Clinical Trials /

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). 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

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
  • Diffuse Large B Cell Lymphoma
  • Esophageal Cancer

Interventions

DrugSynonymsArms
CX-2029CX-2029 Biomarker

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). 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
    

Trial Arms

NameTypeDescriptionInterventions
CX-2029 EscalationExperimentalDose Escalation and Determination
  • CX-2029
CX-2029 BiomarkerExperimentalCharacterization of CX-2029 in the tumor microenvironment in subjects with select tumor types
  • CX-2029
CX-2029 ExpansionExperimentalEvaluate antitumor activity of CX-2029
  • 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

          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
      
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

Last Updated

August 23, 2021