The purpose of this study is to evaluate the anti-tumor activity of 852A when used to treat metastatic breast, ovarian, endometrial or cervical cancer not responding to standard treatment.
852A will be administered as a subcutaneous injection (SC) 2 times per week for 12 weeks (24 doses) with provisions for dose escalation or reduction based on tolerability.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
15
0.2% 852a subcutaneous injection, 2 times per week for 12 weeks (24 doses) starting at 0.6 mg/m2; subsequent dose escalation for additional courses may be increased by 0.2 mg/m2 not to exceed 1.2 mg/m2.
Masonic Cancer Center, University of Minnesota
Minneapolis, Minnesota, United States
Patients With Tumor Response (Response Evaluation Criteria in Solid Tumors) Who Received All 24 Doses of 852A.
Assessment of anti-tumor activity of 852A using Response Evaluation Criteria in Solid Tumors (RECIST) criteria to evaluate tumor response after 24 doses. Complete Response (CR)= disappearance of all target lesions, Partial Response (PR) = at least 30% decrease in sum of longest diameter of target lesions, Progressive Disease (PD) = at least 25% increase in sum of longest diameter of target lesions, Stable Disease = neither PR or PD.
Time frame: after 12 weeks (24 doses of 852A)
Mean Difference Values for Interleukin 1 Receptor Antagonist (IKL1ra)
Measures the difference of IL1ra (cytokine) values as a means of immune activation pre-treatment and 6 hours post-treatment in patients that received at least one dose of study treatment with 852A.
Time frame: Prior to Dose 1 and 6 hours after Dose 1
Mean Difference Values for 10 kDa Interferon-gamma-induced Protein (IP-10)
Measures differences in IP-10 (cytokine) values as a means of immune activation pre-treatment and 6 hours post-treatment in patients that received at least one dose of study treatment with 852A.
Time frame: Prior to Dose 1 and 6 Hours Post-Dose
Mean Difference Values for Macrophage Inflammatory Protein-1 Alpha (MIP-1a)
Measures difference in MIP-1a (cytokine) values as a means of immune activation pre-treatment and 6 hours post-treatment in patients that received at least one dose of study treatment with 852A.
Time frame: Prior to Dose 1 and 6 Hours Post-Dose
Mean Difference Values for Macrophage Inflammatory Protein-1 Beta (MIP-1b)
Measures difference in Macrophage Inflammatory Protein-1 Beta (cytokine) values as a means of immune activation pre-treatment and 6 hours post-treatment in patients that received at least one dose of study treatment with 852A.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Prior to Dose 1 and 6 Hours Post-Dose
Mean Difference Values for Soluble CD40 Ligand (sCD40L)
Measures difference in Soluble CD40 ligand (cytokine) values as a means of immune activation pre-treatment and 6 hours post-treatment in patients that received at least one dose of study treatment with 852A.
Time frame: Prior to Dose 1 and 6 Hours Post-Dose
Mean Difference Values for Tumor Necrosis Factor-alpha (TNF-a)
Measures difference in Tumor necrosis factor-alpha (cytokine) values as a means of immune activation pre-treatment and 6 hours post-treatment in patients that received at least one dose of study treatment with 852A.
Time frame: Prior to Dose 1 and 6 Hours Post-Dose