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EMB-01 + Osimertinib for Lung Cancer

Phase 1 & 2
Waitlist Available
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
Patient had an EGFR T790M mutation, progressed on 2nd- or later-line osimertinib or another 3rd-generation EGFR TKI, and no longer harbors an EGFR T790M mutation
Patient has a documented EGFR Exon20ins activating mutation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from first dose until the date of first documented progression or date of death from any cause, whichever comes first; up to 2 years
Awards & highlights

Study Summary

This trial is studying the side effects and best dose of EMB-01 when given with osimertinib for patients with EGFR-mutant non-small cell lung cancer that has progressed on standard treatment.

Who is the study for?
Adults with advanced EGFR-mutant non-small cell lung cancer who've seen their disease progress after standard treatments can join. They must be willing to provide a blood sample for genetic testing, have an ECOG performance status of 1 or less (which means they're fully active or restricted in physically strenuous activity but ambulatory), and have measurable disease. Those with certain heart conditions, uncontrolled hypertension, significant arrhythmias, or recent serious cardiovascular events cannot participate.Check my eligibility
What is being tested?
The trial is testing the combination of two drugs: EMB-01 and Osimertinib. It aims to find the best dose and assess side effects when these drugs are used together in patients whose lung cancer has spread and worsened despite treatment. The study will explore if this drug combo can better halt tumor growth by blocking enzymes that cancer cells need.See study design
What are the potential side effects?
While specific side effects for EMB-01 aren't detailed here, common ones from similar treatments include nausea, fatigue, skin reactions, diarrhea, and potential heart issues. Osimertinib may cause rash, dry skin, nail problems like redness around the nails or tenderness in fingertips; it might also affect your appetite causing weight loss.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer progressed after treatment with a specific lung cancer drug and no longer has a certain mutation.
Select...
My cancer has a specific EGFR mutation.
Select...
I am 18 years old or older.
Select...
My condition worsened after standard treatment for my disease group.
Select...
My lung cancer has a specific EGFR mutation and is advanced.
Select...
My condition worsened after standard treatment and no other treatments are available.
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My cancer progressed after treatment with a specific lung cancer medication.
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I am fully active and can carry on all my pre-disease activities without restriction.
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I have had 2 or fewer treatments for my cancer if I'm in Group 1 or 4, and up to 3 if I'm in Group 2 or 3.
Select...
My cancer progressed after treatment with a specific lung cancer medication.
Select...
My cancer progressed on osimertinib with a specific EGFR mutation.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from first dose until the date of first documented progression or date of death from any cause, whichever comes first, up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and from first dose until the date of first documented progression or date of death from any cause, whichever comes first, up to 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Maximum tolerated dose (MTD) of EMB-01 and osimertinib (Phase Ib only)
Objective Response Rate (ORR) (Phase II only)
Rate of Adverse Events (AE) and Serious Adverse Events (SAE)
+1 more
Secondary outcome measures
Best Overall Response (BOR)
Clinical Benefit Rate (CBR)
Cmax
+5 more

