Advanced Solid TumorPhase 1NCT05569057
A Phase I Trial of SIM1811-03 in Subjects With Advanced Solid Tumors and Cutaneous T-cell Lymphoma
A Phase 1 study testing SIM1811-03 in people with Advanced Solid Tumor and Cutaneous T-cell Lymphoma (CTCL), run by Jiangsu Simcere Pharmaceutical Co., Ltd. at 6 sites in United States.
Trial summary
This is a first in human, open-label, dose escalation and expansion Phase 1 study of SIM1811-03 in adult patients with advanced solid tumors and cutaneous T-cell lymphoma. SIM1811-03 is a first-in-class IgG1-based humanized anti-tumor necrosis factor type 2 receptor (TNFR2) monoclonal antibody for the treatment of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumor, Cutaneous T-cell Lymphoma (CTCL)
- What is being tested?
- SIM1811-03
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 6 sitesUnited States
- Study dates
- 30 Sep 2022to 31 Mar 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent must be obtained prior to any procedures that are not considered standard of care
- ≥18 years old on the day of signing informed consent, male or female
- Histologically and/or cytologically documented advanced/metastatic solid tumors or histologically confirmed CTCL. Patients with lymphoma other than CTCL are not eligible.
- Have relapsed or refractory advanced solid tumors or CTCL, whose disease has progressed during or after standard therapy
- At least one measurable tumor lesion (RECIST 1.1) for patients with solid tumors. Tumor lesions previously treated with radiotherapy or local therapy should not be considered as measurable unless progression is documented.
- For patients with CTCL, the following criteria must be met:
Show all 16Show fewer
- Have at least one measurable lesion (mSWAT criteria) , the lesion that has previously been treated with local therapy should not be considered as measurable unless progression is documented;
- Provide tissue from a punch biopsy of the skin at screening (except for patients in phase Ia dose escalation phase, for whom skin biopsies is recommended only).
- Mycosis fungoides (MF) or Sézary Syndrome (SS) (Stage IIb-IV based on Tumor Node Metastasis Blood [TNMB] staging system for SS and MF diagnosed at screening) failed of at least 2 prior systemic therapies
- Meet clinical criteria for systemic treatment (patients that can be treated with radiotherapy and/or skin-directly therapies only are to be excluded)
- No current large cell transformation
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1
- Life expectancy of ≥ 12 weeks
- Adequate organ and marrow functions
- Provide archival tumor samples or fresh tumor biopsy (mandatory for Phase Ib, and recommended for Phase Ia)
- Females of childbearing potential require strict contraception during the study
Who cannot join
- Participated in an interventional clinical trial or has used investigational devices within 28 days prior to first dose of study drug or received any following systemic anti-cancer treatments:
- cytotoxic chemotherapy, targeted therapy, immune checkpoint inhibitor within 4 weeks (such as PD-1 inhibitor, PD-L1 inhibitor, or CTLA-4 inhibitor);
- radiotherapy within 2 weeks (palliative radiotherapy is allowed at least 1 week before the study drug treatment).
- Toxicity and side effects (due to previous anticancer treatments) have not recovered to ≤ grade 1, unless such AE is not considered to pose safety risks (such as hair loss and neuropathy ≤ grade 2 caused by chemotherapy).
- Required use of corticosteroids for more than 7 consecutive days within 14 days prior to the first dose of study treatment (> 10 mg daily prednisone equivalent for solid tumors; > 20 mg daily prednisone equivalent for CTCL)
- Patients with active or history of or risk of autoimmune disease
Show all 16Show fewer
- Major surgery (except biopsy) or unhealed wound within 4 weeks prior to first dose of study drug
- Any other current or previous malignancy within the past 2 years except a) adequately treated basal cell or squamous cell skin cancer, b) carcinoma in situ of the cervix, c) carcinoma in situ of the breast d) local prostate cancer after radical resection and/ or definitive radiotherapy with stable prostate specific antigen (PSA) levels for 1 years
- Has known active central nervous system (CNS) metastases
- History of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis, symptomatic interstitial lung disease or evidence of active pneumonia that is not considered appropriate by the investigator
- History of immunodeficiency (including HIV infection)
- Known active hepatitis B or C infection
- Patients with clinically significant cardiovascular diseases
- History of severe allergic reaction to the study drug or excipients used in the protocol
- Has had an allogeneic tissue/solid organ transplant or graft-versus-host disease
- Other conditions that researchers consider inappropriate for inclusion
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites, 6 recruiting
- Not yet recruiting
Mary Crowley Cancer Research
Dallas, Texas, 75230
Douglas Orr, MD
- Not yet recruiting
Henry Ford Health
Detroit, Michigan, 48202
Ahmad Mattour, MD
- Not yet recruiting
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
Sarina Piha-Paul, MD
- Recruiting
Carolina Biooncology Institute
Huntersville, North Carolina, 28078
John Powderly, MD
- Not yet recruiting
NYU Lagone Health
New York, New York, 10016
Salman Punekar, MD
- Not yet recruiting
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Thomas Marron, MD
About this study
This is a first in human, open-label, dose escalation and expansion Phase 1 study of SIM1811-03 in adult patients with advanced solid tumors and cutaneous T-cell lymphoma. SIM1811-03 is a first-in-class IgG1-based humanized anti-tumor necrosis factor type 2 receptor (TNFR2) monoclonal antibody for the treatment of malignant tumors.
