Recurrent/ Metastatic NPCPhase 2NCT07690787
JS207 a Bispecific Antibody Against PD1-VEGF in Nasopharyngeal Carcinoma
A Phase 2 study testing JS207, Paclitaxel and Capecitabine in people with Recurrent/ Metastatic NPC, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
This study is to determine the activity and tolerability of JS207 as a single agent and in combination cohort with chemotherapy. This is an open-labelled, phase Ib/II study of JS207 in patients with previously treated recurrent or metastatic nasopharyngeal carcinoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Recurrent/ Metastatic NPC
- What is being tested?
- JS207, Paclitaxel 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
- 49 participants
- Where
- 1 siteHong Kong
- Study dates
- 29 Jun 2026to 30 Jun 2028
- Phase
- Phase 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Known histologically confirmed diagnosis of nasopharyngeal carcinoma
- Measurable disease according to RECIST ver 1.1.
- Age 18 or above and younger than 80 years old; ECOG performance 0 or 1.
- Adequate bone marrow, renal and hepatic reserve, and clotting profile:
- Absolute neutrophil count ≥ 1.5 × 10^9 /L; Platelets ≥ 90×10^9 /L; Hemoglobin > 9 g/dL.
- Serum creatinine ≤ 1.5 × ULN or calculated creatinine clearance ≥ 50 mL/min (Cockcroft-Gault formula).
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- Total bilirubin ≤ 1.5 × ULN, AST and ALT ≤ 2.5 × ULN for patients without liver metastases.
- Total bilirubin ≤ 3.0 × ULN, AST and ALT ≤ 5.0 × ULN for patients with liver metastases.
- INR and APTT ≤ 1.5 × ULN
- Electrocardiography (ECG): Friderica-corrected QT interval (QTcF): ≤470 (females) or ≤450 (males) milliseconds without a history of congenital long QT syndrome
- Urine strip test (multistix or dipstick) showing protein ≤2+; if urine protein characterization >2+, 24 h urine protein quantification is required; if 24 h urine protein quantification <1 g, it is acceptable;
- Female or male subjects of childbearing potential must agree to have no plans for childbearing and to voluntarily use highly effective contraception with their partner for the duration of the study for up to 6 months after the end of the last dose, and female subjects of childbearing potential must have a negative urine or serum pregnancy test within 7 days prior to the first dose of study medication.
- Prior treatment with PD1/PDL1 inhibitor as part of neoadjuvant treatment or concurrently with radical radiotherapy with curative intent is allowed as long as there is an interval of 6 or more months since administration of the last dose of PD1 inhibitor and more than 12 months since radical radiotherapy +/- concomitant chemotherapy.
- Prior treatment with PD1/PDL1 inhibitor for the first-line treatment of R/N NPC is allowed, as long as there is an interval of 6 or more months since administration of the last dose of PD1/PDL1 inhibitor.
Who cannot join
- Prior radical RT to the primary NPC within 12 months
- Known history of nasopharyngeal necrosis
- Presence of locoregional tumor recurrence or distant metastatic disease associated with invasion of major vascular structure(s) on imaging which may increase the risk of serious bleeding. This may include (but not limited to) regional neck recurrence invading major vascular structures or ;
- Presence of central lung lesions involving major blood vessels;
- History of clinically significant bleeding defined as Grade 2 epistaxis or Grade 3 bleeding at other sites occurring within 4 weeks prior to the first dose of study drug.
- Prior therapy with anti-vascular agents in any clinical setting, including anti-VEGF antibodies or tyrosine kinase-inhibitors targeting VEGFR.
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- Uncontrolled hypertension defined as consistently more than 150/100 mmHg despite adequate medical therapy or history of hypertensive crisis or hypertensive encephalopathy;
- Known history of hypersensitivity to any components of the study drug formulation, or other monoclonal antibodies
- Prior therapy with anti-vascular agents in any clinical setting, including anti-VEGF antibodies, tyrosine kinase-inhibitor agent targeting at VEGFR.
