Solid TumorPhase 1/2NCT05909436
Immuno-Oncology Drugs GLS-012 Alone & in Combination GLS-010 Treating With Advanced Patients Solid Tumors
A Phase 1/2 study testing GLS-012 and GLS-010 in people with Solid Tumor, run by Guangzhou Gloria Biosciences Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Solid Tumor
- What is being tested?
- GLS-012 and GLS-010
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 107 participants
- Where
- 1 siteChina
- Study dates
- 31 Oct 2022to Dec 2026
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
- Subjects must have at least 1 measurable target lesion according to RECIST version 1.1；
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1；
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- Life expectancy more than 12 weeks;
- Adequate organ function and bone marrow function as indicated by the screening assessments in the screening period;
- 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.
Who cannot join
- 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;
- Patients with severe hypersensitivity to macromolecular protein preparations/monoclonal antibodies in the past.
- Patients with other malignant tumors within 5 years before screening, except cured cervical carcinoma in situ and cured skin basal cell carcinoma.
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- Cardiac clinical symptoms or diseases that are not well controlled.
- Known hereditary or acquired bleeding and thrombosis tendency.
- Patients with congenital or acquired immunodeficiency disorders (such as HIV-infection), or a history of organ transplantation.
- 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;
- Patients with poor compliance or other conditions that are not suitable to participate in the clinical trial, as considered by the investigator.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Beijing Cancer Hospital
Beijing
Jun Guo, MD, +86-010-88121122, guoj307@126.com
About this study
Official title: A Phase I/II Study Evaluating the Safety, Tolerability and Preliminary Efficacy of GLS-012 Monotherapy and in Combination With GLS-010 in Patients With Advanced Solid Tumors After Progression on Standard Treatment (Triumph-01)
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.
- Conditions
- Solid Tumor
- Being tested
- GLS-012, GLS-010
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GLS-012Drug
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.
GLS-010Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| Dose escalation and expansion of GLS-012 monotherapy and combination with GLS-010 | Experimental | Not described Receives: Drug: GLS-012; Drug: GLS-010 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with a Dose-Limiting Toxicity (DLT) and MTD in the dose escalation stage
Measured: Up to 21 days after the first dose
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
Measured: Up to approximately 24 months
Secondary outcomes (9)
Maximum plasma concentration (Cmax) of GLS-012 monotherapy and in combination with GLS-010
Measured: Up to approximately 4.5 months
Elimination half-life (T1/2) of GLS-012 monotherapy and in combination with GLS-010
Measured: Up to approximately 4.5 months
Objective response rate (ORR)
Measured: Up to approximately 24 months
Disease control rate (DCR)
Measured: Up to approximately 24 months
Preliminary anti-tumor activity: Duration of response (DOR), time to response (TTR), progression free survival (PFS), overall survival (OS)
Measured: Up to approximately 24 months
Duration of response (DOR)
Measured: Up to approximately 24 months
Time to response (TTR)
Measured: Up to approximately 24 months
Progression free survival (PFS)
Measured: Up to approximately 24 months
Overall survival (OS)
Measured: Up to approximately 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2023
- Study start31 Oct 2022
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 107 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangzhou Gloria Biosciences Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05909436
- Sponsor's protocol ID
- GLS-012-11
- Status last verified
- May 2023
- First submitted
- 4 May 2023
- Last updated
- 18 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Study Evaluating the Safety, Tolerability and Preliminary Efficacy of GLS-012 Monotherapy and in Combination With GLS-010 in Patients With Advanced Solid Tumors After Progression on Standard Treatment (Triumph-01)
- ClinicalTrials.gov ID
- NCT05909436
- Acronym / sponsor ID
- GLS-012-11
- Conditions
- Solid Tumor
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 107 participants (estimated)
- Lead sponsor
- Guangzhou Gloria Biosciences Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 31 Oct 2022 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 18 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dose escalation and expansion of GLS-012 monotherapy and combination with GLS-010 | Experimental | Drug: GLS-012, Drug: GLS-010 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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;
- Subjects must have at least 1 measurable target lesion according to RECIST version 1.1；
Key exclusion criteria (11 listed)
- 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;
- Patients with severe hypersensitivity to macromolecular protein preparations/monoclonal antibodies in the past.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GLS-012In 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. | Drug | Dose escalation and expansion of GLS-012 monotherapy and combination with GLS-010 |
| GLS-010In 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. | Drug | Dose escalation and expansion of GLS-012 monotherapy and combination with GLS-010 |
Primary outcome
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
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
9 secondary outcomes
Maximum plasma concentration (Cmax) of GLS-012 monotherapy and in combination with GLS-010
Time frame: Up to approximately 4.5 months
Elimination half-life (T1/2) of GLS-012 monotherapy and in combination with GLS-010
Time frame: Up to approximately 4.5 months
Objective response rate (ORR)
Time frame: Up to approximately 24 months
Disease control rate (DCR)
Time frame: Up to approximately 24 months
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
Duration of response (DOR)
Time frame: Up to approximately 24 months
Time to response (TTR)
Time frame: Up to approximately 24 months
Progression free survival (PFS)
Time frame: Up to approximately 24 months
Overall survival (OS)
Time frame: Up to approximately 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing GLS-012 and GLS-010 in people with Solid Tumor, run by Guangzhou Gloria Biosciences Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2023.