A Phase I-II, First-in-Human Study of SKB264 in Patients With Locally Advanced Unresectable /Metastatic Solid Tumors Who Are Refractory to Available Standard Therapies

Trial ID # NCT04152499
Phase I/II
Drug Class Antibody Drug Conjugates: TROP2
Drug Name Sacituzumab tirumotecan
Alternate Drug Names sac-TMT, MK-2870, SKB264
Drugs in Trial Sacituzumab tirumotecan
Eligible Participant

Platinum resistant or refractory ovarian cancer

Patients Enrolled

35, at least 2 prior therapies

Therapy Setting

Recurrence

Study Design

Open-Label, Non-randomized

Endpoints

ORR, evaluated per RECIST

Efficacy

ORR: 37.1% (13PR)

Clinically Significant Adverse Events

Serious AE: overall (37.5%)
Grade 3-4 AE: overall (67.5%), anemia (35%), decreased neutrophil counts (30%), decreased white blood cell counts (22.5%), stomatitis (15%)

Conclusion

Sacituzumab tirumotecan (Sac-TMT) monotherapy shows promising anti-tumor activity with a manageable safety profile in patients with platinum resistant or refractory ovarian cancer

Reference

Wang D et al. Safety and efficacy of sacituzumab tirumotecan (sac-TMT) in patients (pts) with previously treated advanced endometrial carcinoma (EC) and ovarian cancer (OC) from a phase II study. Ann Oncol (2024) 35 (2) abstract 715MO

Wang D et al. Safety and efficacy of sacituzumab tirumotecan (sac-TMT) in patients (pts) with previously treated advanced endometrial carcinoma (EC) and ovarian cancer (OC) from a phase II study. Ann Oncol (2024) 35 (2) abstract 715MO
https://www.clearityfoundation.org/wp-content/uploads/2024/11/Sac-TMT-abstract-ESMO-2024.pdf

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