Nasopharyngeal Carcinoma (NPC)Phase 2AK112NCT07565389
Evaluating Ivonescimab in PD-1 Resistant Recurrent or Metastatic Nasopharyngeal Carcinoma
A Phase 2 study testing Ivonescimab 20 mg/kg in people with Nasopharyngeal Carcinoma (NPC), run by National University Hospital, Singapore at 1 site in Singapore.
Trial summary
This study is designed as a single-arm, open-label, phase II trial to evaluate the efficacy and safety of ivonescimab in patients with recurrent or metastatic nasopharyngeal carcinoma (NPC) who have progressed on prior an immune checkpoint inhibitor and platinum-based chemotherapy. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Nasopharyngeal Carcinoma (NPC)
- What is being tested?
- Ivonescimab 20 mg/kg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteSingapore
- Study dates
- May 2026to May 2031
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participant is eligible to be included in the study only if all the following criteria are met:
- The participant (or legally acceptable representative if applicable) provides written consent for the trial.
- Participant is at least 21 years of age on the day of signing informed consent
- Has a locally or centrally determined histologically or cytologically confirmed diagnosis of Epstein Barr Virus (EBV)-positive nasopharyngeal carcinoma Note: The EBV status is to be determined by the EBV-encoded small RNA in situ hybridization (EBER in situ hybridization [ISH]) assay. If EBV-positive status has been previously determined by EBER ISH assay, then no re-testing is required. If EBV status by EBER ISH assay has not been previously determined, tumour tissue from archival tissue may be submitted for EBV determination.
- Has recurrent or metastatic (R/M) disease not amenable to curative local therapy (surgery or radiation)
- Must have seen at least 1 prior line of systemic treatment and has progressed on prior platinum-based chemotherapy and anti-PD1 therapy in the R/M setting OR Progressed within 6 months of previous multimodal therapy containing platinum-based chemotherapy and anti-PD1 therapy in the locally advanced setting.
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- Has measurable disease based on iRECIST.
- Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Has an adequate organ function as defined in the following table (table 1). Specimens must be collected within 10 days prior to the start of study treatment
- Willing to provide blood and tumour tissue samples (newly obtained biopsy if clinically feasible or archival specimen) to support exploratory biomarker analysis.
Who cannot join
- Participant is excluded from the study if ANY of the following criteria apply:
- Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to first dose of study treatment.
- Has prior anti-angiogenic therapy in the R/M setting or within 6 months as part of multimodality therapy in the locally advanced setting. [Applies to cohort A only]
- Has tumour that encases major arteries which in the opinion of the investigator carries high risk of vessel wall dehiscence.
- Has a condition requiring systemic steroid therapy (> 10 mg daily prednisone equivalents) or any other form of immunosuppressive therapy within 14 days prior to the first dose of trial treatment.
- Note: Inhaled or topical steroids and adrenal replacement doses <10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease. Patients are permitted to use topical, ocular, intra-articular, intranasal, and inhalational corticosteroids (with minimal systemic absorption). Physiologic replacement doses of systemic corticosteroids are permitted if < or = 10 mg/day prednisone equivalents. A brief course of corticosteroids for prophylaxis (e.g., contrast dye allergy) or for treatment of non-autoimmune conditions (e.g., delayed-type hypersensitivity reaction caused by contact allergen) is permitted.
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- Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs).
- Note: Replacement therapy (e.g. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc) is not considered a form of systemic treatment.
- Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis.
- Has hypersensitivity to ivonescimab or any of its components.
- Has a known additional malignancy that is progressing or has required active treatment within the past 3 years.
- Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, transitional cell carcinoma of urothelial cancer, or carcinoma in situ (e.g. breast or cervical carcinoma in situ) that have undergone potentially curative therapy are not excluded.
- Has an active infection requiring systemic therapy, or serious non-healing wound, ulcer or bone fracture.
- Uncontrolled hypertension (failure of diastolic blood pressure to fall below 90 mmHg, despite the use of ≥ 3 anti-hypertensive drugs or systolic blood pressure greater than 150 mmHg).
