Last updated:  August 3, 2022 
 Sponsor:  Genor Biopharma Co., Ltd. 
 Overall Status: Active - Recruiting
Phase
 1/2 
Condition
Non-small Cell Lung Cancer
Treatment
N/AClinical Study ID
 NCT05332574 
 GB263T-FIH001 
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- ≥18 years of age.
- Subjects with histologically or cytologically confirmed metastatic or unresectableadvanced NSCLC or other solid tumors who have progressed on prior standard therapy,have been intolerant to prior standard therapy, or have refused all other currentlyavailable therapeutic options.
- Subjects must have evaluable disease according to Response Evaluation Criteria inSolid Tumors (RECIST) v1.1.
- ECOG PS 0-1.
- An expected survival time is ≥3 months.
- Adequate organ function.
- Subjects in Phase II must agree to provide pre-treatment tumor tissue samples.
Exclusion
Exclusion Criteria:
- Subjects who have had prior chemotherapy, targeted cancer therapy, immunotherapy, orany investigational anti-cancer treatment within 2 weeks or five half-lives of thetreatment (whichever is longer), prior to the first administration of the study drug.
- Toxicity (excluding alopecia, peripheral neuropathy, and hypothyroidism) that did notreturn to class 0 or class 1 of NCI CTCAE V5.0 from prior antitumor therapy prior tothe first administration of the study drug.
- Prior radical radiation therapy completed within 4 weeks prior to the firstadministration of the study drug.
- Subjects with untreated symptomatic brain metastases.
- History of interstitial lung disease (ILD).
- Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrentdrainage procedures.
- Received live virus vaccination within 30 days of first dose of study treatment.
Study Design
Total Participants: 120
Study Start date:
May 17, 2022
Estimated Completion Date:
June 30, 2025
Connect with a study center
- Genesis Care- Saint Leonards, New South Wales 2065 
 Australia- Active - Recruiting 
- Westmead Hospital- Westmead, New South Wales 2145 
 Australia- Active - Recruiting 
- Cabrini Hospital Malvern- Malvern, Victoria 3144 
 Australia- Active - Recruiting 
- St Vincent's Hospital Melbourne- Melbourne, Victoria 3065 
 Australia- Active - Recruiting 
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.