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Recurrent or Metastatic Nasopharyngeal CarcinomaPhase 1/2NCT07258979

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

A Phase 1/2 study testing YL201, Toripalimab and Cisplatin in people with Recurrent or Metastatic Nasopharyngeal Carcinoma, run by MediLink Therapeutics (Suzhou) Co., Ltd. at 20 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
YL201, Toripalimab and Cisplatin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
202 participants
Where
20 sitesChina
Study dates
5 Nov 2025to May 2028
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 10Show fewer
  • 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.

Who cannot join

  • 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).

Trial locations and contacts

20 sites in 1 country. Contact the study team or a site near you to ask about taking part.

MediLink Study Team contact

+86 512 62858368

clinicaltrials@medilinkthera.com

20 sites in 1 country

China20 sites, 20 recruiting

  • Hunan Cancer Hospital

    Changsha, Hunan

    Study Coordinator

    Not yet recruiting

  • Sichuan Cancer Hospital

    Chengdu, Sichuan

    Study Coordinator

    Not yet recruiting

  • Chongqing University Cancer Hospital

    Chongqing, Chongqing Municipality

    Study Coordinator

    Not yet recruiting

  • Dongguan People's Hospital

    Dongguan, Guangdong

    Study Coordinator

    Not yet recruiting

  • Fujian Cancer Hospital

    Fuzhou, Fujian

    Study Coordinator

    Not yet recruiting

  • Affiliated Cancer Hospital and Institute of Guangzhou Medical University

    Guangzhou, Guangdong

    Study Coordinator

    Not yet recruiting

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong

    Study Coordinator

    Recruiting

  • The First Affiliated Hospital of Guangdong Pharmaceutical University

    Guangzhou, Guangdong

    Study Coordinator

    Not yet recruiting

  • The Second Affiliated Hospital of Guilin Medical University

    Guilin, Guangxi

    Study Coordinator

    Not yet recruiting

  • The First Affiliated Hospital of Hainan Medical University

    Haikou, Hainan

    Study Coordinator

    Not yet recruiting

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang

    Study Coordinator

    Not yet recruiting

  • Jiangmen Central Hospital

    Jiangmen, Guangdong

    Study Coordinator

    Not yet recruiting

  • Yunnan Cancer Hospital

    Kunming, Yunnan

    Study Coordinator

    Not yet recruiting

  • Jiangxi Cancer Hospital

    Nanchang, Jiangxi

    Study Coordinator

    Not yet recruiting

  • The First Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi

    Study Coordinator

    Not yet recruiting

  • Guangxi Medical University Cancer Hospital

    Nanning, Guangxi

    Study Coordinator

    Not yet recruiting

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality

    Study Coordinator

    Not yet recruiting

  • Yuebei People's Hospital

    Shaoguan, Guangdong

    Study Coordinator

    Not yet recruiting

  • The First Affiliated Hospital of Xiamen University

    Xiamen, Fujian

    Study Coordinator

    Not yet recruiting

  • Zhangzhou Municiple Hospital of Fujian Province

    Zhangzhou, Fujian

    Study Coordinator

    Not yet recruiting

Other trials in China

About this study

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.

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.

Being tested
YL201, Toripalimab, Cisplatin
Keywords
YL201, recurrent or metastatic nasopharyngeal carcinoma, Toripalimab
Medical subject headings
Recurrence, Nasopharyngeal Carcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • YL201Drug

    YL201 will be administered as an IV infusion

  • ToripalimabDrug

    Toripalimab will be administered as an IV infusion

  • CisplatinDrug

    Cisplatin will be administered as an IV infusion

Study groups in NCT07258979
Study groupRoleWhat they receive
Dose Exploration (Part 1)ExperimentalTo evaluate the safety and efficacy of YL201 combined with Toripalimab in subjects with recurrent or metastatic nasopharyngeal carcinoma
Receives: Drug: YL201; Drug: Toripalimab
Dose Exploration (Part 2)ExperimentalTo evaluate the safety and efficacy of YL201 combined with Toripalimab with/without Cisplatin in subjects with recurrent or metastatic nasopharyngeal carcinoma.
Receives: Drug: YL201; Drug: Toripalimab; Drug: Cisplatin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants Experiencing Dose-limiting toxicities (DLTs)

    Measured: Approximately within 36 months

  2. Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)

    Measured: Approximately within 36 months

  3. Progression-Free Survival (PFS) as assessed by RECIST v1.1

    Measured: Approximately within 36 months

Secondary outcomes (10)

  1. Objective Response Rate (ORR)

    Measured: Approximately within 36 months

  2. Disease Control Rate (DCR)

    Measured: Approximately within 36 months

  3. Time to Response (TTR)

    Measured: Approximately within 36 months

  4. Duration of Response (DoR)

    Measured: Approximately within 36 months

  5. Overall survival(OS)

    Measured: Approximately within 36 months

  6. Incidence of anti-drug antibodies (ADA) to YL201 (and to Toripalimab, if necessary)

    Measured: Approximately within 36 months

  7. Characterize the PK parameter AUC of YL201 and its metabolites, if applicable

    Measured: Approximately within 36 months

  8. Characterize the PK parameter Cmax of YL201 and its metabolites, if applicable

    Measured: Approximately within 36 months

  9. Characterize the PK parameter Ctrough of YL201 and its metabolites, if applicable

    Measured: Approximately within 36 months

  10. Characterize the PK parameter t1/2 of YL201 and its metabolites, if applicable

    Measured: Approximately within 36 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Dec 2025
  2. Study start5 Nov 2025
  3. Primary completionFeb 2028 (estimated)
  4. Study completionMay 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
202 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07258979
Sponsor's protocol ID
YL201-CN-105-02
Status last verified
Nov 2025
First submitted
17 Nov 2025
Last updated
2 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing YL201, Toripalimab and Cisplatin in people with Recurrent or Metastatic Nasopharyngeal Carcinoma, run by MediLink Therapeutics (Suzhou) Co., Ltd. at 20 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 2 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact MediLink Study Team (+86 512 62858368, clinicaltrials@medilinkthera.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants Experiencing Dose-limiting toxicities (DLTs) (time frame: Approximately within 36 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07258979.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2025.

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