A Phase 1 First-in Human Multi-Center Open Label Dose-Escalation Study to Determine the Safety Tolerability Pharmacokinetics and RP2D of ABBV-151 as a Single Agent and in Combination with ABBV-181 in Subjects with Locally Advanced or Metastatic Solid Tumors (AbbVie M19-345)
Are you eligible to participate in this study?
You may be eligible for this study if you meet the following criteria:
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Conditions: Urothelial Carcinoma, Solid Tumors
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Age: Between 18 - 100 Years
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Gender: Male or Female
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Other Inclusion Criteria:
1) Subject must weigh at least 35 kg. 2) For Dose Escalation only: Subjects with an advanced solid tumor who are considered refractory to or intolerant of all existing therapy(ies) known to provide a clinical benefit for their condition (i.e., subjects who have progressed on standard therapies known to provide clinical benefit). 3) For Dose Expansion only: All subjects with breast adenocarcinoma that is estrogen receptor (ER) negative, progesterone receptor (PR) negative, and human epidermal growth factor receptor 2 (HER2) negative ("triple negative breast cancer," TNBC) must provide consent to pretreatment and on-treatment fresh tumor biopsies in order to be enrolled.
You may not be eligible for this study if the following are true:
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1) History of inflammatory bowel disease, pneumonitis, myocarditis, Stevens-Johnson syndrome or toxic epidermal necrolysis. 2) Known uncontrolled metastases to the central nervous system.
If you are registered as a volunteer, please log in to contact the study team/express interest in this study.