- Patients who are on anticoagulants.
- Presence of significant bleeding tendencies or history of severe coagulation disorders;
- Known history of nasopharyngeal necrosis
- Patients with arteriovenous thrombosis events, such as cerebrovascular accident (including temporary ischemic attack, cerebral hemorrhage, cerebral infarction), deep venous thrombosis (except venous thrombosis caused by intravenous catheterization due to early chemotherapy) and pulmonary embolism, occurred within 6 months.
- Patients with urine strip test (multi-stix or dipstick) indicating urine protein > 2+ will need a 24-hour urine protein collection. They are excluded if the 24-hour urine protein is >1.0g.
- Presence of symptomatic central nervous system metastases that require use of steroids of dose > prednisolone 10mg daily or equivalent.
- Presence of active autoimmune disease not related to prior use of PD1/PDL1 inhibitor, that require systemic therapy (e.g., use of corticosteroids or immunosuppressive medications) within 2 years prior to the first dose, including, but not limited to: systemic lupus erythematosus, multiple sclerosis, rheumatoid arthritis, inflammatory bowel disease or vasculitis. However, enrollment is allowed for patients with hypothyroidism, adrenal gland, hypophysis, or pituitary gland dysfunction, or type 1 diabetes mellitus that can be controlled with hormone replacement therapy only or vitiligo or psoriasis not requiring systemic therapy;
- History of interstitial lung disease or prior history of pneumonitis that required immunosuppressive therapy including steroids; patients with a history of Grade 1 radiation pneumonitis are eligible;
- Gastrointestinal (GI) perforation of or fistula involving internal organs or intra-abdominal or thoracic abscesses within 6 months prior to the first dose of study drug;
- Presence of severe, unhealed or open wounds, active ulcers or untreated fractures;
- Presence of significant bleeding tendencies or history of severe coagulation disorders;
- Presence of poorly controlled hypertension (systolic blood pressure ≥150 mmHg and/or diastolic blood pressure >100 mmHg) on more than 3 separate readings obtained on different days at the clinic, or history of hypertensive crisis or hypertensive encephalopathy;
- History of immunodeficiency, including a positive test for human immunodeficiency virus (HIV), or a known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;
- Have serious cardiovascular disease including, but not limited to, myocardial infarction, severe/unstable angina pectoris, myocarditis, pericarditis, congestive heart failure (NYHA cardiac function class ≥ grade 2), clinically significant supraventricular or ventricular arrhythmia requiring pharmacologic intervention, aortic aneurysm requiring surgical repair, any arterial thrombotic/embolic event, grade 3 and above (Generic for adverse events, Terminology Criteria [CTCAE 65.0) venous thrombotic/embolic event, transient ischemic attack, cerebrovascular accident;
- Active infections that require intravenous anti-infective agents within 28 days prior to the first study dose. Known active tuberculosis, uncontrolled hepatitis B (hepatitis B surface antigen [HBsAg] positive and HBV DNA above the lower limit of detection of the study center), hepatitis C (HCV Ab positive and HCV RNA above the lower limit of detection of the study center);
- History of another primary malignancy, except for malignancies that were radically treated with curative intent prior to the first dose of study intervention and there is no known active disease (more than 5 years, no time limit for dose-escalation phase patients) and a low risk of potential recurrence (e.g., basal cell carcinoma of the skin and squamous cell carcinoma of the skin, which have been treated with potentially curative therapy);
- Major surgery (excluding placement of central vascular access), radiotherapy within 28 days prior to the first dose (palliative radiotherapy for localized non-target lesions is allowed as long as there is a 14-day washout prior to the day 1 of starting study treatment).
