Trial Review

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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/NCT05263180




Registration number
NCT05263180
Ethics application status
Date submitted
22/02/2022
Date registered
2/03/2022
Date last updated
18/10/2023

Titles & IDs
Public title
A Study of EMB-09 in Participants With Advanced or Metastatic Solid Tumors.
Scientific title
A First-in-human, Phase I Trial of EMB-09, a Bispecific Antibody Targeting PD-L1 and OX-40 in Patients With Advanced or Metastatic Solid Tumors
Secondary ID [1] 0 0
EMB09X101
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - EMB-09

Experimental: Experimental: EMB-09 - Participants enrolled at different time will receive EMB-09 once a week (IV) at different ascending dose levels.


Other interventions: EMB-09
EMB-09 is a FIT-Ig® bispecific antibody against PD-L1 and OX40.
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 30 days after the last dose.
Primary outcome [2] 0 0
Incidence of serious adverse events. (SAE)
Timepoint [2] 0 0
Screening up to 30 days after the last dose, or beyond 30 days if SAE is confirmed to be treatment related.
Primary outcome [3] 0 0
Incidence of dose interruptions.
Timepoint [3] 0 0
Screening up to 30 days after the las dose.
Primary outcome [4] 0 0
Dose intensity.
Timepoint [4] 0 0
Screening up to 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)
Secondary outcome [1] 0 0
Overall response rate
Timepoint [1] 0 0
From the date of dosing until the date of first documented progression or date of death from any cause, whichever case first, expected average 6 months.
Secondary outcome [2] 0 0
Area under the serum concentration-time curve (AUC) of EMB-09
Timepoint [2] 0 0
Through treatment until EOT visit, expected average 6 months
Secondary outcome [3] 0 0
Maximum serum concentration (Cmax) of EMB-09
Timepoint [3] 0 0
Through treatment until EOT visit, expected average 6 months
Secondary outcome [4] 0 0
Trough concentration (Ctrough) of EMB-09
Timepoint [4] 0 0
Through treatment until EOT visit, expected average 6 months
Secondary outcome [5] 0 0
Average concentration over a dosing interval (Css, avg)of EMB-09.
Timepoint [5] 0 0
Through treatment until EOT visit, expected average 6 months
Secondary outcome [6] 0 0
Terminal half-life (T1/2) of EMB-09
Timepoint [6] 0 0
Through treatment until EOT visit, expected average 6 months
Secondary outcome [7] 0 0
Systemic clearance (CL) of EMB-09
Timepoint [7] 0 0
Through treatment until EOT visit, expected average 6 months
Secondary outcome [8] 0 0
Steady state volume of distribution (Vss) of EMB-09
Timepoint [8] 0 0
Through treatment until EOT visit, expected average 6 months
Secondary outcome [9] 0 0
Progression free survival (PFS) of EMB-09 as assessed by RECIST 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-09
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 signed and dated informed consent prior to any
study-related procedures and willing and able to comply with all study procedures.

- Phase I subjects:

1. Patients with histologically or cytologically confirmed locally
advanced/metastatic solid tumors including but not limited to melanoma, non-small
cell lung cancer (NSCLC), triple negative breast cancer (TNBC), head and neck
squamous cell carcinoma (HNSCC), nasopharyngeal cancer (NPC), hepatocellular
carcinoma (HCC), gastric cancer (GC), endometrium cancer (EC), ovarian cancer
(OC), renal cell carcinoma (RCC) and small cell lung cancer (SCLC), colorectal
cancer (CRC).

2. Patients who have failed (progressed on, or are intolerant of) standard therapies
or no available standard treatment

3. Measurable or evaluable disease per RECIST v1.1.

- Patients must provide archival tumor, or a fresh tumor biopsy will be required if
archival tumor sample is not available. Archival tumor sample must be taken <2 years
prior to screening, otherwise a fresh tumor biopsy at screening is required.

- ECOG performance status 0 or 1; 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 TNFRSF agonists including OX40, CD27, CD137 (4-1BB), CD357
(GITR), CD40.

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

- Current or history of idiopathic pulmonary fibrosis, interstitial lung disease, or
organizing pneumonia.

- 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 of 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
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
25/07/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/12/2024
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Peninsula and South Eastern Haematology & Oncology Group - Frankston
Recruitment hospital [2] 0 0
GenesisCareNorthShore - Leonards Hill
Recruitment hospital [3] 0 0
Blacktown Hospital - Sydney
Recruitment postcode(s) [1] 0 0
- Frankston
Recruitment postcode(s) [2] 0 0
- Leonards Hill
Recruitment postcode(s) [3] 0 0
- Sydney
Recruitment outside Australia
Country [1] 0 0
China
State/province [1] 0 0
Shanghai

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

Ethics approval
Ethics application status

Summary
Brief summary
This study is to evaluate the safety and tolerability of EMB-09 and to determine the maximum
tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D). Pharmacokinetics (PK),
immunogenicity, and the anti-multiple myeloma activity of EMB-09 will also be assessed.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05263180
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, MD.
Address 0 0
Country 0 0
Phone 0 0
+86-21-61043299
Fax 0 0
Email 0 0
shqzeng@epimab.com
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05263180