Clinical trial · Interventional
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
NCT03507998CI-TRIAL-00046150unknownPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bile Duct Carcinoma | Cholangiocarcinoma | ALIAS | 0.90 |
| Colorectal Adenocarcinoma | Colorectal Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Esophageal Carcinoma | Esophageal Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Gastric Adenocarcinoma | Gastric Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Gastrointestinal Cancer | Malignant Digestive System Neoplasm | ALIAS | 0.90 |
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Pancreatic Adenocarcinoma | Pancreatic Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CGX1321 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- CGX1321 Dosing
- description
- 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
- interventionNames
- Drug: CGX1321
Primary outcomes (1)
- measure
- Number of participants with adverse events and/or abnormal laboratory values that are related to treatment
- timeFrame
- 21 months
Secondary outcomes (4)
- measure
- CGX1321 maximum or peak concentration
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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
References
Publications (0)
Data not yet available
No reference posted for this study.