NCT05332574

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started May 2022

Typical duration for phase_1

Geographic Reach
1 country

4 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 28, 2022

Completed
21 days until next milestone

First Posted

Study publicly available on registry

April 18, 2022

Completed
29 days until next milestone

Study Start

First participant enrolled

May 17, 2022

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2025

Completed
Last Updated

August 5, 2022

Status Verified

March 1, 2022

Enrollment Period

2.1 years

First QC Date

March 28, 2022

Last Update Submit

August 3, 2022

Conditions

NSCLCOther Solid Tumors

Keywords

NSCLCPhase 1/2GB263TEGFR/cMET/cMET

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (13)

  • 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

  • +8 more secondary outcomes

Study Arms (1)

GB263T

EXPERIMENTAL

Experimental: GB263T

Biological: GB263T

Interventions

GB263TBIOLOGICAL

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.

GB263T

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ≥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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Genesis Care

Saint Leonards, New South Wales, 2065, Australia

RECRUITING

Westmead Hospital

Westmead, New South Wales, 2145, Australia

RECRUITING

Cabrini Hospital Malvern

Malvern, Victoria, 3144, Australia

RECRUITING

St Vincent's Hospital Melbourne

Melbourne, Victoria, 3065, Australia

RECRUITING

Central Study Contacts

Shawn Yu, MD

CONTACT

021-60751991shawn.yu@genorbio.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 28, 2022

First Posted

April 18, 2022

Study Start

May 17, 2022

Primary Completion

June 30, 2024

Study Completion

June 30, 2025

Last Updated

August 5, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations

AU(4)