NCT01723475 is a Phase 1 clinical trial of BAY2010112 in Prostatic Neoplasms, sponsored by Bayer.

Who is sponsoring NCT01723475?

NCT01723475 is sponsored by Bayer.

What drugs are being tested in NCT01723475?

Interventions in NCT01723475: BAY2010112, BAY2010112.

What condition does NCT01723475 study?

NCT01723475 studies Prostatic Neoplasms.

Is NCT01723475 still recruiting?

NCT01723475 is currently completed. Last updated 27 September 2019.

Last reviewed 2019-09-27 · How we verify

NCT01723475

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

First-in-man Dose Escalation Study of BAY2010112 in Patients With Prostate Cancer

Completed Phase 1 Last updated 27 September 2019

What this trial tests

Phase 1 trial testing BAY2010112 in Prostatic Neoplasms in 47 participants. Completed in 26 September 2018.

Timeline

2 November 2012

Primary endpoint
18 July 2018

26 September 2018

Quick facts

Lead sponsor	Bayer
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	47
Start date	2 November 2012
Primary completion	18 July 2018
Estimated completion	26 September 2018
Sites	5 locations across Austria, Germany

Drugs / interventions tested

BAY2010112 — full drug profile →
BAY2010112 — full drug profile →

Conditions studied

Prostatic Neoplasms — all drugs for Prostatic Neoplasms →

Sponsor

Bayer — full company profile →

Who can join

18 and older, male only, with Prostatic Neoplasms. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is the first study where BAY2010112 is given to humans. Patients with castration resistant prostate cancer will be treated. Every patient will receive drug treatment, there is no placebo group. Patients will receive different dosages of BAY2010112 to determine the safety, tolerability and maximum tolerated dose (MTD) of BAY2010112. The study will also assess the pharmacokinetics and the clinical efficacy of BAY2010112. BAY2010112 will be given daily as subcutaneous injection or as continuous intravenous infusion. Treatment will be stopped if the tumor continues to grow, if side effects, which the patient cannot tolerate, occur or if the patient decides to exit treatment.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Bispecific T-cell engagers for cancer immunotherapy.
Huehls AM, Coupet TA, Sentman CL. · · 2015 · cited 370× · PMID 25367186 · DOI 10.1038/icb.2014.93
Emerging new therapeutic antibody derivatives for cancer treatment.
Jin S, Sun Y, Liang X, Gu X, et al · · 2022 · cited 304× · PMID 35132063 · DOI 10.1038/s41392-021-00868-x
Bispecific antibodies and their applications.
Fan G, Wang Z, Hao M, Li J. · · 2015 · cited 200× · PMID 26692321 · DOI 10.1186/s13045-015-0227-0
Bispecific Antibodies: From Research to Clinical Application.
Ma J, Mo Y, Tang M, Shen J, et al · · 2021 · cited 199× · PMID 34025638 · DOI 10.3389/fimmu.2021.626616
The landscape of bispecific T cell engager in cancer treatment.
Zhou S, Liu M, Ren F, Meng X, et al · · 2021 · cited 172× · PMID 34039409 · DOI 10.1186/s40364-021-00294-9
Cancer immunotherapy beyond immune checkpoint inhibitors.
Marin-Acevedo JA, Soyano AE, Dholaria B, Knutson KL, et al · · 2018 · cited 140× · PMID 29329556 · DOI 10.1186/s13045-017-0552-6
A multicenter phase 1 study of solitomab (MT110, AMG 110), a bispecific EpCAM/CD3 T-cell engager (BiTE®) antibody construct, in patients with refractory solid tumors.
Kebenko M, Goebeler ME, Wolf M, Hasenburg A, et al · · 2018 · cited 127× · PMID 30221040 · DOI 10.1080/2162402x.2018.1450710
Overcoming Challenges for CD3-Bispecific Antibody Therapy in Solid Tumors.
Middelburg J, Kemper K, Engelberts P, Labrijn AF, et al · · 2021 · cited 122× · PMID 33466732 · DOI 10.3390/cancers13020287

Verify or expand the search:

Other recruiting trials for Prostatic Neoplasms

Currently open trials in the same condition.

NCT07285057 — Diagnostic Utility of rhPSMA-7.3 (18F) PET/CT in Men With Prostate Cancer on Active Surveillance · Phase 2 · recruiting
NCT07319871 — A Study of Pasritamig (JNJ-78278343) in Combination With JNJ-86974680 for Treatment of Prostate Cancer · Phase 1 · recruiting
NCT07335224 — Men With Prostate Cancer: Optimizing Wellness by Enhanced Relief From Hot Flashes With Acupuncture · NA · recruiting
NCT07451002 — A Study to Assess Adherence to Apalutamide in Metastatic Hormone-Sensitive Prostate Cancer Participants in France · recruiting
NCT06547398 — Prostate Adaptive Radiation Therapy · NA · recruiting

Other Bayer trials

Trials by the same sponsor.

NCT05900388 — A Study to Observe the Pattern of Use and Safety of Rivaroxaban in Children Under 2 Years Old With Venous Thromboembolis · not yet recruiting
NCT07490431 — An Observational Study to Learn More About How Elinzanetant is Used and How Well it Works for Women With Menopause Sympt · not yet recruiting
NCT05477953 — An Observational Pregnancy Safety Study in Women Who Were Exposed to the Drug Nifurtimox During Pregnancy to Learn About · not yet recruiting
NCT07192952 — A Study to Learn More About How Safe Finerenone is, When it is Taken for a Longer Time With Standard Treatment, in Child · Phase 3 · not yet recruiting
NCT07450599 — A Study to Learn How Well a Combination of Darolutamide and Androgen Deprivation Therapy (ADT) Works as a Treatment Befo · Phase 2 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01723475 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Bayer
Last refreshed: 27 September 2019

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01723475.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing