Trial Condition(s):
Dose-escalation study of Lupartumab Amadotin (BAY1129980)
16044
Not Available
Not Available
The purpose of this study is to evaluate:
- The side effects of BAY1129980 when given every 21 days different dose levels.
- Determine the dose level of BAY1129980 that should be tested in future clinical research studies.
- Measure how much BAY1129980 is in the blood at specific times after administration.
- If treatment with BAY1129980 shows any effect on reducing the tumor growth.
- If there are specific biomarkers that might be able to explain why some patients respond to treatment and others do not.
- If treatment with BAY1129980 causes an immune response from the body against the drug (immunogenicity).
- All subjects must be ≥ 18 years at the first screening examination / visit - All subjects must provide a tumor tissue sample from [Formalin Fixed Paraffin Embedded (FFPE) slides] archival tissue or fresh biopsy collected before Cycle 1, Day 1 - Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1 - Life expectancy of at least 12 weeks - Radiographically or clinically evaluable tumor. In the expansion phase, disease must be measurable according to RECIST 1.1. - Adequate bone marrow, liver, and renal function - Histologically or cytologically confirmed solid tumors known to express C4.4a (eg, carcinomas of the lung, head & neck SCC, esophagus SCC (squamous cell carcinoma),colon, ovary, prostate, and breast) that are refractory to any standard therapy, or have no standard therapy available, or for which subjects actively refuse any treatment that would be regarded as standard and in whom, in the opinion of the investigator, experimental therapy with BAY1129980 may be beneficial. - A signed informed consent must be obtained prior to any study-specific procedures. - Measurable disease with at least one lesion that can be accurately measured in at least one dimension according to RECIST 1.1
- Anticancer chemotherapy, experimental cancer therapy, or cancer immunotherapy within 4 weeks prior to first dose study drug. Anticancer therapy is defined as any agent or combination of agents with clinically proven anti tumor activity administered by any route with the purpose of affecting the malignancy, either directly or indirectly, including palliative and therapeutic endpoints. - Skin toxicity including but not limited to erythema, rash, ulceration, and open wound that is still clinically present and considered as acute or chronic. - Subjects with psoriasis or other severe skin disease (eg, autoimmune skin disease, active erythematous skin lesions, etc.) - Serious, non-healing wound, skin ulcer (of any grade), or bone fracture. - Prior local radiotherapy is allowed if it is completed at least 4 weeks prior to the first dose of study drug and the subject has evaluable lesions not previously irradiated - Significant liver dysfunction determined as Child-Pugh score B or C - History of symptomatic metastatic brain or meningeal tumors unless the subject is >3 months from the end of definitive therapy before the first dose of study drug and has clinically or radiologically no evidence of tumor growth. - History of clinically significant cardiac disease. - Anti-platelet drugs within 4 weeks prior to the first dose of study drug. Anti-platelet drugs are defined as any agent or combination of agents with clinically proven anti-thrombotic activity administered by any route with the purpose of affecting blood clotting ability of the subject. - Participation in another clinical trial in which they received active therapy within 4 weeks prior to the first dose of study drug. - Subjects with CNS symptoms should undergo a CT scan or MRI of the brain to exclude new or progressive brain metastases. Spinal cord metastasis is acceptable. However, subjects with spinal cord compression should be excluded. - Subjects with severe renal impairment (GFR <50 mL/min/1.73 m²) or on dialysis. - History of organ allograft (except for corneal transplant) or autologous or allogeneic bone marrow transplant, or stem cell rescue within 3 months prior to the first dose of study drug. - Current evidence or previous medical history of (ie, any absolute risk of latent infection) hepatitis B or C, any active hepatitis, or human immunodeficiency virus (HIV) infection. Active clinically serious infections > CTCAE Grade 2. - Major surgery or significant trauma within 2 weeks prior to the first dose of study drug. - Substance abuse, medical, psychological or social conditions that may interfere with the subject’s participation in the study or evaluation of the study result. - Subjects who are pregnant or are breast-feeding. - Any condition that is unstable or could jeopardize the safety of the subject and his / her compliance to the study.
Locations | Status | |
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Locations Investigative Site Nashville, United States, 37203 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Buffalo, United States, 14263 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Houston, United States, 77030 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Dallas, United States, 75230 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Washington, United States, 20007-2197 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site La Jolla, United States, 92093 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Gainsville, United States, 32610 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site New York, United States | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Aurora, United States, 80045 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Seattle, United States, 98109-1023 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Westwood, United States, 66205 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Durham, United States, 27710 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Stanford, United States, 94305 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Philadelphia, United States, 19104 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Hackensack, United States, 07601 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
An open-label Phase I dose-escalation study to evaluate the safety, tolerability, maximum tolerated dose, pharmacokinetics, and pharmacodynamics of the anti-C4.4a antibody drug conjugate BAY1129980 in subjects with advanced solid tumors known to express C4.4a
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
N/A
Blinding:
Open Label
Assignment:
Single Group Assignment
Trial Arms:
1