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History of Changes for Study: NCT03543813
PROCLAIM-CX-2029: A Trial to Find Safe and Active Doses of an Investigational Drug CX-2029 for Patients With Solid Tumors or DLBCL
Latest version (submitted August 5, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 May 21, 2018 None (earliest Version on record)
2 June 1, 2018 Study Status
3 June 13, 2018 Recruitment Status, Contacts/Locations, Study Status and Oversight
4 July 18, 2018 Study Status and Contacts/Locations
5 September 20, 2018 Study Status and Contacts/Locations
6 April 18, 2019 Contacts/Locations and Study Status
7 November 22, 2019 Contacts/Locations and Study Status
8 November 9, 2020 Contacts/Locations, Study Status, Arms and Interventions and Conditions
9 March 23, 2021 Contacts/Locations and Study Status
10 April 23, 2021 Study Status and Contacts/Locations
11 April 27, 2021 Contacts/Locations and Study Status
12 May 5, 2021 Study Description, Contacts/Locations, Eligibility and Study Status
13 June 10, 2021 Study Status and Contacts/Locations
14 August 20, 2021 Contacts/Locations and Study Status
15 September 16, 2021 Study Status and Contacts/Locations
16 December 14, 2021 Study Status and Contacts/Locations
17 February 25, 2022 Contacts/Locations and Study Status
18 March 24, 2022 Study Status and Contacts/Locations
19 August 5, 2022 Recruitment Status, Study Status and Contacts/Locations
Comparison Format:

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Study NCT03543813
Submitted Date:  May 21, 2018 (v1)

Open or close this module Study Identification
Unique Protocol ID: CTMX-M-2029-001
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)
Secondary IDs:
Open or close this module Study Status
Record Verification: May 2018
Overall Status: Not yet recruiting
Study Start: May 2018
Primary Completion: December 2020 [Anticipated]
Study Completion: December 2022 [Anticipated]
First Submitted: May 21, 2018
First Submitted that
Met QC Criteria:
May 21, 2018
First Posted: June 1, 2018 [Actual]
Last Update Submitted that
Met QC Criteria:
May 21, 2018
Last Update Posted: June 1, 2018 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: CytomX Therapeutics
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: Yes
U.S. FDA-regulated Device: No
Data Monitoring: Yes
Open or close this module 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). PROCLAIM: PRObody CLinical Assessment In Man CX-2029 clinical trial 001

PROBODY is a trademark of CytomX Therapeutics, Inc

Detailed Description:
Open or close this module Conditions
Conditions: Solid Tumor, Adult
Head and Neck Cancer
Non Small Cell Lung Cancer
Pancreatic Cancer
Diffuse Large B Cell Lymphoma
Keywords: cancer
solid tumor
DLBCL
CX-2029
PROBODY™ Therapeutic
Drug Conjugate
Antibody drug conjugate
CD71
Transferrin receptor 1
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 1/Phase 2
Interventional Study Model: Parallel Assignment
Number of Arms: 3
Masking: None (Open Label)
Allocation: Non-Randomized
Enrollment: 150 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: CX-2029 Escalation
CX-2029 Monotherapy
Drug: CX-2029
CX-2029 Monotherapy
Experimental: CX-2029 Biomarker
CX-2029 Monotherapy
Drug: CX-2029
CX-2029 Monotherapy
Experimental: CX-2029 Expansion
CX-2029 Monotherapy
Drug: CX-2029
CX-2029 Monotherapy
Open or close this module Outcome Measures
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 ]

Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
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

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
Open or close this module Contacts/Locations
Central Contact Person: Annie Weaver, PhD
Telephone: 650-515-3185
Email: clinicaltrials@cytomx.com
Study Officials: Matthias Will, MD
Study Director
CytomX Therapeutics, Inc.
Locations:
Open or close this module IPDSharing
Plan to Share IPD: No
Open or close this module References
Citations:
Links:
Available IPD/Information:

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