General Information

Age Group

Adults

Status

Recruiting

Protocol Number

NCT07044336

Background Information

This is a Phase III, 2-arm, randomized, open label, multicenter, global study assessing the efficacy and safety of puxitatug samrotecan compared to physician's choice of chemotherapy (doxorubicin or paclitaxel) in participants with B7-H4 selected advanced/metastatic EC that progressed following platinum-based chemotherapy and anti-PD-1/anti-PD-L1 therapy.

This study aims to see if Puxi-Sam allows participants to live longer without their endometrial cancer getting worse, or simply live longer, compared to participants receiving standard of care chemotherapy. This study is also looking to see how the treatment and the endometrial cancer affect participants' quality of life.

For more information visit: https://clinicaltrials.gov/study/NCT07044336

Offered At

8081 Innovation Park Drive 
Fairfax, VA 22031
Principal Investigator

Saveri Bhattacharya, DO

Eligibility Information

  • Histologically confirmed diagnosis of endometrial carcinoma or carcinosarcoma.
  • Recurrent/metastatic EC i.e., with radiological or objective evidence of recurrence or progression.
  • Has received prior platinum-based chemotherapy and anti-programmed cell death 1 protein (PD-1)/anti- programmed cell death ligand 1 (PD-L1) therapy, either separately or in combination.
  • A WHO/ECOG performance status of 0 or 1 at Screening.
  • Has radiographically measurable disease by RECIST 1.1

Ineligibility Information

  • Had uterine sarcomas or uterine neuroendocrine carcinoma.
  • Has had a recurrence of endometrial carcinoma or carcinosarcoma more than > 12 months after completing platinum-based therapy administered in the curative-intent setting without any additional platinum-based therapy received in the recurrent setting.
  • Had previously received treatment with any therapy (approved or investigational) that contained a TOP1i including ADCs.
  • Had previously received treatment with Puxi-Sam or another B7-H4 targeting agent.
  • History of (non-infectious) ILD/pneumonitis that required steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening.
  • Has clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses.
  • Active or previously documented autoimmune or inflammatory disorders