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A Phase III Trial of BNT324 Versus Docetaxel in Metastatic Castration-resistant Prostate Cancer

ConditionMetastatic Castration-resistant Prostate Cancer
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexMale
Age18+
SponsorBioNTech SE

About this trial

This study will test whether BNT324 is safe and works better against metastatic castration-resistant prostate cancer (mCRPC) than the current standard of care (SoC) chemotherapy, which is docetaxel (given together with the steroid medicines prednisone or prednisolone). The study will include participants with mCRPC that have been previously treated with androgen receptor pathway inhibitor, but with no previous taxane-based systematic chemotherapy for mCRPC.

The main goals of this study are:

* To find out if BNT324 helps participants live longer without their cancer getting worse (radiographic progression-free survival \[rPFS\]). * To find out if BNT324 helps participants live longer overall (overall survival \[OS\]).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Are male adults (defined as ≥18 years of age or of an acceptable age according to local regulations at the time of giving informed consent).

Serum/plasma PSA progression, by local laboratory, defined as two consecutive increases in PSA over a previous reference value, each measured sequentially at least 1 week apart. The PSA value at screening is required to be ≥1.0 ng/mL.

Radiographic soft tissue progression as per PCWG3-modified RECIST v1.1.

Radiographic progression of bone disease: evaluable disease or new bone lesion(s) by bone scan per PCWG3 criteria.

Disqualifiers

Have received prior treatment with B7-H3 targeted therapy, including B7-H3 ADCs.

Have uncontrolled or significant cardiovascular disease, as defined in the protocol.

Have a history of (non-infectious) interstitial lung disease (ILD)/pneumonitis that required steroids or have current ILD/pneumonitis.

Trial design

Design model

Parallel

Treatments tested in this trial

  • BNT324

    Drug

    Intravenous infusion

  • Docetaxel

    Drug

    Intravenous infusion

  • Prednisone/prednisolone

    Drug

    Oral

Treatment groups

736 Participants
are divided into 2 treatment groups
Group A: BNT324Experimental treatment 1 intervention
Group B: Docetaxel plus prednisone/ prednisoloneActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

rPFS assessed by BICR

By arm. rPFS is defined as time from randomization to radiographic disease progression per Prostate Cancer Working Group 3 (PCWG3)-modified Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) criteria, or death from any cause, whichever occurs first.

Time frame
From randomization to end of study, i.e., up to 58 months
2

OS

By arm. OS is defined as time from randomization to death from any cause.

Time frame
From randomization to end of study, i.e., up to 58 months

Secondary outcomes

1

Time to first subsequent therapy (TFTS)

By arm. TFST is defined as time from randomization to initiation of the first subsequent systemic anticancer therapy or death, whichever occurs first.

Time frame
From randomization to end of study, i.e., up to 58 months
2

Objective response rate (ORR)

By arm. ORR is defined as the proportion of participants in whom a confirmed complete response (CR) or partial response (PR) (per PCWG3-modifed RECIST v1.1 as assessed by BICR) is observed as best overall response.

Time frame
From randomization to end of study, i.e., up to 58 months
3

Duration of response (DOR)

By arm. DOR is defined as time from first objective response (confirmed CR or PR per PCWG3-modified RECIST v1.1 criteria as assessed by BICR) to first occurrence of objective tumor progression (progressive disease per PCWG3-modified RECIST v1.1 criteria as assessed by BICR) or death from any cause, whichever occurs first.

Time frame
From randomization to end of study, i.e., up to 58 months
4

Time to pain progression (TTPP)

By arm. TTPP is defined as time from randomization to pain progression as determined by Brief Pain Inventory-Short Form Item 3 "worst pain in 24 hours" and opiate analgesic use (Analgesic Quantification Algorithm score).

Time frame
From randomization to safety follow-up visit (30 days after the last dose), i.e., up to 58 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

BioNTech SE

Lead sponsor

BioNTech (Shanghai) Pharmaceuticals Co., Ltd.

Collaborator

DualityBio Inc.

Collaborator

Source ClinicalTrials.gov
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