Neoplasms Clinical Trial
Official title:
A Phase 1/2 Study of the Highly Selective EGFR Inhibitor, BLU-701, in Patients With EGFR-Mutant Non-Small Cell Lung Cancer
This is a Phase 1/2, open-label, first-in-human (FIH) study is designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and antitumor activity of BLU-701 as monotherapy or in combination with either osimertinib or platinum-based chemotherapy in patients with EGFRm NSCLC.
The study was planned to include an initial Phase 1 portion to determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of BLU-701 as monotherapy (Part 1A; initially in a once daily (QD) regimen with the option to evaluate twice daily (BID) dosing if supported by emerging PK and safety data), as well as additional dose-escalation portions to determine the RP2D of BLU-701 in combination with osimertinib (Part 1B) or in combination with carboplatin and pemetrexed (Part 1C). A Phase 2 part was planned to further evaluate the efficacy and safety of BLU-701 as monotherapy at RP2D (Part 2A). Phase 1 Part 1 A was initiated; however, the study was terminated prior to establishing BLU-701 MTD and/or RP2D. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03826043 -
THrombo-Embolic Event in Onco-hematology
|
N/A | |
Terminated |
NCT03166631 -
A Trial to Find the Safe Dose for BI 891065 Alone and in Combination With BI 754091 in Patients With Incurable Tumours or Tumours That Have Spread
|
Phase 1 | |
Completed |
NCT01938846 -
BI 860585 Dose Escalation Single Agent and in Combination With Exemestane or With Paclitaxel in Patients With Various Advanced and/or Metastatic Solid Tumors
|
Phase 1 | |
Recruiting |
NCT06058312 -
Individual Food Preferences for the Mediterranean Diet in Cancer Patients
|
N/A | |
Completed |
NCT03308942 -
Effects of Single Agent Niraparib and Niraparib Plus Programmed Cell Death-1 (PD-1) Inhibitors in Non-Small Cell Lung Cancer Participants
|
Phase 2 | |
Recruiting |
NCT06018311 -
Exercising Together for Hispanic Prostate Cancer Survivor-Caregiver Dyads
|
N/A | |
Withdrawn |
NCT05431439 -
Omics of Cancer: OncoGenomics
|
||
Completed |
NCT01343043 -
A Pilot Study of Genetically Engineered NY-ESO-1 Specific NY-ESO-1ᶜ²⁵⁹T in HLA-A2+ Patients With Synovial Sarcoma
|
Phase 1 | |
Completed |
NCT01938638 -
Open Label Phase I Dose Escalation Study With BAY1143572 in Patients With Advanced Cancer
|
Phase 1 | |
Recruiting |
NCT05514444 -
Study of MK-4464 as Monotherapy and in Combination With Pembrolizumab in Participants With Advanced/Metastatic Solid Tumors (MK-4464-001)
|
Phase 1 | |
Recruiting |
NCT02292641 -
Beyond TME Origins
|
N/A | |
Terminated |
NCT00954512 -
Study of Robatumumab (SCH 717454, MK-7454) in Combination With Different Treatment Regimens in Participants With Advanced Solid Tumors (P04722, MK-7454-004)
|
Phase 1/Phase 2 | |
Recruiting |
NCT04958239 -
A Study to Test Different Doses of BI 765179 Alone and in Combination With Ezabenlimab in Patients With Advanced Cancer (Solid Tumors)
|
Phase 1 | |
Recruiting |
NCT04627376 -
Multimodal Program for Cancer Related Cachexia Prevention
|
N/A | |
Completed |
NCT01222728 -
Using Positron Emission Tomography to Predict Intracranial Tumor Growth in Neurofibromatosis Type II Patients
|
||
Recruiting |
NCT06004440 -
Real World Registry for Use of the Ion Endoluminal System
|
||
Active, not recruiting |
NCT05636696 -
COMPANION: A Couple Intervention Targeting Cancer-related Fatigue
|
N/A | |
Not yet recruiting |
NCT06035549 -
Resilience in East Asian Immigrants for Advance Care Planning Discussions
|
N/A | |
Recruiting |
NCT06004466 -
Noninvasive Internal Jugular Venous Oximetry
|
||
Completed |
NCT02909348 -
Immunophenotyping of Melanoma Patients on Treatment With Pembrolizumab
|