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Phase I/IIa Study of H002 for NSCLC with EGFR Mutation

This study is testing a new oral medication called H002 for people with non-small cell lung cancer (NSCLC) that has specific changes in the EGFR gene. H002 works by affecting the body's immune system (immunotherapy). We are looking for about 76 participants aged 18 or older who have advanced NSCLC with an active EGFR mutation. The main goals are to find a safe dose of H002 and to see how well it shrinks tumors. The study is currently in an unclear status regarding recruitment.

Study design
This is an open-label study, meaning you and your doctors will know you are receiving H002. It has two parts: a dose-finding phase (Phase I) with about 36 participants, and a dose-expansion phase (Phase IIa) with up to 20 participants per group.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The study will track side effects for up to approximately 30 months. Tumor response will also be measured for up to approximately 30 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05519293

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

UNKNOWN
PHASE1Ages 18+InterventionalTreatment
RedCloud Bio
~76 participants
Updated 2024-04-11 on ClinicalTrials.gov
What's tested:H002

At a glance

Recruiting sites
4 of 4 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
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.
Measured over At the end of Cycle 1 (include 4 days in Cycle 0 and 21 days in Cycle1)
+2 more outcomes measured

Conditions

Non-small Cell Lung Cancer

Explore related trials

Lung Non-Small Cell Carcinoma

Where it's being run

4 sites across 4 states
California1
Massachusetts1
New York1
Virginia1

Study leadership

  • Louis Zhang · STUDY_DIRECTOR · RedCloud Bio

Who to contact

Anna Chen
[email protected]
+886 2 2176-9685
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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.

What this trial 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.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)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.Up to approximately 30 months

    To evaluate the safety at the selected dose(s) of H002 when given orally.