← Back to Search

Other

EMB-01 for Advanced Cancer

Phase 1 & 2

Recruiting

Research Sponsored by Shanghai EpimAb Biotherapeutics Co., Ltd.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from the date fo dosing until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 48 months

Awards & highlights

Study Summary

This trial is testing a new cancer drug in people with advanced or metastatic solid tumors. It is the first time this drug is being tested in humans. The trial is open-label, meaning all participants will receive the study drug.

Who is the study for?

This trial is for adults with advanced or metastatic solid tumors, including NSCLC, who've tried standard treatments without success or can't tolerate them. Phase II specifically requires EGFR mutant/cMET aberration and progression after treatment like osimertinib. Participants need good organ function, an ECOG score of 0-1 (or ≤2 for phase II), and must use contraception if fertile.Check my eligibility

What is being tested?

EMB-01 is being tested in this first-in-human study to see how it works on various advanced cancers. The trial has two parts: dose escalation to find the safe amount (Phase I) and expansion where more patients get that dose to further assess its effects (Phase II).See study design

What are the potential side effects?

While specific side effects of EMB-01 are not listed here, typical reactions may include fatigue, nausea, skin reactions at injection sites, allergic responses, and potential impacts on liver or kidney functions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from the date fo dosing until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 48 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from the date fo dosing until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 48 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and from the date fo dosing until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 48 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Adverse Events (AEs), and Serious Adverse Events (SAEs)

Maximum tolerated dose (MTD) (phase 1 only)

Overall Response Rate (ORR) (phase 2 only)

Secondary outcome measures

Accumulation Ratio (AR)

Anti-Drug Antibodies (ADA)

Area Under the Plasma Concentration-Time Curve (AUC)

+8 more

Other outcome measures

Pharmacodynamic (Soluble EGFR and cMET concentration)

Trial Design

1Treatment groups

Experimental Treatment

Group I: Dose Escalation-Part 1, Expansion-Part 2Experimental Treatment1 Intervention

In part 1, escalating dose cohort, patients will receive intravenous infusions of EMB-01 weekly (QW). The duration of each treatment cycle is 28 days (4 weeks). Dose escalation will continue until the maximum tolerated dose (MTD) or recommended phase II dose (RP2D) is reached or all planned doses are administered. In part 2, participants will receive intravenous infusion of EMB-01 at the recommended Phase II dose (RP2D) regimen(s) once weekly. The duration of each treatment cycle is 28 days (4 weeks).

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Shanghai EpimAb Biotherapeutics Co., Ltd.Lead Sponsor

5 Previous Clinical Trials

406 Total Patients Enrolled

CovanceIndustry Sponsor

119 Previous Clinical Trials

12,630 Total Patients Enrolled

Media Library

EMB-01 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT03797391 — Phase 1 & 2

Tumors Research Study Groups: Dose Escalation-Part 1, Expansion-Part 2

Tumors Clinical Trial 2023: EMB-01 Highlights & Side Effects. Trial Name: NCT03797391 — Phase 1 & 2

EMB-01 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03797391 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the efficacy of EMB-01 been explored in any other examinations?

"Presently, two research trials for EMB-01 are in progress. Neither of these experiments have reached the Phase 3 stage yet and they hail from Guangzhou, Guangdong with 9 other sites participating as well."

Answered by AI

What outcomes is this experiment attempting to demonstrate?

"This trial aims to measure the Maximum tolerated dose (MTD) of a medication over period extending from screening up to 30 days post-treatment, with secondary objectives covering Duration Of Response (DOR), Anti-Drug Antibodies (ADA), and Volume of distribution at steady state (Vss)."

Answered by AI

What is the current recruitment status for this research endeavor?

"Affirmative. Information hosted on clinicaltrials.gov verifies that this medical trial is actively searching for volunteers, and was initially published on December 13th 2018 with the latest update being April 15th 2022. 186 participants need to be recruited from 3 different sites."

Answered by AI

Is this an unprecedented approach to research?

"Presently, there are two ongoing trials for EMB-01 that span 8 cities and 2 countries. The inaugural trial was carried out in 2018 by Shanghai EpimAb Biotherapeutics Co., Ltd. This Phase 1 & 2 study included 186 patients and concluded with the requisite drug approvals. No other studies have been performed since then."

Answered by AI

What is the current participant count for this clinical investigation?

"This clinical trial necessitates 186 qualified volunteers. These individuals can be found at Barbara Ann Karmanos Cancer Institute in Detroit, Michigan and Gabrail Cancer Center Research in Canton, Ohio among other locations."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Dose Escalation With Expansion Study of EMB-01 in Participants With Advanced/Metastatic Solid Tumors

2018. "A Dose Escalation With Expansion Study of EMB-01 in Participants With Advanced/Metastatic Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03797391.

All > Bone Metastases > Metastatic Breast Cancer