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
Ages > 18 All Genders
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
AustraliaActive - Recruiting
Westmead Hospital
Westmead, New South Wales 2145
AustraliaActive - Recruiting
Cabrini Hospital Malvern
Malvern, Victoria 3144
AustraliaActive - Recruiting
St Vincent's Hospital Melbourne
Melbourne, Victoria 3065
AustraliaActive - Recruiting

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