Clinical trial NCT04684108: SG301 Safety Study in Subjects With Relapsed or Refractory Multiple Myeloma and Other Hematological Malignancies
Official title: A Phase 1 Study of SG301 in Subjects With Hematological Malignancies
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Relapsed or Refractory Multiple Myeloma
Hematological Malignancy
Lead sponsor: Hangzhou Sumgen Biotech Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2020-12-24
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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 outcomes:
measure: Incidence of Treatment-Emergent Adverse Events
timeFrame: Through study completion, an average of one year
measure: MTD/MAD/ RP2D
timeFrame: Through study completion, an average of one year
Secondary outcomes:
measure: Pharmacokinetics (PK): AUC
timeFrame: Through study completion, an average of one year
measure: Pharmacokinetics (PK): Cmax
timeFrame: Through study completion, an average of one year
measure: Pharmacokinetics (PK): limination half-life (T 1/2)
timeFrame: Through study completion, an average of one year
measure: receptor occupancy (RO)
timeFrame: Through study completion, an average of one year
measure: Immunogenicity endpoints
timeFrame: Through study completion, an average of one year
measure: Efficacy endpoints
timeFrame: Through study completion, an average of one year
Other outcomes:
Locations:
city: Bengbu
country: China
facility: The First Affiliated Hospital of Bengbu Medical College
state: Anhui
city: Beijing
country: China
facility: Affiliated Beijing Chaoyang Hospital of Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Beijing Jishuitan Hostipal
state: Beijing
city: Shenzhen
country: China
facility: Shenzhen Second People's Hospital
state: Guangzhou
city: Shijiazhuang
country: China
facility: The Fourth Affiliated Hospital of Hebei Medical University
state: Hebei
city: Zhengzhou
country: China
facility: Henan Cancer Hospital
state: Henan
city: Wuhan
country: China
facility: Wuhan University Central South Hospital
state: Hubei
city: Xiangyang
country: China
facility: Xiangyang Central Hospital
state: Hubei
city: Wuxi
country: China
facility: Wuxi Central Hospital
state: Jiangsu
city: Shenyang
country: China
facility: The First Affiliated Hospital of China Medical University
state: Liaoning
city: Shenyang
country: China
facility: Shengjing Hospital Affiliated to China Medical University
state: Liaoning
city: Jinan
country: China
facility: Qilu Hospital of Shandong University
state: Shandong
city: Taiyuan
country: China
facility: Shanxi Norman Bethune Hospital
state: Shanxi
city: Hangzhou
country: China
facility: The Second Affiliated Hospital of Zhejiang University School of Medicine
state: Zhejiang
Study officials:
References: