Colorectal AdenocarcinomaPhase 1NCT03507998
Phase 1 Dose Escalation Study of CGX1321 in Subjects With Advanced Gastrointestinal Tumors
A Phase 1 study testing CGX1321 in people with Colorectal Adenocarcinoma and Gastric Adenocarcinoma, run by Curegenix Inc. at 2 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Adenocarcinoma, Gastric Adenocarcinoma, Pancreatic Adenocarcinoma
- What is being tested?
- CGX1321
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 2 sitesChina
- Study dates
- 17 Jun 2017to 1 Apr 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically-diagnosed advanced Gl tumors, such as colorectal adenocarcinoma, gastric adenocarcinoma, pancreatic adenocarcinoma, bile duct carcinoma, hepatocellular carcinoma, esophageal carcinoma that have relapsed or are refractory to or are not considered medically suitable to receive standard of care treatment
- 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
Who cannot join
- Prior exposure to a WNT inhibitor
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
Beijing Cancer Hospital
Beijing
Lin Shen, MD
Jifang Gong, 86 13683208528, goodjf@163.com
- Recruiting
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijing
Aiping Zhou, MD
Wen Zhang, MD, 86 18611643302, wenwen0605@163.com
About this study
Official title: A Phase 1 Open-label Dose Escalation Study of CGX1321 in Subjects With Advanced Gastrointestinal Tumors
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.
Read the 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
- Being tested
- CGX1321
- Medical subject headings
- Bile Duct Neoplasms, Carcinoma, Hepatocellular, Esophageal Neoplasms, Gastrointestinal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CGX1321Drug
CGX1321 capsules for oral administration
| Study group | Role | What they receive |
|---|---|---|
| CGX1321 Dosing | Experimental | 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 Receives: Drug: CGX1321 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events and/or abnormal laboratory values that are related to treatment
Measured: 21 months
Secondary outcomes (4)
CGX1321 maximum or peak concentration
Measured: 30 days
CGX1321 minimum or trough concentration
Measured: 30 days
CGX1321 time to maximum concentration
Measured: 30 days
CGX1321 half life
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2018
- Study start17 Jun 2017
- Primary completion1 Apr 2021 (estimated)
- Study completion1 Apr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal AdenocarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 39 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Curegenix Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Guangzhou Curegenix Co. Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03507998
- Sponsor's protocol ID
- CGX1321-102
- Status last verified
- Jul 2020
- First submitted
- 16 Apr 2018
- Last updated
- 24 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Open-label Dose Escalation Study of CGX1321 in Subjects With Advanced Gastrointestinal Tumors
- ClinicalTrials.gov ID
- NCT03507998
- Acronym / sponsor ID
- CGX1321-102
- Conditions
- Colorectal Adenocarcinoma, Gastric Adenocarcinoma, Pancreatic Adenocarcinoma, Bile Duct Carcinoma, Hepatocellular Carcinoma, Esophageal Carcinoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 39 participants (estimated)
- Lead sponsor
- Curegenix Inc.Industry (pharma, biotech, devices)
- Collaborators
- Guangzhou Curegenix Co. Ltd.
- Study start
- 17 Jun 2017 (actual)
- Primary completion
- 1 Apr 2021 (estimated)
- Study completion
- 1 Apr 2021 (estimated)
- First posted
- 25 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CGX1321 Dosing | Experimental | Drug: CGX1321Dose 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Histologically-diagnosed advanced Gl tumors, such as colorectal adenocarcinoma, gastric adenocarcinoma, pancreatic adenocarcinoma, bile duct carcinoma, hepatocellular carcinoma, esophageal carcinoma that have relapsed or are refractory to or are not considered medically suitable to receive standard of care treatment
- 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
Key exclusion criteria (15 listed)
- Prior exposure to a WNT inhibitor
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CGX1321CGX1321 capsules for oral administration | Drug | CGX1321 Dosing |
Primary outcome
Number of participants with adverse events and/or abnormal laboratory values that are related to treatment
Time frame: 21 months
4 secondary outcomes
CGX1321 maximum or peak concentration
Time frame: 30 days
CGX1321 minimum or trough concentration
Time frame: 30 days
CGX1321 time to maximum concentration
Time frame: 30 days
CGX1321 half life
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CGX1321 in people with Colorectal Adenocarcinoma and Gastric Adenocarcinoma, run by Curegenix Inc. at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Peter Ding ((86)020-32299929, pding@curegenix.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with adverse events and/or abnormal laboratory values that are related to treatment (time frame: 21 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2020.