Clinical trials

CX-2009-002, a Phase 2 multi-arm study, is now enrolling patients with human epidermal growth factor receptor 2 (HER2)-non-amplified breast cancer.

Praluzatamab ravtansine (CX-2009) is a conditionally activated antibody-drug conjugate (Probody® therapeutic) employing the DM-4 payload and targeting CD166, also known as activated leukocyte cell adhesion molecule (ALCAM). Pacmilimab (CX-072) is an anti-PD-L1 conditionally activated antibody. Each of the Probody therapeutics has a peptide-mask that is held in place by a protease-cleavable linker. Protease activation is tightly controlled in normal tissues but often poorly regulated in tumor tissues leading to abundant levels of activated proteases. 

Praluzatamab ravtansine monotherapy or in combination with pacmilimab is currently being evaluated in a Phase 2 study in three parallel enrolling arms: as monotherapy in patients with either a) hormone receptor-positive, HER2-non-amplified breast cancer (Arm A), or b) triple-negative breast cancer (TNBC; Arm B), and c) in combination with pacmilimab in patients with TNBC (Arm C).

Purpose: The purpose of this first-in-human study is to evaluate the antitumor activity and characterize the safety and pharmacokinetics profiles of praluzatamab ravtansine, as monotherapy and in combination with pacmilimab, in patients with HER2-non-amplified breast cancer.

If you are interested in learning more about this study including participating sites, please visit clinicaltrials.gov.

Start date: December 29, 2020
Estimated Enrollment: 150 Participants
Study Title: Study to Evaluate the Safety and Antitumor Activity of CX-2009 Monotherapy and in Combination With CX-072 in Advanced Breast Cancer

CX-2029-001, a Phase 1/2 study, is now enrolling patients with esophageal, lung, head and neck cancers or lymphoma.

CX-2029 is a conditionally activated antibody-drug conjugate (Probody® therapeutic) employing the MMAE payload and targeting CD71, also known as the transferrin receptor 1. CX-2029 has a peptide-mask that is held in place by a protease-cleavable linker. Protease activation is tightly controlled in normal tissues but often poorly regulated in tumor tissues leading to abundant levels of activated proteases. 

CX-2029 is currently being evaluated in a multi-cohort Phase 2 dose expansion study as monotherapy in patients with squamous non-small cell lung cancer, head and neck squamous cell carcinoma, esophageal or gastroesophageal junction cancer, or diffuse large B-cell lymphoma. CX-2029 is being developed in partnership with AbbVie.

Purpose: The purpose of this first-in-human study is to characterize the safety, tolerability, pharmacokinetics, pharmacodynamics and antitumor activity of CX-2029 in patients with one of four metastatic or locally advanced tumors.

If you are interested in learning more about this study including participating sites, please visit clinicaltrials.gov.

Start date: June 15, 2018
Estimated Enrollment: 150 Participants
Study 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