Testing SIM1811-03 for advanced tumors
An Open-label, Phase I Trial of SIM1811-03 to Assess the Safety, Efficacy and Pharmacokinetics/Pharmacodynamics in Subjects With Advanced Tumors
This study is testing a new treatment called SIM1811-03 to see if it can help adults with advanced tumors and skin lymphoma feel better and fight their cancer.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 255 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Jiangsu Simcere Pharmaceutical Co., Ltd. Industry-sponsored |
| Drugs / interventions | radiation, Sintilimab |
| Locations | 1 site (Guanzhou, Guangdong) |
| Trial ID | NCT05781386 on ClinicalTrials.gov |
What this trial studies
This Phase I trial evaluates the safety and efficacy of SIM1811-03, a humanized monoclonal antibody targeting TNFR2, in adults with advanced solid tumors and cutaneous T cell lymphoma. The study consists of two parts: a dose escalation phase to determine the maximum tolerated dose (MTD) and a dose expansion phase to assess the anti-tumor activity at the recommended dose. Participants must have relapsed or refractory tumors and provide tumor tissue samples for analysis.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with advanced solid tumors or cutaneous T cell lymphoma that are relapsed or refractory.
Not a fit: Patients with early-stage tumors or those who have not yet undergone standard therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could offer a new therapeutic option for patients with advanced tumors that have not responded to standard therapies.
How similar studies have performed: While this approach is novel, similar studies targeting TNFR2 have shown promise in early-phase trials.
Eligibility criteria
Show full inclusion / exclusion criteria
Key Inclusion Criteria: 1. Written informed consent must be obtained prior to any procedures that are not considered standard of care. 2. ≥18 years old on the day of signing informed consent, male or female; 3. Histologically and/or cytologically documented advanced/metastatic solid tumors or histologically confirmed CTCL; 4. Have relapsed or refractory advanced solid tumors or CTCL, whose disease has progressed during or after standard therapy 5. At least one measurable tumor lesion (RECIST 1.1) for participants with solid tumors. Tumor lesions previously treated with radiotherapy or local therapy should not be considered as measurable unless progression is documented. 6. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 7. Life expectancy of ≥ 12 weeks. 8. Adequate organ and marrow functions 9） Provide archived or fresh biopsy tumor tissue samples or tissue sections 10) Females of childbearing potential require strict contraception during the study. Exclusion Criteria: 1) Participated in an interventional clinical trial or has used investigational devices within 28 days prior to first dose of study drug or received systemic anti-cancer treatments. 2）Toxicity due to previous antineoplastic therapy has not recovered to grade 0 or 1 unless such AEs are not considered to pose safety risks. 3) Required use of corticosteroids for more than 7 consecutive days within 14 days prior to the first dose of study treatment. 4) Participated with active or history of or risk of autoimmune disease 5) Major surgery (except biopsy) or unhealed wound within 4 weeks prior to first dose of study drug. 6) Other known malignancies within 2 years prior to enrollment. 7) Has known active central nervous system (CNS) metastases. 8) 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. 9) Participants with a history of active pulmonary tuberculosis infection within 1 year prior to first dose of study drug. 10) History of hemorrhagic disease requiring transfusion within the last 3 months.
Where this trial is running
Guanzhou, Guangdong
- Sun Yat-Sen University Cancer Center — Guanzhou, Guangdong, China (Recruiting)
Study contacts
- Principal investigator: Ruihua Xu, MD — Sun Yat-sen University
- Study coordinator: Jiongyan Li, MD
- Email: lijiongyan@zaiming.com
- Phone: 86(25)8556 6666
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.