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

Last updated: August 3, 2022
Sponsor: Genor Biopharma Co., Ltd.
Overall Status: Active - Recruiting

Phase

1/2

Condition

Non-small Cell Lung Cancer

Treatment

N/A

Clinical Study ID

NCT05332574
GB263T-FIH001
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. ≥18 years of age.
  2. Subjects with histologically or cytologically confirmed metastatic or unresectableadvanced NSCLC or other solid tumors who have progressed on prior standard therapy,have been intolerant to prior standard therapy, or have refused all other currentlyavailable therapeutic options.
  3. Subjects must have evaluable disease according to Response Evaluation Criteria inSolid 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

Exclusion Criteria:

  1. Subjects who have had prior chemotherapy, targeted cancer therapy, immunotherapy, orany investigational anti-cancer treatment within 2 weeks or five half-lives of thetreatment (whichever is longer), prior to the first administration of the study drug.
  2. Toxicity (excluding alopecia, peripheral neuropathy, and hypothyroidism) that did notreturn to class 0 or class 1 of NCI CTCAE V5.0 from prior antitumor therapy prior tothe first administration of the study drug.
  3. Prior radical radiation therapy completed within 4 weeks prior to the firstadministration 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 recurrentdrainage procedures.
  7. Received live virus vaccination within 30 days of first dose of study treatment.

Study Design

Total Participants: 120
Study Start date:
May 17, 2022
Estimated Completion Date:
June 30, 2025

Connect with a study center

  • Genesis Care

    Saint Leonards, New South Wales 2065
    Australia

    Active - Recruiting

  • Westmead Hospital

    Westmead, New South Wales 2145
    Australia

    Active - Recruiting

  • Cabrini Hospital Malvern

    Malvern, Victoria 3144
    Australia

    Active - Recruiting

  • St Vincent's Hospital Melbourne

    Melbourne, Victoria 3065
    Australia

    Active - Recruiting

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