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

NCT ID: NCT04684108

Last Updated: 2025-03-13

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 61 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-04
• Study Completion Date: 2026-06-30

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

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.

Conditions

Relapsed or Refractory Multiple Myeloma; Hematological Malignancy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

SG301

SG301 monotherapy intravenous (IV) infusion

Group Type: EXPERIMENTAL

SG301

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

Eligibility Criteria

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

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hangzhou Sumgen Biotech Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The First Affiliated Hospital of Bengbu Medical College

Bengbu, Anhui, China

Affiliated Beijing Chaoyang Hospital of Capital Medical University

Beijing, Beijing Municipality, China

Beijing Jishuitan Hostipal

Beijing, Beijing Municipality, China

Shenzhen Second People's Hospital

Shenzhen, Guangzhou, China

The Fourth Affiliated Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

Henan Cancer Hospital

Zhengzhou, Henan, China

Wuhan University Central South Hospital

Wuhan, Hubei, China

Xiangyang Central Hospital

Xiangyang, Hubei, China

Wuxi Central Hospital

Wuxi, Jiangsu, China

The First Affiliated Hospital of China Medical University

Shenyang, Liaoning, China

Shengjing Hospital Affiliated to China Medical University

Shenyang, Liaoning, China

Qilu Hospital of Shandong University

Jinan, Shandong, China

Shanxi Norman Bethune Hospital

Taiyuan, Shanxi, China

The Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Countries

China

Other Identifiers

CSG-301-101

Identifier Type: -

Identifier Source: org_study_id