- Any live or live attenuated vaccine within 28 days prior to the first dose, or the need for a live or live attenuated vaccine is anticipated during the study;
- Use of antiplatelet therapy including aspirin, adenosine diphosphate (ADP) receptor inhibitors (e.g., clopidogrel), adenosine reuptake inhibitors (e.g., dipyridamole), glycoprotein platelet inhibitors (abciximab), phosphodiesterase inhibitors (cilostazol), and protease-activated receptor (PAR-1) antagonist (vorapaxar), administered for therapeutic purposes within 10 days prior to the first dose;
- Breastfeeding women;
- Presence of other serious physical or mental illnesses, abnormal laboratory tests, or other conditions that may increase the risk of participation in the study, affect treatment compliance, or interfere with the results of the study, and which the investigator considers not suitable for participation in this study;
- Specific exclusion criteria for phase II component:
- Patients with any prior grade 2 or higher autoimmune toxicities that are directly related to PD1/PDL1 inhibitor that required the use of immunosuppressive agents including steroids (at dose of > prednisolone 10mg daily dose or equivalent dose of other steroids). This may include but not limited to grade 2 or higher autoimmune pneumonitis, hepatitis, pancreatitis, nephritis, myocarditis, neurological, myositis, skin toxicity and hypophysitis.
- Patients with immune-checkpoint inhibitor related autoimmune thyroid and adrenal insufficiency who are clinically stable on hormonal replacement are not excluded.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site, 1 recruiting
- Recruiting
Department of Clinical Oncology, Prince of Wales Hospital
Hong Kong
About this study
Official title: Phase I-II Study of JS207 a Bispecific Antibody Against PD1-VEGF in the Treatment of Recurrent/Metastatic Nasopharyngeal Carcinoma
This study is to determine the activity and tolerability of JS207 as a single agent and in combination cohort with chemotherapy. This is an open-labelled, phase Ib/II study of JS207 in patients with previously treated recurrent or metastatic nasopharyngeal carcinoma. The study will comprise of two phases:
- Phase 1b monotherapy: Consisting of a dose escalation and then expansion phase in patients with recurrent/ metastatic (R/M) NPC, who have failed at least 1 prior line of platinum-based chemotherapy, with or without prior treatment with PD1/ PDL1 inhibitor.
- Randomized phase II: Combination of JS207 with capecitabine or paclitaxel in platinum-refractory patients: Patients who have failed one prior line of platinum-based chemotherapy for R/M NPC will be treated with JS207 in combination with capecitabine.
As phase I portion of the study was completed, the starting dose of JS207 for phase II portion will be 10mg/kg IV every 3 weeks.
- Conditions
- Recurrent/ Metastatic NPC
- Being tested
- JS207, Paclitaxel, Capecitabine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JS207Drug
10mg/kg IV every 3 weeks
PaclitaxelDrug
135 mg/m² b.d. IV at 3-weekly cycle until disease progression or intolerance
CapecitabineDrug
1000 mg/m² b.d. orally from days 1 to 14 at 3-weekly cycle until disease progression or intolerance
| Study group | Role | What they receive |
|---|---|---|
| JS207 + capecitabine combination therapy | Experimental | Not described Receives: Drug: JS207; Drug: Capecitabine |
| JS207 + paclitaxel combination therapy | Experimental | Not described Receives: Drug: JS207; Drug: Paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (ORR)
The proportion of patients with complete response (CR) or partial response (PR) according to RECIST v1.1.
