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

Sponsor
Genor Biopharma Co., Ltd. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05332574
Collaborator
(none)
120
Enrollment
4
Locations
1
Arm
37.5
Anticipated Duration (Months)
30
Patients Per Site
0.8
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Biological: GB263T
 Phase 1/Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
120 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
May 17, 2022
Anticipated Primary Completion Date :
Jun 30, 2024
Anticipated Study Completion Date :
Jun 30, 2025

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Number of Participants With Adverse Events (AEs) and Serious AEs [Screening up to follow-up (30 [+7] days after the last dose)]

  2. DLT in Phase I [During Cycle 1 (up to 28 days)]

  3. ORR in Phase II [Up to End of Treatment (EOT) Follow Up Period (30 [+7] days after the last dose)]

Secondary Outcome Measures

  1. Cmax [At predefined intervals up to 449 days]

  2. Tmax [At predefined intervals up to 449 days]

  3. AUC0-last [At predefined intervals up to 449 days]

  4. AUC0-τ [At predefined intervals up to 449 days]

  5. t1/2 [At predefined intervals up to 449 days]

  6. Cmin [At predefined intervals up to 449 days]

  7. Rac_Cmax [At predefined intervals up to 449 days]

  8. Rac_AUC0-τ [At predefined intervals up to 449 days]

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

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

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

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Genesis Care Saint Leonards New South Wales Australia 2065
2 Westmead Hospital Westmead New South Wales Australia 2145
3 Cabrini Hospital Malvern Malvern Victoria Australia 3144
4 St Vincent's Hospital Melbourne Melbourne Victoria Australia 3065

Sponsors and Collaborators

  • Genor Biopharma Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Genor Biopharma Co., Ltd.
ClinicalTrials.gov Identifier:
NCT05332574
Other Study ID Numbers:
  • GB263T-FIH001
First Posted:
Apr 18, 2022
Last Update Posted:
Aug 5, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Genor Biopharma Co., Ltd.
NSCLC
Phase 1/2
GB263T
EGFR/cMET/cMET
Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung

Study Results

No Results Posted as of Aug 5, 2022