Study of Safety and Efficacy of Novel Immunotherapy Combinations in Patients With Triple Negative Breast Cancer (TNBC).

  • STATUS
    Not Recruiting
  • participants needed
    220
  • sponsor
    Novartis Pharmaceuticals
Updated on 23 May 2022
estrogen
measurable disease
progesterone
triple negative breast cancer
progesterone receptor
erbb2
estrogen receptor
taxane
adjuvant chemotherapy
core needle biopsy

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.

Details
Condition Triple Negative Breast Cancer (TNBC)
Treatment canakinumab, LAG525, MCS110, NIR178, capmatinib, spartalizumab
Clinical Study IdentifierNCT03742349
SponsorNovartis Pharmaceuticals
Last Modified on23 May 2022

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