Novel Drug Will Be Evaluated for EGFR-TKI—Mutant Lung Cancer

The first patient has been treated with H002, a novel drug being investigated for non-small cell lung cancer that is resistant to a prior EGFR TKI treatment.

The phase 1/2a H002-101CN clinical trial recently kicked off with the treatment of the first patient with H002, an investigational drug being studied for the treatment of patients with non-small cell lung cancer that is resistant to an earlier-generation EGFR TKI, according to RedCloud Bio, the manufacturer of the agent.

“H002 has demonstrated in preclinical studies both strong and broad-spectrum activities against multiple EGFR mutation combinations, and high selectivity and safety profile,” said Dr. Mai-Jing Liao, CEO of RedCloud Bio, in a press release.

Part A of the study will include approximately 36 adults with unresectable or locally advanced non-small cell lung cancer that has one or more active EGFR mutations that are associated with EGFR-TKI sensitivity. In this portion of the trial, participants will be given increasing doses of H002 to determine safety, efficacy and maximum tolerated dose.

Using the dosage determined in Part A, researchers then plan on enrolling up to 20 patients into Part B of the trial, which will analyze anti-tumor activity of H002 and incidence and severity of treatment-related side effects in patients with non-small cell lung cancer that has an EGFR C797S mutation.

Researchers plan on following up with patients in Part B for up to 30 months, where they will also look at disease control rate, duration of response, progression-free survival (time from treatment until disease gets worse), time to progression and overall survival (time from treatment until death of any cause).

Researchers will also monitor patients’ biomarker status (the individual characteristics of their tumors) to provide guidance for future clinical trials evaluating H002.

Patients will be excluded from enrolling into the trial for various reasons including, active hepatitis B. The presence of uncontrollable pleural effusion (the buildup of excess fluid between the layers of the pleura outside the lungs), ascites (abdominal swelling caused by accumulation of fluid) or pericardial effusion (too much fluid around the heart) will prohibit patients with non-small cell lung cancer from being enrolled.

Additionally, patients who have symptomatic brain metastases (primary lung cancer that has spread to the brain), meningeal metastasis (cancer that has spread from its primary location to the tissue that protects the brain and spinal cord) or spinal cord compression.

According to a filing of the trial on ClinicalTrials.gov (NCT05519293), the study is expected to be completed by February 2025.

“The drug candidate has great potential to treat prior EGFR-TKI resistant lung cancer patients, including those with brain metastases,” Liao said.

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