Phase I/IIa Study of H002 in Non-Small Cell Lung Cancer with Active EGFR Mutation

Sponsor: RedCloud Bio

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05519293

Provider View

This clinical trial is testing a new oral medication, H002, to see if it is safe and effective for patients with advanced non-small cell lung cancer (NSCLC) that has specific EGFR mutations. The study is divided into two parts: the first part focuses on finding the right dose, and the second part expands to more patients to further evaluate the treatment.

Patient Parameters

Program Overview

This study is designed to test a new drug called H002, taken by mouth, in patients with advanced non-small cell lung cancer (NSCLC) that has specific mutations in the EGFR gene. The trial is in two phases: Phase I will determine the safest dose, and Phase IIa will expand the study to more patients to see how well the drug works.

Description

The study is divided into two parts:

  • Part A (Dose Escalation Phase): This phase will involve about 36 participants. The goal is to find the safest dose of H002 by gradually increasing the dose in small groups of patients.

  • Part B (Dose Expansion Phase): In this phase, up to 20 participants will be enrolled in each group to further evaluate the effectiveness of H002 at the doses determined in Part A. The number of participants may vary based on the results from Part A.

Eligibility Criteria

Inclusion Criteria

  • Adults aged 18 years or older.
  • Diagnosed with advanced or metastatic non-small cell lung cancer (NSCLC) that cannot be surgically removed.
  • Cancer must have specific EGFR mutations that respond to EGFR-TKI treatments.
  • For Part A, providing a tumor sample for EGFR mutation analysis is optional. For Part B, it is required, and the cancer must have the EGFR C797S mutation.
  • Disease must have progressed after previous treatment with osimertinib or another similar drug.
  • At least one tumor that can be measured by scans.
  • Good overall health with an ECOG performance status of 0 or 1.
  • Life expectancy of at least 12 weeks.
  • Adequate blood and organ function.
  • Women of childbearing potential and men with partners who are women of childbearing potential must use effective birth control during the study.
  • Must sign an informed consent form before participating.

Exclusion Criteria

  • Recent treatment with certain cancer therapies, including EGFR-TKIs, immunotherapy, or chemotherapy, within specified timeframes before starting H002.
  • Cancer with only EGFR exon 20 insertion mutations.
  • Previous treatment for EGFR C797S mutation.
  • Participation in another clinical trial or use of investigational drugs recently.
  • Need for other anti-cancer treatments during the study.
  • Unresolved side effects from previous cancer treatments.
  • Certain medications that affect liver enzymes or drug absorption.
  • Uncontrolled fluid buildup in the body or symptomatic brain metastases.
  • Active infections or gastrointestinal disorders affecting drug absorption.
  • Allergies to H002 or similar drugs.
  • Positive for HIV or active hepatitis B.
  • Other cancers, except for certain early-stage cancers.
  • Significant heart problems or recent major surgery.
  • History of lung disease or severe eye disease.
  • Bleeding disorders or psychiatric conditions affecting study participation.
  • Recent live vaccines or pregnancy/lactation.
  • Any other conditions that may affect safety or compliance with the study.

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