A Phase 1b, First-in-Human, Dose Escalation and Expansion Study of XMT-1536 In Patients With Solid Tumors Likely to Express NaPi2b

Trial ID # NCT03319628
Phase Ib
Drug Class Antibody Drug Conjugates: Other
Drug Name XMT-1536
Alternate Drug Names
Drugs in Trial XMT-1536
Patients Enrolled

37; 22 ovarian cancer, 5 median prior therapies (1-11)

Therapy Setting

Recurrence

Study Design

Open-Label, Non-randomized

Endpoints

ORR, DCR, evaluated per RECIST

Efficacy

ORR: 16% (3PR, n=19)
DCR: 58% (3PR, 8SD, n=19)

Clinically Significant Adverse Events

Serious AE: 1 grade 2 pyrexia, 1 grade 3 cardiac failure congestive
Grade 3-4 AE: increased liver enzymes (AST) (11%)

Conclusion

XMT-1536 is well tolerated and shows signs of anti-tumor activity

Reference

Tolcher AW et al. Phase I dose escalation study of XMT-1536, a novel NaPi2b-targeting antibody drug conjugate (ADC), in patients (pts) with solid tumors likely to express NaPi2b. J Clin Oncol (2019) 37 (suppl; abstr 3010)
https://meetinglibrary.asco.org/record/174203/abstract