Puxitatug Samrotecan (AZD8205) Monotherapy vs Chemotherapy in B7-H4-selected Endometrial Cancer (Bluestar-Endometrial01)
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age18+
SponsorAstraZeneca
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Puxitatug Samrotecan
Drug2.4 mg/kg on Day 1 Q3W Route of administration: IV infusion
Doxorubicin
Drug60 mg/m2 on Day 1 Q3W Route of administration: IV
Paclitaxel
Drug80 mg/m2 on Days 1, 8, and 15 in 28-day cycle Route of Administration: IV
Treatment groups
800 Participants
are divided into 2 treatment groupsGroup A: Puxitatug SamrotecanExperimental treatment 1 intervention
Group B: ChemotherapyActive comparator 2 interventions
Trial outcomes
Primary outcomes
1
Progression Free Survival (PFS) for Arm A vs Arm B
PFS is defined as the time from randomization until progression per RECIST 1.1 as assessed by BICR or death due to any cause.
Time frame
Approximately 3 years2
Overall survival (OS) for Arm A vs Arm B
OS is defined as the time from randomization until the date of death due to any cause.
Time frame
Approximately 3 yearsSecondary outcomes
1
Assessment of Overall Response Rate (ORR) for Arm A vs Arm B
ORR is defined as the proportion of participants who have a response of CR or PR, as determined by BICR assessments, per RECIST 1.1.
Time frame
Approximately 3 years2
Assessment of Duration of response (DoR) for Arm A vs Arm B
DoR will be defined as the time from the date of first documented response until the date of documented progression per RECIST 1.1 as assessed by BICR, or death due to any cause.
Time frame
Approximately 3 years3
Assessment of progression-free survival 2 (PFS2) for Arm A vs Arm B
PFS2 will be defined as the time from randomization to the earliest of the progression event (following the initial Investigator-assessed progression), after first subsequent therapy, or death.
Time frame
Approximately 3 years4
Time until first subsequent anticancer therapy after discontinuation of the randomized treatment, or death (TFST) for Arm A vs Arm B
TFST is defined as the time from randomization until the start date of the first subsequent anticancer therapy after discontinuation of the randomized treatment, or death due to any cause.
Time frame
Approximately 3 yearsSponsors and contacts
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Source ClinicalTrials.gov