Recurrent or Metastatic Nasopharyngeal Carcinoma
Conditions
Keywords
YL201, recurrent or metastatic nasopharyngeal carcinoma, Toripalimab
Brief summary
This is a multicenter, open-label, Phase Ib/II study conducted in China to evaluate the safety, efficacy, and pharmacokinetic (PK) characteristics of YL201 combined with Toripalimab (doublet regimen) or YL201 combined with Toripalimab and Cisplatin (triplet regimen) in subjects with recurrent or metastatic nasopharyngeal carcinoma.
Interventions
DRUGYL201
YL201 will be administered as an IV infusion
DRUGToripalimab
Toripalimab will be administered as an IV infusion
DRUGCisplatin
Cisplatin will be administered as an IV infusion
Sponsors
MediLink Therapeutics (Suzhou) Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Voluntarily sign a written informed consent form (ICF). 2. Aged ≥18 years and ≤75 years, male or female. 3. ECOG performance status score of 0 or 1. 4. Life expectancy ≥ 3 months. 5. Disease and treatment history: 1. Histologically or cytologically confirmed recurrent or metastatic nasopharyngeal carcinoma that is not amenable to curative treatment. 2. Patients with newly diagnosed advanced nasopharyngeal carcinoma, categorized as Stage IV according to the 9th Edition of the American Joint Committee on Cancer (AJCC) Staging System; or those with recurrent nasopharyngeal carcinoma deemed unsuitable for local treatment 3. Metastatic or recurrent patients who are systemic treatment naïve. 6. At least one measurable lesion according to RECIST v1.1. 7. Adequate organ function.
Exclusion criteria
1. History of other malignant tumors within 5 years prior to the first dose of study drug. Subjects who have been cured of other tumors by local therapy, such as basal cell carcinoma, squamous cell carcinoma of skin, bladder cancer in situ, cervical carcinoma in situ, or breast cancer in situ, are not excluded. 2. Patients with brainstem metastases, leptomeningeal metastases, spinal cord metastases, or spinal cord compression. 3. Patients with severe, uncontrolled cardiovascular disease. 4. Patients with concomitant pulmonary disease resulting in clinically severe impairment of respiratory function. 5. History of interstitial lung disease (ILD) or non-infectious pneumonitis requiring corticosteroid therapy, OR current ILD or non-infectious pneumonitis. 6. Prior treatment with a B7-H3 targeted therapy (including antibodies, antibody-drug conjugates \[ADCs\], CAR-T cells, and other agents), or with a topoisomerase I inhibitor or an ADC containing a topoisomerase I inhibitor payload. 7. Prior treatment with a PD-(L)1 inhibitor (including antibodies, antibody-drug conjugates \[ADCs\], CAR-T cells, and other agents).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants Experiencing Dose-limiting toxicities (DLTs) | Approximately within 36 months |
| Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) | Approximately within 36 months |
| Progression-Free Survival (PFS) as assessed by RECIST v1.1 | Approximately within 36 months |
Secondary
| Measure | Time frame |
|---|---|
| Duration of Response (DoR) | Approximately within 36 months |
| Overall survival(OS) | Approximately within 36 months |
| Incidence of anti-drug antibodies (ADA) to YL201 (and to Toripalimab, if necessary) | Approximately within 36 months |
| Objective Response Rate (ORR) | Approximately within 36 months |
| Characterize the PK parameter Cmax of YL201 and its metabolites, if applicable | Approximately within 36 months |
| Characterize the PK parameter Ctrough of YL201 and its metabolites, if applicable | Approximately within 36 months |
| Characterize the PK parameter t1/2 of YL201 and its metabolites, if applicable | Approximately within 36 months |
| Characterize the PK parameter AUC of YL201 and its metabolites, if applicable | Approximately within 36 months |
| Disease Control Rate (DCR) | Approximately within 36 months |
| Time to Response (TTR) | Approximately within 36 months |
Countries
China
Contacts
Primary ContactMediLink Study Team
Outcome results
None listed