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

NSCLC Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05332574
• Other study ID #: GB263T-FIH001
• Status: Recruiting
• Phase: Phase 1/Phase 2
• 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
• 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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• NSCLC
• Other Solid Tumors

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)