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

Primary Purpose

Solid Tumor, Adult, Head and Neck Cancer, Non Small Cell Lung Cancer

Status
Active
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
CX-2029
Sponsored by
CytomX Therapeutics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Solid Tumor, Adult focused on measuring cancer, solid tumor, DLBCL, CX-2029, PROBODY™ Therapeutic, Drug Conjugate, Antibody drug conjugate, CD71, Transferrin receptor 1

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Histologically or cytologically confirmed diagnosis of metastatic or locally advanced unresectable tumors
  2. 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
  3. Agreement to provide mandatory archival tissue or fresh biopsy
  4. At least 18 years of age
  5. For Arm A, histologically or cytologically confirmed metastatic or locally advanced unresectable solid tumor
  6. 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
  7. Additional inclusion criteria may apply

Exclusion Criteria:

  1. Neuropathy > Grade 1
  2. Serious concurrent illness, including clinically relevant active infection
  3. Clinically significant iron metabolism disorders (eg, sickle cell anemia)
  4. Significant cardiac disease such as recent myocardial infarction
  5. 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;
  6. Non-healing wound(s) or ulcer(s) except for ulcerative lesions caused by the underlying neoplasm;
  7. History of severe allergic or anaphylactic reactions to previous monoclonal antibody therapy;
  8. Currently receiving anticoagulation therapy with warfarin;
  9. Major surgery (requiring general anesthesia) within 3 months prior to dosing.
  10. Hepatic impairment which is moderate (Child-Pugh B) or severe (Child-Pugh C)
  11. Transfusion dependent anemia with transfusion dependency of ≥3 months
  12. Use of iron chelators
  13. Additional exclusion criteria may apply

Sites / Locations

  • University of Alabama at Birmingham
  • California Cancer Associates for Research and Excellence
  • University of Southern California
  • Yale Cancer Center
  • Florida Cancer Specialists
  • Barbara Ann Karmanos Cancer Institute
  • START Midwest
  • Forrest General Cancer Center
  • Washington University - St. Louis
  • New York University (NYU) Clinical Cancer Center
  • Providence Portland Medical Center
  • Fox Chase Cancer Center
  • The Sarah Cannon Research Institute
  • MD Anderson Cancer Center
  • Virginia Cancer Specialists
  • Seoul National University Hospital
  • Kangbuk Samsung Hospital
  • Severance Hospital- Yonsei Cancer Center
  • Hospital Universitari Vall d'Hebron
  • Hospital Clinic de Barcelona
  • Hospital Universitario La Paz, Servicio de Oncología
  • Centro Integral Oncologico Clara Campal, START Madrid
  • Hospital Universitario Quiron de Madrid
  • The Christie NHS Foundation Trust
  • Beatson, West of Scotland Cancer Centre

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

CX-2029 Escalation

CX-2029 Biomarker

CX-2029 Expansion

Arm Description

Dose Escalation and Determination

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

Evaluate antitumor activity of CX-2029

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
May 21, 2018
Last Updated
February 22, 2023
Sponsor
CytomX Therapeutics
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1. Study Identification

Unique Protocol Identification Number
NCT03543813
Brief Title
PROCLAIM-CX-2029: A Trial to Find Safe and Active Doses of an Investigational Drug CX-2029 for Patients With Solid Tumors or DLBCL
Official 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 (PROCLAIM-CX-2029)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 15, 2018 (Actual)
Primary Completion Date
April 30, 2023 (Anticipated)
Study Completion Date
April 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CytomX Therapeutics

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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
Detailed 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CX-2029 Escalation
Arm Type
Experimental
Arm Description
Dose Escalation and Determination
Arm Title
CX-2029 Biomarker
Arm Type
Experimental
Arm Description
Characterization of CX-2029 in the tumor microenvironment in subjects with select tumor types
Arm Title
CX-2029 Expansion
Arm Type
Experimental
Arm Description
Evaluate antitumor activity of CX-2029
Intervention Type
Drug
Intervention Name(s)
CX-2029
Intervention Description
CX-2029 Monotherapy
Primary Outcome Measure Information:
Title
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)
Secondary Outcome Measure Information:
Title
The percentage of subjects experiencing anti-cancer activity (ORR) at various dose levels when given CX-2029 as a monotherapy
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Monika Vainorius, M.D.
Organizational Affiliation
CytomX Therapeutics, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294-3300
Country
United States
Facility Name
California Cancer Associates for Research and Excellence
City
Encinitas
State/Province
California
ZIP/Postal Code
92024
Country
United States
Facility Name
University of Southern California
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Yale Cancer Center
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Facility Name
Florida Cancer Specialists
City
Lake Mary
State/Province
Florida
ZIP/Postal Code
32746
Country
United States
Facility Name
Barbara Ann Karmanos Cancer Institute
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
START Midwest
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49546
Country
United States
Facility Name
Forrest General Cancer Center
City
Hattiesburg
State/Province
Mississippi
ZIP/Postal Code
39401
Country
United States
Facility Name
Washington University - St. Louis
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
New York University (NYU) Clinical Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Providence Portland Medical Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97213
Country
United States
Facility Name
Fox Chase Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111
Country
United States
Facility Name
The Sarah Cannon Research Institute
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Virginia Cancer Specialists
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Facility Name
Seoul National University Hospital
City
Seoul
State/Province
Jongno-gu
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Kangbuk Samsung Hospital
City
Seoul
State/Province
Jongno-gu
ZIP/Postal Code
03181
Country
Korea, Republic of
Facility Name
Severance Hospital- Yonsei Cancer Center
City
Seoul
State/Province
Seodaemun-gu
ZIP/Postal Code
03772
Country
Korea, Republic of
Facility Name
Hospital Universitari Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Clinic de Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital Universitario La Paz, Servicio de Oncología
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Centro Integral Oncologico Clara Campal, START Madrid
City
Madrid
ZIP/Postal Code
28050
Country
Spain
Facility Name
Hospital Universitario Quiron de Madrid
City
Madrid
ZIP/Postal Code
28223
Country
Spain
Facility Name
The Christie NHS Foundation Trust
City
Withington
State/Province
Manchester Greater
ZIP/Postal Code
M204BX
Country
United Kingdom
Facility Name
Beatson, West of Scotland Cancer Centre
City
Glasgow
ZIP/Postal Code
G12 0YN
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this 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

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