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New treatment option for Recurrent or Metastatic Nasopharyngeal Carcinoma
Official title A Study of YL201 in Combination With Toripalimab and With or Without Cisplatin in Nasopharyngeal Carcinoma.
ClinicalTrials.gov ID: NCT07258979
What this study is testing
What is YL201?
YL201 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for recurrent or metastatic nasopharyngeal carcinoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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:
You likely can't join if
- History of other malignant tumors within 5 years prior to the first dose of study drug. people who have been cured of other tumors by local therapy...
- 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...
- Prior treatment with a B7-H3 targeted therapy (including antibodies, antibody-drug conjugates [ADCs], CAR-T cells, and other agents), or with a...
See the full eligibility 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...
- Metastatic or recurrent patients who are systemic treatment naïve.
- At least one measurable lesion according to RECIST v1.1.
- Adequate organ function.
- History of other malignant tumors within 5 years prior to the first dose of study drug. people who have been cured of other tumors by local therapy, such as basal cell carcinoma, squamous cell carcinoma of skin, bladder...
- 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...
- Prior treatment with a PD-(L)1 inhibitor (including antibodies, antibody-drug conjugates [ADCs], CAR-T cells, and other agents).
The study team makes the final eligibility decision.
Where it's taking place
- Chongqing, Chongqing Municipality, China
- Fuzhou, Fujian, China
- Xiamen, Fujian, China
- Zhangzhou, Fujian, China
- Dongguan, Guangdong, China
- Guangzhou, Guangdong, China
- Jiangmen, Guangdong, China
- Shaoguan, Guangdong, China
- Guilin, Guangxi, China
- Nanning, Guangxi, China
- Haikou, Hainan, China
- Changsha, Hunan, China
- Nanchang, Jiangxi, China
- Shanghai, Shanghai Municipality, China
- Chengdu, Sichuan, China
- Kunming, Yunnan, China
- Hangzhou, Zhejiang, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chongqing, Chongqing Municipality, China; Fuzhou, Fujian, China; Xiamen, Fujian, China; Zhangzhou, Fujian, China; Dongguan, Guangdong, China; Guangzhou, Guangdong, China and 11 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.