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RecruitingNCT05909436Updated Jun 18, 2023

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

A Phase 1/2 interventional study of GLS-012 and GLS-010 in Solid Tumor, sponsored by Guangzhou Gloria Biosciences Co., Ltd.. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-06-18.

Sponsored by Guangzhou Gloria Biosciences Co., Ltd. · Phase 1/2, Interventional, and Treatment

From the registry’s dates

  • Registered 6 months after the study started (first participant enrolled Oct 2022, registered May 2023).
  • Started Oct 2022; still recruiting 3 years 11 months later.
Phase
Phase 1/2
Study type
Interventional
Enrollment
107
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

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.

02

Conditions studied

  • Solid Tumor

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03

In context

Neoplasms

9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.

This study's planned enrollment of 107 is above the median of 50 across 7,253 interventional studies indexed under Neoplasms.

Browse Neoplasms studies →

Lead sponsor

Guangzhou Gloria Biosciences Co., Ltd. is the lead sponsor of 8 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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 screening assessments in the screening period;
  9. Women of childbearing potential must use highly effective contraception during the study period and at least 6 months after the last study drug administration, and must have a negative blood pregnancy test within 3 days before study enrollment.

Exclusion criteria

Exclusion Criteria:

  1. 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.
  2. 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.
  3. Use of corticosteroids or other immunosuppressants for systemic treatment within 14 days before the first study drug administration;
  4. Known central nervous system (CNS) metastases;
  5. Patients with severe hypersensitivity to macromolecular protein preparations/monoclonal antibodies in the past.
  6. Patients with other malignant tumors within 5 years before screening, except cured cervical 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 as HIV-infection), or a history of organ transplantation.
  10. Patients complying with any of hepatitis B surface antigen (HBsAg) positive and HBV-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 participate in the clinical trial, as considered by the investigator.
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
107 participants (estimated)

Study arms

  • Experimental
    Dose escalation and expansion of GLS-012 monotherapy and combination with GLS-010

    Drug: GLS-012 · Drug: GLS-010

Interventions

  • DrugGLS-012

    In the dose escalation stage of GLS-012 monotherapy, RP2D will be determined. All subjects will receive GLS-012 intravenously Q3W. In the expansion stage of GLS-012 monotherapy, subjects will receive up to 17 doses of GLS-012 at the RP2D administered Q3W. In the dose escalation stage of GLS-012 combination with GLS-010, RP2D of GLS-012 in combination with a fixed-dose GLS-010 will be determined. All subjects will receive GLS-012 and GLS-010 intravenously Q3W. In the expansion stage of GLS-012 combination with GLS-010, subjects will receive up to 35 doses of GLS-012 at the RP2D and GLS-010 at a fixed dose administered Q3W.

  • DrugGLS-010

    In the dose escalation stage of GLS-012 combination with GLS-010, RP2D of GLS-012 in combination with a fixed-dose GLS-010 will be determined. All subjects will receive GLS-012 and GLS-010 intravenously Q3W. In the expansion stage of GLS-012 combination with GLS-010, subjects will receive up to 35 doses of GLS-012 at the RP2D and GLS-010 at a fixed dose administered Q3W.

06

What researchers measure

Primary outcomes

  1. Number of Participants with a Dose-Limiting Toxicity (DLT) and MTD in the dose escalation stage

    Time frame: Up to 21 days after the first dose

  2. Number of participants with treatment-related adverse events of GLS-012 monotherapy and in combination with GLS-010 in the expansion stage as assessed by CTCAE V5.0

    Time frame: Up to approximately 24 months

Secondary outcomes

  1. Maximum plasma concentration (Cmax) of GLS-012 monotherapy and in combination with GLS-010

    Time frame: Up to approximately 4.5 months

  2. Elimination half-life (T1/2) of GLS-012 monotherapy and in combination with GLS-010

    Time frame: Up to approximately 4.5 months

  3. Objective response rate (ORR)

    Time frame: Up to approximately 24 months

  4. Disease control rate (DCR)

    Time frame: Up to approximately 24 months

  5. Preliminary anti-tumor activity: Duration of response (DOR), time to response (TTR), progression free survival (PFS), overall survival (OS)

    Time frame: Up to approximately 24 months

  6. Duration of response (DOR)

    Time frame: Up to approximately 24 months

  7. Time to response (TTR)

    Time frame: Up to approximately 24 months

  8. Progression free survival (PFS)

    Time frame: Up to approximately 24 months

  9. Overall survival (OS)

    Time frame: Up to approximately 24 months

Other outcomes

  1. Receptor occupancy (RO) of GLS-012 in the dose escalation stage of GLS-012 monotherapy

    Time frame: Up to approximately 4.5 months

07

Study locations

1 of 1 sites recruiting
  • Beijing Cancer Hospital
    Beijing, China
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 18, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05909436
Lead sponsor
Guangzhou Gloria Biosciences Co., Ltd.
Responsible party
Sponsor
First posted
Jun 18, 2023
Start date
Oct 31, 2022
Primary completion
Dec 2026 (estimated)
Completion
Dec 2026 (estimated)
Last update
Jun 18, 2023

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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