Non-small Cell Lung CancerPhase 1/2NCT05519293

Phase I/IIa Study of H002 in NSCLC With Active EGFR Mutation

A Phase 1/2 study testing H002 in people with Non-small Cell Lung Cancer, run by RedCloud Bio at 4 sites in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

This is a phase I/IIa, open-label, dose-escalation and expansion study to evaluate the safety, tolerability, PK and preliminary anti-tumor activity of H002 when given orally in patients with active EGFR mutation locally advanced or metastatic non-small cell lung cancer (NSCLC). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Non-small Cell Lung Cancer
What is being tested?: H002
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 76 participants
Where: 4 sitesUnited States
Study dates: 15 Dec 2022to 28 Feb 2025
Phase: Phase 1/2
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Males or females aged ≥ 18 years at time of signing informed consent form (ICF).
Histological or cytological confirmed diagnosis of unresectable locally advanced or metastatic NSCLC.
Subjects must have NSCLC harboring one or more active EGFR mutations known to be associated with EGFR-TKI sensitivity (including, but not limited to Del19 and L858R).
Part A: All subjects may provide tumor sample to central laboratory to analyze the EGFR mutation status according to their own willingness;
Part B: All subjects must provide tumor sample to central laboratory to analyze the EGFR mutation status. And subjects must have NSCLC harboring EGFR C797S mutation.
Note: Tumor sample can be either an archival sample or a sample obtained by pretreatment biopsy prior to H002 treatment.

Show all 13Show fewer

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.
Presence of at least one measurable lesion according to RECIST v1.1 per investigator assessment.
ECOG performance status of 0-1.
Life expectancy ≥ 12 weeks.
Adequate hematologic and organ function per protocol.
Women of childbearing potential (WOCBP) and fertile males with WOCBP partners must use highly effective contraception per protocol throughout the study. WOCBP must have a negative serum and/or urine pregnancy test result within 7 days prior to the first dose of H002.
Signed ICF, and this must be obtained before the performance of any protocol-specific procedures.

Who cannot join

Treatment with any of the following:
Prior treatment with an EGFR-TKI within 8 days or approximately 5 × t1/2 prior to the first dose of H002, whichever is longer; Prior treatment with immunotherapy or biotherapy within 4 weeks prior to the first dose of H002; Radiotherapy (palliative radiotherapy is completed at least 2 weeks prior to the first dose of H002 can be enrolled) within 4 weeks prior to the first dose of H002; Herbal therapy that has anti-tumor effects within 2 weeks prior to the first dose of H002; Mitomycin and nitrosourea within 6 weeks prior to the first dose of H002; Oral fluorouracil such as tegafur and capecitabine within 2 weeks prior to the first dose of H002; Chemotherapy (except for mitomycin, nitrosourea, and fluorouracil oral drugs), or other anti-tumor drugs for the treatment of NSCLC within 4 weeks or approximately 5 × t1/2 prior to the first dose of H002, whichever is longer.
Subjects with EGFR exon 20 insertion mutations only.
Prior marketed and/or investigational treatment for EGFR C797S mutation (including, but not limited to BTP-661411, TQB3804 and BLU-945).
Is currently participating and receiving investigational therapy or using an investigational device, or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks or 5 × t1/2 of the investigational product, whichever is longer, prior to the first dose of H002.
Is expected to require any other form of anti-tumor therapy while on study.

