Solid TumorPhase 1/2NCT04407741
Phase Ⅰ/Ⅱ Study of SHR2554 in Combination With SHR1701 in Patients With Advanced Solid Tumors and B-cell Lymphomas
A Phase 1/2 study testing SHR2554+SHR1701 and SHR1701 in people with Solid Tumor and Lymphoma, run by Chinese PLA General Hospital at 1 site in China.
Trial summary
The potency of immune checkpoint blockade is limited in most solid malignancies, one possible reason for which is tumor microenvironment. Enhancer of zeste homolog 2 (EZH2) as a epigenetic target for cancer therapy has attracted significant interest. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Solid Tumor, Lymphoma
- What is being tested?
- SHR2554+SHR1701 and SHR1701
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2020to 1 Dec 2025
- Phase
- Phase 1/2
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Age from 18 to 70 years with estimated life expectancy >3 months.
- 2. Histopathological confirmed locally advanced or metastatic systematically pretreated epidermal growth factor receptor (EGFR) / anaplastic lymphoma kinase (ALK) / c-ros oncogene 1 receptor kinase (ROS1) /BRAF negative non-small cell lung cancer (adenocarcinoma or squamous cell carcinoma), pancreatic adenocarcinoma, cholangiocarcinoma, gastrointestinal adenocarcinoma, triple-negative breast cancer and relapsed/refractory B-cell lymphoma (All enrolled subjects with above solid carcinoma are required to have received at least first-line systematic therapy and subjects with R/R B-cell lymphoma need a history of at least two lines of previous treatment; For solid carcinoma subjects enrolled in phase Ⅱ period, their previous treatment lines are limited to no more than four lines; Besides previously treated subjects, subjects with initially diagnosed pancreatic adenocarcinoma or cholangiocarcinoma are also eligible for enrollment in phase Ⅱ period).
- 3. Have at least one measurable target lesion, determined by the site study team based on RECIST 1.1 and immune related RECIST.
- 4. Fresh tumor samples or formalin-fixed paraffin embedded tumor archival samples within 3 months are necessary; Fresh tumor samples are preferred. Subjects are willing to accept tumor re-biopsy in the process of this study.
- 5. Previous treatment must be completed for more than 4 weeks prior to the enrollment of this study, and subjects have recovered to <= grade 1 toxicity.
- 6. Have an Eastern Cooperative Oncology Group performance status (ECOG) of 0 or 1 at the time of enrollment.
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- 7. Have adequate organ function, as defined in the table below, which should be confirmed within 2 weeks prior to the first dose of study drugs.
- Leukocytes greater than or equal to 3.0 ×10^9/L.
- Absolute neutrophil counts greater than or equal to 1.0 ×10^9/L.
- Platelets greater than or equal to 100 ×10^9/L.
- Hemoglobin greater than or equal to 90 g/L.
- Total bilirubin less than or equal to 2 x ULN.
- Serum albumin should be no less than 30 g/L.
- Alanine aminotransferase or Aspartate aminotransferase less than 2 x Upper Limit of Normal (ULN).
- Measured creatinine clearance ≥ 60 mL per min.
- 8. Previous treatment with anti-PD-1/PD-L1 antibodies or cytotoxic T lymphocyte associated antigen 4 (CTLA-4) inhibitors are allowed.
- 9. Ability to understand and sign a written informed consent document.
- 10.Women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, and up to 90 days after the last dose of the drug.
Who cannot join
- 1. Active, known or suspected autoimmune diseases.
- 2. Known brain metastases or active central nervous system (CNS). Subjects with CNS metastases who were treated with radiotherapy for at least 3 months prior to enrollment, have no central nervous symptoms and are off corticosteroids, are eligible for enrollment, but require a brain MRI screening.
- 3. Subjects are being treated with either corticosteroids (>10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of enrollment.
- 4. History of severe hypersensitive reactions to other monoclonal antibodies.
