EMB-15: EMB-15 is a recombinant humanized bi-specific antibody against ALPP/ALPG and CD3
Study summary
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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
Primary outcome measure(s)
incidence and severity of adverse events as assessed by CTCAE v6.0 and ASTCT. — Screening up to follow-up (30 days after the last dose) Incidence and severity of AE.
Incidence of serious adverse events (SAE) — Screening up to follow-up (30 days after the last dose) Incidence of SAE.
Incidence of dose interruptions — Screening up to follow-up (30 days after the last dose) Incidence of dose interruptions of EMB-15 during treatment as a measure of tolerability.
Dose intensity — Screening up to follow-up (30 days after the last dose) Actual amount of drug taken by patients divided by the planned amount.
The incidence of DLTs during the DLT evaluation period. — First infusion to the end of Cycle 1 (each cycle is 28 days) The Dose Limiting Toxicities (DLTs) are based on drug related adverse events and are specifically defined in study protocol.
Trial sites (1)
Facility
City
Region
Status
Sixth Affiliated Hospital of Sun Yat-sen University
Guangzhou
Guangdong
Recruiting
More Shanghai EpimAb Biotherapeutics Co., Ltd. trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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