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Prostatic NeoplasmsPhase 1NCT01723475

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

A Phase 1 study testing BAY2010112 in people with Prostatic Neoplasms, run by Bayer at 5 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostatic Neoplasms
What is being tested?
BAY2010112
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
47 participants
Where
5 sitesin 2 countries
Study dates
2 Nov 2012to 26 Sep 2018
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male subjects, aged >/= 18 years
  • Subjects with histologically or cytologically proven advanced castration-resistant prostate cancer (CRPC)
  • who failed at least 1 taxane regimen and are refractory to abiraterone and/or enzalutamide therapy OR
  • who have actively refused any treatment which would be regarded standard.
  • Subjects should have undergone bilateral orchiectomy or should be on continuous androgen deprivation therapy with a gonadotropin releasing hormone agonist or antagonist.
  • Subjects must have shown progressive disease after discontinuation of anti-androgen therapy (i.e. flutamide, bicalutamide or nilutamide) before study drug treatment.
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  • Total serum testosterone should be less than 50 ng/ml or 1.7 nmol/L
  • Evidence of progressive disease, defined as one or more (Prostate Cancer Working Group 2 (PCWG2) criteria):
  • PSA level of at least 2 ng/ml that has risen on at least 2 successive occasions at least 1 week apart
  • Nodal (in lymph nodes >/= 2cm) or visceral progression as defined by Response Evaluation Criteria in Solid Tumors (RECIST)
  • Appearance of one more new lesions in bone scan
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 2
  • Life expectancy of at least 3 months

Who cannot join

  • Any anticancer therapy or immunotherapy within 4 weeks of start of first dose
  • Confirmed history or current autoimmune disease or other diseases resulting in permanent immunosuppression or requiring permanent immunosuppressive therapy
  • Prior radiotherapy (local palliative radiotherapy is permitted)
  • History of allergic reactions to monoclonal antibody therapy
  • History of clinical significant cardiac disease: including unstable angina, acute myocardial infarction within 6 months prior to first study treatment, congestive heart failure ≥New York Heart Association (NYHA) Class III), and arrhythmia requiring therapy except for beta-blockers, calcium channel blockers and digoxin or uncontrolled hypertension, despite optimal medical management
  • Clinically relevant findings in the electrocardiogram (ECG) such as a second- or third-degree AV block, prolongation of the QRS complex over 120 msec or of the QT interval corrected for heart rate (QTc)-interval over 450 msec
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  • Current evidence or history of uncured (i.a. any absolute risk of latent infection) of hepatitis B or C or human immunodeficiency virus (HIV) infection
  • Chronic systemic corticosteroid therapy or any other immunosuppressive therapies should have been stopped at screening start
  • Seizure disorder requiring therapy (such as steroids or anti-epileptics)
  • Subjects unable to inject the study drug subcutaneously for intended s.c. application
  • Non-suitable for a central venous access for intended c.i.v. administration

Trial locations and contacts

5 sites in 2 countries.

5 sites in 2 countries

Germany3 sites

  • Study site

    Berlin, 12200

  • Study site

    Heidelberg, Baden-Wurttemberg, 69120

  • Study site

    Würzburg, Bavaria, 97080

Other trials in Germany

Austria2 sites

  • Study site

    Linz, Upper Austria, 4010

  • Study site

    Vienna, 1100

Other trials in Austria

About this study

Official title: An Open-label, Phase I, Dose-escalation Study to Characterize the Safety, Tolerability, Pharmacokinetics, and Maximum Tolerated Dose of BAY 2010112, Given Once Daily by Subcutaneous Administration or by Continuous Intravenous Infusion, in Subjects With Castration-resistant Prostate Cancer

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.

