Safety, Tolerability, PK, Anti-Tumor Activity of STP705 in Subjects With Advanced/Metastatic or Sā¦ (NCT04676633) | Clinical Trial Compass
CompletedPhase 1
Safety, Tolerability, PK, Anti-Tumor Activity of STP705 in Subjects With Advanced/Metastatic or Surgically Unresectable Solid Tumors Who Are Refractory to Standard Therapy
United States5 participantsStarted 2021-03-01
Plain-language summary
This is an open label, dose escalation and dose expansion study to evaluate the safety, tolerability, pharmacokinetics, and anti-tumor activity of STP705 administered intratumorally in cholangiocarcinoma, hepatocellular carcinoma or liver metastasis in subjects with advanced/metastatic or surgically unresectable solid tumors who are refractory to standard therapy.
Goals:
1. To determine the MTD or RP2D of STP705 when administered intratumorally into cholangiocarcinoma, hepatocellular carcinoma, or liver metastasis.
2. To establish the dose of STP705 recommended for future phase 2 studies when administered intratumorally.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
ā. Subjects with histologically or cytologically confirmed advanced/metastatic or surgically unresectable cholangiocarcinoma, hepatocellular carcinoma, or other solid malignancy with one or more qualifying liver metastases who are refractory to standard therapy
ā. Measurable disease per RECIST v 1.1 (primary or metastatic disease)
ā. ECOG performance status or 0 - 1
ā. Life expectancy of at least 3 months
ā. Age ā„ 18 years
ā. Signed, written Institutional Review Board (IRB) approved informed consent
ā. A negative serum pregnancy test (for nonsterile women of child-bearing potential)
ā. Baseline Q-T corrected interval (QTc) interval of ā¤ 480 msec using Frederica's formula
Exclusion criteria
ā. New York Heart Association Class III or IV cardiac disease, or myocardial infarction, severe unstable angina, coronary/peripheral artery bypass graft, congestive heart failure within the past 6 months
ā. Known active, uncontrolled infection with HIV or hepatitis B; patients with hepatitis B allowed if on anti-viral therapy and have a viral load ā¤ 500 IU; patients with a history of HIV must be on antiretroviral therapy for at least four weeks and have an HIV viral load ā¤ 400 copies/mL, have CD4+ T cell counts ā„ 350 cells/uL and no history of AIDS-defining opportunistic infections within 3 months prior to treatment
ā. Hepatocellular carcinoma patients with a Child Pugh score \> B7
ā. Had paracentesis in the last 3 months; presence of ascites must be controlled by diuretics
ā. History of hepatic encephalopathy in the last 6 months
ā. History of variceal bleeding in the last 6 months
ā. Concomitant medications that are strong inhibitors or inducers of CYP450 enzymes that cannot be stopped or replaced during the study
ā. Major surgical procedure within 4 weeks prior to initiation of study treatment, or anticipation of need for a major surgical procedure during the course of the study. (Note: Placement of a central venous access catheter(s) (e.g., port or similar) is not considered a major surgical procedure.)