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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-30

Study Completion Date

2025-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Phase I Trial of SIM1811-03 in Subjects With Advanced Tumors

NCT05781386

Advanced Solid Tumor Cutaneous T Cell Lymphoma

RECRUITING PHASE1

Safety Study of IMC-18F1,to Treat Advanced Solid Tumors in Subjects That no Longer Respond to Standard Therapy

NCT00782002

Advanced Solid Tumors

COMPLETED PHASE1

A Clinical Study on TILs for the Treatment of Advanced Solid Tumors

NCT05971576

Solid Tumor

NOT_YET_RECRUITING EARLY_PHASE1

Study of IMC-1121B in Patients With Tumors That Have Not Responded to Therapy

NCT00793975

Advanced Solid Tumors

COMPLETED PHASE1

Evaluate the Safety and Efficacy of Autologous Tumor-infiltrating Lymphocyte in Patients With Refractory Melanoma Who Failed to Immune Checkpoint Inhibitors

NCT07028008

Melanoma

NOT_YET_RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Advanced Solid Tumor Cutaneous T-cell Lymphoma (CTCL)

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

SIM1811-03 Monotherapy

All participants receive SIM1811-03 alone

Group Type EXPERIMENTAL

SIM1811-03

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

SIM1811-03

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

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

SIM0235, TNFR2 monoclonal antibody

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion 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

Exclusion Criteria

* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No