Clinical Research Directory

FL-261 Imaging for Cancer Diagnosis and Staging

c-MET is a receptor tyrosine kinase overexpressed in multiple malignancies and associated with tumor progression, therapeutic resistance, and poor prognosis, while showing limited expression in normal tissues, making it an attractive imaging and therapeutic target. Current assessment relies on invasive biopsy and is limited by tumor heterogeneity and sampling bias. FL-261 is a novel c-MET-targeting ligand with high affinity and specificity, favorable tumor uptake and retention, rapid background clearance, and good preclinical safety. It can be radiolabeled for both diagnostic imaging and potential theranostic applications. This first-in-human study will evaluate \[68Ga\]Ga-FL-261 PET or \[111In\]In-FL-261 SPECT imaging in patients with advanced malignancies, including non-small cell lung cancer, colorectal cancer, and head and neck cancer. The study aims to assess safety, biodistribution, and tumor-targeting capability, and to explore its diagnostic value by correlating imaging findings with histopathological c-MET expression.

Role of the Immune System in Preventing Laryngeal Cancer

Laryngeal dysplasia and progression to carcinoma: investigating genetic and immune alterations predictive of malignant transformation

The Safety, Dosimetry and Efficacy of 177Lu-INN805 in Patients With Malignant Solid Tumors

This study is a prospective, single-arm, open-label, dose-escalation study. A total of 4 dose groups were pre-defined in this study. The drug was administered once every 6 weeks.The drug would be administered for 1 to 4 cycles. The dosing schedule and dose could also be adjusted according to the patient's condition. After each dose group completed the enrollment and DLT observation, based on the participant's safety tolerance, radiation dosimetry, and preliminary efficacy evaluation results, it was decided whether to adjust the dose of the subsequent dose groups or to suspend the dose escalation.

Impact of Early Response to First-line Anti-PD-1 Monotherapy in Patients With Recurrent and/or Metastatic (R/M) Head and Neck Squamous Cell Carcinoma, Assessed by 18F-FDG PET/CT

This study aims to evaluate the role of early response assessment by 18F-FDG PET/CT in patients with recurrent and/or metastatic (R/M) head and neck squamous cell carcinoma with PD-L1 CPS \>1 treated with pembrolizumab monotherapy, in accordance with routine clinical practice.

Postoperative Radiotherapy Combined With Nimotuzumab Followed by Bemcentinib in High-Risk Patients With Head and Neck Squamous Cell Carcinoma

A Multicenter, Randomized, Controlled, Open-Label, Phase III Clinical Trial.To evaluate the efficacy and safety of postoperative radiotherapy combined with Nimotuzumab followed by Bemcentinib in high-risk patients with head and neck squamous cell carcinoma who are ineligible for cisplatin chemotherapy. The primary endpoint is disease-free survival (DFS). A total of 185 patients will be enrolled in both the study group and the control group, respectively, with a total planned enrollment of 370 patients. Enrollment is expected to be completed within 2 years, followed by a 3-year follow-up period after the last patient is enrolled.

Longitudinal Oral Health Changes After Head and Neck Radiotherapy

This prospective observational study evaluates how head and neck radiotherapy affects oral health over time. Patients with head and neck cancer undergoing standard radiotherapy are followed from before treatment through multiple post-treatment visits. Changes in periodontal health, dental status, salivary function, and patient-reported oral health quality of life are assessed. The study aims to better understand the long-term oral complications of radiotherapy and to support improved preventive and supportive dental care for cancer patients.

A Phase 1b/2 Study of the Safety and Efficacy of the Monoclonal Antibody OM-RCA-01 in Patients With Metastatic Tumors Expressing Fibroblast Growth Factor Receptor 1

One of the most relevant targets in the field of novel targeted anticancer therapy is the family of receptors to fibroblast growth factor receptors (FGFRs). FGFR1 is the main representative of the FGFR family. The goal of this clinical trial is to learn if monoclonal anti-FGFR1 antibody (OM-RCA-01) works to treat metastatic cancers expressing FGFR1. It will also learn about the safety of drug OM-RCA-01. The main questions it aims to answer are: 1. What medical problems do participants have when receiving drug OM-RCA-01? 2. What dose of the drug should patients receive in the next studies? 3. Does tumor growth slow down in patients receiving OM-RCA-01? All patients in this study will receive the antibody treatment. The drug will be given through a vein (by IV infusion) every two weeks, for as long as the disease remains under control and the treatment is well tolerated.

Nimotuzumab Combined With Toripalimab and Chemotherapy for Locally Advanced Tonsillar Cancer

This is a prospective,single-arm,Phase II clinical study to designed to evaluate the efficancy and safety of nimotuzumab Combined with Toripalimab and Chemotherapy for Locally Advanced Tonsillar Cancer

SL-28 for Advanced Solid Tumours

Second Life Therapeutics is developing SL-28, an allogeneic, non-genetically modified cell-based therapy for the treatment of advanced solid tumours. The company has recently demonstrated a novel, non-genetic approach to modulate immune cell activity through targeted manipulation of the Universal Receptive System. The purpose of this open label, multi-center clinical trial is to evaluate the anti-tumor activity, safety, and pharmacokinetics, single-agent SL-28 in patients with a diverse array of solid tumors. The study includes an initial Phase 1 dose escalation to determine recommended dose(s) for expansion of SL-28 as a monotherapy and Phase 2 expansion cohorts. The study will enroll patients with advanced solid tumours, including those who failed previous lines of chemo- and immunotherapies.

Improving Dental Care for Patients With Head and Neck Tumors

This prospective survey study investigates knowledge, attitudes, experiences, and practices related to dental care in patients with head and neck cancer among affected patients and dentists. Participants complete an anonymous online questionnaire before and after receiving written, guideline-based information. The study aims to evaluate whether targeted educational materials improve knowledge and perceptions regarding dental care in the context of head and neck cancer treatment.

Compare Radiotherapy Plus Nimotuzumab Versus Radiotherapy Alone in Platinum-ineligible Patients With Locoregionally Advanced Head and Neck Squamous Cell Carcinoma

This is an open-label, prospective, randomized, Phase III, international multicenter clinical study to compare radiotherapy plus nimotuzumab versus radiotherapy alone in platinum-ineligible patients with locoregionally advanced head and neck squamous cell carcinoma (LA-HNSCC),

Contrast-enhanced Ultrasound for Sentinel Node Detection

This is a prospective single-center interventional non-inferiority study where subjects are participating for one day for patients 18 years or older with melanoma, breast cancer or head \& neck cancer (including melanoma of head and neck area) and scheduled for a surgical SN procedure in the NKI-AvL without any contra-indication for Sonazoid contrast agent, such as an allergy to eggs or egg products. The primary objective is to assess the sensitivity of CEUS for intra-operative SN localization compared to the gold standard (99mTc nanocolloid). Secondary objectives are the specificity of CEUS for intra-operative SN localization, the time required to localize the SNs using CEUS and intraoperative usability of the CEUS-system. The primary endpoint is the sensitivity of the CEUS SN localization method. The conventional gamma probe will be used as ground truth comparison.

Performance of 18F-FDG Micro-PET-CT in the Assessment of Surgical Margins in Head and Neck Cancer

The purpose of this study is to evaluate the diagnostic performance of 18F-FDG micro-PET-CT in malignant Head and neck cancer compared to definitive histological analysis (gold standard).