Solid Tumors That Overexpress HER2 (HER2 Positive) Clinical Trial
Official title:
Phase 1, Multiple Ascending Dose Study of Anti-HER2 FCAB FS102 in HER2 Positive Solid Tumors
To evaluate the safety, tolerability, dose limiting toxicity (DLT), and maximum tolerated dose (MTD), of FS102(BMS-986186) when administered intravenously (IV) to subjects with relapsed or refractory solid tumors that overexpress HER2 and who have no standard treatment options.
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.
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