Being tested
BAY2010112
Keywords
Phase I, Dose Escalation, Prostate cancer, Antibodies, Bispecific T-cell Engager (BiTE)
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BAY2010112Biological

    Subcutaneous (s.c.) administration once daily. Starting dose will be 0.5 µg ; dose will be escalated dependent on any dose limiting toxicities

  • BAY2010112Biological

    Continuous intravenous infusion (c.i.v.) administration. Starting dose will be 5 µg ; dose will be escalated dependent on any dose limiting toxicities.

Study groups in NCT01723475
Study groupRoleWhat they receive
BAY2010112 (s.c.)ExperimentalNot described
Receives: Biological: BAY2010112
BAY2010112 (c.i.v.)ExperimentalNot described
Receives: Biological: BAY2010112

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of participants with Adverse Events as a Measure of Safety and Tolerability

    Measured: Up to 2 years or longer if indicated

  2. Maximum Tolerated Dose (MTD)

    MTD is measured by adverse event profile at the end of Cycle 1. MTD will be the highest dose level achieved during dose escalation where the incidence of dose-limiting toxicities (DLTs) is below 20%

    Measured: Up to 2 years or longer if indicated

Secondary outcomes (4)

  1. Maximum drug concentration (Cmax) of BAY2010112 in serum after single and multiple doses administration

    Measured: Cycle 1 Day1 and 15; (1 Cycle is 21 days long)

  2. Area under the concentration versus time curve (AUC) from zero to infinity after single (first) and multiple doses of BAY2010112

    Measured: Cycle 1 (1 Cycle is 21 days long)

  3. Tumor response

    Tumor response is measured by measurable lesions

    Measured: Up to 2 years or longer if indicated

  4. Prostate-specific antigen (PSA) response

    PSA response is measured by maximum decline in PSA that occurs at any point after treatment

    Measured: Up to 2 years or longer if indicated

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Nov 2012 (estimated)
  2. Study start2 Nov 2012
  3. Primary completion18 Jul 2018
  4. Study completion26 Sep 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
47 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01723475
Sponsor's protocol ID
15590
Other IDs
2012-000691-42
Status last verified
Sep 2019
First submitted
1 Nov 2012
Last updated
27 Sep 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Frankel SR, Baeuerle PA. Targeting T cells to tumor cells using bispecific antibodies. Curr Opin Chem Biol. 2013 Jun;17(3):385-92. doi: 10.1016/j.cbpa.2013.03.029. Epub 2013 Apr 25.

    PubMed 23623807

  • Penny HL, Hainline K, Theoharis N, Wu B, Brandl C, Webhofer C, McComb M, Wittemer-Rump S, Koca G, Stienen S, Bargou RC, Hummel HD, Loidl W, Grullich C, Eggert T, Tran B, Mytych DT. Characterization and root cause analysis of immunogenicity to pasotuxizumab (AMG 212), a prostate-specific membrane antigen-targeting bispecific T-cell engager therapy. Front Immunol. 2023 Oct 23;14:1261070. doi: 10.3389/fimmu.2023.1261070. eCollection 2023.

    PubMed 37942314

  • Hummel HD, Kufer P, Grullich C, Seggewiss-Bernhardt R, Deschler-Baier B, Chatterjee M, Goebeler ME, Miller K, de Santis M, Loidl W, Dittrich C, Buck A, Lapa C, Thurner A, Wittemer-Rump S, Koca G, Boix O, Docke WD, Finnern R, Kusi H, Ajavon-Hartmann A, Stienen S, Sayehli CM, Polat B, Bargou RC. Pasotuxizumab, a BiTE(R) immune therapy for castration-resistant prostate cancer: Phase I, dose-escalation study findings. Immunotherapy. 2021 Feb;13(2):125-141. doi: 10.2217/imt-2020-0256. Epub 2020 Nov 10.

    PubMed 33172323

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing BAY2010112 in people with Prostatic Neoplasms, run by Bayer at 5 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Germany, Austria. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants with Adverse Events as a Measure of Safety and Tolerability (time frame: Up to 2 years or longer if indicated). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01723475, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2019.

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