- 5. History of allergy or intolerance to study drug components.
- 6. Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results.
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- 7. History or concurrent condition of interstitial lung disease of any grade or severely impaired pulmonary function.
- 8. Uncontrolled intercurrent illness, including ongoing or active systemic infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia (excluding insignificant sinus bradycardia and sinus tachycardia) or psychiatric illness/social situations and any other illness that would limit compliance with study requirements and jeopardize the safety of the patient.
- 9. History of human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS).
- 10. Pregnant or breast-feeding. Women of childbearing potential must have a pregnancy test performed within 7 days before the enrollment, and a negative result must be documented.
- 11. Previous or concurrent cancer within 3 years prior to treatment start EXCEPT for curatively treated cervical cancer in situ, non-melanoma skin cancer, superficial bladder tumors [Ta (non-invasive tumor), Tis (carcinoma in situ) and T1 (tumor invades lamina propria)].
- 12. Vaccination within 30 days of study enrollment.
- 13. Active bleeding or known hemorrhagic tendency.
- 14. Subjects with unhealed surgical wounds for more than 30 days.
- 15. Being participating any other trials or withdraw within 4 weeks.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Biotherapeutic, Chinese PLA General Hospital
Beijing
KAICHAO FENG, MD, +86-10-55499341, timothyfkc@126.com
About this study
Official title: An Open-Label Phase Ⅰ/Ⅱ Study of EZH2 Inhibitor SHR2554 in Combination With Anti-PD-L1/TGFβ Antibody SHR1701 in Patients With Advanced or Metastatic Solid Tumors and Relapsed/Refractory B-cell Lymphomas
The potency of immune checkpoint blockade is limited in most solid malignancies, one possible reason for which is tumor microenvironment. Enhancer of zeste homolog 2 (EZH2) as a epigenetic target for cancer therapy has attracted significant interest. The combination of EZH2 inhibitors and programmed death-1 ligands/ transforming growth factor-β (PD-L1/TGFβ) blockade may enhance the efficiency of immunotherapy.The primary objective of this study in phase Ⅰstage is to assess the safety, feasibility of EZH2 inhibitor SHR2554 in combination with anti-PD-L1/TGFβ antibody SHR1701 in advanced pretreated solid tumors and b-cell lymphomas. The phase Ⅱ stage of this study is to primarily evaluate the efficacy of SHR2554 plus SHR1701 and the epigenetic modulating effect of SHR2554.
Read the detailed description
Immune checkpoint blockade has led to great strides in the management of various cancers, however, durable response could be seen in approximately 20% of treated patients with most solid malignancies. Immunosuppressive entities such as transforming growth factor-β (TGF-β) in the tumor microenvironment (TME) remain a major impediment. Enhancer of zeste homolog 2 (EZH2) is the core component of the polycomb group complex, which play a major role in cellular proliferation and differentiation. EZH2 aberration has been seen in a wide range of solid tumors and hematological malignancies, affecting tumor progression and immune cells in the tumor microenvironment, and it is associated with poor clinical prognosis and outcomes. EZH2 is not only an activator of gene expression through different pathways, but also a critical epigenetic repressor through histone methylation. Therefore, EZH2 has attracted significant interest as a potential epigenetic target for cancer treatment. It is hypothesized that the combination of EZH2 inhibitors and programmed death-1 ligands/ transforming growth factor-β (PD-L1/TGFβ) blockade could enhance the efficiency of immunotherapy.
