Status:
ACTIVE_NOT_RECRUITING
SG301 Safety Study in Subjects With Relapsed or Refractory Multiple Myeloma and Other Hematological Malignancies
Lead Sponsor:
Hangzhou Sumgen Biotech Co., Ltd.
Conditions:
Relapsed or Refractory Multiple Myeloma
Hematological Malignancy
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 Hemato...
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 week...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- Patient
Key Trial Info
Start Date :
November 4 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2026
Estimated Enrollment :
61 Patients enrolled
Trial Details
Trial ID
NCT04684108
Start Date
November 4 2021
End Date
June 30 2026
Last Update
March 13 2025
Active Locations (14)
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1
The First Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui, China, 233099
2
Affiliated Beijing Chaoyang Hospital of Capital Medical University
Beijing, Beijing Municipality, China, 100020
3
Beijing Jishuitan Hostipal
Beijing, Beijing Municipality, China, 100032
4
Shenzhen Second People's Hospital
Shenzhen, Guangzhou, China, 518025