ClinicalTrials.Veeva

Menu
The trial is taking place at:
A

Asan Medical Center | Clinical Trial Center

Veeva-enabled site

A Dose Escalation Study Evaluating CPI-818 in Relapsed/Refractory T-Cell Lymphoma

Corvus Pharmaceuticals logo

Corvus Pharmaceuticals

Status and phase

Active, not recruiting
Phase 1

Conditions

T-cell Lymphoma

Treatments

Drug: CPI-818

Study type

Interventional

Funder types

Industry

Identifiers

NCT03952078
CPI-818-001

Details and patient eligibility

About

This is a Phase 1/1b, open-label, first in human study of CPI-818, an oral interleukin-2-inducible tyrosine kinase (ITK) inhibitor for the treatment of relapsed/refractory (R/R) T-cell lymphoma.. This trial will study the safety, tolerability, and anti-tumor activity of CPI-818 as a single drug.

Full description

This is a Phase 1/1b, open-label, first in human study of CPI-818, an oral interleukin-2-inducible tyrosine kinase (ITK) inhibitor for the treatment of relapsed/refractory (R/R) T-cell lymphoma.. This trial will study the safety, tolerability, and anti-tumor activity of CPI-818 as a single drug. This trial is composed of dose escalation and dose expansion cohorts.

Enrollment

151 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Adult subjects age ≥18 years
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
  • Histologically confirmed evidence of T-cell lymphoma
  • Measurable disease.
  • Adequate organ function.
  • At least 2 standard therapies for advanced or recurrent disease or had a disease for which there is no more than one established therapy.

Exclusion criteria

  • Treatment with systemic immunosuppressive medication.
  • History of allogeneic hematopoietic stem cell transplantation.
  • History of primary immunodeficiency, solid organ transplantation.
  • History of opportunistic infection within 180 days of starting study drug.
  • Females who are pregnant, lactating, or intend to become pregnant
  • History of invasive prior malignancy that required systemic therapy within last 3 years.
  • Concomitant use of strong inhibitors or inducers of CYP3A.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Sequential Assignment

Masking

None (Open label)

151 participants in 2 patient groups

CPI-818 Dose Escalation
Experimental group
Description:
Participants will receive CPI-818 capsule, orally, twice per day at an assigned dose, till disease progression, complete response or remission (CR) for >2 months or if dose determined to be unsafe.
Treatment:
Drug: CPI-818
CPI-818 Dose Expansion phase
Experimental group
Description:
Participants with different T-cell lymphoma sub-types will receive CPI-818 capsules at the specific dose selected from the Dose escalation phase of the study. CPI-818 capsules at the selected dose will be taken orally, twice per day until disease progression or CR for > 2 months.
Treatment:
Drug: CPI-818

Trial contacts and locations

22

Loading...

Central trial contact

Director Clinical Operations

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems