BLU-945 for Respiratory Diseases

Phase-Based Progress Estimates

Effectiveness

Safety

Respiratory Diseases+23 MoreBLU-945 - Drug

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Eligibility

18+

All Sexes

What conditions do you have?

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Eligibility

18+

All Sexes

What conditions do you have?

Select

Study Summary

This trial is testing a new cancer drug that targets the EGFR protein. The drug is being tested to see if it is safe and effective at treating cancer.

Eligible Conditions

Respiratory Diseases
Cancer
Epidermal Growth Factor Receptor C797S Mutation
Protein Kinase Inhibitors
Chemotherapy
Adenocarcinoma
Epidermal Growth Factor Receptor L858R Mutation
Epidermal Growth Factor Receptor Activating Mutation
Lung Cancer
Epidermal Growth Factor Receptor Gene Mutations
EGFR Mutation-Associated Tyrosine Kinase Inhibitor Resistance
Epidermal Growth Factor Receptor Exon 19 Deletion
Bronchial Tumors
Tumors
Lung Disease
Neurofibromatosis
Non-Small-Cell Lung Carcinoma
Epidermal Growth Factor Receptor T790M Mutation
Non-Small Cell Lung Cancer (EGFR Positive)

Treatment Effectiveness

Effectiveness Progress

1 of 3

Furmonertinib

Ipilimumab

Study Objectives

8 Primary · 31 Secondary · Reporting Duration: Up to 42 months

Up to 12 months

[Phase 1] Determine recommended Phase 2 dose (RP2D) of BLU-945

[Phase 1] Determine recommended Phase 2 dose (RP2D) of BLU-945 as monotherapy and BLU-945 in combination with osimertinib

[Phase 1] Determine the maximum tolerated dose (MTD) of BLU-945

[Phase 1] Determine the maximum tolerated dose (MTD) of BLU-945 as monotherapy and BLU-945 in combination with osimertinib

[Phase 1] Overall response rate (ORR)

[Phase 1] Overall response rate (ORR) of BLU-945 as monotherapy and BLU-945 in combination with osimertinib

[Phase 1] Rate and severity of adverse events

[Phase 1] Rate and severity of adverse events of BLU-945 as monotherapy and BLU-945 in combination with osimertinib

Up to 25 months

[Phase 2] QTc Assessment

Up to 30 months

[Phase 2] Clinical benefit rate (CBR)

[Phase 2] Clinical benefit rate (CBR) of BLU-945 as monotherapy and BLU-945 in combination with osimertinib

[Phase 2] Disease control rate (DCR)

[Phase 2] Disease control rate (DCR) of BLU-945 as monotherapy and BLU-945 in combination with osimertinib

[Phase 2] Overall response rate (ORR)

[Phase 2] Overall response rate (ORR) of BLU-945 as monotherapy and BLU-945 in combination with osimertinib

Up to 42 months

[Phase 1 and Phase 2] AUC (0-24)

[Phase 1 and Phase 2] Accumulation ratio

[Phase 1 and Phase 2] Assess treatment-induced modulation of EGFR pathway biomarkers.

[Phase 1 and Phase 2] CL/F

[Phase 1 and Phase 2] Cmax

[Phase 1 and Phase 2] Ctrough

[Phase 1 and Phase 2] Duration of response (DOR)

[Phase 1 and Phase 2] Duration of response (DOR) of BLU-945 as monotherapy and BLU-945 in combination with osimertinib

[Phase 1 and Phase 2] R

[Phase 1 and Phase 2] T 1/2

[Phase 1 and Phase 2] Tlast

[Phase 1 and Phase 2] Tmax

[Phase 1 and Phase 2] Vz/F

[Phase 2] Assess intracranial rate

[Phase 2] Assess time to intracranial progression

[Phase 2] Central Nervous System Duration of Response (CNS-DOR) of BLU-945 as monotherapy and BLU-945 in combination with osimertinib

[Phase 2] Central Nervous System Overall Response Rate (CNS-ORR) of BLU-945 as monotherapy and BLU-945 in combination with osimertinib

[Phase 2] Central Nervous System Progression Rate of BLU-945 as monotherapy and BLU-945 in combination with osimertinib

[Phase 2] Overall survival (OS)

[Phase 2] Overall survival (OS) of BLU-945 as monotherapy and BLU-945 in combination with osimertinib

[Phase 2] Progression free survival (PFS)

[Phase 2] Progression free survival (PFS) of BLU-945 as monotherapy and BLU-945 in combination with osimertinib

[Phase 2] Rate and severity of adverse events

[Phase 2] Rate and severity of adverse events of BLU-945 as monotherapy and BLU-945 in combination with osimertinib

Trial Safety

Safety Progress

1 of 3

Furmonertinib

Ipilimumab

Trial Design

7 Treatment Groups

BLU-945

1 of 7

Part 1A: BLU-945 as monotherapy

1 of 7

Phase 2, Group 1: BLU-945 as monotherapy

1 of 7

Phase 2, Group 2: BLU-945 as monotherapy

1 of 7

Part 1B: BLU-945 with osimertinib

1 of 7

Phase 2, Group 4: BLU-945 with osimertinib

1 of 7

Phase 2, Group 3: BLU-945 as monotherapy

1 of 7

Experimental Treatment

190 Total Participants · 7 Treatment Groups

Primary Treatment: BLU-945 · No Placebo Group · Phase 1 & 2

BLU-945

Drug