lan
Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.
This study will collect blood from patients with cancer to study the level of cells which decrease the immune response (suppressor cells) before and after chemotherapy. Patients 18 years of age and older with cancer may participate.
NCT00034216 · Official ClinicalTrials.gov record · National Cancer Institute (NCI)
This study aims to provide long-term follow-up care of patients previously enrolled in a vaccine study that involved poxviral vectors. Vectors are sequences of genetic material that can be used to introduce specific genes into genetic makeup.
NCT00451022 · Official ClinicalTrials.gov record · National Cancer Institute (NCI)
Background: The NCI Surgery Branch has developed an experimental therapy that involves taking white blood cells from patients' tumors, growing them in the laboratory in large numbers, and then giving the cells back to the patient. These cells are called Tumor Infiltrating Lymphocytes, or TIL and we have given this type of treatment to over 200 patients with melanoma.
NCT01174121 · Official ClinicalTrials.gov record · National Cancer Institute (NCI)
The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.
Phase 1. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.
How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary