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EMB-02 for 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
ECOG performance status 0 or 1 for phase I, and ≤2 for phase II; life expectancy > 3 Months
Archival tumor samples available for retrospective analysis or biopsy will be taken
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through treatment until eot visit, expected average 6 months
Awards & highlights

Study Summary

This trial is testing a new cancer drug, EMB-02, to see what dose is safe and how well it works against tumors.

Who is the study for?
This trial is for adults with advanced solid tumors, including melanoma but not uveal melanoma. Participants must have tried at least one prior therapy and should have a certain level of physical fitness (ECOG status). They need functioning organs, controlled diabetes if present, and no recent major surgeries or other treatments.Check my eligibility
What is being tested?
EMB-02 is being tested to find safe dosages and schedules. The study will look into how the body processes the drug, its safety, potential immune responses it may cause, and its effectiveness in shrinking or controlling tumor growth.See study design
What are the potential side effects?
While specific side effects are not listed here, common ones for cancer drugs like EMB-02 might include fatigue, nausea, skin reactions at injection sites, allergic reactions to the drug's components, changes in blood counts leading to increased infection risk or bleeding problems.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can care for myself and expect to live more than 3 months.
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I can provide previous tumor samples or undergo a biopsy.
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My advanced cancer has not responded to standard treatments and can be measured for changes.
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My organs are functioning well enough for me to join the trial.
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I have advanced melanoma, not in the eye, treated with specific immunotherapies and my disease can be measured.
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I have recovered from side effects of my previous cancer treatments.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through treatment until eot visit, expected average 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and through treatment until eot visit, expected average 6 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
Dose intensity
Incidence and severity of adverse events as assessed by CTCAE V5.0
Incidence of dose interruptions
+3 more
Secondary outcome measures
Area under the serum concentration-time curve (AUC) of EMB-02
Average concentration over a dosing interval (Css, avg)of EMB-02.
Duration of response of EMB-02 as assessed by RECIST 1.1
+7 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: EMB-02Experimental Treatment1 Intervention
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.

Find a Location

Who is running the clinical trial?

Shanghai EpimAb Biotherapeutics Co., Ltd.Lead Sponsor
5 Previous Clinical Trials
549 Total Patients Enrolled

Media Library

EMB-02 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04618393 — Phase 1 & 2
Solid Tumors Research Study Groups: EMB-02
Solid Tumors Clinical Trial 2023: EMB-02 Highlights & Side Effects. Trial Name: NCT04618393 — Phase 1 & 2
EMB-02 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04618393 — Phase 1 & 2

Frequently Asked Questions

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

Are people still able to join this clinical trial?

"Yes, this information is accurate according to the clinicaltrials.gov website. The study was posted on March 11th 2021 and updated as recently as March 28th of this year."

Answered by AI

What are we hoping to achieve with this research?

"The primary outcome for this clinical trial, which is set to last an average of 6 months, will be the incidence of DLTs during the first cycle of treatment. Additionally, the sponsor plans to measure secondary outcomes including Steady state volume of distribution (Vss) of EMB-02, Average concentration over a dosing interval (Css, avg)of EMB-02., and Terminal half-life (T1/2) of EMB-02."

Answered by AI
~11 spots leftby Mar 2025