PROCLAIM-CX-2029: A Trial to Find Safe and Active Doses of an Investigational Drug CX-2029 for Patients With Solid Tumors or DLBCL

Completed · Phase 1/Phase 2

Conditions studied: Solid Tumor, Adult, Head and Neck Cancer, Non Small Cell Lung Cancer, Diffuse Large B Cell Lymphoma, Esophageal Cancer

In brief

The purpose of this first-in-human study of CX-2029 is to characterize the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and antitumor activity of CX-2029 in adult subjects with metastatic or locally advanced unresectable solid tumors or diffuse large B-cell lymphoma (DLBCL). The antitumor activity of CX-2029 will be evaluated in subjects with head and neck squamous cell carcinoma (HNSCC), DLBCL, non-small cell lung cancer (NSCLC) (squamous cell histology only), or esophageal (esophageal adenocarcinoma \[EAC\], esophageal squamous cell carcinoma \[ESCC\], or gastroesophageal \[GE\] junction) cancer. PROCLAIM: PRObody CLinical Assessment In Man CX-2029 clinical trial 001 PROBODY is a trademark of CytomX Therapeutics, Inc

Key facts

Study ID

NCT03543813

Run by

CytomX Therapeutics

People needed

133

Starts

2018-06-15

Expected to finish

2023-06-01

Last updated by the study team

2024-01-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically or cytologically confirmed diagnosis of metastatic or locally advanced unresectable tumors
• Patients demonstrating disease progression after treatment with approved therapies that are known to confer life-prolonging benefit, or who are intolerant to or have declined treatment
• Agreement to provide mandatory archival tissue or fresh biopsy
• At least 18 years of age
• For Arm A, histologically or cytologically confirmed metastatic or locally advanced unresectable solid tumor
• For Arms B and C, histologically or cytologically confirmed metastatic or locally advanced unresectable HNSCC, DLBCL, NSCLC (squamous cell histology only), or esophageal (EAC, ESCC, or GE junction) cancer
• Additional inclusion criteria may apply

You may not qualify if…

• Neuropathy > Grade 1
• Serious concurrent illness, including clinically relevant active infection
• Clinically significant iron metabolism disorders (eg, sickle cell anemia)
• Significant cardiac disease such as recent myocardial infarction
• History of multiple sclerosis or other demyelinating disease, Eaton-Lambert syndrome (para-neoplastic syndrome), history of hemorrhagic or ischemic stroke within the last 6 months, or alcoholic liver disease;
• Non-healing wound(s) or ulcer(s) except for ulcerative lesions caused by the underlying neoplasm;
• History of severe allergic or anaphylactic reactions to previous monoclonal antibody therapy;
• Currently receiving anticoagulation therapy with warfarin;
• Major surgery (requiring general anesthesia) within 3 months prior to dosing.
• Hepatic impairment which is moderate (Child-Pugh B) or severe (Child-Pugh C)
• Transfusion dependent anemia with transfusion dependency of ≥3 months
• Use of iron chelators
• Additional exclusion criteria may apply

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• California Cancer Associates for Research and Excellence — Encinitas, California, United States
• University of Southern California — Los Angeles, California, United States
• Yale Cancer Center — New Haven, Connecticut, United States
• Florida Cancer Specialists — Lake Mary, Florida, United States
• Barbara Ann Karmanos Cancer Institute — Detroit, Michigan, United States
• START Midwest — Grand Rapids, Michigan, United States
• Forrest General Cancer Center — Hattiesburg, Mississippi, United States
• Washington University - St. Louis — St Louis, Missouri, United States
• New York University (NYU) Clinical Cancer Center — New York, New York, United States
• Providence Portland Medical Center — Portland, Oregon, United States
• Fox Chase Cancer Center — Philadelphia, Pennsylvania, United States
• The Sarah Cannon Research Institute — Nashville, Tennessee, United States
• MD Anderson Cancer Center — Houston, Texas, United States
• Virginia Cancer Specialists — Fairfax, Virginia, United States
• Seoul National University Hospital — Seoul, Jongno-gu, South Korea
• Kangbuk Samsung Hospital — Seoul, Jongno-gu, South Korea
• Severance Hospital- Yonsei Cancer Center — Seoul, Seodaemun-gu, South Korea
• Hospital Universitari Vall d'Hebron — Barcelona, Spain
• Hospital Clinic de Barcelona — Barcelona, Spain
• Hospital Universitario La Paz, Servicio de Oncología — Madrid, Spain
• Centro Integral Oncologico Clara Campal, START Madrid — Madrid, Spain
• Hospital Universitario Quiron de Madrid — Madrid, Spain
• The Christie NHS Foundation Trust — Withington, Manchester Greater, United Kingdom
• Beatson, West of Scotland Cancer Centre — Glasgow, United Kingdom

Full record on ClinicalTrials.gov

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