A Safety, Tolerability, PK and Preliminary Activity Study of GB263T in Advanced NSCLC and Other Solid Tumor
Phase 1
Recruiting
- Conditions
- NSCLCOther Solid Tumors
- Interventions
- Biological: GB263T
- Registration Number
- NCT05332574
- Lead Sponsor
- Genor Biopharma Co., Ltd.
- 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 extension stage (Phase 2) where participants will be enrolled into indication-specific cohorts.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 120
Inclusion Criteria
- ≥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 Criteria
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description GB263T GB263T Experimental: GB263T
- Primary Outcome Measures
Name Time Method Number of Participants With Adverse Events (AEs) and Serious AEs Screening up to follow-up (30 [+7] days after the last dose) DLT in Phase I During Cycle 1 (up to 28 days) ORR in Phase II Up to End of Treatment (EOT) Follow Up Period (30 [+7] days after the last dose)
- Secondary Outcome Measures
Name Time Method Cmax At predefined intervals up to 449 days DOR Up to End of Treatment (EOT) Follow Up Period (30 [+7] days after the last dose) Rac_AUC0-τ At predefined intervals up to 449 days AUC0-τ At predefined intervals up to 449 days Tmax At predefined intervals up to 449 days AUC0-last At predefined intervals up to 449 days t1/2 At predefined intervals up to 449 days Cmin At predefined intervals up to 449 days Rac_Cmax At predefined intervals up to 449 days ADA Up to End of Treatment (EOT) Follow Up Period (30 [+7] days after the last dose) OS Up to End of Treatment (EOT) Follow Up Period (30 [+7] days after the last dose) PFS Up to End of Treatment (EOT) Follow Up Period (30 [+7] days after the last dose CBR Up to End of Treatment (EOT) Follow Up Period (30 [+7] days after the last dose)
Trial Locations
- Locations (4)
Genesis Care
🇦🇺Saint Leonards, New South Wales, Australia
Westmead Hospital
🇦🇺Westmead, New South Wales, Australia
St Vincent's Hospital Melbourne
🇦🇺Melbourne, Victoria, Australia
Cabrini Hospital Malvern
🇦🇺Malvern, Victoria, Australia