A Phase Ib/II Clinical Study of GH21 Capsules Combined With Osimertinib Mesylate Tablets in Patients With NSCLC

NCT06306456 | Recruiting Phase 1

• 1 other identifier: GH21C201
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 6

Brief Summary

This study, including phase Ib , phase IIa and phase IIb, aims to evaluate the safety, tolerability, PK profile, efficacy and to determine the RP2D of GH21 capsules combined with Osimertinib mesylate tablets in NSCLC patients with EGFR mutations.

Conditions

Non-Small Cell Lung Cancer With EGFR Mutation

Outcome Measures

Primary Outcomes (3)

• Number of Participants with Dose Limiting Toxicities

  Incidence of dose limiting toxicities (DLTs) in the dose escalation phase. A DLT is defined as an adverse event or abnormal laboratory value assessed as unrelated to disease, disease progression, inter-current illness, or concomitant medications that occurs within the first treatment cycle. (phase Ib)

  2 years

• Number of Participants with Adverse Events

  All patients participating in this study will be assessed for incidence and severity of adverse events (AEs) and serious AEs, including changes in laboratory values, vital signs, electrocardiograms, cardiac imaging and ophthalmological assessments (phase Ib/ IIa)

  2 years

• Progression-Free Survival (PFS) Based on RECIST 1.1 Criteria

  PFS is defined as the interval of time between the date of first treatment to the earliest date of disease progression or death which occurs first. (phase IIb)

  2 years

Secondary Outcomes (7)

• Objective Response Rate (ORR) Based on RECIST 1.1 Criteria

  2 years

• Duration of Response (DOR) Based on RECIST 1.1 Criteria

  2 years

• Disease Control Rate (DCR) Based on RECIST 1.1 Criteria

  2 years

• Overall Survival (OS)

  2 years

• Plasma Peak Concentration (Cmax)

  2 years

Study Arms (1)

'GH21+Osimertinib'Group

EXPERIMENTAL

GH21 Capsules Combined with Osimertinib Mesylate Tablets

Drug: GH21; Drug: Tagrisso

Interventions

GH21 DRUG

Oral, 15mg BIW/6mg QD

'GH21+Osimertinib'Group

Tagrisso DRUG

Oral, 80mg QD

'GH21+Osimertinib'Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects or their legal representatives can understand and voluntarily sign the written ICF (before the start of screening and any study procedures);
• Male or female subjects aged ≥18 years;
• Advanced NSCLC patients with EGFR mutations confirmed by cytological or histological assessments, and meet the following requirement:
• Phase Ib： patients with disease progression previously at least treated with third-generation EGFR-TKIs and platinum-containing chemotherapy;
• Phase IIa and IIb：patients with disease progression previously at least treated with a third-generation EGFR-TKIs (Osimertinib, Furmonertinib Almonertinib etc.).
• Patients have at least one measurable lesion as defined by RECIST v1.1 (a tumor lesion in the area that has undergone radiotherapy or other loco-regional therapies, is generally not considered as measurable unless there is a disease progression in the lesion);
• Consent to provide samples for genetic testing;
• Life expectancy of ≥ 3 months;
• ECOG PS score of 0-1;
• The subjects must have adequate organ functions;
• Male and female of reproductive potential must agree to take reliable contraceptive measures (hormone or barrier methods or abstinence) from signing the ICF until 30 days after the last dose. Pregnancy test results must be negative for female of reproductive potential within 7 days prior to the first dose of the investigational product.

You may not qualify if:

• Subjects who receive any chemotherapy or antitumor biologics within 3 weeks, or antitumor therapies such as radiotherapy and endocrine therapy within 4 weeks prior to the first dose of the investigational product, except for the following:
• Use of nitrosoureas or mitomycin C within 6 weeks prior to the first dose of the investigational product;
• Oral administration of fluorouracils, small molecule targeted drugs, and Chinese herbal medicines or Chinese patent medicines with antitumor indications within 5 half-lives or 2 weeks before the first dose of the investigational product (whichever is shorter);
• Small molecule TKI inhibitors within 5 half-lives or 2 weeks prior to the first dose of the investigational product (whichever is shorter);
• Local palliative radiotherapy within 2 weeks prior to the first dose of the investigational product;
• Subjects who have had another investigational new drug or therapy within 4 weeks prior to the first dose of the investigational product;
• Subjects who have had a major organ surgery (excluding needle biopsy) or significant trauma within 4 weeks prior to the first dose of the investigational product, or require an elective surgery during the study;
• Subjects who have received strong CYP3A4 inhibitors or inducers and strong P-gp inhibitors or inducers within 2 weeks or within 5 half-lives (whichever is longer) prior to the first dose of the investigational product;
• Subjects with evidence of the following heart conditions:
• Acute myocardial infarction, unstable angina pectoris, coronary artery bypass grafting, cerebrovascular accident, or transient ischemic attack within 6 months prior to the first dose of the investigational product;
• Grade III-IV heart failure diagnosed according to the cardiac function classification of the New York Heart Association at screening;
• Echocardiography (ECHO) shows the left ventricular ejection fraction (LVEF) ≤ 50% at screening;
• QT interval corrected by Fridericia method (QTcF) is ≥ 450 ms (male) or ≥ 470 ms (female) at screening;
• Uncontrolled hypertension (systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 100 mmHg) despite of medication treatment at screening;
• Subjects with dysphagia, gastrointestinal disorders that affect drug absorption, or other malabsorption conditions, such as intestinal obstruction, Crohn's disease, ulcerative colitis, short bowel syndrome, delayed gastric emptying, or severe gastrointestinal toxicities that have not resolved to Grade 2 or lower prior to the first dose of the investigational product; or subjects are diagnosed with a clinically significant or acute gastrointestinal disease;

Sponsors & Collaborators

• Suzhou Genhouse Bio Co., Ltd.: lead

Study Sites (6)

The Second Hospital of Anhui Medical University

Hefei, Anhui, 230601, China

NOT YET RECRUITING

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, 450000, China

NOT YET RECRUITING

Hunan Cancer Hospital

Changsha, Hunan, 410031, China

RECRUITING

Nanjing Drum Tower Hospital

Nanjing, Jiangsu, 210008, China

RECRUITING

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, 200433, China

RECRUITING

Taizhou Hospital of Zhejiang Province

Linhai, Zhejiang, 317099, China

RECRUITING

MeSH Terms

Interventions

osimertinib

Study Officials

• Caicun Zhou, Doctorate

  （86）021-65115006

  PRINCIPAL INVESTIGATOR

• Haidan Wang, Doctorate

  （86）0512-86861608

  STUDY DIRECTOR

Central Study Contacts

Yiming Zhou, Bachelor

CONTACT

（86）0512-86861608; zhouyiming@genhousebio.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 29, 2024
• First Posted: March 12, 2024
• Study Start: March 5, 2024
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: July 8, 2024

Record last verified: 2024-02

Locations

CN (6)