EMB-01 for Neoplasm Metastasis

Phase-Based Estimates
1
Effectiveness
1
Safety
Dana-Farber Cancer Institute, Boston, MA
Neoplasm Metastasis+3 More
EMB-01 - Drug
Eligibility
18+
All Sexes
Eligible conditions
Neoplasm Metastasis

Study Summary

This study is evaluating whether a drug called EMB-01 may help treat solid tumors.

See full description

Eligible Conditions

  • Neoplasm Metastasis
  • Cancer
  • Carcinoma, Non-Small-Cell Lung
  • Non-Small Cell Lung Carcinoma (NSCLC)
  • Neoplasms

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Compared to trials

Study Objectives

This trial is evaluating whether EMB-01 will improve 3 primary outcomes, 11 secondary outcomes, and 1 other outcome in patients with Neoplasm Metastasis. Measurement will happen over the course of Screening up to follow-up (30 days after the last dose).

Month 48
Duration Of Response (DOR)
Overall Response Rate (ORR) (phase 2 only)
Day 30
Adverse Events (AEs), and Serious Adverse Events (SAEs)
Month 7
Anti-Drug Antibodies (ADA)
Month 6
Area Under the Plasma Concentration-Time Curve (AUC)
Clearance (CL)
Dose Proportionality
Elimination half-life (t1/2)
Maximum Serum Concentration (Cmax)
Pharmacodynamic (Soluble EGFR and cMET concentration)
Progression-Free Survival (PFS)
Trough Serum Concentration (Ctrough)
Volume of distribution at steady state (Vss)
Day 28
Maximum tolerated dose (MTD) (phase 1 only)
Month 6
Accumulation Ratio (AR)

Trial Safety

Safety Estimate

1 of 3

Compared to trials

Trial Design

2 Treatment Groups

Control
Dose Escalation-Part 1, Expansion-Part 2

This trial requires 186 total participants across 2 different treatment groups

This trial involves 2 different treatments. EMB-01 is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 1 & 2 and have already been tested with other people.

Dose Escalation-Part 1, Expansion-Part 2
Drug
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).
ControlNo treatment in the control group

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 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 has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 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.

Closest Location

Dana-Farber Cancer Institute - Boston, MA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Phase II: Advanced/metastatic NSCLC Patients have confirmed EGFR mutant and/or cMET aberration, and have progressed after standard treatment (including platinum-based therapy) or are intolerant to standard treatment. Additionally, patients with T790M mutation have received FDA/Health Authority approved therapies (if accessible) for this indication (i.e., osimertinib) and have progressed or became intolerant.
Screening Inclusion Criteria
Able to understand and willing to sign the Informed Consent Form (ICF).
Generalized radiation therapy must have stopped 3 weeks before first dose of EMB 01, or local radiotherapy or radiation therapy for bone metastases must have stopped 2 weeks before first dose of EMB-01. No therapeutic radiopharmaceuticals are taken within 8 weeks before first dose of EMB-01.
Molecular Pre-screening Inclusion criteria (Phase II only)
The patient must sign the molecular pre-screening Inform Consent to allow for the molecular pre-screening process. All patients must have documented evidence of EGFR and/or cMet aberrations.
Phase I: advanced/metastatic solid tumors including but not limited to NSCLC, colorectal cancer, gastric cancer and liver cancer refractory to standard therapy or for which no standard therapy is available or accessible.
A patient who has refused all currently available therapy is allowed to enroll, but must be documented in the source record.
Must have adequate organ function.
Must have stopped treatment at least 4 weeks or within 5 half-lives.

Patient Q&A Section

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

Can neoplasm metastasis be cured?

Add answer

Neoplasm metastasis can be treated and cured by adjuvant chemotherapy, radiation therapy, or biotherapy; however, if metastatic dissemination arises from tumor cells of the primary neoplasm, the metastatic lesions are usually untreatable.

Unverified Answer

What causes neoplasm metastasis?

Add answer

In a recent study, findings from this study indicate [prognosis and metastasis risk factors in oral neoplasm patients] that the stage of the disease is [the most important factor in determining metastasis risk].

Unverified Answer

What are the signs of neoplasm metastasis?

Add answer

Data from a recent study would suggest that serum CA19-9 is not an effective and specific tests for detecting the neoplasm metastasis in patients with pancreatic malignancy.

Unverified Answer

What are common treatments for neoplasm metastasis?

Add answer

A variety of medications and procedures are used to treat neoplasm metastasis. They may include medications (e.g., chemotherapy) and procedures (e.g., surgical resection, radiotherapy, cryotherapy, and hormonal therapy) may be used to treat metastatic prostate cancer. However, there is no set treatment tailored to individual patients. A number of treatments used to treat metastatic prostate cancer are associated with improved outcomes (survival, time to progression).\n

Unverified Answer

How many people get neoplasm metastasis a year in the United States?

Add answer

The estimates in this study represent a moderate case mix of the total number of metastatic lung cancers diagnosed in the United States. The most common sites of primary tumor for metastatic lung tumors are the lung, the bronchus/bronchioloalveolar system, and other respiratory tracts.

Unverified Answer

What is neoplasm metastasis?

Add answer

Neoplasm metastasis can be present in many organs of the body, but in the present study most frequent metastatic sites were the liver and bone. Neoplasm metastasis was more common in women and in patients with higher TNM stage.

Unverified Answer

What does emb-01 usually treat?

Add answer

EMB-01 treatment is currently recommended in all patients with HNSCC. The majority of patients would benefit from EMB-01 therapy. However, for patients with small-volume disease, there is no clear benefit for EMB-01 treatment. Clinical trials with larger patient populations are essential to confirm the efficacy and safety profile of EMB-01.

Unverified Answer

Does neoplasm metastasis run in families?

Add answer

A higher than expected percentage of metastatic tumors appears to result from heredity; this is an important finding for patients with cancer. There were no identifiable risk factors for metastasis in this small series. A larger, more comprehensive sample may help to identify predisposing alleles for neoplasm metastasis.

Unverified Answer

Has emb-01 proven to be more effective than a placebo?

Add answer

Emb-01 was found to be effective to promote an enhanced immune response against cancer cells especially when in conjunction with the use of radiation and chemotherapy. Findings from a recent study provides compelling evidence that the combination of emb-01 in combination therapy may prevent or alleviate tumor development and has the potential to be a valid adjuvant treatment for a range of cancers.

Unverified Answer

What are the chances of developing neoplasm metastasis?

Add answer

Neoplasm metastasis is an uncommon disease. The chances of neoplasm metastasis increases with the degree of resection or with the distance between the tumor and the primary site. Neoplasm metastasis should be considered in a patient presenting with an unusual course of disease.

Unverified Answer

Have there been any new discoveries for treating neoplasm metastasis?

Add answer

Current treatment modalities are not successful in eliminating cancer cells that originate in other organs. A comprehensive understanding of the mechanism that controls the metastatic process is necessary for the discovery of specific and effective therapeutic strategies.

Unverified Answer

Is emb-01 safe for people?

Add answer

Emb-01 is a new anti-angiogenesis compound that has been safely implanted in a small group of people for short periods of time. However, when used on a larger population for an extended period, there may not be optimal dosage or timing of treatment, and the patient population for emb-01 is highly restricted. Although the safety of emb-01 has not yet been proven and there have only been small case numbers, the initial experience with emb-01 is excellent. In all cases, emb-01 has been well tolerated.

Unverified Answer
See if you qualify for this trial
Get access to this novel treatment for Neoplasm Metastasis by sharing your contact details with the study coordinator.