Nasopharyngeal CarcinomaPhase 3NCT06629597
A Phase III Study of YL201 in Recurrent or Metastatic Nasopharyngeal Carcinoma (TAISHAN-301)
A Phase 3 study testing YL201, Docetaxel and Capecitabine in people with Nasopharyngeal Carcinoma, run by MediLink Therapeutics (Suzhou) Co., Ltd. at 1 site in China.
Trial summary
This study was designed to compare the efficacy and safety of YL201 with Investigator's choice of chemotherapy in subjects with recurrent or metastatic nasopharyngeal carcinoma who have failed prior PD-(L)1 inhibitor and at least two lines of chemotherapy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Nasopharyngeal Carcinoma
- What is being tested?
- YL201, Docetaxel and Capecitabine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- 31 Dec 2024to 1 Dec 2028
- Phase
- Phase 3
- 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.
- Histologically or cytologically confirmed recurrent or metastatic nasopharyngeal carcinoma that is not amenable to curative treatment.
- Have failed prior treatment with PD-(L)1 inhibitors and at least two lines of chemotherapy.
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- Suitable for treatment with investigator's choice of chemotherapy (docetaxel, capecitabine, or gemcitabine).
- At least one measurable lesion according to RECIST v1.1.
- Subjects are willing to provide the archived or freshly obtained tumor tissue (freshly obtained or archived) for detection of B7-H3 expression
- 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.
- Previously received B7-H3-targeted drug therapy, including antibody, antibody-drug conjugate (ADC), and chimeric antigen receptor T cell (CAR-T).
- Prior treatment with a topoisomerase I inhibitor or an antibody-drug conjugate containing a topoisomerase I inhibitor.
- Inadequate washout period for prior anti-tumor treatment before the first dose of study drug.
- Received radical radiotherapy within 4 weeks prior to the first dose of study drug; local palliative radiation for symptom control is allowed, but treatment must be completed at least 2 weeks prior to the first dose of study drug, and there is no plan for additional radiotherapy to the same lesion.
- Received systemic steroids or other immunosuppressive therapy within 2 weeks before the first dose of study drug.
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- Received any live vaccine within 4 weeks before the first dose of study drug or intend to receive a live vaccine during the study.
- Presence of brain stem or meningeal metastases, spinal cord metastases or compression.
- Presence of central nervous system (CNS) metastasis. Participants with treated brain metastases are eligible if the metastases are asymptomatic and stable, and no immediate local or systemic treatment is needed within 2 weeks before the first dose.
- Has an uncontrolled concurrent disease.
- Presence of severe uncontrolled cardiovascular disorder.
- History of interstitial lung disease (ILD) or pneumonitis that required corticosteroids, or current ILD/ pneumonitis.
- Concomitant pulmonary disorder leading to clinically severe respiratory impairment.
- Chronic autoimmune or inflammatory diseases requiring systemic therapy within 2 years prior to the first dose or currently receiving systemic therapy.
- Clinical symptoms of pleural effusion, pericardial effusion, or ascites or requiring relevant repeated drainage.
- Serious infections within 4 weeks prior to the first dose.
- Known active pulmonary tuberculosis (TB).
- Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
- Unresolved toxicities from previous antitumor therapy.
- Known allergy to any component of the study drug; history of severe allergic reactions or known history of severe hypersensitivity to other monoclonal antibodies or recombinant proteins, or history of severe infusion reactions.
- Pregnancy, breastfeeding, or women planning to become pregnant or breastfeed during the study.
- Any illness, medical condition, organ system dysfunction, or social situation deemed by the investigator to be likely to interfere with a subject's ability to sign ICF, adversely affect the subject's ability to cooperate and participate in the study, or compromise the interpretation of study results.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Controlled, Multicenter Phase III Clinical Study of YL201 Versus Investigator's Choice of Chemotherapy in Subjects With Recurrent or Metastatic Nasopharyngeal Carcinoma Who Have Failed Prior PD-(L)1 Inhibitor and at Least Two Lines of Chemotherapy
This study was designed to compare the efficacy and safety of YL201 with Investigator's choice of chemotherapy in subjects with recurrent or metastatic nasopharyngeal carcinoma who have failed prior PD-(L)1 inhibitor and at least two lines of chemotherapy.
