A Study of YL201 in Combination With Toripalimab and With or Without Cisplatin in Nasopharyngeal Carcinoma.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

202 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-05

Study Completion Date

2028-05-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Recurrent or Metastatic Nasopharyngeal Carcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Dose Exploration (Part 1)

To evaluate the safety and efficacy of YL201 combined with Toripalimab in subjects with recurrent or metastatic nasopharyngeal carcinoma

Group Type EXPERIMENTAL

YL201

Intervention Type DRUG

YL201 will be administered as an IV infusion

Toripalimab

Intervention Type DRUG

Toripalimab will be administered as an IV infusion

Dose Exploration (Part 2)

To evaluate the safety and efficacy of YL201 combined with Toripalimab with/without Cisplatin in subjects with recurrent or metastatic nasopharyngeal carcinoma.

Group Type EXPERIMENTAL

YL201

Intervention Type DRUG

YL201 will be administered as an IV infusion

Toripalimab

Intervention Type DRUG

Toripalimab will be administered as an IV infusion

Cisplatin

Intervention Type DRUG

Cisplatin will be administered as an IV infusion

Interventions

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YL201

YL201 will be administered as an IV infusion

Intervention Type DRUG

Toripalimab

Toripalimab will be administered as an IV infusion

Intervention Type DRUG

Cisplatin

Cisplatin will be administered as an IV infusion

Intervention Type DRUG

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Locations

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