NCT03507998

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
39

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jun 2017

Typical duration for phase_1

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 17, 2017

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

April 16, 2018

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 25, 2018

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2021

Completed
Last Updated

July 24, 2020

Status Verified

July 1, 2020

Enrollment Period

3.8 years

First QC Date

April 16, 2018

Last Update Submit

July 22, 2020

Conditions

Colorectal AdenocarcinomaGastric AdenocarcinomaPancreatic AdenocarcinomaBile Duct CarcinomaHepatocellular CarcinomaEsophageal CarcinomaGastrointestinal Cancer

Outcome Measures

Primary Outcomes (1)

  • Number of participants with adverse events and/or abnormal laboratory values that are related to treatment

    21 months

Secondary Outcomes (4)

  • CGX1321 maximum or peak concentration

    30 days

  • CGX1321 minimum or trough concentration

    30 days

  • CGX1321 time to maximum concentration

    30 days

  • CGX1321 half life

    30 days

Study Arms (1)

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

Drug: CGX1321

Interventions

CGX1321DRUG

CGX1321 capsules for oral administration

CGX1321 Dosing

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Beijing Cancer Hospital

Beijing, China

RECRUITING

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Beijing, China

RECRUITING

MeSH Terms

Conditions

Bile Duct NeoplasmsCarcinoma, HepatocellularEsophageal NeoplasmsGastrointestinal Neoplasms

Interventions

CGX1321

Condition Hierarchy (Ancestors)

Biliary Tract NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsBile Duct DiseasesBiliary Tract DiseasesDigestive System DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeLiver NeoplasmsLiver DiseasesHead and Neck NeoplasmsEsophageal DiseasesGastrointestinal Diseases

Central Study Contacts

Peter Ding

CONTACT

(86)020-32299929pding@curegenix.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 16, 2018

First Posted

April 25, 2018

Study Start

June 17, 2017

Primary Completion

April 1, 2021

Study Completion

April 1, 2021

Last Updated

July 24, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations

CN(2)