Overview
SG301 Safety Study in Subjects With Relapsed or Refractory Multiple Myeloma and Other Hematological Malignancies
Status:
Not yet recruiting
Not yet recruiting
Trial end date:
2022-10-15
2022-10-15
Target enrollment:
0
0
Participant gender:
All
All
Summary
This is an open-label, dose escalation, Phase I study to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy in patients with relapsed or refractory multiple myeloma and other hematological malignanciesPhase:
Phase 1Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Hangzhou Sumgen Biotech Co., Ltd.Treatments:
Antibodies, Monoclonal
Criteria
Inclusion Criteria:- Patients must meet all the following criteria to be eligible for participation in this
study:
1. Able to understand, voluntarily participate in and willing to sign the ICF.
2. Male or female subject ≥ 18 years.
3. Histologically or cytologically confirmed hematologic malignancy that has
relapsed or is refractory to standard therapy and has exhausted all available
therapies or rejects other therapy. For Part 1, the expression of CD38 in
subjects will be tested, but not necessarily required to be positive in order to
enroll; patients with CLL and indolent NHL should have disease that requires
treatment. For Part 2, NHL and HL must be CD38+ confirmed with a validated
method.
4. Subjects are able to follow the study protocol and complete the trial.
5. Presence of measurable or evaluable disease.
6. Must have adequate organ function, prior to start of SG301, including the
following:
1. Bone marrow reserve: absolute neutrophil count (ANC) ≥ 1.0 ×109/L without
growth factor support within 7 days prior to entry (no ANC requirement for
patients with acute leukemia; ANC ≤20×109/L for leukemias, except for CLL
where an elevated WBC count will not exclude patients from study entry);
platelet count ≥ 75 × 109/L without transfusion within 7 days prior to
entry; hemoglobin ≥ 8 g/dL or ≥ 5.6 mmol/L without transfusion within 7 days
prior to entry;
2. Hepatic: total bilirubin ≤ 1.5 times the upper limit of normal (ULN),
aspartate transaminase (AST) and/or alanine aminotransferase (ALT) ≤ 2.5 ×
ULN.
3. Renal: serum creatinine ≤1.5 times the ULN or estimated creatinine clearance
≥50 mL/min (Cockroft and Gault formula
[http://www.mdcalc.com/creatinine-clearance-cockcroft-gault-equation/]).
4. Coagulation tests INR≤ 2 or prothrombin time ≤ 2×ULN.
7. Left ventricular ejection fraction (LVEF) ≥50% measured by ECHO or MUGA (only if
ECHO not available) or lower limit for institutional normal value.
8. Recovery, to Grade 0-1, from adverse events related to prior anticancer therapy
except alopecia, < Grade 2 sensory neuropathy, lymphopenia, and endocrinopathies
controlled with hormone replacement therapy
9. Subjects (women of child-bearing potential and males with fertile female partner)
must be willing to use currently accepted reliable contraception method
throughout the treatment period and for at least three months following the last
dose of study drug. These measures include, but are not limited to, oral or
implantable injections of hormonal contraceptives; intrauterine birth control
ring or placement of IUS intrauterine device); or use of barrier methods such as
condoms or septum and spermicide products. Postmenopausal women must have been
amenorrheic for at least 12 months to be considered of non-childbearing
potential. Women of childbearing age must have a negative pregnancy test.
10. ECOG score<2 for dose escalation part, and ECOG ≤ 2 for dose expansion part; life
expectancy ≥3 months.
Exclusion Criteria:
- Subjects must not have any of following:
1. Participated in any experimental treatment of any diseases within 4 weeks prior
to entry.
2. Prior therapy with other monoclonal antibodies targeting the CD38 antigen or
prior therapy with other IgG monoclonal antibodies within 3 months prior to first
study treatment, or IgM monoclonal antibodies within 1 month prior to first study
treatment".
3. Received any other anti-tumor drug therapies within 5 half-lives, or 4 weeks,
whichever is shorter.
4. Known history of a Grade 3-4 allergic reaction to treatment with any humanized
products.
5. Patients with symptomatic or untreated CNS metastases, or those requiring ongoing
treatment for CNS metastases, including steroids and antiepileptic agents.
6. Pregnant or nursing females.
7. History of life-threatening hypersensitivity, or known to be allergic to protein
drugs or recombinant proteins or excipients in SG301 drug formulation.
8. Peripheral neuropathy ≥ Grade 3.
9. Active hepatitis B or C. HBV carriers without active disease (HBV DNA titer< 1000
cps/mL or 200 IU/mL), or cured Hepatitis C (negative HCV RNA test) may be
enrolled.
10. Subjects with known positive HIV status.
11. Active infection requiring intravenous therapy within 2 weeks prior to entry.
12. Known severe chronic obstruction respiratory disease or asthma defined FEV1% <
60% predicted.
13. Severe or 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, serious arrhythmias
requiring medication (with exception of atrial fibrillation or paroxysmal
supraventricular tachycardia).
14. Uncontrolled hypertension (systolic blood pressure >150 mmHg and diastolic blood
pressure >100 mmHg), a history of hypertension crisis, or a history of
hypertensive encephalopathy.
15. Received allogeneic stem cell transplantation within 3 months prior to entry, or
GVHD after allogeneic stem cell transplantation requiring systemic
immunosuppressants, such as cyclosporin or tacrolimus.
16. Concurrent malignancy within 2 years prior to entry other than adequately treated
cervical carcinoma-in-situ, localized squamous cell cancer of the skin, basal
cell carcinoma, prostate cancer under active surveillance.
17. Major surgery within 4 weeks prior to study entry; Minor surgery within 2 weeks
prior to study entry.
18. Intolerant to IV infusion.
19. Any condition that the Investigator or primary physician believes may not be
appropriate for participating the study.
20. Excluding subject who was treated with corticosteroid exceeding 15mg/day of
prednisone or equivalent in the last 2 weeks