A First-in-human Phase I Study to Evaluate EMB-15 in Patients With Locally Advanced or Metastatic Solid Tumors.

Phase 1RecruitingNCT07607054

Shanghai EpimAb Biotherapeutics Co., Ltd.50 enrolled

Overview

The primary purpose of this study is to evaluate safety and tolerability profile of EMB-15, identify the recommended Phase 2 dose(s) (RP2Ds) for EMB-15. Pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity, and the anti-tumor activity of EMB-15 will also be assessed.

This is a first-in-human (FIH), open-label, Phase I, multicenter dose escalation study to identify the RP2D and to evaluate the safety, tolerability, pharmacokinetics, and antitumor activities of EMB-15 in adult patients with locally advanced/metastatic solid tumors who have progressed on available standard of care or for which no standard therapy exists.This is an open-label, non-randomized dose-escalation study comprising a dose-escalation phase and a dose-expansion phase. It's planned to recruit approximately 50 patients (the final number will be determined depending on the number of dose levels) with locally advanced or metastatic solid tumors. The trial consists of a screening period (Day -28 to Day -1), a step-up dose period (applicable only to doses with higher CRS risk, lasting 7 days or longer), a treatment period (28 days per cycle, up to 2 years), and a safety follow-up period (30 days after the last dose).

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Locally Advanced or Metastatic Solid Tumors

Interventions

EMB-15BIOLOGICAL

EMB-15 is a recombinant humanized bi-specific antibody against ALPP/ALPG and CD3

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: \- 1) Able to understand and willing to sign an ICF 2) Males or females with the age ≥ 18 years 3) Life expectancy \> 3 months. 4) ECOG performance status 0 or 1 5) Patients must have histologically or cytologically confirmed locally advanced or metastatic solid tumors, without standard therapy. 6\) Patients must provide archived tumor samples collected within 1 year. 7) Adequate hematological and organ function. Exclusion Criteria: * Patients meeting any of the following criteria will not be enrolled: 1. Any prior ALPP/ALPG targeting therapy 2. Has received anticancer therapy, radiotherapy, or investigational drug within \< 5 half-lives or 4 weeks (whichever is shorter) prior to study treatment; 3. Active autoimmune disease or history of autoimmune disease 4. Concurrent malignancy \< 5 years prior to study entry 5. active infection 6. Severe or uncontrolled cardiovascular disease requiring treatment 7. Other severe medical conditions

Locations (1)

Sixth Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China

RECRUITING

Outcomes

Primary Outcomes

incidence and severity of adverse events as assessed by CTCAE v6.0 and ASTCT.

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-15 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 DLT evaluation period.

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)

Secondary Outcomes

Area under the serum concentration-time curve (AUC) of EMB-15

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-15

Blood samples for serum PK analysis will be obtained (Cmax)

Time frame: Through treatment until EOT visit, expected average 6 months

Central Contacts

Xi Yang

CONTACT

86-21-61951000 xyang@epimab.com

Data from ClinicalTrials.gov

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