Your session is about to expire
← Back to Search
Other
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
Must not have
Patients with primary central nervous system (CNS) malignancy or symptomatic CNS metastases
History of primary immunodeficiency, stem cell or organ transplant, or previous clinical diagnosis of tuberculosis
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
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.
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.
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 belowSelect...
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.
Select...
My cancer progressed after treatment with a specific lung cancer medication.
Select...
I am fully active and can carry on all my pre-disease activities without restriction.
Select...
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.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a brain tumor or cancer that has spread to my brain.
Select...
I have had a primary immunodeficiency, stem cell or organ transplant, or tuberculosis.
Select...
I haven't had a blood clot, heart attack, stroke, or similar issues recently.
Select...
My heart's pumping ability is below the normal range.
Select...
I have myocarditis.
Select...
My blood pressure is often 150/90 mm Hg or higher, even with medication.
Select...
I have been diagnosed with congestive heart failure.
Select...
My heart's electrical activity is irregular or I have a device to control it.
Select...
I have inflammation or significant fluid around my heart.
Timeline
Screening ~ 3 weeks3 visits
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
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
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Objective Response Rate (ORR) (Phase II only)
Rate of Adverse Events (AE) and Serious Adverse Events (SAE)
Secondary study objectives
Best Overall Response (BOR)
Clinical Benefit Rate (CBR)
Cmax
+5 moreSide effects data
From 2023 Phase 3 trial • 29 Patients • NCT0245493347%
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%
Back pain
18%
Productive cough
18%
Rhinorrhoea
18%
Nausea
18%
Upper respiratory tract infection
18%
Neutrophil count decreased
18%
Dry skin
18%
Constipation
18%
Pneumonia
12%
Electrocardiogram QT prolonged
12%
Aspartate aminotransferase increased
12%
Vomiting
12%
Lung infection
12%
Musculoskeletal chest pain
12%
Alanine aminotransferase increased
12%
Decreased appetite
12%
Dizziness
12%
Dysphonia
12%
Epistaxis
12%
Rash maculo-papular
6%
Epigastric discomfort
6%
Hypertension
6%
Orthostatic hypotension
6%
Anaemia
6%
Spontaneous haemorrhage
6%
Ear discomfort
6%
Tinnitus
6%
Blepharitis
6%
Ocular hyperaemia
6%
Hypoacusis
6%
Blepharospasm
6%
Mouth ulceration
6%
Fatigue
6%
Gastritis
6%
Asthenia
6%
Catheter site injury
6%
Complication associated with device
6%
Gastroenteritis
6%
Ligament sprain
6%
Joint swelling
6%
Muscle spasms
6%
Osteoarthritis
6%
Headache
6%
Hypoaesthesia
6%
Anxiety
6%
Insomnia
6%
Renal vein embolism
6%
Urinary incontinence
6%
Milia
6%
Uterine mass
6%
Laryngeal haemorrhage
6%
Organising pneumonia
6%
Sinus congestion
6%
Onychoclasis
6%
Pain of skin
6%
Pruritus generalised
6%
Rash macular
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%
Palmar-plantar erythrodysaesthesia syndrome
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
~1100
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
481 Total Patients Enrolled
Labcorp Corporation of America Holdings, IncIndustry Sponsor
19 Previous Clinical Trials
4,501 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are not expected to live for more than 3 months.My cancer progressed after treatment with a specific lung cancer drug and no longer has a certain mutation.I have a brain tumor or cancer that has spread to my brain.My cancer has a specific EGFR mutation.I have had a primary immunodeficiency, stem cell or organ transplant, or tuberculosis.I haven't had a blood clot, heart attack, stroke, or similar issues recently.I am willing to provide a blood sample for genetic testing.My heart's pumping ability is below the normal range.I am 18 years old or older.My condition worsened after standard treatment for my disease group.My lung cancer has a specific EGFR mutation and is advanced.My condition worsened after standard treatment and no other treatments are available.I have a condition or family history that increases my risk of heart rhythm problems.My cancer progressed after treatment with a specific lung cancer medication.I am fully active and can carry on all my pre-disease activities without restriction.I have no major side effects from cancer treatment, except for possible hair loss, mild fatigue, mild nerve pain, or stable thyroid issues.I have myocarditis.Patients must have a way for doctors to measure or evaluate their disease according to a specific set of guidelines.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.My cancer progressed after treatment with a specific lung cancer medication.My cancer progressed on osimertinib with a specific EGFR mutation.I have or can provide a sample of my tumor for testing before starting the study treatment.My blood pressure is often 150/90 mm Hg or higher, even with medication.I have been diagnosed with congestive heart failure.My heart's electrical activity is irregular or I have a device to control it.I have inflammation or significant fluid around my heart.
Research Study Groups:
This trial has the following groups:- Group 1: Part 1 Dose Escalation (Phase Ib), Part 2 Dose Expansion (Phase II)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Share this study with friends
Copy Link
Messenger