Hematological Malignancy, Relapsed or Refractory Multiple Myeloma
Conditions
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.
Interventions
DRUGSG301
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.
Sponsors
Hangzhou Sumgen Biotech Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics (PK): AUC | Through study completion, an average of one year | The area under the curve (AUC) of serum concentration of the drug after the administration |
| Pharmacokinetics (PK): Cmax | Through study completion, an average of one year | Maximum concentration(Cmax) of the drug after administration |
| Pharmacokinetics (PK): limination half-life (T 1/2) | Through study completion, an average of one year | Descripition: limination half-life (T 1/2) of the drug after administration |
| receptor occupancy (RO) | Through study completion, an average of one year | receptor occupancy (RO) of CD38 on the surface of peripheral blood cells |
| Immunogenicity endpoints | Through study completion, an average of one year | levels of anti-drug antibodies (ADAs) and neutralizing antibodies (tested in ADA-positive samples only). |
| Efficacy endpoints | Through study completion, an average of one year | objective response rate (ORR) |
Countries
China
Outcome results
None listed