- Recent cardiovascular thromboembolic event, such as the following:
- Cardiac chest pain, defined as moderate pain that limits instrumental activities of daily living, ≤ 4 weeks before enrolment
- Symptomatic pulmonary embolism ≤ 4 weeks before enrolment
- Any history of acute myocardial infarction ≤ 6 months before enrolment
- Any history of heart failure meeting New York Heart Association (NYHA) Classification III or IV (Appendix 4) ≤ 6 months before enrolment
- Any event of ventricular arrhythmia ≥ Grade 2 in severity ≤ 6 months before enrolment
- Any history of cerebrovascular accident ≤ 6 months before enrolment
- Persistent proteinuria of NCI-CTCAE Grade 3 or higher (> 3.5 g/24 hours, measured by urine protein/creatinine ratio on a random urine sample).
- Clinically significant bleeding (NCI-CTCAE Grade 3 or higher) within 30 days prior to start of study medication.
- Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
- Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
- Is pregnant, breastfeeding or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through 120 days after the last dose of trial treatment.
- A woman of childbearing potential (WOCBP) who has a positive urine pregnancy test within 72 hours prior to randomization/allocation (see Appendix 3). If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
- Note: If 72 hours have elapsed between the screening pregnancy test and the first dose of study treatment, another pregnancy test (urine or serum) must be performed and must be negative for subject to start receiving study medication.
- Has a known history of Human Immunodeficiency Virus (HIV). Note: No HIV testing is required unless mandated by local health authority.
- Known active Hepatitis B (defined as hepatitis B viral load detected) or Hepatitis C virus (defined as HCV RNA [qualitative] detected) infection. Patients on anti-virals but with undetectable Hepatitis B or C viral loads are not excluded.
- Note: No testing for Hepatitis B and Hepatitis C is required unless mandated by local health authority.
- History of having received a live virus vaccination (e.g., yellow fever, MMR, nasal flu, chicken pox or Zostavax) within 4 weeks prior to the first dose of trial treatment. Note: Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however intranasal influenza vaccines (e.g., Flu-Mist®) are live attenuated vaccines and are not allowed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Singapore1 site
National University Cancer Institute, Singapore, National University Health System
Singapore
Wan Qin Chong, 69082222, wan_qin_chong@nuhs.edu.sg
About this study
Official title: Phase II Open-label Study Evaluating Ivonescimab in PD-1 Resistant Recurrent or Metastatic Nasopharyngeal Carcinoma
This study is designed as a single-arm, open-label, phase II trial to evaluate the efficacy and safety of ivonescimab in patients with recurrent or metastatic nasopharyngeal carcinoma (NPC) who have progressed on prior an immune checkpoint inhibitor and platinum-based chemotherapy.
Read the detailed description
Participants will receive intravenous ivonescimab at a dose of 20 mg/kg administered every 3 weeks until disease progression, intolerable toxicities, or withdrawal from the study. All study treatments will be administered in an outpatient setting.
Participants will undergo clinical assessments every 3 weeks during the treatment period. Imaging assessments will be conducted every 6 weeks (±7 days) for the first 24 weeks of treatment, followed by every 9 weeks (±7 days) thereafter, continuing until treatment discontinuation.
- Conditions
- Nasopharyngeal Carcinoma (NPC)
- Being tested
- Ivonescimab 20 mg/kg
- Keywords
- Ivonescimab
- Medical subject headings
- Nasopharyngeal Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ivonescimab 20 mg/kgDrug
Subjects will receive intravenous ivonescimab at a dose of 20 mg/kg administered every 3 weeks until disease progression, intolerable toxicities, or withdrawal from the study.
| Study group | Role | What they receive |
|---|---|---|
| Cohort A & B | Experimental | We plan to enrol 32 patients with R/M NPC and who had failed prior platinum-based chemotherapy and anti-PD1 therapy in this study from (Cohort A) and we will have an additional cohort B consisting of 10 patients with R/M NPC and who had failed prior platinum-based chemotherapy, PD1-inhibitor and anti-angiogenic therapy. Receives: Drug: Ivonescimab 20 mg/kg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR)
Objective Response Rate (ORR), defined as the proportion of patients with a confirmed complete response (CR) or partial response (PR) as assessed by investigator review using iRECIST
Measured: Best response at 1 year
Secondary outcomes (8)
Progression-Free Survival (PFS)
defined as time from first dose of ivonescimab to documented disease progression or death from any cause, whichever occurs first, as assessed by iRECIST.
Measured: 3 years
Overall Survival (OS)
defined as time from first dose of ivonescimab to death from any cause.
Measured: 3 years
Duration of Response (DoR)
defined as time from the first documentation of objective response (Complete response or Partial response) to disease progression or death.
