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

Primary Purpose

NSCLC, Other Solid Tumors

Status

Recruiting

Phase

Phase 1

Locations

Australia

Study Type

Interventional

Intervention

GB263T

About this trial

This is an interventional treatment trial for NSCLC focused on measuring NSCLC, Phase 1/2, GB263T, EGFR/cMET/cMET

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Genesis CareRecruiting
Westmead HospitalRecruiting
Cabrini Hospital MalvernRecruiting
St Vincent's Hospital MelbourneRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

GB263T

Arm Description

Experimental: GB263T

Outcomes

Primary Outcome Measures

Number of Participants With Adverse Events (AEs) and Serious AEs

DLT in Phase I

ORR in Phase II

Secondary Outcome Measures

Cmax

Tmax

AUC0-last

AUC0-τ

t1/2

Cmin

Rac_Cmax

Rac_AUC0-τ

ADA

PFS

DOR

CBR

Full Information

NCT ID

NCT05332574

First Posted

March 28, 2022

Last Updated

August 3, 2022

Sponsor

Genor Biopharma Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT05332574

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2022

Overall Recruitment Status

Recruiting

Study Start Date

May 17, 2022 (Actual)

Primary Completion Date

June 30, 2024 (Anticipated)

Study Completion Date

June 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Genor Biopharma Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

NSCLC, Other Solid Tumors

Keywords

NSCLC, Phase 1/2, GB263T, EGFR/cMET/cMET

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

GB263T

Arm Type

Experimental

Arm Description

Experimental: GB263T

Intervention Type

Biological

Intervention Name(s)

GB263T

Intervention Description

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.

Primary Outcome Measure Information:

Title

Number of Participants With Adverse Events (AEs) and Serious AEs

Time Frame

Screening up to follow-up (30 [+7] days after the last dose)

Title

DLT in Phase I

Time Frame

During Cycle 1 (up to 28 days)

Title

ORR in Phase II

Time Frame

Up to End of Treatment (EOT) Follow Up Period (30 [+7] days after the last dose)

Secondary Outcome Measure Information:

Title

Cmax

Time Frame