SG301 Safety Study in Subjects With Relapsed or Refractory Multiple Myeloma and Other Hematological Malignancies
- Conditions
- Relapsed or Refractory Multiple MyelomaHematological Malignancy
- Interventions
- Registration Number
- NCT04684108
- Lead Sponsor
- Hangzhou Sumgen Biotech Co., Ltd.
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 61
-
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.
Patient Exclusion Criteria:
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description SG301 SG301 SG301 monotherapy intravenous (IV) infusion
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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): 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
Pharmacokinetics (PK): Cmax Through study completion, an average of one year Maximum concentration(Cmax) of the drug after administration
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)
Trial Locations
- Locations (14)
Shenzhen Second People's Hospital
🇨🇳Shenzhen, Guangzhou, China
The First Affiliated Hospital of Bengbu Medical College
🇨🇳Bengbu, Anhui, China
Beijing Jishuitan Hostipal
🇨🇳Beijing, Beijing, China
Affiliated Beijing Chaoyang Hospital of Capital Medical University
🇨🇳Beijing, Beijing, 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
Qilu Hospital of Shandong University
🇨🇳Jinan, Shandong, China
Shengjing Hospital Affiliated to China Medical University
🇨🇳Shenyang, Liaoning, China
Shanxi Norman Bethune Hospital
🇨🇳Taiyuan, Shanxi, China
The Second Affiliated Hospital of Zhejiang University School of Medicine
🇨🇳Hangzhou, Zhejiang, China