A Phase 1-2, Open-Label, Dose-Finding, Proof of Concept, First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of CX-2009 in Adults With Metastatic or Locally Advanced Unresectable Solid Tumors (PROCLAIM-CX-2009)

Trial ID #	NCT03149549
Phase	I/II
Drug Class	Antibody Drug Conjugates: CD166
Drug Name	Praluzatamab ravtansine
Alternate Drug Names	CX-2009, anti-CD166 probody-drug conjugate CX-2009, PDC CX-2009, anti-CD166-DM4 CX-2009, ADC CX-2009
Drugs in Trial	Praluzatamab ravtansine
Eligible Participant	Advanced solid tumors
Patients Enrolled	96 patients; 18 Pt-R/Pt-Rf ovarian
Therapy Setting	Recurrence
Study Design	Open-Label, Non-randomized
Endpoints	ORR, DCR, RP2D, evaluated per RECIST
Efficacy	RP2D: 7mg/kg Q3W 18 ovarian at doses 4mg/kg Q3W or above: ORR: 11.1% (2PR) DCR: 66.7% (2PR, 10SD)
Clinically Significant Adverse Events	Serious AE: all (35%) Grade 3-4 AE: all (38%) Ocular toxicity was observed and prophylaxis with steroidal eye drops was introduced
Conclusion	CX-2009 is well tolerated with early evidence of biological activity
Reference	Boni V et al. CX-2009, a CD166-directed probody drug conjugate (PDC): Results from the first-in-human study in patients (Pts) with advanced cancer including breast cancer (BC). J Clin Oncol (2020) 38: (suppl; abstr 526) https://ascopubs.org/doi/10.1200/JCO.2020.38.15_suppl.526 Boni V et al. Graph from poster https://www.clearityfoundation.org/wp-content/uploads/2020/06/CX-2009-ASCO-2020.pdf