Register a trial

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04618393




Registration number
NCT04618393
Ethics application status
Date submitted
18/10/2020
Date registered
5/11/2020

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
Treatment: Other - 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.


Treatment: Other: EMB-02
EMB-02 is a FIT-Ig® bispecific antibody against PD-1 and LAG-3.
Intervention code [1] 0 0
Treatment: Other
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
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
Stopped early
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
Trial website
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04618393