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Advanced Solid TumorsPhase 1NCT03713905

Study of Recombinant Human Anti-PD-1 Monoclonal Antibody for Patients With Advanced Solid Tumors

A Phase 1 study testing GLS-010 in people with Advanced Solid Tumors, run by Guangzhou Gloria Biosciences Co., Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

To investigate the safety and tolerability of GLS-010 in subjects with advanced solid tumors (mainly gastric cancer, esophageal cancer). To investigate the preliminary relationship between the expression of the ligand of PD-1 (PD-L1) and efficacy. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Advanced Solid Tumors
What is being tested?
GLS-010
Could I receive a placebo?
No, everyone receives an active treatment
How many people
293 participants
Where
1 siteChina
Study dates
1 Jul 2017to 28 Feb 2022
Phase
Phase 1
Are there results?
None posted in the registry

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

  • Willingness to participate in the clinical trial. Provide written informed consent prior to any study-specific screening procedures. Willingness and capability to comply with the requirements of the study;
  • Male or female, Age between 18 and 75 years old (margin included) on the day of signing informed consent.
  • Imaging and histologically/cytologically confirmed diagnosis of advanced solid tumor;Dose escalation study: Subjects with advanced solid tumor (mainly gastric cancer, esophageal cancer)Expansion study: It is estimated that subjects with gastric cancer and esophageal cancer are to be enrolled. The specific cancer type is to be identified later regarding the dose escalation study result.
  • Paraffin embedding sample or biopsy sample available during screening, or be willing to provide tissue from a newly obtained core or excisional biopsy.
  • Have no effective standard treatment or are not respond to standard treatment.
  • Must have at least one measurable lesion as defined per RECIST Version 1.1.
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  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Has a predicted survival period ≥ 12 weeks.
  • Demonstrate adequate organ and hematopoietic function as defined below. a) Hemoglobin (HGB)≥90 g/L;b)White blood cell count (WBC) ≥3×109/L;c)Absolute neutrophil count (ANC) ≥1.5×109/L;d)Platelets ≥100×109/L;e) Serum total bilirubin (TBIL) ≤ 1.5 X upper limit of normal ULN;f) Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 X ULN or ≤5 X ULN for subjects with liver metastases;g)Serum creatinine ≤1.5 X ULN;h)International Normalized Ratio (INR) or Prothrombin Time (PT) ≤1.5 X ULN.
  • Since signing the ICF, female or male subjects of childbearing potential should be willing to use an adequate method of contraception with the spouse for the course of the study through 5 months after the last dose of study medication

Who cannot join

  • Subjects with meningeal or symptomatic central nervous system metastases.
  • Patients with any autoimmune disease, i.e., but not limited to, interstitial pneumonia, uveitis, enteritis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism (hypothyroidism without clinical symptoms or caused by radiotherapy and chemotherapy can be included); Patients with vitiligo or asthma CR in Childhood, not requiring any intervention in adulthood are permitted to enroll.; patients with asthma requiring a bronchiectasis intervention are not permitted to enroll.
  • Subjects who require systemic corticosteroids (at doses equivalent to or greater than 10 mg/day of prednisone) or other immunosuppressive drugs within 14 days prior to or during the study.
  • Subjects who have received anti-tumor vaccine or who have received anti-tumor drug treatment with immune-stimulating effect within 4 weeks prior to screening.
  • Prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137 or anti CTLA-4 antibody (including Ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways)
  • Presence of other active cancers within 5 years prior to enrollment. Patients with cervical carcinoma in situ/ cured skin basal cell carcinoma who have received definitive adequate treatment are eligible.
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  • Participants with active viral hepatitis (positive HepB sAg and/or positive HepB core Ab with positive HepB DNA>103 copies/mL, or positive HepC antibody), or syphilis positive.
  • Subjects with a history of infection with human immunodeficiency virus, or other acquired, congenital immunodeficiency disease, or organ transplantation.
  • Subjects with active tuberculosis infection or active tuberculosis infection within 1 year prior to administration, or subjects with active tuberculosis infection more than 1 year prior to administration without formal treatment.
  • Subjects with active infection or unexplained fever >38.5℃ during screening and prior to first administration (subject with fever caused by tumor may be included in the group as determined by the investigator).
  • History of allergic reactions attributed to any macromolecular protein preparation/monoclonal antibody, or any other composition of the study drug.
  • Investigational drug therapy outside of this trial during or within 4 weeks prior to administration.
  • Has had prior chemotherapy, radiation therapy, targeted small molecule therapy or major surgery within 2 weeks prior to administration; who has not recovered (i.e. ≤ Grade 1 or at baseline) from adverse events due to a previously administered agent (alopecia excluded)
  • Poorly controlled heart disease, such as uncontrolled hyper hypertension, unstable angina pectoris, myocardial infarction within 6 months prior to screening, arrhythmias(including male QTc intervals≥ 450 ms, female QTc intervals≥ 470 ms, QTc intervals calculated by Formula Fridericia).
  • Has history of Interstitial Lung Disease or non-infectious pneumonitis. (Patients caused by radiotherapy are eligible)
  • Has history of alcoholism or drug abuse within 1 year.
  • Has clear history of neurological or mental disorders, i.e. epilepsy, dementia, and poor compliance.
  • Other conditions that do not permit compliance with the protocol, evaluated by the investigator.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Peking University Cancer Hospital & Institute

    Beijing, Beijing Municipality

Other trials in China

About this study

Official title: A Phase I Study to Investigate the Safety, Tolerability, Pharmacokinetics and Antitumor Activities of the Recombinant Human Anti-PD-1 Monoclonal Antibody for Subjects With Advanced Solid Tumors

To investigate the safety and tolerability of GLS-010 in subjects with advanced solid tumors (mainly gastric cancer, esophageal cancer).

