Clinical trial · Interventional
Study of CPI-200 in Patients With Advanced Tumors
A Phase 1, First-in-Human Study Evaluating the Safety, Tolerability, and Pharmacokinetics of CPI-200 Via Intravenous Infusion in Patients With Advanced Solid Tumors
NCT03953742CI-TRIAL-00056716completedPhase 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 prospective, open-label, single arm, non-randomized study of CPI-200 in patients with advanced tumors. CPI-200 is administered via intravenous infusion using an accelerated titration method followed by a conventional 3 + 3 study design to identify the maximum tolerated dose (MTD)
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CPI-200 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- CPI-200
- description
- Dose Escalation Group: CPI-200 will be administered via intravenous infusion once every 3 weeks for up to 7 dose levels using an accelerated titration method followed by a conventional 3 + 3 study design Dose Expansion Group: Maximum tolerated dose or the recommended Phase 2 dose (RP2D) from dose escalation group
- interventionNames
- Drug: CPI-200
Primary outcomes (1)
- measure
- Maximum Tolerated Dose (MTD)
- timeFrame
- 21 days
- description
- • To determine the maximum tolerated dose (MTD), which is defined as the dose level at which fewer than 33% of patients experience a dose limiting toxicity (DLT) using a 3+3 strategy as assessed by CTCAE
Secondary outcomes (4)
- measure
- Rate of Clinical Benefit
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age \>18 years * Males and females * Have a histologically or cytologically confirmed diagnosis of advanced solid tumor * Have advanced or metastatic disease refractory to standard curative or palliative therapy or contraindication to standard therapy * Have an ECOG performance status of 0-1 * Have a life expectancy of at least 12 weeks (in the opinion of the investigator) * Have adequate bone marrow reserve, liver and renal function * Be reasonably recovered from preceding major surgery and no major surgery within 4 weeks prior to the start of Day 1 treatment * Have a negative pregnancy test for females with child bearing age at screening and should not be breast feeding * Be willing to abstain from sexual activity or practice physical barrier contraception from study entry to 3 months after the last day of treatment Exclusion Criteria: * Have peripheral sensory neuropathy of Grade 2 or greater at screening * Have known hypersensitivity to chemotherapeutic agents * Have thrombocytopenia with complications including hemorrhage or bleeding \> Grade 2 that required medical intervention or any hemolytic condition or coagulation disorders that would make participation unsafe * Have unresolved toxicity from previous treatment or previous investigational agents; excluding alopecia * Received investigational agents or systemic anticancer agents (other than neurotoxic compounds) within 5 half lives or 28 days, whichever is shorter, prior to Day 1 of treatment * Have signs or symptoms of end organ failure, major chronic illnesses other than cancer, or any severe concomitant conditions * Have experienced any of the following within the 6-month period prior to screening: unstable angina, myocardial infarction or cerebrovascular accident, transient ischemic attack, cardiac failure with known ejection fraction less than 40% * Have other severe acute or chronic medical or psychiatric conditions or laboratory abnormality that would make the patient inappropriate for enrollment in this study * Is pregnant or breast-feeding
References
Publications (0)
Data not yet available
No reference posted for this study.