Measured: 3 years
Disease Control Rate (DCR)
defined as the proportion of patients achieving Complete Response (CR) + Partial Response (PR) + Stable disease for at least 12 weeks.
Measured: 3 years
Incidence, nature, and severity of adverse events (AEs) and serious adverse events (SAEs)
Incidence, nature, and severity of adverse events (AEs) and serious adverse events (SAEs) graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0.
Measured: from enrolment till 3 months after end of treatment
Frequency and proportion of treatment-related adverse events (TRAEs)
Treatment-related adverse events (TRAEs) graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0.
Measured: from enrolment till 3 months after end of treatment
Incidence of immune-related adverse events (irAEs)
Events will be identified based on clinical assessment and investigator attribution, summarized by type, frequency, and proportion of affected participants, and graded for severity according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), version 5.0.
Measured: from enrolment till 3 months after end of treatment
Rates of dose delays, modifications, or treatment discontinuations due to adverse events.
Measures how many participants had their treatment delayed, adjusted, or stopped completely because of treatment side effects.
Measured: from enrolment till 3 months after end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2026
- Study startMay 2026 (estimated)
- Primary completionMay 2031 (estimated)
- Study completionMay 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Nasopharyngeal Carcinoma (NPC)Studies of the same condition, open and under way.
- More trials run by National University Hospital, SingaporeThe 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
- Not applicable
- Intervention model
- Single group
- Model description
- This study is designed as a single-arm, open-label, phase II trial to evaluate the efficacy and safety of ivonescimab in patients with recurrent or metastatic nasopharyngeal carcinoma (NPC) who have progressed on prior an immune checkpoint inhibitor and platinum-based chemotherapy.
- Masking
- None (open label)
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National University Hospital, Singapore
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wan Qin Chong, Principal investigator, National University Hospital, Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07565389
- Sponsor's protocol ID
- 2025-1970
- Acronym
- AK112
- Status last verified
- Feb 2026
- First submitted
- 9 Mar 2026
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual patient data will be available, including data dictionaries and all clinical data collected in the conduct of the trial, in a deidentified format. These will be available beginning 3 months after Article publication with no end date. other researchers should submit requests for access to the patient-level data to the corresponding author, including a proposal outlining their reasons for required data. Following a signed data access agreement, the data will be made available by a link sent from the corresponding author to the requester.
Publications
Wei WI, Sham JS. Nasopharyngeal carcinoma. Lancet. 2005 Jun 11-17;365(9476):2041-54. doi: 10.1016/S0140-6736(05)66698-6.
PubMed 15950718Petersson F. Nasopharyngeal carcinoma: a review. Semin Diagn Pathol. 2015 Jan;32(1):54-73. doi: 10.1053/j.semdp.2015.02.021. Epub 2015 Feb 25.
PubMed 25769204
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Open-label Study Evaluating Ivonescimab in PD-1 Resistant Recurrent or Metastatic Nasopharyngeal Carcinoma
- ClinicalTrials.gov ID
- NCT07565389
- Acronym / sponsor ID
- AK112 / 2025-1970
- Conditions
- Nasopharyngeal Carcinoma (NPC)
- Keywords
- Ivonescimab
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- National University Hospital, SingaporeUniversity, hospital or other
- Study start
- May 2026 (estimated)
- Primary completion
- May 2031 (estimated)
- Study completion
- May 2031 (estimated)
- First posted
- 4 May 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 designed as a single-arm, open-label, phase II trial to evaluate the efficacy and safety of ivonescimab in patients with recurrent or metastatic nasopharyngeal carcinoma (NPC) who have progressed on prior an immune checkpoint inhibitor and platinum-based chemotherapy.
Detailed description
Participants will receive intravenous ivonescimab at a dose of 20 mg/kg administered every 3 weeks until disease progression, intolerable toxicities, or withdrawal from the study. All study treatments will be administered in an outpatient setting.
