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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



Inclusion and Exclusion Criteria

  • Histologically or cytologically confirmed diagnosis of metastatic or locally advanced unresectable tumors
  • 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
  • Agreement to provide mandatory archival tissue or fresh biopsy
  • At least 18 years of age
  • For Arm A, histologically or cytologically confirmed metastatic or locally advanced unresectable solid tumor
  • 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
  • Additional inclusion criteria may apply

  • Neuropathy > Grade 1
  • Serious concurrent illness, including clinically relevant active infection
  • Clinically significant iron metabolism disorders (eg, sickle cell anemia)
  • Significant cardiac disease such as recent myocardial infarction
  • 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;
  • Non-healing wound(s) or ulcer(s) except for ulcerative lesions caused by the underlying neoplasm;
  • History of severe allergic or anaphylactic reactions to previous monoclonal antibody therapy;
  • Currently receiving anticoagulation therapy with warfarin;
  • Major surgery (requiring general anesthesia) within 3 months prior to dosing.
  • Hepatic impairment which is moderate (Child-Pugh B) or severe (Child-Pugh C)
  • Transfusion dependent anemia with transfusion dependency of ≥3 months
  • Use of iron chelators
  • Additional exclusion criteria may apply


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