Advanced Solid Tumors or LymphomaPhase 1NCT03821363
Safety, Tolerability, Pharmacokinetics and Efficacy of SCT-I10A in Patients With Advanced Solid Tumors or Lymphoma
A Phase 1 study testing SCT-I10A in people with Advanced Solid Tumors or Lymphoma, run by Sinocelltech Ltd. at 1 site in China.
Trial summary
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of recombinant humanized anti- PD-1 monoclonal antibody（SCT-I10A）in patients with advanced solid tumors or lymphoma treated after failure of standard therapy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Solid Tumors or Lymphoma
- What is being tested?
- SCT-I10A
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 206 participants
- Where
- 1 siteChina
- Study dates
- 13 Dec 2018to Jul 2020
- 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
- Able to provide written informed consent before screening；
- Males or females. Aged 18 to 75 years old;
- Life expectancy≥12 weeks before starting treatment (clinical assessment);
- With an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1;
- Histologically or cytologically confirmed advanced solid tumor or lymphoma;
- Advanced solid tumor or lymphoma with standard treatment failed or no effective therapy;
Show all 9Show fewer
- According to RECIST 1.1 or Lugano 2014 criteria, patients must have at least one measurable lesion that can be accurately assessed;
- Adequate organ and bone marrow function as defined below:
- Absolute neutrophil count (ANC) greater than/equal to 1.5×l09/L; Platelets greater than/equal to 75×109/L; Hemoglobin greater than/equal to 80g/L; Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) less than/equal to 2.5 times ULN, or less than/equal to 5 times ULN if known liver metastases; Total bilirubin less than/equal to 1.5 times ULN; Serum creatinine less than/equal to 1.5 times ULN or Ccr>50ml/min; Thyroid stimulating hormone (TSH) hormone levels less than/equal to ULN.
Who cannot join
- Patients who are allergic to analogue of SCT-I10A and/or its inactive ingredients;
- Patients have been treated with anti-PD-L1 and anti-PD-1 antibody;
- Patients are currently enrolled in other research devices or in research drugs, or less than 4 weeks from other research drugs or devices;
- Within 4 weeks prior to the first dose of study drug, patients have received anti-tumor drugs (such as chemotherapy, endocrine therapy, targeted therapy, immune therapy, tumor embolization). Within 6 weeks prior to the first dose of study drug, patients have been treated with biological products, nitrosourea or mitomycin C;
- Within 2 weeks prior to the first dose of study drug, patients have received corticosteroids or other immunosuppressive agents;
- Within 4 weeks prior to the first dose of study drug, patients have received live attenuated vaccine (LAV), or who planned to use LAV during the study period;
Show all 19Show fewer
- Within 4 weeks prior to the first dose of study drug, patients have received major surgery, or had wounds, ulcers or fractures that haven't healed;
- Prior to the first dose of study drug, patients had toxicity due to previous anti-tumor treatment, which hasn't return to Grade 0-1 according to the NCI CTCAEv4.03;
- Patient with cerebrospinal meningitis metastasis or central nervous system metastasis with untreated or uncontrolled with other treatment;
- Patients with an active, known or suspected autoimmune disease or a history of autoimmune disease;
- Patients with a history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;
- Within 6 months prior to study, patients had uncontrolled concurrent diseases, including but not limited to acute myocardial infarction, unstable angina pectoris, stroke, or transient ischemic attack, congestive heart failure (NYHA, greater than II), left ventricular ejection fraction (LVEF) <50%, and with related heart disease. Patients with chronic or acute disease, psychological or psychiatric disorders, laboratory abnormalities which may affect subject compliance and outcomes in this clinical study;
- Patients with HIV, active hepatitis B (HBV DNA≥104 copies/ml) or active hepatitis C (HCV RNA≥103 copies/ml), etc.;
- Patients who have interstitial lung disease, such as interstitial pneumonia, pulmonary fibrosis, or CT or MRI reminder ILD.
