A Phase 1/2 interventional study of EMB-02 in Advanced Solid Tumors, sponsored by Shanghai EpimAb Biotherapeutics Co., Ltd.. Terminated at 10 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-05-21.
Sponsored by Shanghai EpimAb Biotherapeutics Co., Ltd. · Phase 1/2, Interventional, and Treatment
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.
This is a Phase I/II, multi-center, open label, multiple-dose, first in human study, designed to assess safety and tolerability, and to identify the maximum tolerated dose (MTD) and/or recommended Phase 2 dos(s)e (RP2D[s]) for EMB-02 in patients with advanced solid tumors. Pharmacokinetics, pharmacodynamics, immunogenicity, and response will also be assessed.
9,616 studies on the registry are indexed under Neoplasms; 2,508 are open to participants now.
This study's enrollment of 47 is close to the median of 50 across 7,432 interventional studies indexed under Neoplasms.
Browse Neoplasms studies →Shanghai EpimAb Biotherapeutics Co., Ltd. is the lead sponsor of 10 studies on the registry; 8 are open to participants now.
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Exclusion Criteria:
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.
Biological: EMB-02
EMB-02 is a FIT-Ig® bispecific antibody against PD-1 and LAG-3.
Incidence and severity of adverse events as assessed by CTCAE V5.0
Incidence and severity of AE.
Time frame: Screening up to follow-up (30 days after the last dose)
Incidence of serious adverse events (SAE)
Incidence of SAE.
Time frame: Screening up to follow-up (30 days after the last dose)
Incidence of dose interruptions
Incidence of dose interruptions of EMB-02 during treatment as a measure of tolerability.
Time frame: Screening up to follow-up (30 days after the last dose)
Dose intensity
Actual amount of drug taken by patients divided by the planned amount.
Time frame: Screening up to follow-up (30 days after the last dose)
The incidence of DLTs during the first cycle of treatment.
The Dose Limiting Toxicities (DLTs) are based on drug related adverse events and are specifically defined in study protocol.
Time frame: First infusion to the end of Cycle 1 (each cycle is 28 days)
Antitumor activity(Objective Response Rate (ORR)
Measured by RECIST 1.1, only applicable in Phase II part
Time frame: 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
Area under the serum concentration-time curve (AUC) of EMB-02
Blood samples for serum PK analysis will be obtained (AUC).
Time frame: Through treatment until EOT visit, expected average 6 months
Maximum serum concentration (Cmax) of EMB-02
Blood samples for serum PK analysis will be obtained (Cmax)
Time frame: Through treatment until EOT visit, expected average 6 months
Trough concentration (Ctrough) of EMB-02
Blood samples for serum PK analysis will be obtained (Ctrough)
Time frame: Through treatment until EOT visit, expected average 6 months
Average concentration over a dosing interval (Css, avg)of EMB-02.
Blood samples for serum PK analysis will be obtained (Css, avg).
Time frame: Through treatment until EOT visit, expected average 6 months
Terminal half-life (T1/2) of EMB-02
Blood samples for serum PK analysis will be obtained (T1/2)
Time frame: Through treatment until EOT visit, expected average 6 months.
Systemic clearance (CL) of EMB-02
Blood samples for serum PK analysis will be obtained (CL).
Time frame: Through treatment until EOT visit, expected average 6 months
Steady state volume of distribution (Vss) of EMB-02
Blood samples for serum PK analysis will be obtained (Vss).
Time frame: Through treatment until EOT visit, expected average 6 months
Progression free survival (PFS) of EMB-02 as assessed by RECIST 1.1
Preliminary anti-tumor activity of EMB-02 will be obtained (PFS).
Time frame: 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
Duration of response of EMB-02 as assessed by RECIST 1.1
Preliminary anti-tumor activity of EMB-02 will be obtained (DOR).
Time frame: 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
Incidence and titer of anti-drug antibodies stimulated by EMB-02
Antibodies to EMB-02 will be assessed to evaluate potential immunogenicity.
Time frame: Up to End of Treatment Follow Up Period (30 days after the last dose)
Plan to share: No
Ran from Mar 2021 to primary completion in Jul 2023, 28 months.
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This study is terminated, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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Shanghai EpimAb Biotherapeutics Co., Ltd.