Read the detailed description
The primary objective of this study is to assess whether treatment with YL201 prolongs overall survival (OS) and increases objective response rate (ORR) by blinded independent central review (BICR) compared with treatment of investigator's choice of chemotherapy among subjects with recurrent or metastatic nasopharyngeal carcinoma.
The secondary objectives of the study are to further evaluate the efficacy, safety, pharmacokinetics, and immunogenicity of YL201, and the correlation between B7-H3 expression level and the efficacy of YL201.
- Conditions
- Nasopharyngeal Carcinoma
- Being tested
- YL201, Docetaxel, Capecitabine, Gemcitabine
- Medical subject headings
- 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 intravenously on Day 1 of each 3-week cycle at RP3D dose level.
DocetaxelDrug
Docetaxel will be administered intravenously at 75 mg/m2 on Day 1 of each 3-week cycle.
CapecitabineDrug
Capecitabine will be administered orally at 1000 mg/m2 twice a day (BID) on Days 1 to 14 of each 3-week cycle
GemcitabineDrug
Gemcitabine will be administered intravenously at 1000 mg/m2 on Day 1 and 8 of each 3-week cycle
| Study group | Role | What they receive |
|---|---|---|
| YL201 | Experimental | Participants are randomized to receive YL201 monotherapy intravenously on Day 1 of each 3-week cycle at RP3D dose level, until progressive disease (PD), unacceptable toxicity, or withdrawal of consent as specified in the protocol. Receives: Drug: YL201 |
| Investigator's choice of chemotherapy, including docetaxel, capecitabine, or gemcitabine | Active comparator | Participants are randomized to receive docetaxel/capecitabine/gemcitabine every 3 weeks per prescribing information, until PD, unacceptable toxicity, or withdrawal of consent as specified in the protocol. Receives: Drug: Docetaxel; Drug: Capecitabine; Drug: Gemcitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the ORR of YL201 versus investigator's choice of chemotherapy in recurrent or metastatic nasopharyngeal carcinoma assessed by BICR based on Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).
ORR is defined as the proportion of subjects who achieve a best overall response (BOR) of complete response (CR) or partial response (PR).
Measured: Approximately within 36 months
To compare the OS of YL201 versus investigator's choice of chemotherapy in recurrent or metastatic nasopharyngeal carcinoma.
OS defined as the time interval from the randomization to death from any cause.
Measured: Approximately within 36 months
Secondary outcomes (14)
To compare the ORR of YL201 versus investigator's choice of chemotherapy in recurrent or metastatic nasopharyngeal carcinoma assessed by Investigator.
ORR is defined as the proportion of subjects who achieve a best overall response (BOR) of complete response (CR) or partial response (PR).
Measured: Approximately within 36 months
To compare the PFS of YL201 versus investigator's choice of chemotherapy in recurrent or metastatic nasopharyngeal carcinoma assessed by BICR and Investigator.
PFS defined as the time interval from randomization to the first documented PD or death due to any cause, whichever occurs first.
Measured: Approximately within 36 months
To compare the DOR of YL201 versus investigator's choice of chemotherapy in subjects with recurrent or metastatic nasopharyngeal carcinoma assessed by BICR and Investigator.
DOR defined as the time interval from the first documentation of response (CR or PR) to the first documentation of PD or death, whichever occurred first.
Measured: Approximately within 36 months
To compare the DCR of YL201 versus investigator's choice of chemotherapy in subjects with recurrent or metastatic nasopharyngeal carcinoma assessed by BICR and Investigator.
DCR is defined as the proportion of subjects with a BOR of CR, PR, or stable disease (SD).
Measured: Approximately within 36 months
To compare the TTR of YL201 versus investigator's choice of chemotherapy in subjects with recurrent or metastatic nasopharyngeal carcinoma assessed by BICR and Investigator.
