A Phase III Study of YL201 in Recurrent or Metastatic Nasopharyngeal Carcinoma
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
1 other identifier
interventional
400
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Dec 2024
Typical duration for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 24, 2024
CompletedFirst Posted
Study publicly available on registry
October 8, 2024
CompletedStudy Start
First participant enrolled
December 31, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2028
February 10, 2025
November 1, 2024
2.9 years
September 24, 2024
February 6, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
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).
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.
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.
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.
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.
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.
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.
Approximately within 36 months
- +9 more secondary outcomes
Study Arms (2)
YL201
EXPERIMENTALParticipants 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 COMPARATORParticipants 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.
Interventions
YL201 will be administered intravenously on Day 1 of each 3-week cycle at RP3D dose level.
Docetaxel will be administered intravenously at 75 mg/m2 on Day 1 of each 3-week cycle.
Capecitabine will be administered orally at 1000 mg/m2 twice a day (BID) on Days 1 to 14 of each 3-week cycle
Gemcitabine will be administered intravenously at 1000 mg/m2 on Day 1 and 8 of each 3-week cycle
Eligibility Criteria
You may qualify 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.
- 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.
- 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.
You may not qualify if:
- 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.
- 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.
- +7 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510000, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 24, 2024
First Posted
October 8, 2024
Study Start
December 31, 2024
Primary Completion (Estimated)
December 1, 2027
Study Completion (Estimated)
December 1, 2028
Last Updated
February 10, 2025
Record last verified: 2024-11