Immuno-Oncology Drugs GLS-012 Alone & in Combination GLS-010 Treating With Advanced Patients Solid Tumors

Last updated: June 11, 2023
Sponsor: Guangzhou Gloria Biosciences Co., Ltd.
Overall Status: Active - Recruiting

Phase

1/2

Condition

Neuroblastoma

Neoplasms

Treatment

GLS-010

GLS-012

Clinical Study ID

NCT05909436
GLS-012-11
  • Ages 18-75
  • All Genders

Study Summary

This is a phase I/II study to investigate the safety, tolerability, and preliminary efficacy of GLS-012 monotherapy and in combination with GLS-010 in subjects with advanced solid rumor after progression on standard treatment.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Patients who are willing to sign the informed consent form;
  2. Aged 18-75 years, male or female;
  3. Histologically confirmed diagnosis of a solid tumor;
  4. Patients with advanced solid tumors after progression on standard treatment;
  5. Subjects must have at least 1 measurable target lesion according to RECIST version 1.1;
  6. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1;
  7. Life expectancy more than 12 weeks;
  8. Adequate organ function and bone marrow function as indicated by the screeningassessments in the screening period;
  9. Women of childbearing potential must use highly effective contraception during thestudy period and at least 6 months after the last study drug administration, and musthave a negative blood pregnancy test within 3 days before study enrollment.

Exclusion

Exclusion Criteria:

  1. Patients with irAEs of grade ≥ 3 in the previous immunotherapy, and the AEs of thelast anti-tumor treatment have not recovered to grade ≤ 1, except forhypothyroidism/hyperthyroidism and dermatitis that have recovered to grade ≤ 2, andAEs with no safety risks judged by the investigators, for example, alopecia.
  2. Patients with primary or secondary immunodeficiency, or patients who are receivinglong-term systemic steroid therapy or any other form of immunosuppressive therapywithin 7 days before randomization.
  3. Use of corticosteroids or other immunosuppressants for systemic treatment within 14days before the first study drug administration;
  4. Known central nervous system (CNS) metastases;
  5. Patients with severe hypersensitivity to macromolecular proteinpreparations/monoclonal antibodies in the past.
  6. Patients with other malignant tumors within 5 years before screening, except curedcervical carcinoma in situ and cured skin basal cell carcinoma.
  7. Cardiac clinical symptoms or diseases that are not well controlled.
  8. Known hereditary or acquired bleeding and thrombosis tendency.
  9. Patients with congenital or acquired immunodeficiency disorders (such asHIV-infection), or a history of organ transplantation.
  10. Patients complying with any of hepatitis B surface antigen (HBsAg) positive andHBV-DNA copies being more than 2500 copies/ml (or 500 IU/ml); or positive HCV-RNA;
  11. Patients with poor compliance or other conditions that are not suitable to participatein the clinical trial, as considered by the investigator.

Study Design

Total Participants: 107
Treatment Group(s): 2
Primary Treatment: GLS-010
Phase: 1/2
Study Start date:
October 31, 2022
Estimated Completion Date:
December 31, 2026

Connect with a study center

  • Beijing Cancer Hospital

    Beijing,
    China

    Active - Recruiting

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