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


Study Design

Open-Label, Non-randomized


ORR, DCR, RP2D, evaluated per RECIST


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


CX-2009 is well tolerated with early evidence of biological activity


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)

Boni V et al. Graph from poster

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