Recruiting NCT07258979
A Study of YL201 in Combination With Toripalimab and With or Without Cisplatin in Nasopharyngeal Carcinoma.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: YL201, Toripalimab, Cisplatin.
- Who it may be relevant to
- Registry conditions: Recurrent or Metastatic Nasopharyngeal Carcinoma. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Multicenter, Open-label, Phase Ib/II Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of YL201 Combined With Toripalimab, With or Without Cisplatin, in Subjects With Recurrent or Metastatic Nasopharyngeal Carcinoma.
Overview
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
- Drug YL201
YL201 will be administered as an IV infusion - Drug Toripalimab
Toripalimab will be administered as an IV infusion - Drug Cisplatin
Cisplatin will be administered as an IV infusion
Primary outcome measures
- Number of Participants Experiencing Dose-limiting toxicities (DLTs) [Time frame: Approximately within 36 months]
- Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) [Time frame: Approximately within 36 months]
- Progression-Free Survival (PFS) as assessed by RECIST v1.1 [Time frame: Approximately within 36 months]
Secondary outcome measures (10)
- Objective Response Rate (ORR) [Time frame: Approximately within 36 months]
- Disease Control Rate (DCR) [Time frame: Approximately within 36 months]
- Time to Response (TTR) [Time frame: Approximately within 36 months]
- Duration of Response (DoR) [Time frame: Approximately within 36 months]
- Overall survival(OS) [Time frame: Approximately within 36 months]
- Incidence of anti-drug antibodies (ADA) to YL201 (and to Toripalimab, if necessary) [Time frame: Approximately within 36 months]
- Characterize the PK parameter AUC of YL201 and its metabolites, if applicable [Time frame: Approximately within 36 months]
- Characterize the PK parameter Cmax of YL201 and its metabolites, if applicable [Time frame: Approximately within 36 months]
- Characterize the PK parameter Ctrough of YL201 and its metabolites, if applicable [Time frame: Approximately within 36 months]
- Characterize the PK parameter t1/2 of YL201 and its metabolites, if applicable [Time frame: Approximately within 36 months]
Eligibility criteria
Inclusion criteria
- Voluntarily sign a written informed consent form (ICF).
- Aged ≥18 years and ≤75 years, male or female.
- ECOG performance status score of 0 or 1.
- Life expectancy ≥ 3 months.
- Disease and treatment history:
- Histologically or cytologically confirmed recurrent or metastatic nasopharyngeal carcinoma that is not amenable to curative treatment.
- 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
- Metastatic or recurrent patients who are systemic treatment naïve.
- At least one measurable lesion according to RECIST v1.1.
- Adequate organ function.
Exclusion criteria
- 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.
- Patients with brainstem metastases, leptomeningeal metastases, spinal cord metastases, or spinal cord compression.
- Patients with severe, uncontrolled cardiovascular disease.
- Patients with concomitant pulmonary disease resulting in clinically severe impairment of respiratory function.
- History of interstitial lung disease (ILD) or non-infectious pneumonitis requiring corticosteroid therapy, OR current ILD or non-infectious pneumonitis.
- 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.
- Prior treatment with a PD-(L)1 inhibitor (including antibodies, antibody-drug conjugates \[ADCs\], CAR-T cells, and other agents).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 20 centers
- Chongqing University Cancer Hospital — Chongqing
- Fujian Cancer Hospital — Fuzhou
- The First Affiliated Hospital of Xiamen University — Xiamen
- Zhangzhou Municiple Hospital of Fujian Province — Zhangzhou
- Dongguan People's Hospital — Dongguan
- Affiliated Cancer Hospital and Institute of Guangzhou Medical University — Guangzhou
- Sun Yat-sen University Cancer Center — Guangzhou
- The First Affiliated Hospital of Guangdong Pharmaceutical University — Guangzhou
- … and 12 more centers
Identifiers
NCT: NCT07258979 · YL201-CN-105-02