SG2501 Safety Study in Subjects with Relapsed or Refractory Hematological Malignancies and Lymphoma.

NCT05293912 | Terminated Phase 1 FDA Drug

• 1 other identifier: CSG-2501-101
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 8

Brief Summary

This is a phase Ia/Ib, first-in-Human, open-Label, multicenter, dose escalation and dose expansion study designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and preliminary efficacy of SG2501 in subjects with relapsed or refractory hematological malignancies and lymphoma.

Conditions

Hematological Malignancy; Lymphoma

Outcome Measures

Primary Outcomes (2)

• Number of patients with AEs and SAEs

  To evaluate the safety and tolerability of SG2501 \[Adverse events (AEs), Serious Adverse Events (SAE)\].

  At the end of treatment phase (24 weeks)

• The Maximum tolerated dose (MTD) and Recommended Phase 2 dose (RP2D) for SG2501

  MTD/Recommended Phase 2 dose (RP2D) determined by DLTs and other safety data,as well as available PK data.

  At the end of treatment phase (24 weeks)

Secondary Outcomes (8)

• Pharmacokinetics (PK): AUC

  At the end of treatment phase (24 weeks)

• Pharmacokinetics (PK): Cmax

  At the end of treatment phase (24 weeks)

• Immunogenicity: percentage of ADA positive patients

  At the end of treatment phase (24 weeks)

• Preliminary anti-tumor activity of SG2501 (Objective Response Rate)

  At the end of treatment phase (24 weeks)

• Receptor occupancy

  At the end of treatment phase (24 weeks)

Study Arms (1)

SG2501

EXPERIMENTAL

SG2501 monotherapy intravenous (IV) infusion - Weekly doses

Drug: SG2501

Interventions

SG2501 DRUG

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.

Also known as: Recombinant Anti-cluster of Differentiation 38(CD38)/47(CD47) Bispecific Antibody

SG2501

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must meet all the following criteria to be eligible for participation in this study:
• Male or female ≥ 18 years.
• Willing and able to provide signed and dated informed consent prior to any study-related procedures and willing and able to comply with all study procedurs.
• Phase Ia,dose escalation:
• Patients with histologically or cytologically confirmed relapsed or refractory hematological malignancies and lymphoma based on WHO(2016) diagnosis who are refractory to or intolerant of established therapies known to provide clinical benefit.
• Note: the histologic subtypes that are eligible for enrollment per the 2016 WHO criteria include multiple myeloma(MM), Chronic Lymphoid Leukemias (CLL) , Waldenstrom Macroglobulinemia (WM) primary systemic amyloidosis (PSA), Hodgkin's Lymphoma(HL) and Non-Hodgkin's Lymphoma(NHL).
• Phase Ib, Cohort1 MM Histologically or cytologically confirmed relapsed or refractory multiple myeloma based on WHO diagnosis. Subject has received at least 3 prior anti-myeloma regimens including a proteasome inhibitor (PI), a CD38 antibody and an immunomodulatory agent.
• Induction,bone marrow transplant with or without maintenance therapy is considered one regimen.
• Refractory is defined as disease that is nonresponsive on therapy, or progresses within 60 days of last therapy. Nonresponsive disease is defined as either failure to achieve minimal response or development of progressive disease while on therapy
• For subjects who received more than 1 regimen containing a PI their disease must be refractory to the most recent PI containing regimen.
• For subiects who received more than 1 regimen containing an immunomodulatory agent their disease must be refractory to the most recent immunomodulatory agent containing regimen.
• Phase Ib,Cohort DLBCL
• Histologically confirmed de novo or transformed DLBCL based on WHO diagnosis , relapsed or refractory to first line chemoimmunotherapy (eg, R-CHOP or equivalent) and second line salvage regimens or autologous hematopoetic cell transplantation, and for whom no further therapy is available that is known to provide clinical benefit.
• Disease that is measurable or assessable for response according to Lugano Classification for lymphomas.
• Note: This may depend on the patient's mutational status, eligibility for allogeneic transplant. Patients must be willing to undergo bone marrow aspirates/biopsies per protocol specifications; These will be performed per protocol schedule to evaluate patient response to treatment.

You may not qualify if:

• Patients who meet any of the following criteria cannot be enrolled:
• Symptomatic central nervous system (CNS) metastases or leptomeningeal disease or primary CNS tumors. Patients with asymptomatic CNS metastases who are radiologically and neurologically stable ≥ 4 weeks following CNS-directed therapy and are off steroids for at least 2 weeks prior to dosing may be eligible for study entry.
• For lymphoma: red blood cell transfusion within 2 weeks prior to study entry.
• History of hemolytic anemia of any cause (including Evans syndrome) within 3 months.
• Positive direct antiglobulin test (DAT).
• Severe or uncontrolled cardiac disease requiring treatment, congestive heart failure NYHA III or IV, unstable angina pectoris even if medically controlled, history of myocardial infarction during the last 6 months, serious arrhythmias requiring medication.
• Significant (requiring anticoagulation or transfusion) thrombotic or hemorrhagic event within 6 months prior to study entry.
• Active infection requiring intravenous therapy within 2 weeks prior to study drug administration.
• HIV infection with a current or a history of AIDS-defining illness or HIV infection with a CD4+ T cell count \< 350 cells/μL regardless of history of AIDS-defining illness.
• Patients with active viral (any etiology) hepatitis are excluded. Patients with serologic evidence of chronic HBV infection (defined by a positive hepatitis B surface antigen test and a positive anti-hepatitis core antibody test) who have a viral load below the limit quantification (HBV DNA titer \< 200 IU/mL) and are not currently on viral suppressive therapy may be eligible and should be discussed with the Medical Monitor. Patients with a history of HCV infection should have completed curative antiviral treatment and have a viral load below the limit of quantification.
• Anticancer therapy within 5 half-lives or 4 weeks (whichever is shorter) or radiation therapy within 14 days prior to study entry; palliative radiotherapy to a single area of metastasis within 2 weeks prior to study entry. If a patient is receiving high dose cytarabine, liposomal cytarabine, or standard-dose cytarabine (100-200 mg/m2/day), the patient must be off the drug for at least 2 weeks or until the patient has recovered from toxic effects.
• Previous exposure to any anti-CD47 monoclonal antibody or SIRPα antibody or SIRPα fusion construct.
• Major surgery within 4 weeks prior to study entry.
• Allergy to study drug or components of its formulation or history of a Grade 3-4 allergic reaction to treatment with another protein product.
• Pregnant or breast-feeding females.

Sponsors & Collaborators

• Hangzhou Sumgen Biotech Co., Ltd.: lead

Study Sites (8)

Northside Hospital

Atlanta, Georgia, 30342, United States

Location

John Theurer Cancer Center at Hackensack UMC

Hackensack, New Jersey, 07601, United States

Location

Westchester Medical Center

Hawthorne, New York, 10532, United States

Location

Novant Health Forsyth Medical Center

Charlotte, North Carolina, 27103, United States

Location

Duke University

Durham, North Carolina, 27705, United States

Location

Novant Health Cancer Institute Hematology - Forsyth

Winston-Salem, North Carolina, 27103, United States

Location

Gabrail Cancer Center Research, LLC

Canton, Ohio, 44718, United States

Location

Texas Oncology / Baylor Charles A. Sammons Cancer Center

Dallas, Texas, 75246, United States

Location

MeSH Terms

Conditions

Hematologic Neoplasms; Lymphoma

Interventions

Antibodies, Bispecific

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Neoplasms by Histologic Type; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2022
• First Posted: March 24, 2022
• Study Start: March 3, 2023
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2023
• Last Updated: March 18, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (8)