Read the detailed description
This is a phase I trial to evaluate the safety, efficacy, and pharmacokinetic/ pharmacodynamic characteristics of SIM1811-03 in subjects with advanced solid tumors and subjects with CTCL.
The trial is composed of two parts, phase Ia and phase Ib. Phase Ia is a dose escalation part to determine the MTD and/or RD of SIM1811-03. Phase Ib is a dose expansion part at RD level SIM1811-03 determined in phase Ia to primarily assess the anti-tumor activity of SIM1811-03 in subjects with solid tumors or CTCL. The tumor types in PhIb will be adjusted based on the response observed in PhIa. Approximately 50 subjects will be enrolled in this phase.
Cohort 1: Patients with CTCL (approximately 20 patients). Cohort 2: Patients with advanced/metastatic solid tumors, including ovarian cancer (approximately 10 patients), NSCLC (approximately 10 patients), and hepatocellular carcinoma etc.
Each subject will undergo Screening, Treatment, Safety Follow-up, and survival Follow-up periods. Any subject who has discontinued from study treatment other than disease progression will also enter PFS follow up period and to continue to have tumor assessments until disease progression, initiation of subsequent anticancer therapies, or death, whichever occurs first. Upon completion of the safety follow up and PFS follow-up, as applicable, all patients, except those who died, withdrew consent or were lost to follow-up, will be followed for survival.
Eligible subjects will receive intravenous infusion of SIM1811-03 on Days 1 and 15 of each 28-day cycle.
- Being tested
- SIM1811-03
- Medical subject headings
- Lymphoma, T-Cell, Cutaneous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SIM1811-03Drug
Also called SIM0235, TNFR2 monoclonal antibody
SIM1811-03 is a first-in-class igG-1 based humanized anti-tumor necrosis factor type 2 receptor (TNFR2) monoclonal antibody for the treatment of malignant tumors
| Study group | Role | What they receive |
|---|---|---|
| SIM1811-03 Monotherapy | Experimental | All participants receive SIM1811-03 alone Receives: Drug: SIM1811-03 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase 1a: Incidence Rate of Dose-Limiting Toxicity (DLT)
To estimate the maximum tolerated dose (MTD) or recommended dose (RD) of SIM1811-03
Measured: Within 28 days after the first dose
Phase 1b: ORR Solid tumors: objective response rate (ORR) assessed by Investigator per RECIST 1.1 CTCL: ORR assessed by Investigator per global response (Olsen 2011)
Phase 1b (dose expansion): To evaluate the anti-tumor activity of SIM1811-03 at the proposed RD
Measured: Assessed up to an average of 1 year
Secondary outcomes (14)
Incidence and severity of adverse events (AEs)
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0".
Measured: All AEs/SAEs will be collected in this study from the time the subject signs the informed consent form until 90 days after the last dose
Incidence of dose interruptions, delays and discontinuations
To assess the tolerability of SIM1811-03
Measured: All AEs/SAEs will be collected in this study from the time the subject signs the informed consent form until 90 days after the last dose
AUC
To evaluate the area under the curve (AUC) plasma-concentration of SIM1811-03
Measured: Days 1, 2, 4, 8, and 15 of Cycle 1 (each cycle is 28 days), then assessed in subsequent cycles, up to an average of 1 year
Cmax
To evaluate the maximum observed concentration (Cmax) of SIM1811-03 in the blood after a dose is given
Measured: Days 1, 2, 4, 8, and 15 of Cycle 1 (each cycle is 28 days), then assessed in subsequent cycles, up to an average of 1 year
Ctrough
To evaluate the lowest concentration of a drug just before the next dose of SIM1811-03
Measured: Days 1, 2, 4, 8, and 15 of Cycle 1 (each cycle is 28 days), then assessed in subsequent cycles, up to an average of 1 year
Tmax
To evaluate the time take to reach Cmax of SIM1811-03
Measured: Days 1, 2, 4, 8, and 15 of Cycle 1 (each cycle is 28 days), then assessed in subsequent cycles, up to an average of 1 year
Half-life (T1/2)
To evaluate the time it takes for the concentration of SIM1811-03 in the plasma or the total amount in the body to be reduced by 50%
Measured: Days 1, 2, 4, 8, and 15 of Cycle 1 (each cycle is 28 days), then assessed in subsequent cycles, up to an average of 1 year
Incidence of anti-drug antibodies (ADAs) to SIM1811-03
To assess the occurrence of anti-drug antibodies (ADAs) to SIM1811-03
Measured: Days 1, 2, 4, 8, and 15 of Cycle 1 (each cycle is 28 days), then assessed in subsequent cycles, up to an average of 1 year
Titer of anti-drug antibodies (ADAs) to SIM1811-03
To evaluate the quasi-quantitative expression of the level of ADA
Measured: Days 1, 2, 4, 8, and 15 of Cycle 1 (each cycle is 28 days), then assessed in subsequent cycles, up to an average of 1 year
