Relapsed or Refractory Multiple MyelomaHematological Malignancy
Investigational drug(s) / intervention(s)
SG301
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.
Study 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
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
Incidence of Treatment-Emergent Adverse Events — Through study completion, an average of one year Number and percentage of AE which is calculated by worst CTCAE grade by CTCAE 5.0
MTD/MAD/ RP2D — Through study completion, an average of one year 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.
Trial sites (14)
Facility
City
Region
Status
The First Affiliated Hospital of Bengbu Medical College
Bengbu
Anhui
Affiliated Beijing Chaoyang Hospital of Capital Medical University
Beijing
Beijing Municipality
Beijing Jishuitan Hostipal
Beijing
Beijing Municipality
Shenzhen Second People's Hospital
Shenzhen
Guangzhou
The Fourth Affiliated Hospital of Hebei Medical University
Shijiazhuang
Hebei
Henan Cancer Hospital
Zhengzhou
Henan
Wuhan University Central South Hospital
Wuhan
Hubei
Xiangyang Central Hospital
Xiangyang
Hubei
Wuxi Central Hospital
Wuxi
Jiangsu
The First Affiliated Hospital of China Medical University
Shenyang
Liaoning
Shengjing Hospital Affiliated to China Medical University
Shenyang
Liaoning
Qilu Hospital of Shandong University
Jinan
Shandong
Shanxi Norman Bethune Hospital
Taiyuan
Shanxi
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou
Zhejiang
More Hangzhou Sumgen Biotech Co., Ltd. trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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