A Safety, Tolerability, PK and Preliminary Activity Study of GB263T in Advanced NSCLC and Other Solid Tumor

Study Overview
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Brief Summary
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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.

Official Title
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A Phase I/II, First-in-Human, Open-Label, Multicenter Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of a Trispecific EGFR/cMET/cMET Antibody GB263T in Subjects With Advanced Non-Small Cell Lung Cancer (NSCLC) and Other Solid Tumors

Conditions
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NSCLC, Other Solid Tumors

Intervention / Treatment
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* Biological: GB263T


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GB263T<br>Experimental: GB263T | Biological: GB263T<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax |  | At predefined intervals up to 449 days | 
| Tmax |  | At predefined intervals up to 449 days | 
| 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 | 
| Rac_AUC0-τ |  | At predefined intervals up to 449 days | 
| 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) | 
| OS |  | Up to End of Treatment (EOT) Follow Up Period (30 [+7] days after the last dose) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NSCLC, Phase 1/2, GB263T, EGFR/cMET/cMET