TTR is defined as the time interval from randomization to the first documentation of response (CR or PR).
Measured: Approximately within 36 months
Evaluate the incidence and severity of adverse events (AEs) of YL201
AEs are assessed based on NCI CTCAE v5.0.
Measured: Approximately within 36 months
Characterize the PK parameter AUC
Measured: Approximately within 36 months
Characterize the PK parameter Cmax
Measured: Approximately within 36 months
Characterize the PK parameter Ctrough
Measured: Approximately within 36 months
Characterize the PK parameter CL
Measured: Approximately within 36 months
Characterize the PK parameter Vd
Measured: Approximately within 36 months
Characterize the PK parameter t1/2
Measured: Approximately within 36 months
Assessment of the number of subjects who are Anti-Drug Antibody (ADA)-positive at any time and who have a treatment-emergent ADA.
Measured: Approximately within 36 months
Assessment of B7H3 expression level in tumor tissue and the correlation between the expression level and the efficacy of YL201.
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.
- First posted8 Oct 2024
- Study start31 Dec 2024
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasopharyngeal CarcinomaStudies of the same condition, open and under way.
- More trials run by MediLink Therapeutics (Suzhou) Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MediLink Therapeutics (Suzhou) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06629597
- Sponsor's protocol ID
- YL201-CN-301-01
- Status last verified
- Sep 2026
- First submitted
- 24 Sep 2024
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled, Multicenter Phase III Clinical Study of YL201 Versus Investigator's Choice of Chemotherapy in Subjects With Recurrent or Metastatic Nasopharyngeal Carcinoma Who Have Failed Prior PD-(L)1 Inhibitor and at Least Two Lines of Chemotherapy
- ClinicalTrials.gov ID
- NCT06629597
- Acronym / sponsor ID
- YL201-CN-301-01
- Conditions
- Nasopharyngeal Carcinoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- MediLink Therapeutics (Suzhou) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 31 Dec 2024 (actual)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 1 Dec 2028 (estimated)
- First posted
- 8 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study was designed to compare the efficacy and safety of YL201 with Investigator's choice of chemotherapy in subjects with recurrent or metastatic nasopharyngeal carcinoma who have failed prior PD-(L)1 inhibitor and at least two lines of chemotherapy.
Detailed description
The primary objective of this study is to assess whether treatment with YL201 prolongs overall survival (OS) and increases objective response rate (ORR) by blinded independent central review (BICR) compared with treatment of investigator's choice of chemotherapy among subjects with recurrent or metastatic nasopharyngeal carcinoma.
The secondary objectives of the study are to further evaluate the efficacy, safety, pharmacokinetics, and immunogenicity of YL201, and the correlation between B7-H3 expression level and the efficacy of YL201.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| YL201 | Experimental | Drug: YL201Participants are randomized to receive YL201 monotherapy intravenously on Day 1 of each 3-week cycle at RP3D dose level, until progressive disease (PD), unacceptable toxicity, or withdrawal of consent as specified in the protocol. |
| Investigator's choice of chemotherapy, including docetaxel, capecitabine, or gemcitabine | Active comparator | Drug: Docetaxel, Drug: Capecitabine, Drug: GemcitabineParticipants are randomized to receive docetaxel/capecitabine/gemcitabine every 3 weeks per prescribing information, until PD, unacceptable toxicity, or withdrawal of consent as specified in the protocol. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
- Histologically or cytologically confirmed recurrent or metastatic nasopharyngeal carcinoma that is not amenable to curative treatment.
Key exclusion criteria (22 listed)
- 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.
- Previously received B7-H3-targeted drug therapy, including antibody, antibody-drug conjugate (ADC), and chimeric antigen receptor T cell (CAR-T).
- Prior treatment with a topoisomerase I inhibitor or an antibody-drug conjugate containing a topoisomerase I inhibitor.
- Inadequate washout period for prior anti-tumor treatment before the first dose of study drug.
