NSCLC, Other Solid Tumors
Conditions
Keywords
NSCLC, Phase 1/2, GB263T, EGFR/cMET/cMET
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.
Interventions
BIOLOGICALGB263T
Participants will receive IV infusions of GB263T at increased dose level until maximum tolerated dose is reached or all planned doses are administered. Participants will receive GB263T at predefined dose levels and frequency, based upon observed safety and protocol defined criteria. The duration of each treatment cycle is 28 days.
Sponsors
Genor Biopharma Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. ≥18 years of age. 2. 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. 3. Subjects must have evaluable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. 4. ECOG PS 0-1. 5. An expected survival time is ≥3 months. 6. Adequate organ function. 7. Subjects in Phase II must agree to provide pre-treatment tumor tissue samples.
Exclusion criteria
1. 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. 2. 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. 3. Prior radical radiation therapy completed within 4 weeks prior to the first administration of the study drug. 4. Subjects with untreated symptomatic brain metastases. 5. History of interstitial lung disease (ILD). 6. Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures. 7. Received live virus vaccination within 30 days of first dose of study treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| AUC0-last | At predefined intervals up to 449 days |
| AUC0-τ | 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 |
| OS | Up to End of Treatment (EOT) Follow Up Period (30 [+7] days after the last dose) |
| ADA | 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 |
| DOR | 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) |
| Rac_AUC0-τ | At predefined intervals up to 449 days |
| Cmax | At predefined intervals up to 449 days |
| Tmax | At predefined intervals up to 449 days |
Countries
Australia
Contacts
Primary ContactShawn Yu, MD
Outcome results
None listed