Lung Cancer Clinical Trial

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

Summary

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

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Full Description

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

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Study is for people with:

Lung Cancer

Phase:

Phase 1

Estimated Enrollment:

133

Study ID:

NCT03543813

Recruitment Status:

Completed

Sponsor:

CytomX Therapeutics

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There are 25 Locations for this study

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University of Alabama at Birmingham
Birmingham Alabama, 35294, United States
California Cancer Associates for Research and Excellence
Encinitas California, 92024, United States
University of Southern California
Los Angeles California, 90033, United States
Yale Cancer Center
New Haven Connecticut, 06510, United States
Florida Cancer Specialists
Lake Mary Florida, 32746, United States
Barbara Ann Karmanos Cancer Institute
Detroit Michigan, 48201, United States
START Midwest
Grand Rapids Michigan, 49546, United States
Forrest General Cancer Center
Hattiesburg Mississippi, 39401, United States
Washington University - St. Louis
Saint Louis Missouri, 63110, United States
New York University (NYU) Clinical Cancer Center
New York New York, 10016, United States
Providence Portland Medical Center
Portland Oregon, 97213, United States
Fox Chase Cancer Center
Philadelphia Pennsylvania, 19111, United States
The Sarah Cannon Research Institute
Nashville Tennessee, 37203, United States
MD Anderson Cancer Center
Houston Texas, 77030, United States
Virginia Cancer Specialists
Fairfax Virginia, 22031, United States
Seoul National University Hospital
Seoul Jongno-gu, 03080, Korea, Republic of
Kangbuk Samsung Hospital
Seoul Jongno-gu, 03181, Korea, Republic of
Severance Hospital- Yonsei Cancer Center
Seoul Seodaemun-gu, 03772, Korea, Republic of
Hospital Universitari Vall d'Hebron
Barcelona , 08035, Spain
Hospital Clinic de Barcelona
Barcelona , 08036, Spain
Hospital Universitario La Paz, Servicio de Oncología
Madrid , 28046, Spain
Centro Integral Oncologico Clara Campal, START Madrid
Madrid , 28050, Spain
Hospital Universitario Quiron de Madrid
Madrid , 28223, Spain
The Christie NHS Foundation Trust
Withington Manchester Greater, M204B, United Kingdom
Beatson, West of Scotland Cancer Centre
Glasgow , G12 0, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 1

Estimated Enrollment:

133

Study ID:

NCT03543813

Recruitment Status:

Completed

Sponsor:


CytomX Therapeutics

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