The primary objective of this study in phase Ⅰstage is to assess the safety, feasibility of EZH2 inhibitor SHR2554 in combination with anti-PD-L1/TGFβ antibody SHR1701 in advanced pretreated solid tumors and b-cell lymphomas. The second objectives include characterizing the pharmacokinetics of SHR2554 in combination with SHR1701, evaluating the preliminary efficacy of SHR2554 plus SHR1701 and the epigenetic modulating effect of SHR2554 in its combination with anti-PD-L1/TGFβ antibody. The exploratory objectives are to evaluate the pathological, immunological or clinical predictive factors for efficacy and toxicity. Based on the data of safety, efficacy and recommended dose level obtained from phase Ⅰtrial, this study moves into phase Ⅱ stage, in which enrolled subjects are randomized to SHR2554 plus SHR 1701 or SHR1701 monotherapy, to primarily evaluate the efficacy of SHR2554 plus SHR1701 and the epigenetic modulating effect of SHR2554. The second objectives include evaluating safety and other efficacy parameters, such as overall response rate (ORR), disease control rate (DCR), duration of response (DOR) and overall survival (OS). The exploratory objectives are to evaluate laboratory predicting biomarkers.
- Conditions
- Solid Tumor, Lymphoma
- Being tested
- SHR2554+SHR1701, SHR1701
- Keywords
- Anti-PD-L1/TGFβ, EZH2, SHR2554, SHR1701, Advanced
- Medical subject headings
- Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR2554+SHR1701Drug
SHR2554: recommended dose from phase I trial, PO, twice a day. SHR1701: 30mg/kg, IV, over 30 minutes
SHR1701Drug
SHR1701: 30mg/kg, IV, over 30 minutes
| Study group | Role | What they receive |
|---|---|---|
| SHR2554+ SHR1701 | Experimental | Drug: SHR2554 recommended dose from phase Ⅰstudy, PO, twice a day, every 3 weeks SHR1701 30mg/kg IV over 30 minutes on day 1, every 3 weeks Receives: Drug: SHR2554+SHR1701 |
| SHR1701 | Experimental | Drug: SHR1701 30mg/kg IV over 30 minutes on day 1, every 3 weeks Receives: Drug: SHR1701 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Median amount of time subject survives without disease progression following the initiation of treatment
The primary endpoint is progression free survival (PFS) after treatment. PFS is defined as the time from first treatment to the date of the first documented tumor progression or death due to any cause.
Measured: up to 36 months
Secondary outcomes (3)
Number of subjects with treatment related adverse events as assessed by CTCAE v5.0.
Establishing the safety profile following the initiation of treatment and grading these toxicities by CTCAE v5.0
Measured: Up to 90 days after the last dose of study drugs.
The percentage of subjects respond to treatment.
Overall response rate is defined as the sum of partial responses and complete responses.
Measured: up to 36 months
Median amount of times subjects alive after treatment
The median overall survival (OS) time is defined as the time from enrollment to the date of death.
Measured: up tp 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2020
- Study start1 Sep 2020
- Primary completion1 Dec 2024 (estimated)
- Study completion1 Dec 2025 (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.
- More trials run by Chinese PLA General HospitalThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- In phase I period, patients that meet inclusion and exclusion criteria are enrolled to evaluate the safety, feasibility and pharmacokinetics of SHR2554 plus SHR1701. In the following phase II period, based on the recommended dose level from phase I study, enrolled patients are randomized to trial group (SHR2554 plus SHR1701) and control group (SHR1701) to assess the clinical efficacy of SHR2554 plus SHR1701 and immunomodulating effect of SHR2554 to SHR1701 in each cohort.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Han weidong, Chinese PLA General Hospital
- Investigators
- Weidong Han, PhD, Study director, Department of Bio-therapeutic, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04407741
- Sponsor's protocol ID
- CHN-PLAGH-BT-055
- Status last verified
- Dec 2023
- First submitted
- 20 May 2020
- Last updated
- 12 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Phase Ⅰ/Ⅱ Study of EZH2 Inhibitor SHR2554 in Combination With Anti-PD-L1/TGFβ Antibody SHR1701 in Patients With Advanced or Metastatic Solid Tumors and Relapsed/Refractory B-cell Lymphomas
- ClinicalTrials.gov ID
- NCT04407741
- Acronym / sponsor ID
- CHN-PLAGH-BT-055
- Conditions
- Solid Tumor, Lymphoma
- Keywords
- Anti-PD-L1/TGFβ, EZH2, SHR2554, SHR1701, Advanced
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 29 May 2020 (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.
