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

January 22, 2024 updated by: CytomX Therapeutics

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)

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

133

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Jongno-gu
      • Seoul, Jongno-gu, Korea, Republic of, 03080
        • Seoul National University Hospital
      • Seoul, Jongno-gu, Korea, Republic of, 03181
        • Kangbuk Samsung Hospital
    • Seodaemun-gu
      • Seoul, Seodaemun-gu, Korea, Republic of, 03772
        • Severance Hospital- Yonsei Cancer Center
  • Spain
      • Barcelona, Spain, 08036
        • Hospital Clinic de Barcelona
      • Barcelona, Spain, 08035
        • Hospital Universitari Vall d'Hebron
      • Madrid, Spain, 28046
        • Hospital Universitario La Paz, Servicio de Oncología
      • Madrid, Spain, 28050
        • Centro Integral Oncologico Clara Campal, START Madrid
      • Madrid, Spain, 28223
        • Hospital Universitario Quiron de Madrid
  • United Kingdom
      • Glasgow, United Kingdom, G12 0YN
        • Beatson, West of Scotland Cancer Centre
    • Manchester Greater
      • Withington, Manchester Greater, United Kingdom, M204BX
        • The Christie NHS Foundation Trust
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294-3300
        • University of Alabama at Birmingham
    • California
      • Encinitas, California, United States, 92024
        • California Cancer Associates for Research and Excellence
      • Los Angeles, California, United States, 90033
        • University of Southern California
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Yale Cancer Center
    • Florida
      • Lake Mary, Florida, United States, 32746
        • Florida Cancer Specialists
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Barbara Ann Karmanos Cancer Institute
      • Grand Rapids, Michigan, United States, 49546
        • START Midwest
    • Mississippi
      • Hattiesburg, Mississippi, United States, 39401
        • Forrest General Cancer Center
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington University - St. Louis
    • New York
      • New York, New York, United States, 10016
        • New York University (NYU) Clinical Cancer Center
    • Oregon
      • Portland, Oregon, United States, 97213
        • Providence Portland Medical Center
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19111
        • Fox Chase Cancer Center
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • The Sarah Cannon Research Institute
    • Texas
      • Houston, Texas, United States, 77030
        • MD Anderson Cancer Center
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Virginia Cancer Specialists

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CX-2029 Escalation
Dose Escalation and Determination
Drug: CX-2029
CX-2029 Monotherapy
Experimental: CX-2029 Biomarker
Characterization of CX-2029 in the tumor microenvironment in subjects with select tumor types
Drug: CX-2029
CX-2029 Monotherapy
Experimental: CX-2029 Expansion
Evaluate antitumor activity of CX-2029
Drug: CX-2029
CX-2029 Monotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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)
21 days (dose-limiting toxicity period)

Secondary Outcome Measures

Outcome Measure
Time Frame
The percentage of subjects experiencing anti-cancer activity (ORR) at various dose levels when given CX-2029 as a monotherapy
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CytomX Therapeutics

Investigators

  • Study Director: Monika Vainorius, M.D., CytomX Therapeutics, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 15, 2018

Primary Completion (Actual)

June 1, 2023

Study Completion (Actual)

June 1, 2023

Study Registration Dates

First Submitted

May 21, 2018

First Submitted That Met QC Criteria

May 21, 2018

First Posted (Actual)

June 1, 2018

Study Record Updates

Last Update Posted (Actual)

January 23, 2024

Last Update Submitted That Met QC Criteria

January 22, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CTMX-M-2029-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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