Ignite Creation Date:
2024-05-06 @ 7:01 PM
Last Modification Date:
2024-10-26 @ 2:59 PM
Study NCT ID:
NCT05869240
Status:
RECRUITING
Last Update Posted:
2023-06-06
First Post:
2023-04-23
Brief Title:
BPB-101 in Subjects With Metastatic or Locally Advanced Solid Tumors
Sponsor:
Betta Pharmaceuticals Co Ltd
Organization:
Betta Pharmaceuticals Co Ltd
Study Overview
Official Title:
A Phase III Clinical Study to Evaluate the Safety Tolerability Pharmacokinetics and Preliminary Efficacy of BPB-101 in Patients With Advanced Malignant Solid Tumors
Status:
RECRUITING
Status Verified Date:
2023-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a multi-center open-label Phase III clinical study of BPB-101 as monotherapy in patients with advanced solid tumors to evaluate the safety pharmacokinetic characteristics and antitumor activity of BPB-101
Detailed Description:
This trial consist of 3 parts dose escalationphase Ia dose expansionphase Ib and clinical expansionphase II part The current trial is composed of dose escalation with accelerated titration and 3 3 cohort design phase Ia for which 1 to 6 subjects will be enrolled at each dose level depending on the occurrence of dose limiting toxicities DLT followed by a consecutive parallel-group expansion in selected dose levels phase Ib and selected solid tumor indications phase II Participants enrolled in Phase 2 will receive the Recommend Phase 2 Dose RP2D of BPB-101 determined by phase Ia dose escalation and phase Ib dose expansion until confirmed progression unacceptable toxicity or any criterion for stopping the study drug or withdrawal from the trial occurs
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None