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

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

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.

Study Overview

• Status: Recruiting
• Conditions: NSCLC; Other Solid Tumors
• Intervention / Treatment: Biological: GB263T

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Shawn Yu, MD; Phone Number: 021-60751991; Email: shawn.yu@genorbio.com

Study Locations

• Australia
  • New South Wales
    • Saint Leonards, New South Wales, Australia, 2065
      • Recruiting
      • Genesis Care
    • Westmead, New South Wales, Australia, 2145
      • Recruiting
      • Westmead Hospital
  • Victoria
    • Malvern, Victoria, Australia, 3144
      • Recruiting
      • Cabrini Hospital Malvern
    • Melbourne, Victoria, Australia, 3065
      • Recruiting
      • St Vincent's Hospital Melbourne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: GB263T; Experimental: GB263T	Biological: GB263T; 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.

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome Measure	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)

Collaborators and Investigators

• Sponsor: Genor Biopharma Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): May 17, 2022
• Primary Completion (Anticipated): June 30, 2024
• Study Completion (Anticipated): June 30, 2025

Study Registration Dates

• First Submitted: March 28, 2022
• First Submitted That Met QC Criteria: April 12, 2022
• First Posted (Actual): April 18, 2022

Study Record Updates

• Last Update Posted (Actual): August 5, 2022
• Last Update Submitted That Met QC Criteria: August 3, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: NSCLC; Phase 1/2; GB263T; EGFR/cMET/cMET
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: GB263T-FIH001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No