RECRUITING

A Phase I Trial of SIM1811-03 in Subjects With Advanced Solid Tumors and Cutaneous T-cell Lymphoma

Conditions

Advanced Solid Tumor Cutaneous T-cell Lymphoma (CTCL)

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Phase I Trial of SIM1811-03 in Subjects With Advanced Solid Tumors and Cutaneous T-cell Lymphoma

Quick Facts

Study Start:2022-09-30

Study Completion:2025-03-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05569057

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* 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: * 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	* 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: 1. cytotoxic chemotherapy, targeted therapy, immune checkpoint inhibitor within 4 weeks (such as PD-1 inhibitor, PD-L1 inhibitor, or CTLA-4 inhibitor); 2. 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 * 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

Inclusion Criteria

Exclusion Criteria

* 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:
* 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

* 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:
1. cytotoxic chemotherapy, targeted therapy, immune checkpoint inhibitor within 4 weeks (such as PD-1 inhibitor, PD-L1 inhibitor, or CTLA-4 inhibitor);
2. 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
* 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

Contacts and Locations

Study Contact

Bijoyesh Mookerjee, M.D.

CONTACT

856-261-0153

bijoyesh.mookerjee@simceregroup.com

Adam Cox

CONTACT

905-486-0339

Adam.Cox@allucent.com

Study Locations (Sites)

Henry Ford Health

Detroit, Michigan, 48202

United States

NYU Lagone Health

New York, New York, 10016

United States

Icahn School of Medicine at Mount Sinai

New York, New York, 10029

United States

Carolina Biooncology Institute

Huntersville, North Carolina, 28078

United States

Mary Crowley Cancer Research

Dallas, Texas, 75230

United States

The University of Texas MD Anderson Cancer Center

Houston, Texas, 77030

United States

Collaborators and Investigators

Sponsor: Jiangsu Simcere Pharmaceutical Co., Ltd.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-09-30

Study Completion Date2025-03-31

Study Record Updates

Study Start Date2022-09-30

Study Completion Date2025-03-31

Terms related to this study

Additional Relevant MeSH Terms

Advanced Solid Tumor
Cutaneous T-cell Lymphoma (CTCL)