Phase 3 study for people with Prostate Cancer

Recruiting Phase 3

Sources: ClinicalTrials.gov Checked: 11 October 2026 Not medical advice

This trial at a glance

Status Recruiting
Phase Phase 3
Sponsor BioNTech SE
Registry number NCT07365995
Started 22 April 2026 Today 16 October 2026 Estimated completion 1 February 2031

Where this trial is running

Trial sites and the status recorded for each
SiteCityState or countryStatus at this site
Tasman Onco Research Pty Ltd Southport QLD Recruiting

voxsanity.com.au · trial sites from public registries · registry record synced 11 October 2026 · not medical advice

Who can join

Age 18 Years and over
Sex Male participants only
Healthy volunteers Not accepted
Enrolment target 736

The official eligibility criteria

Registry text, reproduced exactly. These are the words the trial's sponsor published on ClinicalTrials.gov. They have not been edited, shortened or rewritten, and they are written for researchers rather than for patients.

Key Inclusion Criteria:

* 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).

* Must have documented progressive prostate cancer based on at least one of the following criteria:

* 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.

* Had previously received one or two prior androgen receptor pathway inhibitor treatments and experienced disease progression during or after a minimum of 8 weeks of therapy.

* Must not have received systemic cytotoxic chemotherapy, including taxane-based chemotherapy, for mCRPC.

* Must have had prior orchiectomy and/or have ongoing androgen-deprivation therapy and a castrate-level of serum/plasma testosterone (\<50 ng/dL or \<1.7 nmol/L). Participant being treated with luteinizing hormone-releasing hormone agonists or antagonists must continue such treatment throughout the study.

* Must have an Eastern Cooperative Oncology Group performance score of 0 or 1.

Key Exclusion Criteria:

* 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.

NOTE: Other protocol defined Inclusion/Exclusion criteria apply.

Dates on the record

Started 22 April 2026
Estimated completion 1 February 2031
Registry last updated 18 September 2026
Checked by Voxsanity 11 October 2026

Results, publications and the official record

Sources and dates

  • ClinicalTrials.gov – the record this page reformats
  • ClinicalTrials.gov processing date: 18 September 2026.
  • This page last checked by Voxsanity: 11 October 2026.

Voxsanity reformats data from public registries into this layout. It does not edit, interpret or add to what the registry published.

Not medical advice.

Individual trial records are refreshed on a rolling basis rather than all at once, so a record may be up to several weeks old. Each trial page and trial card shows the date its own record was last synced. Where a record has lagged, its status, sites and enrolment can differ from the current registry state in either direction, so check the registry link on the trial page before acting on them.

Letter for your doctor

A one-page summary of this trial to print or email to your GP. It carries the registry's own record of the trial and its eligibility criteria, and nothing Voxsanity has written about whether it suits you.