Participants will undergo clinical assessments every 3 weeks during the treatment period. Imaging assessments will be conducted every 6 weeks (±7 days) for the first 24 weeks of treatment, followed by every 9 weeks (±7 days) thereafter, continuing until treatment discontinuation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This study is designed as a single-arm, open-label, phase II trial to evaluate the efficacy and safety of ivonescimab in patients with recurrent or metastatic nasopharyngeal carcinoma (NPC) who have progressed on prior an immune checkpoint inhibitor and platinum-based chemotherapy.
| Arm | Type | Receives |
|---|---|---|
| Cohort A & B | Experimental | Drug: Ivonescimab 20 mg/kgWe plan to enrol 32 patients with R/M NPC and who had failed prior platinum-based chemotherapy and anti-PD1 therapy in this study from (Cohort A) and we will have an additional cohort B consisting of 10 patients with R/M NPC and who had failed prior platinum-based chemotherapy, PD1-inhibitor and anti-angiogenic therapy. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Participant is eligible to be included in the study only if all the following criteria are met:
Key exclusion criteria (32 listed)
- Participant is excluded from the study if ANY of the following criteria apply:
- Note: Inhaled or topical steroids and adrenal replacement doses <10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease. Patients are permitted to use topical, ocular, intra-articular, intranasal, and inhalational corticosteroids (with minimal systemic absorption). Physiologic replacement doses of systemic corticosteroids are permitted if < or = 10 mg/day prednisone equivalents. A brief course of corticosteroids for prophylaxis (e.g., contrast dye allergy) or for treatment of non-autoimmune conditions (e.g., delayed-type hypersensitivity reaction caused by contact allergen) is permitted.
- Note: Replacement therapy (e.g. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc) is not considered a form of systemic treatment.
- Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, transitional cell carcinoma of urothelial cancer, or carcinoma in situ (e.g. breast or cervical carcinoma in situ) that have undergone potentially curative therapy are not excluded.
- Note: If 72 hours have elapsed between the screening pregnancy test and the first dose of study treatment, another pregnancy test (urine or serum) must be performed and must be negative for subject to start receiving study medication.
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 |
|---|---|---|
| Ivonescimab 20 mg/kgSubjects will receive intravenous ivonescimab at a dose of 20 mg/kg administered every 3 weeks until disease progression, intolerable toxicities, or withdrawal from the study. | Drug | Cohort A & B |
Primary outcome
Objective Response Rate (ORR)
Time frame: Best response at 1 year
Objective Response Rate (ORR), defined as the proportion of patients with a confirmed complete response (CR) or partial response (PR) as assessed by investigator review using iRECIST
8 secondary outcomes
Progression-Free Survival (PFS)
Time frame: 3 years
Overall Survival (OS)
Time frame: 3 years
Duration of Response (DoR)
Time frame: 3 years
Disease Control Rate (DCR)
Time frame: 3 years
Incidence, nature, and severity of adverse events (AEs) and serious adverse events (SAEs)
Time frame: from enrolment till 3 months after end of treatment
Frequency and proportion of treatment-related adverse events (TRAEs)
Time frame: from enrolment till 3 months after end of treatment
Incidence of immune-related adverse events (irAEs)
Time frame: from enrolment till 3 months after end of treatment
Rates of dose delays, modifications, or treatment discontinuations due to adverse events.
Time frame: from enrolment till 3 months after end of treatment
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 4 May 2026.
- Background: PubMed 15950718Wei WI, Sham JS. Nasopharyngeal carcinoma. Lancet. 2005 Jun 11-17;365(9476):2041-54. doi: 10.1016/S0140-6736(05)66698-6.
- Background: PubMed 25769204Petersson F. Nasopharyngeal carcinoma: a review. Semin Diagn Pathol. 2015 Jan;32(1):54-73. doi: 10.1053/j.semdp.2015.02.021. Epub 2015 Feb 25.
- Individual participant dataSharing planned: Yes. Individual patient data will be available, including data dictionaries and all clinical data collected in the conduct of the trial, in a deidentified format. These will be available beginning 3 months after Article publication with no end date. other researchers should submit requests for access to the patient-level data to the corresponding author, including a proposal outlining their reasons for required data. Following a signed data access agreement, the data will be made available by a link sent from the corresponding author to the requester.
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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.
Wan Qin Chong principal investigator
National University Hospital, Singapore
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 Ivonescimab 20 mg/kg in people with Nasopharyngeal Carcinoma (NPC), run by National University Hospital, Singapore at 1 site in Singapore.
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 32 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: opening soon, as of the sponsor's last update on 4 May 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 Singapore. 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 Wan Qin Chong (+65 69082222, wan_qin_chong@nuhs.edu.sg), 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: Best response at 1 year). 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 NCT07565389, which also lists 2 linked publications.
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 4 May 2026.