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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/NCT05607498




Registration number
NCT05607498
Ethics application status
Date submitted
27/10/2022
Date registered
7/11/2022
Date last updated
22/09/2023

Titles & IDs
Public title
First in Human Study of EMB-07 in Locally Advanced/Metastatic Solid Tumors or Relapse/Refractory Lymphoma
Scientific title
A First-in-human, Phase I, Open-Label Study of EMB-07, a Bi-specific Antibody Anti-CD3 and Receptor Tyrosine Kinase-like Orphan Receptor 1 (ROR1) in Patients With Locally Advanced/Metastatic Solid Tumors or Relapse/Refractory Lymphoma
Secondary ID [1] 0 0
EMB07X101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced/Metastatic Solid Tumors 0 0
Relapse/Refractory Lymphoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - EMB07

Experimental: EMB-07-Patients with solid tumor - Patients with solid tumor will receive intravenous infusions of EMB-07 weekly (QW). Dose escalation will continue until the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) is reached or all planned doses are administered.

Experimental: EMB07-Patients with lymphoma - Patients with lymphoma will receive intravenous infusions of EMB-07 weekly (QW). Dose escalation will continue until the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) is reached or all planned doses are administered.


Treatment: Drugs: EMB07
EMB07 is a MAT-Fab bispecific antibody against CD3 and RORI
Intervention code [1] 0 0
Treatment: Drugs
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 last 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 untill the date of first documented progression or date of death from any casue, whichever case first, expected average 6 months.
Secondary outcome [2] 0 0
Area under the serum concentration-time curve (AUC) of EMB-07.
Timepoint [2] 0 0
Through treatment until EOT visit, expected average 6 months.
Secondary outcome [3] 0 0
Maximum serum concentration (Cmax) of EMB-07.
Timepoint [3] 0 0
Through treatment until EOT visit, expected average 6 months.
Secondary outcome [4] 0 0
Trough concentration (Ctrough) of EMB-07.
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-07.
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-07.
Timepoint [6] 0 0
Through treatment until EOT visit, expected average 6 months.
Secondary outcome [7] 0 0
Systemic clearance (CL) of EMB-07.
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-07.
Timepoint [8] 0 0
Through treatment until EOT visit, expected average 6 months.
Secondary outcome [9] 0 0
Progression free survival (PFS) of EMB-07 as assessed by RECIST 1.1, iWCLL-2018, Lugano 2014
Timepoint [9] 0 0
Through treatment discontinuation: an average of 6 months
Secondary outcome [10] 0 0
Incidence and titer of anti-drug antibodies stimulated by EMB-07.
Timepoint [10] 0 0
Up to End of Treatment Follow Up Period (30 days after the last dose)

Eligibility
Key inclusion criteria
1. 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.

2. Male or female, and aged = 18 years

3. Treatment group A: Patients with histologically or cytologically locally advanced
unresectable or metastatic solid tumors limiting to triple-negative breast cancer,
lung adenocarcinoma, ovarian cancer, pancreatic cancer, colorectal cancer, gastric
cancer, prostate cancer, bladder cancer, and uterus cancer. Treatment group B:
Patients with histologically or cytologically relapse/refractory lymphoma limiting to
chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), mantle cell
lymphoma (MCL) and diffuse large B cell lymphoma (DLBCL).

4. Treatment group A: Standard therapies do not exist, or are no longer effective, or are
not tolerable or accessible to the patient measurable or evaluable disease per RECIST
V1.1. Treatment group B: Presence of at least one two-dimensional measurable lesion
confirmed by imaging (CT or MRI) (either lymph nodes lesions with any long diameter >
1.5 cm or extranodal lesions with any long diameter > 1.0 cm); for CLL patients whose
baseline imaging evaluation determined that no two-dimensional measurable lesions,
their peripheral blood monoclonal B lymphocytes should be = 5.0×109/L.

5. Patients must provide archival tumor samples, or a 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.

6. ECOG performance status 0 or 1

7. Adequate organ function to participate in the trial.

8. Recovery from adverse events (AEs) related to prior anticancer therapy.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Prior treatment with any agent targeting ROR1.

2. History of Grade 4 immune-related adverse events (irAEs) or irAEs requiring
discontinuation of prior therapies.

3. Patient with primary central nervous system (CNS) malignancy or symptomatic CNS
metastases. Patients with solid tumors with CNS metastases are eligible if they do not
need to receive local radiation treatment at the discretion of investigator or if
radiation therapy for CNS metastases is completed = 4 weeks prior to study treatment.

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

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

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
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
Parallel
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
1/03/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/03/2026
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC,WA
Recruitment hospital [1] 0 0
Peninsula and South Eastern Haematology and Oncology Group - Frankston
Recruitment hospital [2] 0 0
One Clinical Research - Nedlands
Recruitment postcode(s) [1] 0 0
- Frankston
Recruitment postcode(s) [2] 0 0
- Nedlands
Recruitment outside Australia
Country [1] 0 0
China
State/province [1] 0 0
Hunan
Country [2] 0 0
China
State/province [2] 0 0
Baoding
Country [3] 0 0
China
State/province [3] 0 0
Beijing
Country [4] 0 0
China
State/province [4] 0 0
Bengbu
Country [5] 0 0
China
State/province [5] 0 0
Guangzhou
Country [6] 0 0
China
State/province [6] 0 0
Harbin
Country [7] 0 0
China
State/province [7] 0 0
Shandong
Country [8] 0 0
China
State/province [8] 0 0
Tianjin

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

Ethics approval
Ethics application status

Summary
Brief summary
For solid tumors and lymphoma, respectively: This study is to evaluate the safety and
tolerability of EMB-07 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-07 will also be assessed.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05607498
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
Xiaodong Sun
Address 0 0
Country 0 0
Phone 0 0
+8618512158506
Fax 0 0
Email 0 0
xdsun@epimab.com
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05607498