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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

NCT03543813

Description:

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

Related Conditions:
  • Diffuse Large B-Cell Lymphoma
  • Malignant Solid Tumor
Recruiting Status:

Recruiting

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Title

  • 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)

Clinical Trial IDs

  • ORG STUDY ID: CTMX-M-2029-001
  • NCT ID: NCT03543813

Conditions

  • Solid Tumor, Adult
  • Head and Neck Cancer
  • Non Small Cell Lung Cancer
  • Pancreatic Cancer
  • Diffuse Large B Cell Lymphoma

Interventions

DrugSynonymsArms
CX-2029CX-2029 Escalation

Purpose

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

Trial Arms

NameTypeDescriptionInterventions
CX-2029 EscalationExperimentalCX-2029 Monotherapy
  • CX-2029
CX-2029 BiomarkerExperimentalCX-2029 Monotherapy
  • CX-2029
CX-2029 ExpansionExperimentalCX-2029 Monotherapy
  • CX-2029

Eligibility 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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure: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)
Safety Issue:
Description:

Secondary Outcome Measures

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

Details

Phase:Phase 1/Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:CytomX Therapeutics

Trial Keywords

  • cancer
  • solid tumor
  • DLBCL
  • CX-2029
  • PROBODY™ Therapeutic
  • Drug Conjugate
  • Antibody drug conjugate
  • CD71
  • Transferrin receptor 1

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