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
This is an open-label, Phase 1-2, first-in-human study for CX-2029 in subjects with metastatic or locally advanced unresectable solid tumors or Diffuse large B-cell lymphoma (DLBCL) without approved life-prolonging treatment options for their malignancy. The study is divided into 3 parts (arms), as follows: * Part A: Dose escalation and determination of the Maximum tolerated dose (MTD) and/or Recommended Phase 2 dose (RP2D) * Part B: Characterization of CX-2029 in the Tumor microenvironment (TME) in subjects with select tumor types using previously cleared dose levels from Part A * Part C: Expansions in select tumor types at the MTD/RP2D as established in Part A
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
133
CX-2029 Monotherapy
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
...and 15 more locations
The number of subjects experiencing a dose-limiting toxicity at various dose levels when given CX-2029 as a monotherapy
Time frame: 21 days (dose-limiting toxicity period)
The percentage of subjects experiencing anti-cancer activity (ORR) at various dose levels when given CX-2029 as a monotherapy
Time frame: 2 years
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