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

ConditionSolid Tumor
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorGuangzhou Gloria Biosciences Co., Ltd.

About this trial

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

Qualifiers

Patients who are willing to sign the informed consent form;

Aged 18-75 years, male or female;

Histologically confirmed diagnosis of a solid tumor;

Patients with advanced solid tumors after progression on standard treatment;

Disqualifiers

Patients with irAEs of grade ≥ 3 in the previous immunotherapy, and the AEs of the last anti-tumor treatment have not recovered to grade ≤ 1, except for hypothyroidism/hyperthyroidism and dermatitis that have recovered to grade ≤ 2, and AEs with no safety risks judged by the investigators, for example, alopecia.

Patients with primary or secondary immunodeficiency, or patients who are receiving long-term systemic steroid therapy or any other form of immunosuppressive therapy within 7 days before randomization.

Use of corticosteroids or other immunosuppressants for systemic treatment within 14 days before the first study drug administration;

Known central nervous system (CNS) metastases;

Trial design

Treatments tested in this trial

  • GLS-012
  • GLS-010

Treatment groups

107 Participants
are divided into 1 treatment group