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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-000691-42 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BAY2010112 (s.c.) | Experimental |
| |
| BAY2010112 (c.i.v.) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BAY2010112 | Biological | Subcutaneous (s.c.) administration once daily. Starting dose will be 0.5 µg ; dose will be escalated dependent on any dose limiting toxicities |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with Adverse Events as a Measure of Safety and Tolerability | Up to 2 years or longer if indicated | |
| 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% | Up to 2 years or longer if indicated |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum drug concentration (Cmax) of BAY2010112 in serum after single and multiple doses administration | Cycle 1 Day1 and 15; (1 Cycle is 21 days long) | |
| Area under the concentration versus time curve (AUC) from zero to infinity after single (first) and multiple doses of BAY2010112 |
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Inclusion Criteria:
Male subjects, aged >/= 18 years
Subjects with histologically or cytologically proven advanced castration-resistant prostate cancer (CRPC)
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.
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
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Linz | Upper Austria | 4010 | Austria | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23623807 | Result | 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. | |
| 37942314 | Derived | 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. |
| Label | URL |
|---|---|
| Click here to find information about studies related to Bayer Healthcare products conducted in Europe | View source |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| BAY2010112 | Biological | Continuous intravenous infusion (c.i.v.) administration. Starting dose will be 5 µg ; dose will be escalated dependent on any dose limiting toxicities. |
|
| Cycle 1 (1 Cycle is 21 days long) |
| Tumor response | Tumor response is measured by measurable lesions | Up to 2 years or longer if indicated |
| Prostate-specific antigen (PSA) response | PSA response is measured by maximum decline in PSA that occurs at any point after treatment | Up to 2 years or longer if indicated |
| Vienna |
| 1100 |
| Austria |
| Heidelberg | Baden-Wurttemberg | 69120 | Germany |
| Würzburg | Bavaria | 97080 | Germany |
| Berlin | 12200 | Germany |
| 33172323 | Derived | 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. |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |