A Phase III, Randomized, Open-Label, Multicenter, Global Study of Puxitatug Samrotecan (AZD8205) Monotherapy versus Treatment of Physician’s Choice in Participants with B7-H4-Positive Advanced/Metastatic Endometrial Cancer Who Progressed After Platinum and Anti-PD-1/Anti-PD-L1 Therapy
Objective
This study aims to see if Puxi-Sam allows participants to live longer without their endometrial cancer getting worse, or simply to live longer, compared to participants receiving standard of care chemotherapy. This study is also looking to see how the treatment and the endometrial cancer affects participants' quality of life.
Eligibility
Key Inclusion Criteria:
- Histologically confirmed diagnosis of endometrial carcinoma or carcinosarcoma.
- Recurrent/metastatic EC ie, 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
Key Exclusion Criteria:
- 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
NCT ID
NCT07044336