Side effects data

From 2023 Phase 3 trial • 29 Patients • NCT02454933
47%
Diarrhoea
41%
Paronychia
41%
Dermatitis acneiform
29%
Stomatitis
29%
Arthralgia
24%
Viral upper respiratory tract infection
24%
Cough
24%
Neutropenia
24%
Dyspnoea
24%
Pruritus
18%
Rhinorrhoea
18%
Back pain
18%
Productive cough
18%
Nausea
18%
Upper respiratory tract infection
18%
Neutrophil count decreased
18%
Dry skin
18%
Constipation
18%
Pneumonia
12%
Musculoskeletal chest pain
12%
Electrocardiogram QT prolonged
12%
Lung infection
12%
Aspartate aminotransferase increased
12%
Vomiting
12%
Alanine aminotransferase increased
12%
Decreased appetite
12%
Dizziness
12%
Dysphonia
12%
Epistaxis
12%
Rash maculo-papular
6%
Joint swelling
6%
Orthostatic hypotension
6%
Fatigue
6%
Blepharospasm
6%
Blepharitis
6%
Catheter site injury
6%
Tinnitus
6%
Hypoaesthesia
6%
Pain of skin
6%
Insomnia
6%
Hypoacusis
6%
Spontaneous haemorrhage
6%
Ear discomfort
6%
Gastroenteritis
6%
Sinus congestion
6%
Complication associated with device
6%
Asthenia
6%
Hypertension
6%
Anxiety
6%
Anaemia
6%
Onychoclasis
6%
Headache
6%
Ocular hyperaemia
6%
Epigastric discomfort
6%
Gastritis
6%
Mouth ulceration
6%
Ligament sprain
6%
Muscle spasms
6%
Osteoarthritis
6%
Renal vein embolism
6%
Urinary incontinence
6%
Uterine mass
6%
Laryngeal haemorrhage
6%
Rash macular
6%
Organising pneumonia
6%
Hot flush
6%
Dry eye
6%
Eyelid pain
6%
Retinal drusen
6%
Abdominal pain
6%
Flatulence
6%
Oesophageal pain
6%
Toothache
6%
Pain
6%
Seasonal allergy
6%
Atypical pneumonia
6%
Cystitis
6%
Influenza
6%
Lower respiratory tract infection
6%
Oral candidiasis
6%
Sinusitis
6%
Avulsion fracture
6%
Fall
6%
Urine analysis abnormal
6%
Bone pain
6%
Musculoskeletal pain
6%
Osteoporosis
6%
Pain in extremity
6%
Amnesia
6%
Paraesthesia
6%
Vaginal haemorrhage
6%
Nasal congestion
6%
Pleural effusion
6%
Sneezing
6%
Eczema asteatotic
6%
Intertrigo
6%
Milia
6%
Palmar-plantar erythrodysaesthesia syndrome
6%
Pruritus generalised
6%
Rash
6%
Skin fissures
6%
Urticaria
6%
Xanthelasma
6%
Urinary tract infection
6%
Pyrexia
6%
Colorectal cancer
100%
80%
60%
40%
20%
0%
Study treatment Arm
Osimertinib 80 mg
Osimertinib 80 mg + Durvalumab 10 mg/kg

Trial Design

1Treatment groups
Experimental Treatment
Group I: Part 1 Dose Escalation (Phase Ib), Part 2 Dose Expansion (Phase II)Experimental Treatment2 Interventions
In Part 1 dose escalation, patients will receive EMB-01 IV once weekly and osimertinib PO QD on days 1-28. The treatment cycle repeats every 28 days in the absence of disease progression or unacceptable toxicity. 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 dose expansion, patients will receive EMB-01 IV once weekly and osimertinib PO QD on days 1-28 at the recommended phase II dose (RP2D) regimen. The treatment cycle repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Osimertinib
2017
Completed Phase 4
~1010

Find a Location

Who is running the clinical trial?

Labcorp Drug Development, Inc.Industry Sponsor
10 Previous Clinical Trials
422 Total Patients Enrolled
Shanghai EpimAb Biotherapeutics Co., Ltd.Lead Sponsor
5 Previous Clinical Trials
477 Total Patients Enrolled
Labcorp Corporation of America Holdings, IncIndustry Sponsor
18 Previous Clinical Trials
4,111 Total Patients Enrolled

Media Library

EMB-01 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05498389 — Phase 1 & 2
Lung Cancer Research Study Groups: Part 1 Dose Escalation (Phase Ib), Part 2 Dose Expansion (Phase II)
Lung Cancer Clinical Trial 2023: EMB-01 Highlights & Side Effects. Trial Name: NCT05498389 — Phase 1 & 2
EMB-01 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05498389 — Phase 1 & 2

Frequently Asked Questions

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

What are the primary goals of this medical research endeavor?

"Labcorp Drug Development, Inc., the company that is funding this trial states its primary objective will be measured within a maximum of 28 days and revolves around finding out the Recommended phase II dose (RP2D) of EMB-01 and osimertinib (Phase Ib). This study's secondary goals include measuring Duration of Response with RECIST v1.1 criteria as well as Best Overall Response using the same set of standards, plus ascertaining Tmax or Time to Maximum Plasma Concentration."

Answered by AI

Are volunteers currently being recruited for this investigation?

"According to records on clinicaltrials.gov, this medical experiment is not presently recruiting patients. It was first posted in October 1st 2022 and last updated August 10th 2022; while it has no current need for participants there are 4164 other trials accepting volunteers right now."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
EMB-01 in Combination With Osimertinib in Patients With EGFR Mutant Lung Cancer
2023. "EMB-01 in Combination With Osimertinib in Patients With EGFR Mutant Lung Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05498389.
~18 spots leftby Jul 2024
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