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

NCT03742349 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2025-05-18

No results posted yet for this study

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

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

Sponsors & Collaborators

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-31
Primary Completion
2023-02-06
Completion
2023-02-06
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Hong Kong
  • Israel
  • Italy
  • Japan
  • Netherlands
  • Singapore
  • Spain

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03742349 on ClinicalTrials.gov