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

NCT03543813 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: CTMX-M-2029-001
• Study Type: interventional
• Target: 133
• Locations: 4 countries
• Sites: 25

Brief 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

Conditions

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

Keywords

cancer; solid tumor; DLBCL; CX-2029; PROBODY™ Therapeutic; Drug Conjugate; Antibody drug conjugate; CD71; Transferrin receptor 1

Outcome Measures

Primary Outcomes (1)

• The number of subjects experiencing a dose-limiting toxicity at various dose levels when given CX-2029 as a monotherapy

  21 days (dose-limiting toxicity period)

Secondary Outcomes (1)

• The percentage of subjects experiencing anti-cancer activity (ORR) at various dose levels when given CX-2029 as a monotherapy

  2 years

Study Arms (3)

CX-2029 Escalation

EXPERIMENTAL

Dose Escalation and Determination

Drug: CX-2029

CX-2029 Biomarker

EXPERIMENTAL

Characterization of CX-2029 in the tumor microenvironment in subjects with select tumor types

Drug: CX-2029

CX-2029 Expansion

EXPERIMENTAL

Evaluate antitumor activity of CX-2029

Drug: CX-2029

Interventions

CX-2029 DRUG

CX-2029 Monotherapy

CX-2029 Biomarker; CX-2029 Escalation; CX-2029 Expansion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

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

Sponsors & Collaborators

• CytomX Therapeutics: lead

Study Sites (25)

University of Alabama at Birmingham

Birmingham, Alabama, 35294-3300, United States

Location

California Cancer Associates for Research and Excellence

Encinitas, California, 92024, United States

Location

University of Southern California

Los Angeles, California, 90033, United States

Location

Yale Cancer Center

New Haven, Connecticut, 06510, United States

Location

Florida Cancer Specialists

Lake Mary, Florida, 32746, United States

Location

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

Location

START Midwest

Grand Rapids, Michigan, 49546, United States

Location

Forrest General Cancer Center

Hattiesburg, Mississippi, 39401, United States

Location

Washington University - St. Louis

St Louis, Missouri, 63110, United States

Location

New York University (NYU) Clinical Cancer Center

New York, New York, 10016, United States

Location

Providence Portland Medical Center

Portland, Oregon, 97213, United States

Location

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

The Sarah Cannon Research Institute

Nashville, Tennessee, 37203, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Virginia Cancer Specialists

Fairfax, Virginia, 22031, United States

Location

Seoul National University Hospital

Seoul, Jongno-gu, 03080, South Korea

Location

Kangbuk Samsung Hospital

Seoul, Jongno-gu, 03181, South Korea

Location

Severance Hospital- Yonsei Cancer Center

Seoul, Seodaemun-gu, 03772, South Korea

Location

Hospital Universitari Vall d'Hebron

Barcelona, 08035, Spain

Location

Hospital Clinic de Barcelona

Barcelona, 08036, Spain

Location

Hospital Universitario La Paz, Servicio de Oncología

Madrid, 28046, Spain

Location

Centro Integral Oncologico Clara Campal, START Madrid

Madrid, 28050, Spain

Location

Hospital Universitario Quiron de Madrid

Madrid, 28223, Spain

Location

The Christie NHS Foundation Trust

Withington, Manchester Greater, M204BX, United Kingdom

Location

Beatson, West of Scotland Cancer Centre

Glasgow, G12 0YN, United Kingdom

Location

MeSH Terms

Conditions

Head and Neck Neoplasms; Carcinoma, Non-Small-Cell Lung; Lymphoma, Large B-Cell, Diffuse; Esophageal Neoplasms; Neoplasms

Interventions

CX-2029

Condition Hierarchy (Ancestors)

Neoplasms by Site; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Study Officials

• Monika Vainorius, M.D.

  CytomX Therapeutics, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2018
• First Posted: June 1, 2018
• Study Start: June 15, 2018
• Primary Completion: June 1, 2023
• Study Completion: June 1, 2023
• Last Updated: January 23, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2); ES (5); US (15); KR (3)