RecruitingPhase 1Phase 2NCT05552781

H002 in Patients With EGFR Mutation Locally Advanced or Metastatic NSCLC

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 EGFR Mutation Locally Advanced or Metastatic NSCLC


Sponsor

RedCloud Bio

Enrollment

76 participants

Start Date

Aug 26, 2022

Study Type

INTERVENTIONAL

Conditions

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 EGFR mutation-positive 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).


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a new drug called H002 in people with non-small cell lung cancer (NSCLC) that has a specific genetic mutation called EGFR — which makes cancer cells grow out of control. H002 targets cells with this mutation to stop their growth. **You may be eligible if...** - You are 18 or older - You have advanced or metastatic NSCLC confirmed by biopsy - Your cancer has an EGFR mutation (such as Del19 or L858R, or specifically the C797S mutation for Part B) - You have progressed on prior EGFR-targeted therapy - You are in good physical condition and have adequate organ function **You may NOT be eligible if...** - Your cancer does not have an EGFR mutation - You have active or untreated brain metastases - You have had certain specific prior treatments that overlap with this drug - You are pregnant or breastfeeding - You have serious heart rhythm problems or significant organ dysfunction Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGH002 capsule

Small molecule, Capsule


Locations(8)

Harbin Medical University Cancer Hospital

Haerbin, Heilongjiang, China

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Union Hospital Affiliated to Tongji Medical College Huazhong University of Science and Technology

Wuhan, Hubei, China

Hunan Cancer Hospital

Changsha, Hunan, China

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, China

West China Hospital, Sichuan University

Chengdu, Sichuan, China

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

The First Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT05552781


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