To investigate the preliminary relationship between the expression of the ligand of PD-1 (PD-L1) and efficacy.

Read the detailed description

Dose escalation study: Primary purpose: To investigate the safety and tolerability of GLS-010 in subjects with advanced solid tumors (mainly gastric cancer, esophageal cancer). Secondary purpose: 1. To characterize the pharmacokinetics(PK) profile of GLS-010; 2. To determine dose-limiting toxicity(DLT), maximum tolerated dose (MTD) and recommended Phase II dose (RP2D) for GLS-010; 3. To assess the preliminary anti tumor activity of GLS-010; 4. To assess programmed cell death-1 (PD-1) receptor occupancy. Exploratory purpose: 1. To investigate the preliminary relationship between the expression of the ligand of PD-1 (PD-L1) /PD-L2 and efficacy; 2. To characterize immunogenicity of GLS-010. Expansion study: Primary purpose: To assess the preliminary anti-tumor activity of GLS-010 in subjects with advanced solid tumors(gastric cancer, esophageal cancer); Secondary purpose: 1. To further assess the safety and tolerability of GLS-010; 2. To further assess the safety and tolerability of GLS-010 in subjects with advanced tumors. Exploratory purpose: 1. To assess PD-1 receptor occupancy of GLS-010; 2. To assess the relationship between the expression of PD-L1/PD-L2 and efficacy; 3. To further assess the immunogenicity of GLS-010.

Being tested
GLS-010

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GLS-010Drug

    Also called Recombinant Human Anti-PD-1 Monoclonal Antibody

    Recombinant Human Anti-PD-1 Monoclonal Antibody

Study groups in NCT03713905
Study groupRoleWhat they receive
GLS-010ExperimentalUse Full-human anti-pd-1 monoclonal antibodies for treatment
Receives: Drug: GLS-010

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety and tolerability of GLS-010 by assessing the percentage of participants who experience a dose-limiting toxicity (DLT)

    To investigate the safety and tolerance profile tolerance profile and the preliminary anti-tumor activity of GLS-010 in subjects with advanced solid tumors ( gastric cancer, esophageal cancer)

    Measured: 28 days after patient enrolled

Secondary outcomes (4)

  1. Dose Escalation: Area under the plasma concentration time curve (AUC) of GLS-010

    To characterize the pharmacokinetics(PK) profile of GLS-010

    Measured: within 2 years after patient enrolled

  2. severity, seriousness, and relatedness of adverse events

    Descriptive statistics will be used to summarize results

    Measured: within 2 years of last patient enrolled

  3. Dose Escalation: Maximum concentration (Cmax) of GLS-010

    To characterize the pharmacokinetics(PK) profile of GLS-010

    Measured: within 2 years after patient enrolled

  4. Dose Escalation: Half life Period (t1/2) of GLS-010

    To characterize the Ppharmacokinetics(K) profile of GLS-010

    Measured: within 2 years after patient enrolled

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Oct 2018
  2. Study start1 Jul 2017
  3. Primary completion28 Feb 2022
  4. Study completion28 Feb 2022

Resources

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
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential
Model description
1 mg per kg, Q2W; 4 mg per kg, Q2W; 10 mg per kg, Q2W; 240 mg fixed dose, Q2W
Masking
None (open label)
Enrolment
293 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03713905
Sponsor's protocol ID
YH-S001-01
Status last verified
Apr 2023
First submitted
25 Sep 2018
Last updated
10 Apr 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Liu D, Ma C, Lu P, Gong J, Ye D, Wang S, Peng P, Bai Y, Song Y, Chen J, Jiang O, Zhang G, Ba Y, Chen L, Pan J, Li Q, Zhang L, Gu S, Yin X, Cao B, Han W, Dong H, Guo J, Zhang H, Su H, Jiang Y, Ouyang W, Ma L, Sun Y, Zhang F, Lv J, Guo Y, Xu C, Qi J, Wang L, Wang X, Liu Z, Shen L. Dose escalation and expansion (phase Ia/Ib) study of GLS-010, a recombinant fully human antiprogrammed death-1 monoclonal antibody for advanced solid tumors or lymphoma. Eur J Cancer. 2021 May;148:1-13. doi: 10.1016/j.ejca.2021.01.020. Epub 2021 Mar 7.

    PubMed 33691262

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing GLS-010 in people with Advanced Solid Tumors, 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 10 inclusion and 18 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: finished, as of the sponsor's last update on 10 Apr 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 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.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety and tolerability of GLS-010 by assessing the percentage of participants who experience a dose-limiting toxicity (DLT) (time frame: 28 days after patient enrolled). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03713905, which also lists 1 linked publication.

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 10 Apr 2023.

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