- Received radical radiotherapy within 4 weeks prior to the first dose of study drug; local palliative radiation for symptom control is allowed, but treatment must be completed at least 2 weeks prior to the first dose of study drug, and there is no plan for additional radiotherapy to the same lesion.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| YL201YL201 will be administered intravenously on Day 1 of each 3-week cycle at RP3D dose level. | Drug | YL201 |
| DocetaxelDocetaxel will be administered intravenously at 75 mg/m2 on Day 1 of each 3-week cycle. | Drug | Investigator's choice of chemotherapy, including docetaxel, capecitabine, or gemcitabine |
| CapecitabineCapecitabine will be administered orally at 1000 mg/m2 twice a day (BID) on Days 1 to 14 of each 3-week cycle | Drug | Investigator's choice of chemotherapy, including docetaxel, capecitabine, or gemcitabine |
| GemcitabineGemcitabine will be administered intravenously at 1000 mg/m2 on Day 1 and 8 of each 3-week cycle | Drug | Investigator's choice of chemotherapy, including docetaxel, capecitabine, or gemcitabine |
Primary outcome
To compare the ORR of YL201 versus investigator's choice of chemotherapy in recurrent or metastatic nasopharyngeal carcinoma assessed by BICR based on Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).
Time frame: Approximately within 36 months
ORR is defined as the proportion of subjects who achieve a best overall response (BOR) of complete response (CR) or partial response (PR).
To compare the OS of YL201 versus investigator's choice of chemotherapy in recurrent or metastatic nasopharyngeal carcinoma.
Time frame: Approximately within 36 months
OS defined as the time interval from the randomization to death from any cause.
14 secondary outcomes
To compare the ORR of YL201 versus investigator's choice of chemotherapy in recurrent or metastatic nasopharyngeal carcinoma assessed by Investigator.
Time frame: Approximately within 36 months
To compare the PFS of YL201 versus investigator's choice of chemotherapy in recurrent or metastatic nasopharyngeal carcinoma assessed by BICR and Investigator.
Time frame: Approximately within 36 months
To compare the DOR of YL201 versus investigator's choice of chemotherapy in subjects with recurrent or metastatic nasopharyngeal carcinoma assessed by BICR and Investigator.
Time frame: Approximately within 36 months
To compare the DCR of YL201 versus investigator's choice of chemotherapy in subjects with recurrent or metastatic nasopharyngeal carcinoma assessed by BICR and Investigator.
Time frame: Approximately within 36 months
To compare the TTR of YL201 versus investigator's choice of chemotherapy in subjects with recurrent or metastatic nasopharyngeal carcinoma assessed by BICR and Investigator.
Time frame: Approximately within 36 months
Evaluate the incidence and severity of adverse events (AEs) of YL201
Time frame: Approximately within 36 months
Characterize the PK parameter AUC
Time frame: Approximately within 36 months
Characterize the PK parameter Cmax
Time frame: Approximately within 36 months
Characterize the PK parameter Ctrough
Time frame: Approximately within 36 months
Characterize the PK parameter CL
Time frame: Approximately within 36 months
Characterize the PK parameter Vd
Time frame: Approximately within 36 months
Characterize the PK parameter t1/2
Time frame: Approximately within 36 months
Assessment of the number of subjects who are Anti-Drug Antibody (ADA)-positive at any time and who have a treatment-emergent ADA.
Time frame: Approximately within 36 months
Assessment of B7H3 expression level in tumor tissue and the correlation between the expression level and the efficacy of YL201.
Time frame: Approximately within 36 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing YL201, Docetaxel and Capecitabine in people with Nasopharyngeal Carcinoma, run by MediLink Therapeutics (Suzhou) Co., Ltd. at 1 site 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 22 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: under way, not looking for participants, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To compare the ORR of YL201 versus investigator's choice of chemotherapy in recurrent or metastatic nasopharyngeal carcinoma assessed by BICR based on Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1). (time frame: Approximately within 36 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Sep 2026.