Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
Bristol-Myers Squibb
This is a Phase 1, open-label, multiple dose escalation study in subjects with solid tumors that over express HER2. Subjects with locally un-resectable and/or metastatic solid cancers that over express human epidermal growth factor tyrosine kinase receptor 2 (HER2) by standard clinical pathology criteria and who have no standard treatment options will be enrolled into a series of escalating dose cohorts. Within each dose cohort, subjects will receive weekly (± 1 day) or less frequent IV (Q3W) infusions of FS102 during an initial 28-day (4-week) DLT observation period. During the DLT observation period, subjects will be assessed for safety, tolerability, dose limiting toxicity, PK, immunogenicity, and clinical disease response. Following assessment by the Investigator, subjects without clinical disease progression and without unacceptable toxicity will be eligible to continue receiving FS102 for up to six 21 (Q3W) to 28-day (weekly) cycles. Continuation Phase. Subjects who complete six 21-28-day cycles of treatment will be evaluated for entry into an extended Continuation Phase of the study. Subjects will be eligible for continuation if: * They demonstrate no evidence of disease progression; * In the opinion of the Investigator they are deemed reasonably likely to continue to benefit from treatment; and * They have not experienced any toxicity requiring discontinuation. During the Continuation Phase, subjects will continue to receive FS102 at the same dose they were originally assigned, unless modified downward for earlier toxicity. No dose escalation within subjects will be permitted. Treatment may continue until one of the following criteria applies: * Disease progression; * Intervening illness that prevents further administration of treatment; * Unacceptable adverse events; * Significant subject non-compliance with protocol; * Pregnancy; * Subject decides to withdraw from study; * General or specific changes in the subject's condition that render the subject unacceptable for further treatment in the judgment of the Investigator; or * Sponsor decides to end the study.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