The potency of immune checkpoint blockade is limited in most solid malignancies, one possible reason for which is tumor microenvironment. Enhancer of zeste homolog 2 (EZH2) as a epigenetic target for cancer therapy has attracted significant interest. The combination of EZH2 inhibitors and programmed death-1 ligands/ transforming growth factor-β (PD-L1/TGFβ) blockade may enhance the efficiency of immunotherapy.The primary objective of this study in phase Ⅰstage is to assess the safety, feasibility of EZH2 inhibitor SHR2554 in combination with anti-PD-L1/TGFβ antibody SHR1701 in advanced pretreated solid tumors and b-cell lymphomas. The phase Ⅱ stage of this study is to primarily evaluate the efficacy of SHR2554 plus SHR1701 and the epigenetic modulating effect of SHR2554.
Detailed description
Immune checkpoint blockade has led to great strides in the management of various cancers, however, durable response could be seen in approximately 20% of treated patients with most solid malignancies. Immunosuppressive entities such as transforming growth factor-β (TGF-β) in the tumor microenvironment (TME) remain a major impediment. Enhancer of zeste homolog 2 (EZH2) is the core component of the polycomb group complex, which play a major role in cellular proliferation and differentiation. EZH2 aberration has been seen in a wide range of solid tumors and hematological malignancies, affecting tumor progression and immune cells in the tumor microenvironment, and it is associated with poor clinical prognosis and outcomes. EZH2 is not only an activator of gene expression through different pathways, but also a critical epigenetic repressor through histone methylation. Therefore, EZH2 has attracted significant interest as a potential epigenetic target for cancer treatment. It is hypothesized that the combination of EZH2 inhibitors and programmed death-1 ligands/ transforming growth factor-β (PD-L1/TGFβ) blockade could enhance the efficiency of immunotherapy.
The primary objective of this study in phase Ⅰstage is to assess the safety, feasibility of EZH2 inhibitor SHR2554 in combination with anti-PD-L1/TGFβ antibody SHR1701 in advanced pretreated solid tumors and b-cell lymphomas. The second objectives include characterizing the pharmacokinetics of SHR2554 in combination with SHR1701, evaluating the preliminary efficacy of SHR2554 plus SHR1701 and the epigenetic modulating effect of SHR2554 in its combination with anti-PD-L1/TGFβ antibody. The exploratory objectives are to evaluate the pathological, immunological or clinical predictive factors for efficacy and toxicity. Based on the data of safety, efficacy and recommended dose level obtained from phase Ⅰtrial, this study moves into phase Ⅱ stage, in which enrolled subjects are randomized to SHR2554 plus SHR 1701 or SHR1701 monotherapy, to primarily evaluate the efficacy of SHR2554 plus SHR1701 and the epigenetic modulating effect of SHR2554. The second objectives include evaluating safety and other efficacy parameters, such as overall response rate (ORR), disease control rate (DCR), duration of response (DOR) and overall survival (OS). The exploratory objectives are to evaluate laboratory predicting biomarkers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- In phase I period, patients that meet inclusion and exclusion criteria are enrolled to evaluate the safety, feasibility and pharmacokinetics of SHR2554 plus SHR1701. In the following phase II period, based on the recommended dose level from phase I study, enrolled patients are randomized to trial group (SHR2554 plus SHR1701) and control group (SHR1701) to assess the clinical efficacy of SHR2554 plus SHR1701 and immunomodulating effect of SHR2554 to SHR1701 in each cohort.
| Arm | Type | Receives |
|---|---|---|
| SHR2554+ SHR1701 | Experimental | Drug: SHR2554+SHR1701Drug: SHR2554 recommended dose from phase Ⅰstudy, PO, twice a day, every 3 weeks SHR1701 30mg/kg IV over 30 minutes on day 1, every 3 weeks |
| SHR1701 | Experimental | Drug: SHR1701Drug: SHR1701 30mg/kg IV over 30 minutes on day 1, every 3 weeks |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- 1. Age from 18 to 70 years with estimated life expectancy >3 months.