Show all 27Show fewer

Unresolved toxicity greater than CTCAE v5.0 Grade 1 from prior anti-tumor therapy.
≥ CTCAE v5.0 Grade 2 skin toxicity at screening.
Treatment with strong inhibitors, strong inducers and sensitive substrates of CYP3A4, substrates and inhibitors for P-glycoprotein (P-gp), as well as substrates for breast cancer resistance protein (BCRP) within 2 weeks prior to the first dose of H002, or anticipation of need for such drugs during study treatment.
Uncontrollable pleural effusion, ascites, or pericardial effusion.
Subjects who have symptomatic brain metastases, meningeal metastasis or spinal cord compression.
Subjects who have a chronic or active infection that required systemic treatment within 2 weeks prior to the first dose of H002.
Subjects who have gastrointestinal disorders that will affect oral administration or the investigator judges that the absorption of H002 will be interfered.
History of hypersensitivity to active or inactive excipients of H002 or drugs with a similar chemical structure or class to H002.
Subjects who received a diagnosis of, and/or tested positive at screening for human immunodeficiency virus (HIV).
Subjects with active hepatitis B.
Presence or history of malignancy other than NSCLC with the exception of some certain early-stage cancers.
Subjects who have clinically significant cardiovascular diseases that occurred within 6 months prior to the first dose of H002, include but not limited to QTc interval ≥ 470 msec.
Major surgery or significant traumatic injury occurring within 4 weeks prior to the first dose of H002 or anticipation of need for a major surgery during the study.
Medical history of ILD.
Medical history of severe eye disease without recovery to CTCAE v5.0 Grade 0 or 1.
Severe gastrointestinal disease within 4 weeks prior to the first dose of H002 and did not recover to ≤ CTCAE v5.0 Grade 2.
Has any bleeding tendency or coagulopathy within 6 months prior to the first dose of H002.
Has known psychiatric disorders that would interfere with cooperation with the requirements of the trial or is still requiring for medication control.
Administration of a live, attenuated vaccine within 4 weeks prior to the first dose of H002 or anticipation of need for such a vaccine during the study. Administration of an mRNA Corona Virus Disease 2019 (COVID-19) vaccine within 72 hours prior to the first dose of H002.
Female subjects in pregnancy or lactation.
Any other circumstances that would, in the investigator's judgment, prevent the subject's participation in the clinical study due to safety concerns or compliance with clinical study procedures.

Trial locations and contacts

4 sites in 1 country.

Anna Chen contact

+886 2 2176-9685

Anna.Chen@parexel.com

United States4 sites, 4 recruiting

Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
Julia Rotow, MD, 617-582-8844, Julia_Rotow@DFCI.HARVARD.EDU
Kathryn Miller, MPH, 617-582-8844, kathrynw_miller@dfci.harvard.edu
Recruiting
NEXT Virginia
Fairfax, Virginia, 22031
Alex Spira, 703-280-5390, aspira@nextoncology.com
Alex Spira, MD
Recruiting
Valkyrie Clinical Trials
Los Angeles, California, 90067
David Berz, MD, 424-535-1874, david.berz@valkyrieclinicaltrials.com
Francisco Capilla, (424) 535-1874, Francisco.capilla@valkyrieclinicaltrials.com
Recruiting
Columbia University
New York, New York, 10032
Catherine Shu, MD, 212-305-3248, cas2145@cumc.columbia.edu
Robert Garofano, MA, 212-305-3248, rfg2115@cumc.columbia.edu
Recruiting

Other trials in United States

About this study

Official title: A Phase I/IIa, Open-label, Dose-escalation and Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetic and Preliminary Anti-tumor Activity of H002 in Patients With Active EGFR Mutation Locally Advanced or Metastatic NSCLC

The study will contain two parts: Part A is dose escalation phase (i.e., Phase I) and Part B is dose expansion phase (i.e., Phase IIa).

Read the detailed description

Part A (Dose Escalation Phase) Approximately 36 subjects will be enrolled, based on the "3+3" design for dose escalation and safety evaluation requirements. The total number of subjects will depend upon the number of dose escalations necessary.

Part B (Dose Expansion Phase) Up to 20 subjects will be enrolled in each expansion arm, the total number of subjects will depend upon the number of dose expansions (expansions may be at more than one dose depending upon emerging data).

Conditions: Non-small Cell Lung Cancer
Being tested: H002
Medical subject headings: Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

H002Drug
Small molecule, Capsule

Study groups in NCT05519293
Study group	Role	What they receive
20 mg QD, oral	Experimental	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. Receives: Drug: H002
40 mg QD, oral	Experimental	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. Receives: Drug: H002
80 mg QD, oral	Experimental	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. Receives: Drug: H002
150 mg QD, oral	Experimental	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. Receives: Drug: H002
250 mg QD, oral	Experimental	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. Receives: Drug: H002
350 mg QD, oral	Experimental	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. Receives: Drug: H002