- Patients with clinical symptoms, required clinical intervention or stable time less than 4 weeks of serous cavity effusion (such as pleural effusion and ascites);
- Patients with other primary malignancies;
- Pregnant or lactating women;
- Patients who were not willing to accept effective contraceptive measures during treatment and within 6 months after treatment;
- Subjects who are considered not suitable for the study by investigator.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The Fifth Medical Center of PLA General Hospital
Beijing, Beijing Municipality, 100071
jianming xu, MD, +8613910866712, jmxu2003@163.com
About this study
Official title: Recombinant Humanized Anti- PD-1 Monoclonal Antibody（SCT-I10A） in Patients With Advanced Solid Tumors or Lymphoma :a Phase Ⅰ, Open-label, Multicenter Study
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of recombinant humanized anti- PD-1 monoclonal antibody（SCT-I10A）in patients with advanced solid tumors or lymphoma treated after failure of standard therapy.
Read the detailed description
This open label, multicenter phase I study is designed to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy in advanced solid tumors or lymphoma treated with anti- PD-1 monoclonal antibody SCT-I10A. The trial will be divided into two parts: dose-exploration and indication expansion.
- Conditions
- Advanced Solid Tumors or Lymphoma
- Being tested
- SCT-I10A
- Keywords
- Neoplasms, Solid Tumors, Lymphoma, PD-1, SCT-I10A
- Medical subject headings
- Lymphoma, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SCT-I10ABiological
Experimental: Anti- PD-1 monoclonal antibody（SCT-I10A）
| Study group | Role | What they receive |
|---|---|---|
| Low dose group | Experimental | SCT-I10A will be administered at a dose of 60mg, Q3W up to 24 months. Receives: Biological: SCT-I10A |
| Middle dose group | Experimental | SCT-I10A will be administered at a dose of 200mg, Q3W up to 24 months. Receives: Biological: SCT-I10A |
| High dose group | Experimental | SCT-I10A will be administered at a dose of 600mg, Q3W up to 24 months. Receives: Biological: SCT-I10A |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety/Tolerability
Incidence of adverse events and outlier of laboratory tests, positive rate of immunogenicity
Measured: 24 months
Secondary outcomes (5)
Objective response rate (ORR)
ORR is defined as proportion of patients achieving complete response (CR) or partial response (PR) according to RECIST v1.1 or Lugano 2014 criteria during trial treatment.
Measured: 24 months
Duration of response (DOR)
DOR is defined as time from the date when a patient first meets the criteria for CR or PR according to RECIST v1.1 or Lugano 2014 criteria, until the date that progressive disease (PD) is objectively documented or death, whichever occurs first.
Measured: 24 months
Disease control rate (DCR)
PFS is defined as the time from first dose of SCT200 until the date of first documentation of progression or date of death, whichever occurs first,according to RECIST v1.1 or Lugano 2014 criteria.
Measured: 24 months
Progression free survival (PFS)
PFS is defined as the time from first dose of SCT200 until the date of first documentation of progression or date of death, whichever occurs first,according to RECIST v1.1 or Lugano 2014 criteria.
Measured: 24 months
Overall survival (OS)
OS is defined as time from first dose of SCT200 until the date of death from any cause.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2019
- Study start13 Dec 2018
- Primary completionJul 2020 (estimated)
- Study completionJul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid Tumors or LymphomaStudies of the same condition, open and under way.
- More trials run by Sinocelltech Ltd.The 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Groups of participants are assigned to receive interventions based on prior milestones being reached in the study, such as in some dose escalation and adaptive design studies
- Masking
- None (open label)
- Enrolment
- 206 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sinocelltech Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03821363
- Sponsor's protocol ID
- SCT-I10A-X101
- Status last verified
- Jul 2018
- First submitted
- 24 Jan 2019
- Last updated
- 29 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Recombinant Humanized Anti- PD-1 Monoclonal Antibody（SCT-I10A） in Patients With Advanced Solid Tumors or Lymphoma :a Phase Ⅰ, Open-label, Multicenter Study
- ClinicalTrials.gov ID
- NCT03821363
- Acronym / sponsor ID
- SCT-I10A-X101
- Conditions
- Advanced Solid Tumors or Lymphoma
- Keywords
- Neoplasms, Solid Tumors, Lymphoma, PD-1, SCT-I10A
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 206 participants (estimated)
- Lead sponsor
- Sinocelltech Ltd.Industry (pharma, biotech, devices)
- Study start
- 13 Dec 2018 (actual)
- Primary completion
- Jul 2020 (estimated)
- Study completion
- Jul 2020 (estimated)
- First posted
- 29 Jan 2019 (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 purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of recombinant humanized anti- PD-1 monoclonal antibody（SCT-I10A）in patients with advanced solid tumors or lymphoma treated after failure of standard therapy.
