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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05332574
Other study ID # GB263T-FIH001
Secondary ID
Status Recruiting
Phase Phase 1/Phase 2
First received
Last updated
Start date May 17, 2022
Est. completion date June 30, 2025

Study information

Verified date March 2022
Source Genor Biopharma Co., Ltd.
Contact Shawn Yu, MD
Phone 021-60751991
Email shawn.yu@genorbio.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 120
Est. completion date June 30, 2025
Est. primary completion date June 30, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Australia Cabrini Hospital Malvern Malvern Victoria
Australia St Vincent's Hospital Melbourne Melbourne Victoria
Australia Genesis Care Saint Leonards New South Wales
Australia Westmead Hospital Westmead New South Wales

Sponsors (1)

Lead Sponsor Collaborator
Genor Biopharma Co., Ltd.

Country where clinical trial is conducted

Australia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Participants With Adverse Events (AEs) and Serious AEs Screening up to follow-up (30 [+7] days after the last dose)
Primary DLT in Phase I During Cycle 1 (up to 28 days)
Primary ORR in Phase II Up to End of Treatment (EOT) Follow Up Period (30 [+7] days after the last dose)
Secondary Cmax At predefined intervals up to 449 days
Secondary Tmax At predefined intervals up to 449 days
Secondary AUC0-last At predefined intervals up to 449 days
Secondary AUC0-t At predefined intervals up to 449 days
Secondary t1/2 At predefined intervals up to 449 days
Secondary Cmin At predefined intervals up to 449 days
Secondary Rac_Cmax At predefined intervals up to 449 days
Secondary Rac_AUC0-t At predefined intervals up to 449 days
Secondary ADA Up to End of Treatment (EOT) Follow Up Period (30 [+7] days after the last dose)
Secondary PFS Up to End of Treatment (EOT) Follow Up Period (30 [+7] days after the last dose
Secondary DOR Up to End of Treatment (EOT) Follow Up Period (30 [+7] days after the last dose)
Secondary CBR Up to End of Treatment (EOT) Follow Up Period (30 [+7] days after the last dose)
Secondary OS Up to End of Treatment (EOT) Follow Up Period (30 [+7] days after the last dose)
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