Measured: 2 years
Secondary outcomes (4)
Progression-free survival (PFS)
The time from treatment initiation to disease progression or death from any cause
Measured: 2 years
Overall survival (OS)
The survival time until death from any cause
Measured: 2 years
Duration of response (DoR)
The time from the first evidence of response to disease progression or death
Measured: 2 years
Site of tumour progression at disease progression
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2026
- Study start29 Jun 2026
- Primary completion31 Dec 2027 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent/ Metastatic NPCStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 49 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brigette Ma, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07690787
- Sponsor's protocol ID
- NPC040
- Status last verified
- Jul 2026
- First submitted
- 2 Jul 2026
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I-II Study of JS207 a Bispecific Antibody Against PD1-VEGF in the Treatment of Recurrent/Metastatic Nasopharyngeal Carcinoma
- ClinicalTrials.gov ID
- NCT07690787
- Acronym / sponsor ID
- NPC040
- Conditions
- Recurrent/ Metastatic NPC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 49 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 29 Jun 2026 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 8 Jul 2026 (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 is to determine the activity and tolerability of JS207 as a single agent and in combination cohort with chemotherapy. This is an open-labelled, phase Ib/II study of JS207 in patients with previously treated recurrent or metastatic nasopharyngeal carcinoma. The study will comprise of two phases:
- Phase 1b monotherapy: Consisting of a dose escalation and then expansion phase in patients with recurrent/ metastatic (R/M) NPC, who have failed at least 1 prior line of platinum-based chemotherapy, with or without prior treatment with PD1/ PDL1 inhibitor.
- Randomized phase II: Combination of JS207 with capecitabine or paclitaxel in platinum-refractory patients: Patients who have failed one prior line of platinum-based chemotherapy for R/M NPC will be treated with JS207 in combination with capecitabine.
As phase I portion of the study was completed, the starting dose of JS207 for phase II portion will be 10mg/kg IV every 3 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| JS207 + capecitabine combination therapy | Experimental | Drug: JS207, Drug: Capecitabine |
| JS207 + paclitaxel combination therapy | Experimental | Drug: JS207, Drug: Paclitaxel |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Known histologically confirmed diagnosis of nasopharyngeal carcinoma
- Measurable disease according to RECIST ver 1.1.
- Age 18 or above and younger than 80 years old; ECOG performance 0 or 1.
- Adequate bone marrow, renal and hepatic reserve, and clotting profile:
- Urine strip test (multistix or dipstick) showing protein ≤2+; if urine protein characterization >2+, 24 h urine protein quantification is required; if 24 h urine protein quantification <1 g, it is acceptable;
Key exclusion criteria (33 listed)
- Prior radical RT to the primary NPC within 12 months
- Known history of nasopharyngeal necrosis
- Presence of locoregional tumor recurrence or distant metastatic disease associated with invasion of major vascular structure(s) on imaging which may increase the risk of serious bleeding. This may include (but not limited to) regional neck recurrence invading major vascular structures or ;
- Presence of central lung lesions involving major blood vessels;
- History of clinically significant bleeding defined as Grade 2 epistaxis or Grade 3 bleeding at other sites occurring within 4 weeks prior to the first dose of study drug.
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 |
|---|---|---|
| JS20710mg/kg IV every 3 weeks | Drug | JS207 + capecitabine combination therapy, JS207 + paclitaxel combination therapy |
| Paclitaxel135 mg/m² b.d. IV at 3-weekly cycle until disease progression or intolerance | Drug | JS207 + paclitaxel combination therapy |
| Capecitabine1000 mg/m² b.d. orally from days 1 to 14 at 3-weekly cycle until disease progression or intolerance | Drug | JS207 + capecitabine combination therapy |
Primary outcome
Objective response rate (ORR)
Time frame: 2 years
The proportion of patients with complete response (CR) or partial response (PR) according to RECIST v1.1.
4 secondary outcomes
Progression-free survival (PFS)
Time frame: 2 years
Overall survival (OS)
Time frame: 2 years
Duration of response (DoR)
Time frame: 2 years
Site of tumour progression at disease progression
Time frame: 2 years
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 13 Jul 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing JS207, Paclitaxel and Capecitabine in people with Recurrent/ Metastatic NPC, run by Chinese University of Hong Kong at 1 site in Hong Kong.
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 14 inclusion and 33 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 13 Jul 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 Hong Kong. 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 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 Brigette BY MA, MBBS, MD (852 3505 1042, brigette@clo.cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (ORR) (time frame: 2 years). 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 13 Jul 2026.