SG301 Safety Study in Subjects With Relapsed or Refractory Multiple Myeloma and Other Hematological Malignancies

Hematological Malignancy Clinical Trial

Official title:

A Phase 1 Study of SG301 in Subjects With Hematological Malignancies

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04684108
• Other study ID #: CSG-301-101
• Status: Active, not recruiting
• Phase: Phase 1
• 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
• 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.

Related Conditions & MeSH terms

• Hematologic Neoplasms
• Hematological Malignancy
• Multiple Myeloma
• Neoplasms
• Neoplasms, Plasma Cell
• Relapsed or Refractory Multiple Myeloma

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