Phase 1 Dose Escalation Study of CGX1321 in Subjects With Advanced Gastrointestinal Tumors
NCT ID: NCT03507998
Last Updated: 2020-07-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE1
39 participants
INTERVENTIONAL
2017-06-17
2021-04-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy, Phase 1 Study of CMG901
NCT04805307
First-Line and Neoadjuvant Immunotherapy for Gastric Cancer
NCT06727981
To Evaluate the Efficacy of CT041 in Sequential Treatment After First-line Treatment of Advanced Gastric/Esophagogastric Junction Adenocarcinoma
NCT07179484
Study to Evaluate the Efficacy, Safety and Pharmacokinetics of CT041 Autologous CAR T-cell Injection
NCT04581473
New Adjuvant Treatment of Locally Advanced Resectable Gastric Cancer With Carelizumab and XELOX
NCT05715632
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
CGX1321 Dosing
Dose Escalation Phase: Ascending doses of CGX1321 will be administered by cohort to determine the maximum tolerated dose. Patients will receive CGX1321, once daily, orally, for 3 weeks (21 days) followed by a one week (7 day) washout period in each 28 day cycle, according to the cohort they are assigned.
Dose Expansion Phase: Patients will receive the recommended dose (identified in the Dose Expansion Phase) of CGX1321
CGX1321
CGX1321 capsules for oral administration
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
CGX1321
CGX1321 capsules for oral administration
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Eastern Cooperative Oncology Group (ECOG) score of 0 - 1
* Minimum estimated life expectancy of 3 months
* Adequate organ function
* Recovery from prior treatment-related toxicities
* Ability to swallow capsules
* Willingness for subjects of reproductive potential to use adequate methods of contraception during and for 3 months after study treatment
Exclusion Criteria
* Received previous therapy for malignancy within 21 days
* Major surgery within 4 weeks of first dose of study drug
* Radiotherapy within 2 weeks of first dose of study drug
* Significant GI or variceal bleeding or subdural hematoma within 3 months of treatment start
* Uncontrolled central nervous system metastases or leptomeningeal metastases
* Requirement for immunosuppressive agents (must be off for at least 7 days)
* Currently receiving medications that are known CYP3A4/5 inhibitors. Patients currently receiving medications of known inducers of CYP3A4/5 or substrates of CYP2C8/9 and CYP1A2 may be excluded.
* Bone abnormalities
* Hypercalcemia
* Cardiac abnormalities
* Known human immunodeficiency virus positive, or active hepatitis A, B or C
* History of additional prior malignancy with the exception of surgically cured carcinomas such as skin, prostate, bladder, thyroid, cervix or other carcinomas in situ
* Active systemic infection requiring intravenous antibiotics within 2 weeks of treatment start
* Pregnancy or lactation
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Guangzhou Curegenix Co. Ltd.
UNKNOWN
Curegenix Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Beijing Cancer Hospital
Beijing, , China
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijing, , China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Lin Shen, MD
Role: primary
Aiping Zhou, MD
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CGX1321-102
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.