NCT03742349

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

A Phase Ib, Multicenter, Open-label Dose Escalation and Expansion Platform Study of Select Immunotherapy Combinations in Adult Patients With Triple-negative Breast Cancer

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Triple Negative Breast Cancer (TNBC)

Interventions

Type	Name	Description
BIOLOGICAL	spartalizumab	LIVI (Liquid in vial) Concentrate for Solution for infusion
BIOLOGICAL	LAG525	LAG525 LIVI (Liquid in vial) Concentrate for Solution for infusion
DRUG	NIR178	Capsule
DRUG	capmatinib	Tablet
BIOLOGICAL	MCS110	LIVI (Liquid in vial) Concentrate for Solution for infusion
BIOLOGICAL	canakinumab	LIVI (Liquid in vial) Solution for injection

Timeline

• Start date: 2019-01-31
• Primary completion: 2023-02-06
• Completion: 2023-02-06
• First posted: 2018-11-15
• Last updated: 2025-05-18

Locations

13 sites across 9 countries: United States, Australia, Hong Kong, Israel, Italy, Japan, Netherlands, Singapore, Spain

Regulatory

• FDA-regulated drug study