- 2. Histopathological confirmed locally advanced or metastatic systematically pretreated epidermal growth factor receptor (EGFR) / anaplastic lymphoma kinase (ALK) / c-ros oncogene 1 receptor kinase (ROS1) /BRAF negative non-small cell lung cancer (adenocarcinoma or squamous cell carcinoma), pancreatic adenocarcinoma, cholangiocarcinoma, gastrointestinal adenocarcinoma, triple-negative breast cancer and relapsed/refractory B-cell lymphoma (All enrolled subjects with above solid carcinoma are required to have received at least first-line systematic therapy and subjects with R/R B-cell lymphoma need a history of at least two lines of previous treatment; For solid carcinoma subjects enrolled in phase Ⅱ period, their previous treatment lines are limited to no more than four lines; Besides previously treated subjects, subjects with initially diagnosed pancreatic adenocarcinoma or cholangiocarcinoma are also eligible for enrollment in phase Ⅱ period).
- 3. Have at least one measurable target lesion, determined by the site study team based on RECIST 1.1 and immune related RECIST.
- 4. Fresh tumor samples or formalin-fixed paraffin embedded tumor archival samples within 3 months are necessary; Fresh tumor samples are preferred. Subjects are willing to accept tumor re-biopsy in the process of this study.
- 5. Previous treatment must be completed for more than 4 weeks prior to the enrollment of this study, and subjects have recovered to <= grade 1 toxicity.
Key exclusion criteria (15 listed)
- 1. Active, known or suspected autoimmune diseases.
- 2. Known brain metastases or active central nervous system (CNS). Subjects with CNS metastases who were treated with radiotherapy for at least 3 months prior to enrollment, have no central nervous symptoms and are off corticosteroids, are eligible for enrollment, but require a brain MRI screening.
- 3. Subjects are being treated with either corticosteroids (>10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of enrollment.
- 4. History of severe hypersensitive reactions to other monoclonal antibodies.
- 5. History of allergy or intolerance to study drug components.
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 |
|---|---|---|
| SHR2554+SHR1701SHR2554: recommended dose from phase I trial, PO, twice a day. SHR1701: 30mg/kg, IV, over 30 minutes | Drug | SHR2554+ SHR1701 |
| SHR1701SHR1701: 30mg/kg, IV, over 30 minutes | Drug | SHR1701 |
Primary outcome
Median amount of time subject survives without disease progression following the initiation of treatment
Time frame: up to 36 months
The primary endpoint is progression free survival (PFS) after treatment. PFS is defined as the time from first treatment to the date of the first documented tumor progression or death due to any cause.
3 secondary outcomes
Number of subjects with treatment related adverse events as assessed by CTCAE v5.0.
Time frame: Up to 90 days after the last dose of study drugs.
The percentage of subjects respond to treatment.
Time frame: up to 36 months
Median amount of times subjects alive after treatment
Time frame: up tp 36 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2023.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Weidong Han, PhD study director
Department of Bio-therapeutic, Chinese PLA General Hospital
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 SHR2554+SHR1701 and SHR1701 in people with Solid Tumor and Lymphoma, run by Chinese PLA General Hospital 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 18 inclusion and 15 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: status not confirmed, as of the sponsor's last update on 12 Dec 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Weidong Han, PhD (+86-10-66937463, hanwdrsw@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Median amount of time subject survives without disease progression following the initiation of treatment (time frame: up to 36 months). 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 12 Dec 2023.