SG2501 Safety Study in Subjects With Relapsed or Refractory Hematological Malignancies and Lymphoma.
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|ClinicalTrials.gov Identifier: NCT05293912|
Recruitment Status : Recruiting
First Posted : March 24, 2022
Last Update Posted : August 4, 2022
|Condition or disease||Intervention/treatment||Phase|
|Hematological Malignancy Lymphoma||Drug: SG2501||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||72 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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.|
|Actual Study Start Date :||August 3, 2022|
|Estimated Primary Completion Date :||February 1, 2023|
|Estimated Study Completion Date :||September 1, 2024|
SG2501 monotherapy intravenous (IV) infusion - Weekly doses
During study treatment, subjects will receive SG2501 treatment via IV infusion once every week at doses of: 0.01, 0.03, 0.1, 0.3, 1, 2, 4 and 6mg/kg.
Other Name: Recombinant Anti-cluster of Differentiation 38(CD38)/47(CD47) Bispecific Antibody
- Number of patients with AEs and SAEs [ Time Frame: At the end of treatment phase (24 weeks) ]To evaluate the safety and tolerability of SG2501 [Adverse events (AEs), Serious Adverse Events (SAE)].
- The Maximum tolerated dose (MTD) and Recommended Phase 2 dose (RP2D) for SG2501 [ Time Frame: At the end of treatment phase (24 weeks) ]MTD/Recommended Phase 2 dose (RP2D) determined by DLTs and other safety data,as well as available PK data.
- Pharmacokinetics (PK): AUC [ Time Frame: At the end of treatment phase (24 weeks) ]The area under the curve (AUC) of serum concentration of the drug after the administration.
- Pharmacokinetics (PK): Cmax [ Time Frame: At the end of treatment phase (24 weeks) ]Maximum Concentration (Cmax) of the drug after administration.
- Immunogenicity: percentage of ADA positive patients [ Time Frame: At the end of treatment phase (24 weeks) ]Number and percentage of subjects with ADAs.
- Preliminary anti-tumor activity of SG2501 (Objective Response Rate) [ Time Frame: At the end of treatment phase (24 weeks) ]To assess the preliminary antitumor activity of SG2501 following IV infusion in subjects with relapsed or refractory hematological malignancies and lymphoma.
- Receptor occupancy [ Time Frame: At the end of treatment phase (24 weeks) ]CD47 and CD38 receptor occupancy (%).
- Immune-cell type assessment [ Time Frame: At the end of treatment phase (24 weeks) ]Cell counts and percentages of T lymphocytes, NK cells, and B lymphocytes, including but not limited to CD4+, CD8+ T lymphocytes, CD38+MDSCs, CD38+Tregs, CD38+Bregs, CD16+CD56+, CD16+CD56dim assessed by FACS analysis of peripheral blood leukocytes.
- Cytokine level [ Time Frame: At the end of treatment phase (24 weeks) ]Levels of inflammatory cytokine biomarkers, including, but not limited to TNF α, IFN γ, IL-2, IL-4, IL-6, IL-8 and IL-1β.
- Correlation antitumor activity [ Time Frame: At the end of treatment phase (24 weeks) ]To explore the correlation of SG2501 antitumor activity and potential tumor markers, including but not limited to CD47and CD38 expression in archived tumor samples.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05293912
|Contact: Nashat Gabrail||330-492-3345 ext firstname.lastname@example.org|
|Contact: Carrie Smithemail@example.com|