PROCLAIM-CX-2029
Research type
Research Study
Full title
A Phase 1-2, First-in-Human Study of CX-2029 in Adults with Metastatic or Locally Advanced Unresectable Solid Tumors or Diffuse Large B-cell Lymphomas
IRAS ID
253532
Contact name
Louise Carter
Contact email
Sponsor organisation
CytomX Therapeutics, Inc.
Eudract number
2018-001456-34
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
135009, IND Number
Duration of Study in the UK
3 years, 6 months, days
Research summary
This is the first study in humans for an investigational drug called CX-2029. CX-2029 is a Probody™ therapeutic which when administered is not active, but later becomes active in the body. It is activated by enzymes that occur in the cancer region, but not elsewhere in the body. The specific antibody that is a part of CX-2029 targets an antigen (marker on cells) called CD71. Once the active antibody recognises cells it will deliver the cancer killing therapy, to the tumour with the aim of shrinking the patients cancer.
Probody™ therapeutics are designed to limit binding to healthy tissues, thereby, potentially minimizing CX-2029 binding to healthy tissue and potentially creating safer, more effective cancer therapies.The study has 3 parts.
Part A (dose escalation, determination of maximum tolerated dose (MTD)): Aim is to determine the MTD. Up to 72 patients with selected advanced or recurrent solid tumours will participate.
Part B (additional enrolment in specific types of cancer of previously cleared dose levels from Part A) Up to 30 patients with head and neck squamous cell carcinoma (HNSCC), diffuse large B-cell lymphoma (DLBCL), non-small cell lung cancer (NSCLC) or pancreatic cancer will participate.
Part C (expansions in specific types of cancer at the MTD as established in Part A) will begin after the MTD has been determined from Part A. Up to 25 patients from each of the following types of cancer: HNSCC, DLBCL, NSCLC or pancreatic cancer will receive CX-2029 based on the MTD from Part A and available data from part B.The study will be done at about 30 study centres in US and Europe. About 200 patients 18 years old and older, will participate. Each participant will be in the study for a variable amount of time as determined by the patient and study doctor.
REC name
South Central - Oxford B Research Ethics Committee
REC reference
19/SC/0017
Date of REC Opinion
29 Mar 2019
REC opinion
Further Information Favourable Opinion