SG301 Safety Study in Subjects With Relapsed or Refractory Multiple Myeloma and Other Hematological Malignancies

A Phase 1 Study of SG301 in Subjects With Hematological Malignancies

This is a Phase 1a/1b Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of SG301 in Patients with Relapsed or Refractory Multiple Myeloma and Other Hematological Malignancies

Study Overview

• Status: Active, not recruiting
• Conditions: Relapsed or Refractory Multiple Myeloma; Hematological Malignancy
• Intervention / Treatment: Drug: SG301

Detailed Description

After a screening period of up to 28 days for each study phase, qualified patients will be enrolled to receive their assigned dose of SG301, administered weekly for the first 2 cycles and every 2 weeks thereafter, until disease progression or intolerable toxicity, starting of a new anticancer treatment, withdrawal of consent, lost to follow up, death, or end of the study, whichever occurs first.

The study consists of a dose escalation phase (Phase 1a) and a dose expansion phase (Phase 1b) in subjects with relapsed or refractory multiple myeloma and other hematological malignancies.

• Study Type: Interventional
• Enrollment (Actual): 61
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Lingling Liu; Phone Number: 86-13466612412; Email: liulingling@sumgenbio.com

Study Locations

• China
  • Anhui
    • Bengbu, Anhui, China, 233099
      • The First Affiliated Hospital of Bengbu Medical College
  • Beijing
    • Beijing, Beijing, China, 100020
      • Affiliated Beijing Chaoyang Hospital of Capital Medical University
    • Beijing, Beijing, China, 100032
      • Beijing Jishuitan Hostipal
  • Guangzhou
    • Shenzhen, Guangzhou, China, 518025
      • Shenzhen Second People's Hospital
  • Hebei
    • Shijiazhuang, Hebei, China, 050011
      • The Fourth Affiliated Hospital of Hebei Medical University
  • Henan
    • Zhengzhou, Henan, China, 450003
      • Henan Cancer Hospital
  • Hubei
    • Wuhan, Hubei, China, 430062
      • Wuhan University Central South Hospital
    • Xiangyang, Hubei, China, 441021
      • Xiangyang Central Hospital
  • Jiangsu
    • Wuxi, Jiangsu, China, 214125
      • Wuxi Central Hospital
  • Liaoning
    • Shenyang, Liaoning, China, 110002
      • The First Affiliated Hospital of China Medical University
    • Shenyang, Liaoning, China, 110136
      • Shengjing Hospital affiliated to China Medical University
  • Shandong
    • Jinan, Shandong, China, 250063
      • Qilu Hospital of Shandong University
  • Shanxi
    • Taiyuan, Shanxi, China, 030032
      • Shanxi Norman Bethune Hospital
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310003
      • The second affiliated hospital of zhejiang university school of medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Understand and voluntarily sign the informed consent form (ICF).
2. Age ≥18 years.
3. Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0, 1 or 2.
4. Expected survival time of ≥3 months.

5. Patients with histologically or cytologically confirmed hematological malignancies who are relapsed or refractory to or intolerant of standard therapies.

   For patients with multiple myeloma: should be relapsed or refractory multiple myeloma with measurable disease

6. Adequate organ function
7. Toxicity caused by prior anti-tumor therapy recovered to Grade 0 to 1 (CTCAE 5.0), except for alopecia, controlled Grade ≤2 sensory neuropathy, lymphocytopenia, and endocrine disorders.
8. Female patients of childbearing potential and male patients whose female partners are of childbearing potential need to use at least one approved contraceptive (e.g., intrauterine device, pill, or condom) during study treatment and for at least 6 months (180 days) after the last dose; female patients of childbearing potential must have a negative blood human chorionic gonadotropin (HCG) test during screening period and must not be lactating.

Exclusion Criteria:

Patient Exclusion Criteria:

1. Presence of central nervous system metastatic lesions.
2. 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.
3. Active infection requiring antimicrobial therapy within 2 weeks prior to study drug administration.
4. Patients with active viral hepatitis (any etiology) are excluded.
5. Anticancer therapy within 5 half-lives or 2 weeks (whichever is longer)
6. Primary refractory to previous anti-CD38 therapy.
7. Major surgery within 4 weeks prior to study entry.
8. Prior or concurrent malignancy within 2 years prior to entry, other than adequately controlled skin basal cell carcinoma, cervical carcinoma in situ, breast carcinoma in situ, skin squamous cell carcinoma.
9. Any other condition that, in the opinion of the Investigator, may lead to inappropriate participation in this study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SG301; SG301 monotherapy intravenous (IV) infusion	Drug: SG301; Phase 1a will use an accelerated titration and 3+3 design with 9 dose cohorts: 0.005 mg/kg, 0.05 mg/kg,0.5 mg/kg, 1 mg/kg, 2 mg/kg, 4 mg/kg, 8 mg/kg, 12 mg/kg and 16 mg/kg by IV infusion. Accelerated titration (i.e., 1 patient each) will be applied to the first 3 cohorts.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Treatment-Emergent Adverse Events	Number and percentage of AE which is calculated by worst CTCAE grade by CTCAE 5.0	Through study completion, an average of one year
MTD/MAD/ RP2D	To determine the maximum tolerated dose (MTD) or maximum administered dose (MAD) for intravenous (IV) administration of SG301 in patients with relapsed or refractory multiple myeloma and other hematological malignancies; To preliminarily determine the recommended Phase 2 dose (RP2D) of SG301 given intravenously in patients with relapsed or refractory multiple myeloma and other hematological malignancies.	Through study completion, an average of one year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetics (PK): AUC	The area under the curve (AUC) of serum concentration of the drug after the administration	Through study completion, an average of one year
Pharmacokinetics (PK): Cmax	Maximum concentration(Cmax) of the drug after administration	Through study completion, an average of one year
Pharmacokinetics (PK): limination half-life (T 1/2)	Descripition: limination half-life (T 1/2) of the drug after administration	Through study completion, an average of one year
receptor occupancy (RO)	receptor occupancy (RO) of CD38 on the surface of peripheral blood cells	Through study completion, an average of one year
Immunogenicity endpoints	levels of anti-drug antibodies (ADAs) and neutralizing antibodies (tested in ADA-positive samples only).	Through study completion, an average of one year
Efficacy endpoints	objective response rate (ORR)	Through study completion, an average of one year

Collaborators and Investigators

• Sponsor: Hangzhou Sumgen Biotech Co., Ltd.
• Investigators: Study Director: Lingling Liu, Hangzhou Sumgen Biotech Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): November 4, 2021
• Primary Completion (Estimated): June 30, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: December 10, 2020
• First Submitted That Met QC Criteria: December 21, 2020
• First Posted (Actual): December 24, 2020

Study Record Updates

• Last Update Posted (Actual): March 28, 2024
• Last Update Submitted That Met QC Criteria: March 26, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Immune System Diseases; Neoplasms by Histologic Type; Lymphoproliferative Disorders; Immunoproliferative Disorders; Neoplasms by Site; Hematologic Diseases; Hemorrhagic Disorders; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Neoplasms; Hematologic Neoplasms; Multiple Myeloma; Neoplasms, Plasma Cell
• Other Study ID Numbers: CSG-301-101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No