Actively Recruiting
A Phase Ib/II Clinical Study of GH21 Capsules Combined With Osimertinib Mesylate Tablets in Patients With NSCLC
Led by Suzhou Genhouse Bio Co., Ltd. · Updated on 2024-07-08
94
Participants Needed
6
Research Sites
147 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
A Phase Ib/II Clinical Study of GH21 Capsules Combined With Osimertinib Mesylate Tablets in Patients With NSCLC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants or their legal representatives can understand and voluntarily sign the informed consent form
- Male or female participants aged 18 years or older
- Advanced NSCLC patients with EGFR mutations confirmed by tissue or cytological tests
- For Phase Ib: disease progression after treatment with third-generation EGFR-TKIs and platinum chemotherapy
- For Phases IIa and IIb: disease progression after treatment with third-generation EGFR-TKIs such as Osimertinib
- At least one measurable tumor lesion according to RECIST v1.1
- Consent to provide samples for genetic testing
- Life expectancy of at least 3 months
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1
- Adequate organ function
- Male and female participants of reproductive potential agree to reliable contraception from consent until 30 days after last dose
- Negative pregnancy test within 7 days prior to first dose for females of reproductive potential
You will not qualify if you...
- Receiving chemotherapy or antitumor biologics within 3 weeks prior to first dose, or radiotherapy/endocrine therapy within 4 weeks (with some exceptions)
- Use of nitrosoureas or mitomycin C within 6 weeks prior to first dose
- Taking oral fluorouracils, small molecule targeted drugs, or Chinese herbal medicines with antitumor effects within 5 half-lives or 2 weeks prior to first dose
- Small molecule TKI inhibitors within 5 half-lives or 2 weeks prior to first dose
- Local palliative radiotherapy within 2 weeks prior to first dose
- Participation in another investigational drug or therapy within 4 weeks prior to first dose
- Major organ surgery or significant trauma within 4 weeks prior to first dose
- Use of strong CYP3A4 or P-gp inhibitors or inducers within 2 weeks or 5 half-lives prior to first dose
- Recent serious heart conditions including heart attack, unstable angina, stroke, severe heart failure, low heart function, prolonged QTc interval, or uncontrolled hypertension
- Gastrointestinal disorders affecting drug absorption or severe unresolved gastrointestinal toxicities
- Poorly controlled pleural or abdominal fluid buildup
- Active central nervous system metastases or carcinomatous meningitis
- Active interstitial lung disease within 6 months prior to first dose
- History of other malignancies except certain cured cancers without relapse for 5 years
- History of severe allergies or allergies to Osimertinib or multiple drugs
- Hepatitis B, hepatitis C, or HIV infection
- Active infections requiring treatment or fever over 38 degrees Celsius within 28 days prior to first dose
- Unresolved toxicity from prior antitumor therapy above specified grades
- Pregnant or breastfeeding females
- Any clinical or laboratory abnormality deemed unsuitable for study participation by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 6 locations
1
The Second Hospital of Anhui Medical University
Hefei, Anhui, China, 230601
Not Yet Recruiting
2
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China, 450000
Not Yet Recruiting
3
Hunan Cancer Hospital
Changsha, Hunan, China, 410031
Actively Recruiting
4
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, China, 210008
Actively Recruiting
5
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, China, 200433
Actively Recruiting
6
Taizhou Hospital of Zhejiang Province
Linhai, Zhejiang, China, 317099
Actively Recruiting
Research Team
Y
Yiming Zhou, Bachelor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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