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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Subjects must have radiological documented disease progression while on a previous continuous treatment with osimertinib or another third-generation EGFR-TKI as well as disease progression on the last treatment administered prior to enrolling in the study
Histological or cytological confirmed diagnosis of unresectable locally advanced or metastatic NSCLC
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 30 months
Awards & highlights
Study Summary
This trial is testing a new drug, H002, to treat patients with EGFR-mutated NSCLC that has progressed despite standard treatments. The goal is to find the safest dose of H002 and to see if it has any activity against the cancer.
Who is the study for?
Adults (≥18 years) with advanced non-small cell lung cancer (NSCLC) and specific EGFR mutations who have progressed on certain treatments like osimertinib. They must have measurable disease, a life expectancy of at least 12 weeks, and an ECOG performance status of 0-1. Women able to bear children and men with partners of childbearing potential must commit to effective contraception.Check my eligibility
What is being tested?
The trial is testing H002, an oral medication for NSCLC patients with active EGFR mutations. It has two phases: Phase I determines the safe dosage while Phase IIa expands the study to more patients at that dose level, assessing safety and preliminary effectiveness against tumors.See study design
What are the potential side effects?
While not explicitly listed in the provided information, common side effects for similar targeted therapies may include diarrhea, skin rash or acneiform dermatitis, dry skin, nail changes, mouth sores, fatigue and decreased appetite.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer progressed despite treatment with a specific lung cancer medication.
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My lung cancer cannot be removed by surgery and has spread.
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My lung cancer has a specific EGFR mutation.
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I am using effective birth control and have a negative pregnancy test.
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My NSCLC has EGFR mutations sensitive to treatment.
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I am fully active or can carry out light work.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to approximately 30 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 30 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
DOSE ESCALATION PHASE：Incidence of dose-limiting toxicities (DLTs) at Cycle 0 and Cycle1. Incidence and severity of treatment-emergent adverse events (TEAEs), with severity determined according to National Cancer Institute (NCI) CTCAE v5.0.
DOSE EXPANSION PHASE：Incidence and severity of TEAEs, with severity determined according to NCI CTCAE v5.0.
DOSE EXPANSION PHASE：Objective Response Rate (ORR)
Secondary outcome measures
Area under the plasma concentration versus time curve (AUC)
DOSE ESCALATION PHASE：Objective Response Rate (ORR)
Disease control rate (DCR)
+7 moreTrial Design
6Treatment groups
Experimental Treatment
Group I: 80 mg QD, oralExperimental Treatment1 Intervention
H002 80mg QD, orally administered in fasting state, receive a single dose of H002 orally, followed by a 4-day washout period. Then, the same dose of H002 will be administered QD until disease progression or not tolerated.
Group II: 40 mg QD, oralExperimental Treatment1 Intervention
H002 40mg QD, orally administered in fasting state, receive a single dose of H002 orally, followed by a 4-day washout period. Then, the same dose of H002 will be administered QD until disease progression or not tolerated.
Group III: 350 mg QD, oralExperimental Treatment1 Intervention
H002 350mg QD, orally administered in fasting state, receive a single dose of H002 orally, followed by a 4-day washout period. Then, the same dose of H002 will be administered QD until disease progression or not tolerated.
Group IV: 250 mg QD, oralExperimental Treatment1 Intervention
H002 250mg QD, orally administered in fasting state, receive a single dose of H002 orally, followed by a 4-day washout period. Then, the same dose of H002 will be administered QD until disease progression or not tolerated.
Group V: 20 mg QD, oralExperimental Treatment1 Intervention
H002 20mg QD, orally administered in fasting state, receive a single dose of H002 orally, followed by a 4-day washout period. Then, the same dose of H002 will be administered QD until disease progression or not tolerated.
Group VI: 150 mg QD, oralExperimental Treatment1 Intervention
H002 150mg QD, orally administered in fasting state, receive a single dose of H002 orally, followed by a 4-day washout period. Then, the same dose of H002 will be administered QD until disease progression or not tolerated.
