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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04684108




Registration number
NCT04684108
Ethics application status
Date submitted
10/12/2020
Date registered
24/12/2020
Date last updated
8/03/2023

Titles & IDs
Public title
SG301 Safety Study in Subjects With Relapsed or Refractory Multiple Myeloma and Other Hematological Malignancies
Scientific title
A First-in-human Phase 1 Study to Evaluate Safety, Tolerability, and Preliminary Efficacy of SG301 in Subjects With Relapsed or Refractory Multiple Myeloma and Other Hematological Malignancies
Secondary ID [1] 0 0
SG301-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Relapsed or Refractory Multiple Myeloma 0 0
Hematological Malignancy 0 0
Condition category
Condition code
Cancer 0 0 0 0
Other cancer types
Cancer 0 0 0 0
Leukaemia - Acute leukaemia
Cancer 0 0 0 0
Leukaemia - Chronic leukaemia

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - SG301

Experimental: SG301 - Study treatment: SG301 administered every week via intravenous infusion


Treatment: Drugs: SG301
During study treatment, subjects will receive SG301 treatment via IV infusion once every week at doses of 0.01, 0.03, 0.1, 0.3, 1.0, 2.0, 4.0, 8.0, 12.0 and 16.0mg/kg
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of patients with AEs and SAEs
Timepoint [1] 0 0
At the end of treatment phase (24 weeks)
Primary outcome [2] 0 0
The Maximum tolerated dose (MTD) and Recommended Phase 2 dose (RP2D) for SG301
Timepoint [2] 0 0
At the end of treatment phase (24 weeks)
Secondary outcome [1] 0 0
Pharmacokinetics (PK): AUC
Timepoint [1] 0 0
Approximately 2 years
Secondary outcome [2] 0 0
Pharmacokinetics (PK): Cmax
Timepoint [2] 0 0
Approximately 2 years
Secondary outcome [3] 0 0
Preliminary anti-tumor activity of SG301 (Objective Response Rate)
Timepoint [3] 0 0
Approximately 2 years
Secondary outcome [4] 0 0
Immunogenicity: percentage of ADA positive patients
Timepoint [4] 0 0
Approximately 2 years

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Withdrawn
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
15/01/2021
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
15/10/2022
Actual
Sample size
Target
Accrual to date
Final
0
Recruitment in Australia
Recruitment state(s)
QLD,VIC
Recruitment hospital [1] 0 0
University of Sunshine Coast - Maroochydore
Recruitment hospital [2] 0 0
John Flynn Private Hospital - Tugun
Recruitment hospital [3] 0 0
Peninsula and Southeast Oncology - Frankston
Recruitment postcode(s) [1] 0 0
4558 - Maroochydore
Recruitment postcode(s) [2] 0 0
4224 - Tugun
Recruitment postcode(s) [3] 0 0
3199 - Frankston

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Hangzhou Sumgen Biotech Co., Ltd.
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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 malignancies
Trial website
https://clinicaltrials.gov/ct2/show/NCT04684108
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Lingling Liu
Address 0 0
Hangzhou Sumgen Biotech Co., Ltd.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT04684108