Ignite Creation Date:
2025-12-18 @ 8:28 AM
Ignite Modification Date:
2025-12-23 @ 11:09 PM
Study NCT ID:
NCT05293912
Status:
None
Last Update Posted:
2025-03-18 00:00:00
First Post:
2022-03-01 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
SG2501 Safety Study in Subjects with Relapsed or Refractory Hematological Malignancies and Lymphoma.
Sponsor:
None
Organization:
Study Overview
Official Title:
A Phase Ia/Ib, First-in-Human, Open-Label, Multicenter, Dose Escalation and Dose Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity, and Preliminary Efficacy of SG2501 in Subjects with Relapsed or Refractory Hematological Malignancies and Lymphoma.
Status:
None
Status Verified Date:
2025-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Adjustment of clinical development plan
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Phase Ia will consist of two parts:an accelerated titration using single patient cohorts to evaluate SG2501 at lower dose levels(Part A), followed by dose-escalation using multipatient cohorts to establish a maximum tolerated dose(MTD)(Part B). Phase Ib will consist of dose expansion cohorts with SG2501 monotherapy in subjects with relapsed or refractory multiple myeloma(MM) or diffuse large B-cell lymphoma(DLBCL).
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?: