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

NCT04684108 | Active Not Recruiting Phase 1 FDA Drug

• 1 other identifier: CSG-301-101
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 14

Brief Summary

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

Conditions

Relapsed or Refractory Multiple Myeloma; Hematological Malignancy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• Pharmacokinetics (PK): AUC

  Through study completion, an average of one year

• Pharmacokinetics (PK): Cmax

  Through study completion, an average of one year

• Pharmacokinetics (PK): limination half-life (T 1/2)

  Through study completion, an average of one year

• receptor occupancy (RO)

  Through study completion, an average of one year

• Immunogenicity endpoints

  Through study completion, an average of one year

Study Arms (1)

SG301

EXPERIMENTAL

SG301 monotherapy intravenous (IV) infusion

Drug: SG301

Interventions

SG301 DRUG

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.

SG301

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• Presence of central nervous system metastatic lesions.
• 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.
• Active infection requiring antimicrobial therapy within 2 weeks prior to study drug administration.
• Patients with active viral hepatitis (any etiology) are excluded.
• Anticancer therapy within 5 half-lives or 2 weeks (whichever is longer)
• Primary refractory to previous anti-CD38 therapy.
• Major surgery within 4 weeks prior to study entry.
• 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.
• Any other condition that, in the opinion of the Investigator, may lead to inappropriate participation in this study.

Sponsors & Collaborators

• Hangzhou Sumgen Biotech Co., Ltd.: lead

Study Sites (14)

The First Affiliated Hospital of Bengbu Medical College

Bengbu, Anhui, 233099, China

Location

Affiliated Beijing Chaoyang Hospital of Capital Medical University

Beijing, Beijing Municipality, 100020, China

Location

Beijing Jishuitan Hostipal

Beijing, Beijing Municipality, 100032, China

Location

Shenzhen Second People's Hospital

Shenzhen, Guangzhou, 518025, China

Location

The Fourth Affiliated Hospital of Hebei Medical University

Shijiazhuang, Hebei, 050011, China

Location

Henan Cancer Hospital

Zhengzhou, Henan, 450003, China

Location

Wuhan University Central South Hospital

Wuhan, Hubei, 430062, China

Location

Xiangyang Central Hospital

Xiangyang, Hubei, 441021, China

Location

Wuxi Central Hospital

Wuxi, Jiangsu, 214125, China

Location

The First Affiliated Hospital of China Medical University

Shenyang, Liaoning, 110002, China

Location

Shengjing Hospital Affiliated to China Medical University

Shenyang, Liaoning, 110136, China

Location

Qilu Hospital of Shandong University

Jinan, Shandong, 250063, China

Location

Shanxi Norman Bethune Hospital

Taiyuan, Shanxi, 030032, China

Location

The Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310003, China

Location

MeSH Terms

Conditions

Recurrence; Multiple Myeloma; Hematologic Neoplasms

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases; Neoplasms by Site

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: December 10, 2020
• First Posted: December 24, 2020
• Study Start: November 4, 2021
• Primary Completion: June 30, 2024
• Study Completion (Estimated): June 30, 2026
• Last Updated: March 13, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (14)