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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04735575




Registration number
NCT04735575
Ethics application status
Date submitted
28/01/2021
Date registered
3/02/2021
Date last updated
1/09/2023

Titles & IDs
Public title
A Ph1/2 Study of EMB-06 in Participants With Relapsed or Refractory Myeloma
Scientific title
A First-in-human, Phase I/II, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of EMB-06 in Patients With Relapsed or Refractory Multiple Myeloma
Secondary ID [1] 0 0
EMB06X101
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
Condition category
Condition code
Cancer 0 0 0 0
Other cancer types

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - EMB-06

Experimental: EMB-06 - In Phase I part: participants enrolled at different time will receive EMB-06 by IV infusion at different ascending dose levels.

In Phase II part: participants will receive EMB-06 by IV infusion at previously defined RP2D.


Treatment: Other: EMB-06
EMB-06 is a FIT-Ig® bispecific antibody against BCMA and CD3.
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence and severity of adverse events
Timepoint [1] 0 0
Screening up to follow-up (30 days after the last dose)
Primary outcome [2] 0 0
Incidence of serious adverse events (SAE)
Timepoint [2] 0 0
Screening up to follow-up (30 days after the last dose)
Primary outcome [3] 0 0
Incidence of dose interruptions.
Timepoint [3] 0 0
Screening up to follow-up (30 days after the last dose)
Primary outcome [4] 0 0
Dose intensity
Timepoint [4] 0 0
Screening up to follow-up (30 days after the last dose)
Primary outcome [5] 0 0
The incidence of DLTs during treatment.
Timepoint [5] 0 0
First infusion to the end of Cycle 1 (each cycle is 28 days)
Primary outcome [6] 0 0
Overall Response Rate (ORR)
Timepoint [6] 0 0
From the date of dosing until the date of first documented progression or date of death from any cause, whichever came first, expected average 6 months
Secondary outcome [1] 0 0
Area under the serum concentration-time curve (AUC) of EMB-06.
Timepoint [1] 0 0
Through treatment until EOT visit, expected average 6 months
Secondary outcome [2] 0 0
Maximum serum concentration (Cmax) of EMB-06.
Timepoint [2] 0 0
Through treatment until EOT visit, expected average 6 months
Secondary outcome [3] 0 0
Trough concentration (Ctrough) of EMB-06.
Timepoint [3] 0 0
Through treatment until EOT visit, expected average 6 months
Secondary outcome [4] 0 0
Average concentration over a dosing interval (Css, avg) of EMB-06.
Timepoint [4] 0 0
Through treatment until EOT visit, expected average 6 months
Secondary outcome [5] 0 0
Terminal half-life (T1/2) of EMB-06.
Timepoint [5] 0 0
Through treatment until EOT visit, expected average 6 months
Secondary outcome [6] 0 0
Systemic clearance (CL) of EMB-06.
Timepoint [6] 0 0
Through treatment until EOT visit, expected average 6 months
Secondary outcome [7] 0 0
Steady state volume of distribution (Vss) of EMB-06.
Timepoint [7] 0 0
Through treatment until EOT visit, expected average 6 months
Secondary outcome [8] 0 0
Progression free survival (PFS) of EMB-06 as assessed by IMWG criteria.
Timepoint [8] 0 0
From the date of dosing until the date of first documented progression or date of death from any cause, whichever came first, expected average 6 months
Secondary outcome [9] 0 0
Duration of response of EMB-06 as assessed by IMWG criteria
Timepoint [9] 0 0
From the date of dosing until the date of first documented progression or date of death from any cause, whichever came first, expected average 6 months
Secondary outcome [10] 0 0
Incidence and titer of anti-drug antibodies stimulated by EMB-06.
Timepoint [10] 0 0
Up to End of Treatment Follow Up Period (30 days after the last dose)

Eligibility
Key inclusion criteria
* Able to understand and willing to sign the informed consent form (ICF)
* Patients who have been diagnosed with multiple myeloma according to IMWG diagnostic criteria 2014 and have relapsed or refractory multiple myeloma with at least one measurable lesion.
* The patient must have received at least two lines (for patients in the US, at least three lines which should include anti-CD38 antibody) of prior antimyeloma therapies, and must have received treatment with proteasome inhibitors, immunomodulatory agents, and if accessible, an anti-CD38 targeting monoclonal antibody.
* ECOG performance status 0 or 1 for phase I, and =2 for phase II.
* Adequate organ function and reasonable laboratory test results to participate in the trial.
* Highly effective contraception
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Life expectancy is less than 3 months.
* Patient participated in any other clinical study within 1 month prior to enrollment in this clinical study.
* Patients with ongoing AE.
* Previously treated with any BCMA-targeted therapy.(Exception: in Phase 2 portion, up to 10 patients who have received prior anti-BCMA ADC or BCMA targeted CAR-T can be enrolled)
* History of allogeneic stem cell transplantation.
* Previously treated with the following anti-tumor therapy (prior to first dosing of EMB-06)

1. Treated with monoclonal antibody for multiple myeloma within 28 days
2. Treated with proteasome inhibitors within 14 days
3. Treated with immunomodulatory agents within 14 days
4. Treated with cytotoxic therapy within 14 days
5. Received investigational drug within 28 days or at least 5 half-lives, whichever is shorter (if a, b, c, d not applicable)
6. Received radiotherapy within 21 days. Except that the radiation portal covered = 5% of the bone marrow reserve, the patient will be eligible to participate in the study regardless of the end date of radiation therapy
7. Plasmapheresis within 7 days
* Patient received autologous stem cell transplantation within 12 weeks prior to the start of study treatment.
* Active or historically multiple myeloma related central nervous system involvement.
* Patients requiring high dose of systemic treatment with corticosteroids.
* Patients with active infections, including COVID-19, hepatitis, etc..
* History of severe allergic reactions
* Patients with severe or uncontrolled cardiovascular disorder requiring treatment
* Pre-existing other serious medical conditions

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
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
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
20/05/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/03/2025
Actual
Sample size
Target
66
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD,VIC,WA
Recruitment hospital [1] 0 0
Sunshine Coast Haematology and Oncology Clinic (SCHOC) - Buderim
Recruitment hospital [2] 0 0
Cabrini Health - Melbourne
Recruitment hospital [3] 0 0
Epworth Healthcare - Richmond
Recruitment hospital [4] 0 0
One Clinical Research (OCR) - Nedlands
Recruitment postcode(s) [1] 0 0
4556 - Buderim
Recruitment postcode(s) [2] 0 0
- Melbourne
Recruitment postcode(s) [3] 0 0
3121 - Richmond
Recruitment postcode(s) [4] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
China
State/province [1] 0 0
Beijing
Country [2] 0 0
China
State/province [2] 0 0
Shanghai
Country [3] 0 0
China
State/province [3] 0 0
Guangzhou
Country [4] 0 0
China
State/province [4] 0 0
Hangzhou
Country [5] 0 0
China
State/province [5] 0 0
Wuhan
Country [6] 0 0
China
State/province [6] 0 0
Zhengzhou

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Shanghai EpimAb Biotherapeutics Co., Ltd.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The primary purpose of this study is to identify the recommended Phase 2 dose(s) (RP2Ds) and schedule assessed to be safe for EMB-06 and to characterize the safety and tolerability of EMB-06 at the RP2Ds. Pharmacokinetics (PK), immunogenicity, and the anti-multiple myeloma activity of EMB-06 will also be assessed.
Trial website
https://clinicaltrials.gov/study/NCT04735575
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Shuqi Zeng
Address 0 0
Country 0 0
Phone 0 0
+8618621781427
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT04735575