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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 : May 7, 2021
Sponsor:
Information provided by (Responsible Party):
CytomX Therapeutics

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


Condition or disease Intervention/treatment Phase
Solid Tumor, Adult Head and Neck Cancer Non Small Cell Lung Cancer Diffuse Large B Cell Lymphoma Esophageal Cancer Drug: CX-2029 Phase 1 Phase 2

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Actual Study Start Date : June 15, 2018
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022


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




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


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03543813


Contacts
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Contact: Fred Kerwood 650-515-3185 clinicaltrials@cytomx.com

Locations
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Sponsors and Collaborators
CytomX Therapeutics
Investigators
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Study Director: Alison Hannah, MD CytomX Therapeutics, Inc.
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Responsible Party: CytomX Therapeutics
ClinicalTrials.gov Identifier: NCT03543813    
Other Study ID Numbers: CTMX-M-2029-001
First Posted: June 1, 2018    Key Record Dates
Last Update Posted: May 7, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by CytomX Therapeutics:
cancer
solid tumor
DLBCL
CX-2029
PROBODY™ Therapeutic
Drug Conjugate
Antibody drug conjugate
CD71
Transferrin receptor 1
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin