Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06585488
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-03
Brief Title:
A First-in-human Study of BGB-53038 a Pan-KRAS Inhibitor Alone or in Combinations in Participants with Advanced or Metastatic Solid Tumors with KRAS Mutations or Amplification
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase 1a1b Study to Investigate the Safety Tolerability Pharmacokinetics Pharmacodynamics and Preliminary Antitumor Activity of BGB-53038 a Pan-KRAS Inhibitor As Monotherapy or in Combinations in Patients with Advanced or Metastatic Solid Tumors with KRAS Mutations or Amplifications
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a first-in-human FIH open-label multicenter dose escalation and dose expansion study to evaluate the safety tolerability pharmacokinetics PK pharmacodynamics and preliminary antitumor activity of BGB-53038 as monotherapy in participants with advanced or metastatic solid tumors harboring KRAS mutations or amplification as well as when used in combination with tislelizumab also known as BGB-A317 in participants with nonsquamous non-small cell lung cancer NSCLC and used in combination with cetuximab in participants with colorectal cancer CRC The study consists of 2 phases Phase 1a Dose Escalation and Safety Expansion and Phase 1b Dose Expansion
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None