Trials / Unknown
UnknownNCT03507998
Phase 1 Dose Escalation Study of CGX1321 in Subjects With Advanced Gastrointestinal Tumors
A Phase 1 Open-label Dose Escalation Study of CGX1321 in Subjects With Advanced Gastrointestinal Tumors
- Status
- Unknown
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 39 (estimated)
- Sponsor
- Curegenix Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a multi-center, open label, repeat dose, Phase 1 study consisting of a Dose Escalation Phase and a Dose Expansion Phase to evaluate safety, pharmacokinetics, and clinical activity.
Detailed description
The purpose of the Dose Escalation Phase is to examine the safety and determine the maximum tolerated dose of CGX1321 when administered to subjects with advanced GI tumors that have relapsed or are refractory to or not considered medically suitable to receive standard of care treatment. Once the dose is identified in the Dose Escalation Phase, the Dose Expansion Phase will start. The purpose of the Dose Expansion Phase is to continue to examine the safety and confirm the final Phase 2 dose of CGX1321 when administered to subjects with advanced GI tumors who meet the entry criteria.
Conditions
- Colorectal Adenocarcinoma
- Gastric Adenocarcinoma
- Pancreatic Adenocarcinoma
- Bile Duct Carcinoma
- Hepatocellular Carcinoma
- Esophageal Carcinoma
- Gastrointestinal Cancer
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | CGX1321 | CGX1321 capsules for oral administration |
Timeline
- Start date
- 2017-06-17
- Primary completion
- 2021-04-01
- Completion
- 2021-04-01
- First posted
- 2018-04-25
- Last updated
- 2020-07-24
Locations
2 sites across 1 country: China
Source: ClinicalTrials.gov record NCT03507998. Inclusion in this directory is not an endorsement.