Detailed description
This open label, multicenter phase I study is designed to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy in advanced solid tumors or lymphoma treated with anti- PD-1 monoclonal antibody SCT-I10A. The trial will be divided into two parts: dose-exploration and indication expansion.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Groups of participants are assigned to receive interventions based on prior milestones being reached in the study, such as in some dose escalation and adaptive design studies
| Arm | Type | Receives |
|---|---|---|
| Low dose group | Experimental | Biological: SCT-I10ASCT-I10A will be administered at a dose of 60mg, Q3W up to 24 months. |
| Middle dose group | Experimental | Biological: SCT-I10ASCT-I10A will be administered at a dose of 200mg, Q3W up to 24 months. |
| High dose group | Experimental | Biological: SCT-I10ASCT-I10A will be administered at a dose of 600mg, Q3W up to 24 months. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Able to provide written informed consent before screening；
- Males or females. Aged 18 to 75 years old;
- Life expectancy≥12 weeks before starting treatment (clinical assessment);
- With an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1;
- Histologically or cytologically confirmed advanced solid tumor or lymphoma;
Key exclusion criteria (19 listed)
- Patients who are allergic to analogue of SCT-I10A and/or its inactive ingredients;
- Patients have been treated with anti-PD-L1 and anti-PD-1 antibody;
- Patients are currently enrolled in other research devices or in research drugs, or less than 4 weeks from other research drugs or devices;
- Within 4 weeks prior to the first dose of study drug, patients have received anti-tumor drugs (such as chemotherapy, endocrine therapy, targeted therapy, immune therapy, tumor embolization). Within 6 weeks prior to the first dose of study drug, patients have been treated with biological products, nitrosourea or mitomycin C;
- Within 2 weeks prior to the first dose of study drug, patients have received corticosteroids or other immunosuppressive agents;
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 |
|---|---|---|
| SCT-I10AExperimental: Anti- PD-1 monoclonal antibody（SCT-I10A） | Biological | High dose group, Low dose group, Middle dose group |
Primary outcome
Safety/Tolerability
Time frame: 24 months
Incidence of adverse events and outlier of laboratory tests, positive rate of immunogenicity
5 secondary outcomes
Objective response rate (ORR)
Time frame: 24 months
Duration of response (DOR)
Time frame: 24 months
Disease control rate (DCR)
Time frame: 24 months
Progression free survival (PFS)
Time frame: 24 months
Overall survival (OS)
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2019.
Related trials for Advanced Solid Tumors or Lymphoma
RecruitingPhase 1/2
A Study of Neladalkib (NVL-655) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ALK Rearrangement or Activating ALK Mutation (ALKOVE-1)
Locally Advanced Solid Tumor, Metastatic Solid Tumor
Active, not recruitingPhase 2
Testing GDC-0032 (Taselisib) as a Potential Targeted Treatment in Cancers With PIK3CA Genetic Changes (MATCH-Subprotocol I)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
Active, not recruitingPhase 2
Testing MLN0128 (TAK-228) as Potentially Targeted Treatment in Cancers With TSC1 or TSC2 Genetic Changes (MATCH - Subprotocol M)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
RecruitingPhase 1/2
VMD-928 Monotherapy and in Combination With Pembrolizumab to Treat TrkA Overexpression Driven Solid Tumors or Lymphoma
Head and Neck Carcinoma, Adenoid Cystic Carcinoma
Active, not recruitingPhase 2
Ensartinib in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With ALK or ROS1 Genomic Alterations (A Pediatric MATCH Treatment Trial)
Advanced Malignant Solid Neoplasm, Malignant Solid Neoplasm
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SCT-I10A in people with Advanced Solid Tumors or Lymphoma, run by Sinocelltech 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 19 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 29 Jan 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact jianming xu, MD (+8613910866712, jmxu2003@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety/Tolerability (time frame: 24 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 29 Jan 2019.