Overall Response Rate (ORR)
ORR is defined as the proportion of participants who have a partial response (PR) or better per RECIST 1.1
Measured: Assessed up to an average of 1 year
Duration of Response (DOR)
DOR is defined as time from date of initial documentation of a response (PR or better) to date of first documented evidence of PD per RECIST 1.1
Measured: Assessed up to an average of 1 year
Disease Control Rate (DCR)
Disease Control Rate (DCR) is defined as the percentage of patients with advanced or metastatic cancer who have achieved complete response, partial response and stable disease to a therapeutic intervention in clinical trials of anticancer agents
Measured: Assessed up to an average of 1 year
Progression-Free Survival (PFS)
PFS is defined as time from date of first dose of study drug to date of first documented PD, per RACIST 1.1, or death due to any cause, whichever occurs first.
Measured: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to an average of 1 year
Overall survival (OS)
Overall survival is defined as the duration from the date of enrollment to the date of the participant's death
Measured: Up to an average of 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2022
- Study start30 Sep 2022 (estimated)
- Primary completion1 Jun 2024 (estimated)
- Study completion31 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorStudies of the same condition, open and under way.
- More trials run by Jiangsu Simcere Pharmaceutical Co., 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu Simcere Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05569057
- Sponsor's protocol ID
- SIM1811-03-TNFR2-102
- Status last verified
- Oct 2022
- First submitted
- 27 Sep 2022
- Last updated
- 7 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Trial of SIM1811-03 in Subjects With Advanced Solid Tumors and Cutaneous T-cell Lymphoma
- ClinicalTrials.gov ID
- NCT05569057
- Acronym / sponsor ID
- SIM1811-03-TNFR2-102
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Jiangsu Simcere Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 30 Sep 2022 (estimated)
- Primary completion
- 1 Jun 2024 (estimated)
- Study completion
- 31 Mar 2025 (estimated)
- First posted
- 6 Oct 2022 (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 first in human, open-label, dose escalation and expansion Phase 1 study of SIM1811-03 in adult patients with advanced solid tumors and cutaneous T-cell lymphoma. SIM1811-03 is a first-in-class IgG1-based humanized anti-tumor necrosis factor type 2 receptor (TNFR2) monoclonal antibody for the treatment of malignant tumors.
Detailed description
This is a phase I trial to evaluate the safety, efficacy, and pharmacokinetic/ pharmacodynamic characteristics of SIM1811-03 in subjects with advanced solid tumors and subjects with CTCL.
The trial is composed of two parts, phase Ia and phase Ib. Phase Ia is a dose escalation part to determine the MTD and/or RD of SIM1811-03. Phase Ib is a dose expansion part at RD level SIM1811-03 determined in phase Ia to primarily assess the anti-tumor activity of SIM1811-03 in subjects with solid tumors or CTCL. The tumor types in PhIb will be adjusted based on the response observed in PhIa. Approximately 50 subjects will be enrolled in this phase.
Cohort 1: Patients with CTCL (approximately 20 patients). Cohort 2: Patients with advanced/metastatic solid tumors, including ovarian cancer (approximately 10 patients), NSCLC (approximately 10 patients), and hepatocellular carcinoma etc.
Each subject will undergo Screening, Treatment, Safety Follow-up, and survival Follow-up periods. Any subject who has discontinued from study treatment other than disease progression will also enter PFS follow up period and to continue to have tumor assessments until disease progression, initiation of subsequent anticancer therapies, or death, whichever occurs first. Upon completion of the safety follow up and PFS follow-up, as applicable, all patients, except those who died, withdrew consent or were lost to follow-up, will be followed for survival.
Eligible subjects will receive intravenous infusion of SIM1811-03 on Days 1 and 15 of each 28-day cycle.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SIM1811-03 Monotherapy | Experimental | Drug: SIM1811-03All participants receive SIM1811-03 alone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Written informed consent must be obtained prior to any procedures that are not considered standard of care
- ≥18 years old on the day of signing informed consent, male or female
- Histologically and/or cytologically documented advanced/metastatic solid tumors or histologically confirmed CTCL. Patients with lymphoma other than CTCL are not eligible.
