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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03543813
Recruitment Status : Recruiting
First Posted : June 1, 2018
Last Update Posted : June 14, 2021
Sponsor:
Information provided by (Responsible Party):
CytomX Therapeutics

Tracking Information
First Submitted Date  ICMJE May 21, 2018
First Posted Date  ICMJE June 1, 2018
Last Update Posted Date June 14, 2021
Actual Study Start Date  ICMJE June 15, 2018
Estimated Primary Completion Date December 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 21, 2018)
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) ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 21, 2018)
The percentage of subjects experiencing anti-cancer activity (ORR) at various dose levels when given CX-2029 as a monotherapy [ Time Frame: 2 years ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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  ICMJE 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)
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Solid Tumor, Adult
  • Head and Neck Cancer
  • Non Small Cell Lung Cancer
  • Diffuse Large B Cell Lymphoma
  • Esophageal Cancer
Intervention  ICMJE Drug: CX-2029
CX-2029 Monotherapy
Study Arms  ICMJE
  • Experimental: CX-2029 Escalation
    Dose Escalation and Determination
    Intervention: Drug: CX-2029
  • Experimental: CX-2029 Biomarker
    Characterization of CX-2029 in the tumor microenvironment in subjects with select tumor types
    Intervention: Drug: CX-2029
  • Experimental: CX-2029 Expansion
    Evaluate antitumor activity of CX-2029
    Intervention: Drug: CX-2029
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 21, 2018)
150
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2022
Estimated Primary Completion Date December 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Fred Kerwood 650-515-3185 clinicaltrials@cytomx.com
Listed Location Countries  ICMJE Spain,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03543813
Other Study ID Numbers  ICMJE CTMX-M-2029-001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party CytomX Therapeutics
Study Sponsor  ICMJE CytomX Therapeutics
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Alison Hannah, MD CytomX Therapeutics, Inc.
PRS Account CytomX Therapeutics
Verification Date June 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP