Study of Safety and Efficacy of Novel Immunotherapy Combinations in Patients With Triple Negative Breast Cancer (TNBC).
Status:
Recruiting
Trial end date:
2022-01-17
Target enrollment:
Participant gender:
Summary
This is a Phase Ib, open label, dose escalation study of spartalizumab + LAG525 in
combination with NIR178, capmatinib, MCS110, or canakinumab, followed by a dose expansion in
adult patients with advanced or metastatic TNBC.
During the dose-escalation part of each treatment arm, patients will be treated with fixed
doses of spartalizumab + LAG525 in combination with partner investigational drugs to be
escalated until the MTD is reached or a lower RDE is established: NIR178, capmatinib, MCS110,
or canakinumab. It is anticipated that other partner study drugs may be added in the future
by protocol amendment.
After the determination of the MTD/RDE for a particular treatment arm, dose expansion may
begin in that arm in order to further assess safety, tolerability, PK/PD, and anti-tumor
activity of each combination at the MTD/RDE. Dose expansion arms may initiate only after
consideration by the Investigators and Novartis of all available toxicity information, the
assessment of risk to future patients from the BLRM, and the available PK, preliminary
efficacy, and PD information. There is no requirement for dose-escalation treatment arms
reaching an MTD/RDE to proceed to dose expansion.