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
To evaluate the safety and tolerability of H002 and to determine the maximal tolerable dose (MTD), or if possible, a dose/exposure predicted to result in optimal biological dose (OBD) or recommended phase II dose (RP2D).
Measured: At the end of Cycle 1 (include 4 days in Cycle 0 and 21 days in Cycle1)
DOSE EXPANSION PHASE：Objective Response Rate (ORR)
To obtain a preliminary evaluation of the anti-tumor activity at the selected dose(s) of H002 when given orally as determined according to RECIST v1.1.
Measured: Up to approximately 30 months
DOSE EXPANSION PHASE：Incidence and severity of TEAEs, with severity determined according to NCI CTCAE v5.0.
To evaluate the safety at the selected dose(s) of H002 when given orally.
Measured: Up to approximately 30 months

Secondary outcomes (10)

Peak Plasma Concentration (Cmax)
To evaluate the pharmacokinetic (PK) characteristics of H002 when given orally following single and multiple doses.
Measured: Up to approximately 30 months
Time to reach maximum concentration (Tmax)
To evaluate the pharmacokinetic (PK) characteristics of H002 when given orally following single and multiple doses.
Measured: Up to approximately 30 months
Area under the plasma concentration versus time curve (AUC)
To evaluate the pharmacokinetic (PK) characteristics of H002 when given orally following single and multiple doses.
Measured: Up to approximately 30 months
Time for half the drug concentration to be eliminated（t1/2）
To evaluate the pharmacokinetic (PK) characteristics of H002 when given orally following single and multiple doses.
Measured: Up to approximately 30 months
DOSE ESCALATION PHASE：Objective Response Rate (ORR)
To obtain a preliminary evaluation of the anti-tumor activity of H002 when given orally as determined according to response evaluation criteria in solid tumors version 1.1 (RECIST v1.1).
Measured: Up to approximately 30 months
Disease control rate (DCR)
To obtain a preliminary evaluation of the anti-tumor activity of H002 when given orally as determined according to response evaluation criteria in solid tumors version 1.1 (RECIST v1.1).
Measured: Up to approximately 30 months
Duration of response (DOR)
To obtain a preliminary evaluation of the anti-tumor activity of H002 when given orally as determined according to response evaluation criteria in solid tumors version 1.1 (RECIST v1.1).
Measured: Up to approximately 30 months
Progression-free survival (PFS)
To obtain a preliminary evaluation of the anti-tumor activity of H002 when given orally as determined according to response evaluation criteria in solid tumors version 1.1 (RECIST v1.1).
Measured: Up to approximately 30 months
Time to progression (TTP)
To obtain a preliminary evaluation of the anti-tumor activity of H002 when given orally as determined according to response evaluation criteria in solid tumors version 1.1 (RECIST v1.1).
Measured: Up to approximately 30 months
Overall survival (OS)
To obtain a preliminary evaluation of the anti-tumor activity of H002 when given orally as determined according to response evaluation criteria in solid tumors version 1.1 (RECIST v1.1).
Measured: Up to approximately 30 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Dec 202228 Feb 2025

First posted29 Aug 2022
Study start15 Dec 2022
Primary completion28 Feb 2025 (estimated)
Study completion28 Feb 2025 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Non-small Cell Lung CancerStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1/2
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Model description: Dose-escalation and Expansion
Masking: None (open label)
Enrolment: 76 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05519293
Sponsor's protocol ID: H002-101
Status last verified: Apr 2024
First submitted: 3 Aug 2022
Last updated: 11 Apr 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Study at a glance

From the registry record, last updated by the sponsor on 11 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase I/IIa, Open-label, Dose-escalation and Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetic and Preliminary Anti-tumor Activity of H002 in Patients With Active EGFR Mutation Locally Advanced or Metastatic NSCLC
ClinicalTrials.gov ID: NCT05519293
Acronym / sponsor ID: H002-101
Conditions: Non-small Cell Lung Cancer
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 76 participants (estimated)
Lead sponsor: RedCloud BioIndustry (pharma, biotech, devices)
Collaborators: Parexel
Study start: 15 Dec 2022 (actual)
Primary completion: 28 Feb 2025 (estimated)
Study completion: 28 Feb 2025 (estimated)
First posted: 29 Aug 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The study will contain two parts: Part A is dose escalation phase (i.e., Phase I) and Part B is dose expansion phase (i.e., Phase IIa).

