PROCLAIM-CX-2029: A Trial to Find Safe and Active Doses of an Investigational Drug CX-2029 for Patients With Solid Tumors or DLBCL

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 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

Exclusion criteria

• 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