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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04684108
Other study ID # CSG-301-101
Secondary ID
Status Active, not recruiting
Phase Phase 1
First received
Last updated
Start date November 4, 2021
Est. completion date December 31, 2024

Study information

Verified date March 2024
Source Hangzhou Sumgen Biotech Co., Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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 information / eligibility

Status Active, not recruiting
Enrollment 61
Est. completion date December 31, 2024
Est. primary completion date June 30, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
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.

Locations

Country Name City State
China Affiliated Beijing Chaoyang Hospital of Capital Medical University Beijing Beijing
China Beijing Jishuitan Hostipal Beijing Beijing
China The First Affiliated Hospital of Bengbu Medical College Bengbu Anhui
China The Second Affiliated Hospital of Zhejiang University School of Medicine Hangzhou Zhejiang
China Qilu Hospital of Shandong University Jinan Shandong
China Shengjing Hospital Affiliated to China Medical University Shenyang Liaoning
China The First Affiliated Hospital of China Medical University Shenyang Liaoning
China Shenzhen Second People's Hospital Shenzhen Guangzhou
China The Fourth Affiliated Hospital of Hebei Medical University Shijiazhuang Hebei
China Shanxi Norman Bethune Hospital Taiyuan Shanxi
China Wuhan University Central South Hospital Wuhan Hubei
China Wuxi Central Hospital Wuxi Jiangsu
China Xiangyang Central Hospital Xiangyang Hubei
China Henan Cancer Hospital Zhengzhou Henan

Sponsors (1)

Lead Sponsor Collaborator
Hangzhou Sumgen Biotech Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of Treatment-Emergent Adverse Events Number and percentage of AE which is calculated by worst CTCAE grade by CTCAE 5.0 Through study completion, an average of one year
Primary MTD/MAD/ RP2D 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. Through study completion, an average of one year
Secondary Pharmacokinetics (PK): AUC The area under the curve (AUC) of serum concentration of the drug after the administration Through study completion, an average of one year
Secondary Pharmacokinetics (PK): Cmax Maximum concentration(Cmax) of the drug after administration Through study completion, an average of one year
Secondary Pharmacokinetics (PK): limination half-life (T 1/2) Descripition: limination half-life (T 1/2) of the drug after administration Through study completion, an average of one year
Secondary receptor occupancy (RO) receptor occupancy (RO) of CD38 on the surface of peripheral blood cells Through study completion, an average of one year
Secondary Immunogenicity endpoints levels of anti-drug antibodies (ADAs) and neutralizing antibodies (tested in ADA-positive samples only). Through study completion, an average of one year
Secondary Efficacy endpoints objective response rate (ORR) Through study completion, an average of one year
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