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Who is running the clinical trial?
RedCloud BioLead Sponsor
1 Previous Clinical Trials
76 Total Patients Enrolled
ParexelIndustry Sponsor
304 Previous Clinical Trials
101,112 Total Patients Enrolled
Louis ZhangStudy DirectorRedCloud Bio
1 Previous Clinical Trials
59 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer progressed despite treatment with a specific lung cancer medication.I have a history of interstitial lung disease.I have a severe eye condition that hasn't improved to mild or no symptoms.You are expected to live for at least 12 more weeks.I have brain metastases, meningeal metastasis, or spinal cord compression that causes symptoms.My lung cancer has a specific EGFR mutation.I am using effective birth control and have a negative pregnancy test.I am 18 years or older.My lung cancer cannot be removed by surgery and has spread.I am willing to provide a tumor sample for EGFR mutation analysis.I haven't taken EGFR-TKI medication for at least 8 days before starting H002.I haven't had immunotherapy or biotherapy in the last 4 weeks.I have been diagnosed with or tested positive for HIV.I haven't taken strong medication that affects liver enzymes or drug transporters in the last 2 weeks.I haven't had a live vaccine in the last 4 weeks or an mRNA COVID-19 vaccine in the last 72 hours.My cancer has EGFR exon 20 insertion mutations.I haven't had severe stomach or intestine problems in the last 4 weeks.I haven't had major heart issues or a long QTc interval in the last 6 months.I finished any palliative radiotherapy at least 2 weeks before starting H002.I have active hepatitis B.I haven't taken oral fluorouracil drugs like tegafur or capecitabine in the last 2 weeks.I have fluid buildup that can't be controlled with treatment.I haven't needed treatment for an infection in the last 2 weeks.My NSCLC has EGFR mutations sensitive to treatment.You have at least one visible and measurable abnormality as determined by the doctor.I have been treated for an EGFR C797S mutation.I haven't taken chemotherapy or other cancer drugs for my lung cancer in the last 4 weeks.I have had bleeding problems or blood clotting disorders in the last 6 months.You are currently taking part in a study with an experimental treatment or device, or have done so within the last 4 weeks or a certain period based on the specific investigational product.I will not need other cancer treatments during the study.I haven't had major surgery or serious injury in the last 4 weeks and don't expect to need major surgery during the study.I am not pregnant or breastfeeding.I have moderate to severe skin problems due to treatment.I have side effects from cancer treatment that are not severe.I am fully active or can carry out light work.I have or had cancer other than non-small cell lung cancer, but it was early stage and treated.You have had a bad reaction to the ingredients in H002 or similar drugs in the past.I have not used any herbal treatments with anti-tumor effects in the last 2 weeks.I have no stomach or bowel issues affecting medicine absorption.My blood and organs are functioning well.I haven't taken Mitomycin or nitrosourea in the last 6 weeks.
Research Study Groups:
This trial has the following groups:- Group 1: 350 mg QD, oral
- Group 2: 150 mg QD, oral
- Group 3: 250 mg QD, oral
- Group 4: 80 mg QD, oral
- Group 5: 20 mg QD, oral
- Group 6: 40 mg QD, oral
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the goal of this experiment?
"According to the sponsor of this clinical trial, RedCloud Bio, the primary outcome being measured over a period of up to approximately 30 months is the incidence of dose-limiting toxicities (DLTs) at Cycle 0 and Cycle1. Additionally, they will be evaluating the secondary outcomes of time for half the drug concentration to be eliminated（t1/2), progression-free survival (PFS), and objective response rate (ORR)."
Answered by AI
Do we still need participants for this experiment?
"This clinical trial, as indicated on the website clinicaltrials.gov, is no longer recruiting patients for participation. This study was originally posted on 8/31/2022 but was last edited on 8/25/2022. Although this specific trial has completed recruitment, there are 1,452 other studies that are currently looking for participants."
Answered by AI
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