Loading clinical trials...

Phase I/IIa Study of H002 in NSCLC With Active EGFR Mutation | Clinical Trials | Clareo Health

RECRUITINGPHASE1/PHASE2

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

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

NCT05519293•RedCloud Bio

View on ClinicalTrials.gov

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). 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

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).

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Males or females aged ≥ 18 years at time of signing informed consent form (ICF).
•2. Histological or cytological confirmed diagnosis of unresectable locally advanced or metastatic NSCLC.
•3. 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.
•4. 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.
•5. Presence of at least one measurable lesion according to RECIST v1.1 per investigator assessment.
•6. ECOG performance status of 0-1.
•7. Life expectancy ≥ 12 weeks.
+3 more criteria

Exclusion Criteria

•1. 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.
•2. Subjects with EGFR exon 20 insertion mutations only.
•3. Prior marketed and/or investigational treatment for EGFR C797S mutation (including, but not limited to BTP-661411, TQB3804 and BLU-945).
•4. 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.
•5. Is expected to require any other form of anti-tumor therapy while on study.
•6. Unresolved toxicity greater than CTCAE v5.0 Grade 1 from prior anti-tumor therapy.
•7. ≥ CTCAE v5.0 Grade 2 skin toxicity at screening.
•8. 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.
•9. Uncontrollable pleural effusion, ascites, or pericardial effusion.
+17 more criteria

Locations (4)

Valkyrie Clinical Trials

Los Angeles, California, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Columbia University

New York, New York, United States

NEXT Virginia

Fairfax, Virginia, United States

Key Dates

Start Date

December 15, 2022

Primary Completion Date

February 28, 2025

Completion Date

February 28, 2025

Last Updated

April 11, 2024

Enrollment

ESTIMATED participants

Conditions

Non-small Cell Lung Cancer

Interventions

H002

DRUG

Contacts

Anna Chen

CONTACT

+886 2 2176-9685 Anna.Chen@parexel.com

A Clinical Study of Calderasib (MK-1084) and Other Treatments for Participants With Non-Small Cell Lung Cancer (MK-1084-007/KANDLELIT-007)

NCT07190248

Non-small Cell Lung Cancer

View study

RECRUITINGPHASE3

Sacituzumab Tirumotecan (MK-2870) Versus Pemetrexed and Carboplatin Combination Therapy in Participants With Epidermal Growth Factor (EGFR)-Mutated, Advanced Nonsquamous Non-small Cell Lung Cancer (NSCLC) Who Have Progressed on Prior EGFR Tyrosine Kinase Inhibitors (MK-2870-009)

NCT06305754

Non-small Cell Lung Cancer (NSCLC)

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 11, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

A Clinical Study of Calderasib (MK-1084) and Other Treatments for Participants With Non-Small Cell Lung Cancer (MK-1084-007/KANDLELIT-007)

Sacituzumab Tirumotecan (MK-2870) Versus Pemetrexed and Carboplatin Combination Therapy in Participants With Epidermal Growth Factor (EGFR)-Mutated, Advanced Nonsquamous Non-small Cell Lung Cancer (NSCLC) Who Have Progressed on Prior EGFR Tyrosine Kinase Inhibitors (MK-2870-009)

Study of Izalontamab Brengitecan (BMS-986507) Versus Platinum-Pemetrexed for EGFR-mutated Non-small Cell Lung Cancer After Failure of EGFR TKI Therapy (IZABRIGHT-Lung01)

Beamion LUNG-3: A Study to Test Whether Zongertinib Helps People With Surgically Removed, Non-small Cell Lung Cancer With HER2 Mutations Compared With Standard Treatment

Phase III, Open-label, Study of First-line Dato-DXd in Combination With Rilvegostomig for Advanced Non-squamous NSCLC With High PD-L1 Expression (TC ≥ 50%) and Without Actionable Genomic Alterations

Reduced CT + Anti-PD-1 as First Line Tx in Vulnerable Older Adults w/Adv <50% PD-L1 Non-Small Cell Lung Cancer (NSCLC)