Detailed description

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Number of arms: 6
Model description: Dose-escalation and Expansion

Arm	Type	Receives
20 mg QD, oral	Experimental	Drug: H002H002 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.
40 mg QD, oral	Experimental	Drug: H002H002 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.
80 mg QD, oral	Experimental	Drug: H002H002 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.
150 mg QD, oral	Experimental	Drug: H002H002 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.
250 mg QD, oral	Experimental	Drug: H002H002 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.
350 mg QD, oral	Experimental	Drug: H002H002 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (13 listed)

Males or females aged ≥ 18 years at time of signing informed consent form (ICF).
Histological or cytological confirmed diagnosis of unresectable locally advanced or metastatic NSCLC.
Subjects must have NSCLC harboring one or more active EGFR mutations known to be associated with EGFR-TKI sensitivity (including, but not limited to Del19 and L858R).
Note: Tumor sample can be either an archival sample or a sample obtained by pretreatment biopsy prior to H002 treatment.
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.

Key exclusion criteria (27 listed)

Treatment with any of the following:
Prior treatment with an EGFR-TKI within 8 days or approximately 5 × t1/2 prior to the first dose of H002, whichever is longer; Prior treatment with immunotherapy or biotherapy within 4 weeks prior to the first dose of H002; Radiotherapy (palliative radiotherapy is completed at least 2 weeks prior to the first dose of H002 can be enrolled) within 4 weeks prior to the first dose of H002; Herbal therapy that has anti-tumor effects within 2 weeks prior to the first dose of H002; Mitomycin and nitrosourea within 6 weeks prior to the first dose of H002; Oral fluorouracil such as tegafur and capecitabine within 2 weeks prior to the first dose of H002; Chemotherapy (except for mitomycin, nitrosourea, and fluorouracil oral drugs), or other anti-tumor drugs for the treatment of NSCLC within 4 weeks or approximately 5 × t1/2 prior to the first dose of H002, whichever is longer.
Subjects with EGFR exon 20 insertion mutations only.
Prior marketed and/or investigational treatment for EGFR C797S mutation (including, but not limited to BTP-661411, TQB3804 and BLU-945).
Is currently participating and receiving investigational therapy or using an investigational device, or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks or 5 × t1/2 of the investigational product, whichever is longer, prior to the first dose of H002.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
H002Small molecule, Capsule	Drug	150 mg QD, oral, 20 mg QD, oral, 250 mg QD, oral, 350 mg QD, oral, 40 mg QD, oral, 80 mg QD, oral

Primary outcome

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.
Time frame: At the end of Cycle 1 (include 4 days in Cycle 0 and 21 days in Cycle1)
To evaluate the safety and tolerability of H002 and to determine the maximal tolerable dose (MTD), or if possible, a dose/exposure predicted to result in optimal biological dose (OBD) or recommended phase II dose (RP2D).
DOSE EXPANSION PHASE：Objective Response Rate (ORR)
Time frame: Up to approximately 30 months
To obtain a preliminary evaluation of the anti-tumor activity at the selected dose(s) of H002 when given orally as determined according to RECIST v1.1.
DOSE EXPANSION PHASE：Incidence and severity of TEAEs, with severity determined according to NCI CTCAE v5.0.
Time frame: Up to approximately 30 months
To evaluate the safety at the selected dose(s) of H002 when given orally.

10 secondary outcomes

Peak Plasma Concentration (Cmax)
Time frame: Up to approximately 30 months
Time to reach maximum concentration (Tmax)
Time frame: Up to approximately 30 months
Area under the plasma concentration versus time curve (AUC)
Time frame: Up to approximately 30 months
Time for half the drug concentration to be eliminated（t1/2）
Time frame: Up to approximately 30 months
DOSE ESCALATION PHASE：Objective Response Rate (ORR)
Time frame: Up to approximately 30 months
Disease control rate (DCR)
Time frame: Up to approximately 30 months
Duration of response (DOR)
Time frame: Up to approximately 30 months
Progression-free survival (PFS)
Time frame: Up to approximately 30 months
Time to progression (TTP)
Time frame: Up to approximately 30 months
Overall survival (OS)
Time frame: Up to approximately 30 months

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2024.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Anna Chen contact

+886 2 2176-9685

Anna.Chen@parexel.com

Louis Zhang study director

RedCloud Bio

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing H002 in people with Non-small Cell Lung Cancer, run by RedCloud Bio at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 11 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Anna Chen (+886 2 2176-9685, Anna.Chen@parexel.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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. (time frame: At the end of Cycle 1 (include 4 days in Cycle 0 and 21 days in Cycle1)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05519293.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2024.