Status:
UNKNOWN
A Safety, Tolerability, PK and Preliminary Activity Study of GB263T in Advanced NSCLC and Other Solid Tumor
Lead Sponsor:
Genor Biopharma Co., Ltd.
Conditions:
NSCLC
Other Solid Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
This is a Phase 1/2 study of GB263T in participants with advanced NSCLC and other solid tumor. The study will consist of a dose-escalation and expansion stage to determine RP2D (Phase 1), and an exten...
Eligibility Criteria
Inclusion
- ≥18 years of age.
- Subjects with histologically or cytologically confirmed metastatic or unresectable advanced NSCLC or other solid tumors who have progressed on prior standard therapy, have been intolerant to prior standard therapy, or have refused all other currently available therapeutic options.
- Subjects must have evaluable disease according to Response Evaluation Criteria in Solid 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
- Subjects who have had prior chemotherapy, targeted cancer therapy, immunotherapy, or any investigational anti-cancer treatment within 2 weeks or five half-lives of the treatment (whichever is longer), prior to the first administration of the study drug.
- Toxicity (excluding alopecia, peripheral neuropathy, and hypothyroidism) that did not return to class 0 or class 1 of NCI CTCAE V5.0 from prior antitumor therapy prior to the first administration of the study drug.
- Prior radical radiation therapy completed within 4 weeks prior to the first administration of the study drug.
- Subjects with untreated symptomatic brain metastases.
- History of interstitial lung disease (ILD).
- Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures.
- Received live virus vaccination within 30 days of first dose of study treatment.
Key Trial Info
Start Date :
May 17 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2025
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT05332574
Start Date
May 17 2022
End Date
June 30 2025
Last Update
August 5 2022
Active Locations (4)
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1
Genesis Care
Saint Leonards, New South Wales, Australia, 2065
2
Westmead Hospital
Westmead, New South Wales, Australia, 2145
3
Cabrini Hospital Malvern
Malvern, Victoria, Australia, 3144
4
St Vincent's Hospital Melbourne
Melbourne, Victoria, Australia, 3065