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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/NCT04618393




Registration number
NCT04618393
Ethics application status
Date submitted
18/10/2020
Date registered
5/11/2020
Date last updated
21/05/2024

Titles & IDs
Public title
A Study of EMB-02 in Participants With Advanced Solid Tumors
Scientific title
A Phase I/II Trial of EMB-02, a Bi-specific Antibody Against PD-1 and LAG-3, in Patients With Advanced Solid Tumors
Secondary ID [1] 0 0
EMB02X101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced Solid Tumors 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - EMB-02

Experimental: EMB-02 - In Phase I part: participants enrolled in the different time will receive EMB-02 once weekly (IV) at different ascending dose levels.
In Phase II part: participants will receive EMB-02 once weekly (IV) at previously defined RP2D.


Other interventions: EMB-02
EMB-02 is a FIT-Ig® bispecific antibody against PD-1 and LAG-3.
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence and severity of adverse events as assessed by CTCAE V5.0
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 the first cycle of treatment.
Timepoint [5] 0 0
First infusion to the end of Cycle 1 (each cycle is 28 days)
Primary outcome [6] 0 0
Antitumor activity(Objective 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-02
Timepoint [1] 0 0
Through treatment until EOT visit, expected average 6 months
Secondary outcome [2] 0 0
Maximum serum concentration (Cmax) of EMB-02
Timepoint [2] 0 0
Through treatment until EOT visit, expected average 6 months
Secondary outcome [3] 0 0
Trough concentration (Ctrough) of EMB-02
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-02.
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-02
Timepoint [5] 0 0
Through treatment until EOT visit, expected average 6 months.
Secondary outcome [6] 0 0
Systemic clearance (CL) of EMB-02
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-02
Timepoint [7] 0 0
Through treatment until EOT visit, expected average 6 months
Secondary outcome [8] 0 0
Progression free survival (PFS) of EMB-02 as assessed by RECIST 1.1
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-02 as assessed by RECIST 1.1
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-02
Timepoint [10] 0 0
Up to End of Treatment Follow Up Period (30 days after the last dose)

Eligibility
Key inclusion criteria
- Willing and able to provide written informed consent.

- Phase I: Patients with histologically or cytologically confirmed locally
advanced/metastatic solid tumors and have failed (progressed on, or are intolerant of)
standard therapies. Moreover, the disease should be measurable or evaluable per RECIST
v1.1

- Phase II Cohort A: Patients with histologically or cytologically confirmed locally
advanced/metastatic melanoma, excluding uveal melanoma. > 1 prior therapy, including
prior treatment with PD-1/L1(mandatory) and/or CTLA-4 inhibitors(optional). And the
disease is measurable or evaluable per RECIST v1.1

- Archival tumor samples available for retrospective analysis or biopsy will be taken.

- ECOG performance status 0 or 1 for phase I, and =2 for phase II; life expectancy > 3
Months

- Adequate organ function to participate in the trial.

- Recovery from adverse events (AEs) related to prior anticancer therapy.

- Highly effective contraception
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Patients who have active autoimmune disease or history of autoimmune disease

- History of severe irAE.

- History of severe allergic reactions

- Use of systemic corticosteroids.

- Symptomatic central nervous system metastases.

- Patients with cardiac dysfunction

- Uncontrolled diabetes mellitus with hemoglobin A1c > 8% (via medical history)

- Prior treatment with a LAG-3 inhibitor

- Anticancer therapy or radiation < 5 half-lives or 4 weeks (whichever is shorter) prior
to study treatment;

- Prior organ or stem cell/bone marrow transplant.

- Concurrent malignancy < 5 years prior to entry.

- Patients with active infections.

- Major surgery < 4 weeks or minor surgery < 2 weeks prior to study treatment

- Live virus vaccines < 30 days prior to screening

- Pregnant or breast-feeding females

- Any investigational agents or study drugs from a previous clinical study within 30
days of the first dose of study treatment

- Any other serious underlying medical conditions

- Abuse on alcohol, cannabis- derived products or other drugs

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/Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
11/03/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
21/03/2024
Sample size
Target
Accrual to date
Final
47
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Southern Medical Day Care Centre - Wollongong
Recruitment hospital [2] 0 0
Monash Health - Clayton
Recruitment hospital [3] 0 0
Peninsula & South Eastern Haematology & Oncology Group (PASO) - Frankston
Recruitment postcode(s) [1] 0 0
2500 - Wollongong
Recruitment postcode(s) [2] 0 0
3168 - Clayton
Recruitment postcode(s) [3] 0 0
3199 - Frankston
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Colorado
Country [2] 0 0
United States of America
State/province [2] 0 0
South Carolina
Country [3] 0 0
China
State/province [3] 0 0
Beijing
Country [4] 0 0
China
State/province [4] 0 0
Fujian
Country [5] 0 0
China
State/province [5] 0 0
Hebei
Country [6] 0 0
China
State/province [6] 0 0
Henan
Country [7] 0 0
China
State/province [7] 0 0
Sichuan

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-02 and to characterize the safety and tolerability of
EMB-02 at the RP2Ds. Pharmacokinetics (PK), immunogenicity, and the anti-tumor activity of
EMB-02 will also be assessed.
Trial website
https://clinicaltrials.gov/ct2/show/NCT04618393
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
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/NCT04618393