- Have relapsed or refractory advanced solid tumors or CTCL, whose disease has progressed during or after standard therapy
- At least one measurable tumor lesion (RECIST 1.1) for patients with solid tumors. Tumor lesions previously treated with radiotherapy or local therapy should not be considered as measurable unless progression is documented.
Key exclusion criteria (16 listed)
- Participated in an interventional clinical trial or has used investigational devices within 28 days prior to first dose of study drug or received any following systemic anti-cancer treatments:
- Toxicity and side effects (due to previous anticancer treatments) have not recovered to ≤ grade 1, unless such AE is not considered to pose safety risks (such as hair loss and neuropathy ≤ grade 2 caused by chemotherapy).
- Required use of corticosteroids for more than 7 consecutive days within 14 days prior to the first dose of study treatment (> 10 mg daily prednisone equivalent for solid tumors; > 20 mg daily prednisone equivalent for CTCL)
- Patients with active or history of or risk of autoimmune disease
- Major surgery (except biopsy) or unhealed wound within 4 weeks prior to first dose of study drug
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 |
|---|---|---|
| SIM1811-03Also: SIM0235, TNFR2 monoclonal antibodySIM1811-03 is a first-in-class igG-1 based humanized anti-tumor necrosis factor type 2 receptor (TNFR2) monoclonal antibody for the treatment of malignant tumors | Drug | SIM1811-03 Monotherapy |
Primary outcome
Phase 1a: Incidence Rate of Dose-Limiting Toxicity (DLT)
Time frame: Within 28 days after the first dose
To estimate the maximum tolerated dose (MTD) or recommended dose (RD) of SIM1811-03
Phase 1b: ORR Solid tumors: objective response rate (ORR) assessed by Investigator per RECIST 1.1 CTCL: ORR assessed by Investigator per global response (Olsen 2011)
Time frame: Assessed up to an average of 1 year
Phase 1b (dose expansion): To evaluate the anti-tumor activity of SIM1811-03 at the proposed RD
14 secondary outcomes
Incidence and severity of adverse events (AEs)
Time frame: All AEs/SAEs will be collected in this study from the time the subject signs the informed consent form until 90 days after the last dose
Incidence of dose interruptions, delays and discontinuations
Time frame: All AEs/SAEs will be collected in this study from the time the subject signs the informed consent form until 90 days after the last dose
AUC
Time frame: Days 1, 2, 4, 8, and 15 of Cycle 1 (each cycle is 28 days), then assessed in subsequent cycles, up to an average of 1 year
Cmax
Time frame: Days 1, 2, 4, 8, and 15 of Cycle 1 (each cycle is 28 days), then assessed in subsequent cycles, up to an average of 1 year
Ctrough
Time frame: Days 1, 2, 4, 8, and 15 of Cycle 1 (each cycle is 28 days), then assessed in subsequent cycles, up to an average of 1 year
Tmax
Time frame: Days 1, 2, 4, 8, and 15 of Cycle 1 (each cycle is 28 days), then assessed in subsequent cycles, up to an average of 1 year
Half-life (T1/2)
Time frame: Days 1, 2, 4, 8, and 15 of Cycle 1 (each cycle is 28 days), then assessed in subsequent cycles, up to an average of 1 year
Incidence of anti-drug antibodies (ADAs) to SIM1811-03
Time frame: Days 1, 2, 4, 8, and 15 of Cycle 1 (each cycle is 28 days), then assessed in subsequent cycles, up to an average of 1 year
Titer of anti-drug antibodies (ADAs) to SIM1811-03
Time frame: Days 1, 2, 4, 8, and 15 of Cycle 1 (each cycle is 28 days), then assessed in subsequent cycles, up to an average of 1 year
Overall Response Rate (ORR)
Time frame: Assessed up to an average of 1 year
Duration of Response (DOR)
Time frame: Assessed up to an average of 1 year
Disease Control Rate (DCR)
Time frame: Assessed up to an average of 1 year
Progression-Free Survival (PFS)
Time frame: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to an average of 1 year
Overall survival (OS)
Time frame: Up to an average of 2 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2022.
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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.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SIM1811-03 in people with Advanced Solid Tumor and Cutaneous T-cell Lymphoma (CTCL), run by Jiangsu Simcere Pharmaceutical Co., Ltd. at 6 sites in United States.
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 16 inclusion and 16 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 7 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. 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 Bijoyesh Mookerjee, M.D. (856-261-0153, bijoyesh.mookerjee@simceregroup.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase 1a: Incidence Rate of Dose-Limiting Toxicity (DLT) (time frame: Within 28 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 7 Oct 2022.