HNSCCPhase 1LONG'ENCT07040072
Finotonlimab Combined With Stapokibart in the Treatment of Recurrent/Metastatic HNSCC
A Phase 1 study testing Stapokibart and Finotonlimab in people with HNSCC, run by Beijing Tongren Hospital at 1 site in China.
Trial summary
This is a single-arm, phase Ib study involving HNSCC patients who had received first-line treatment with either PD-1 combined with platinum-based drugs or PD-1 monotherapy. The aim of the study is to evaluate the safety and efficacy of Finotonlimab in combination with Stapokibart in the treatment of… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- HNSCC
- What is being tested?
- Stapokibart and Finotonlimab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 9 Oct 2025to Jun 2028
- Phase
- Phase 1
- 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 the ICF;
- Recurrent/metastatic HNSCC of the oral cavity, oropharyngeal, pharyngeal, and laryngeal regions;
- Male/female, ≥ 18 years old, ECOG 0~1;
- After PD-1 and platinum therapy, or PD-1 monotherapy, disease progression occurs within 24 weeks after the last ICI administration (as assessed by RECIST 1.1);
- Target lesion (RECIST 1.1);
- Previous PD-L1 expression test results may provide tissue for PD-L1 immunohistochemical testing;
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- Expected to survive for more than 3 months;
- The main organ functions must meet the following requirements (laboratory test values within 7 days before enrollment must meet the following standards):
- Blood routine examination: (No blood transfusion, no use of granulocyte colony-stimulating factor, no medication correction within 14 days before screening): a) Neutrophils ≥ 1.5 × 10^9/L; b) Platelets ≥ 75 × 10^9/L; c) Hemoglobin ≥ 90g/L; ② Biochemical examination: (No albumin transfusion within 14 days before screening): a) Blood creatinine ≤ 1.5 x upper limit of normal (ULN), or creatinine clearance rate>50 mL/min; b) Serum total bilirubin ≤ 1.5 × ULN; c) Aspartate transaminase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN; ③ Coagulation function: a) International normalized ratio (INR) ≤ 2.3 or prothrombin time (PT) exceeding the normal control range ≤ 6 seconds.
Who cannot join
- Suitable for local treatment;
- Merge with other malignant tumors;
- Brain metastasis;
- If the toxicity does not recover to level 0-1 after surgery/radiotherapy/drug treatment, excluding chronic toxicity;
- Allergic to known medication ingredients;
- Major surgeries, radiation therapy (excluding palliative care), chemotherapy, immunotherapy, and biologics within 4 weeks prior to enrollment;
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- Received TKI, palliative surgery, and non-specific immunomodulatory therapy (such as thymosin and interferon) within 2 weeks before enrollment;
- Use immunosuppressive drugs within 4 weeks before enrollment (excluding short-term, local, and physiological dose hormone therapy);
- Patients with the following infection conditions:
- Active infections require systemic use of antibiotics; Active mycobacterium tuberculosis infection (i.e. tuberculosis infection); Hepatitis C virus antibody (HCV Ab) positive and hepatitis C virus ribonucleic acid (HCV-RNA) positive; Hepatitis B virus deoxyribonucleic acid (HBV-DNA) ≥ 1000 IU/mL; History of human immunodeficiency virus (HIV) infection or HIV antibody positivity during screening period.
- Uncontrollable pleural effusion, abdominal effusion, and pericardial effusion;
- Previous grade ≥ 3 irAE or grade ≥ 2 myocarditis;
- Have a serious history of cardiovascular and cerebrovascular diseases, including but not limited to:
- Major cardiovascular and cerebrovascular diseases (such as congestive heart failure, acute myocardial infarction, unstable angina, stroke, transient ischemic attack, deep vein thrombosis or pulmonary embolism, etc.) occurred within 6 months before the first administration; Corrected QT interval (QTcF)>480 msec; Echocardiography (ECHO) indicates that the subject's left ventricular ejection fraction (LVEF) < 50%; New York Heart Association (NYHA) heart function classification ≥ 2; Clinically uncontrollable hypertension (If blood pressure is controlled with or without intervention, subjects can continue to be screened); Other cardiovascular and cerebrovascular diseases that have been evaluated by the researchers as unsuitable for participation in this study;
- Active autoimmune diseases;
- There is a significant risk of bleeding;
- Receive a live vaccine within 4 weeks before enrollment;
- During pregnancy or lactation, subjects with fertility do not receive contraceptive measures;
- The presence of mental illness may affect the conduct of clinical trials;
- History of organ transplantation or stem cell transplantation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Beijing Tongren Hospital, Capital Medical University
Beijing, Beijing Municipality
Luo Zhang, (86)13910830399, dr.luozhang@gmail.com
About this study
Official title: The Safety and Efficacy of Finotonlimab Combined With Stapokibart in the Treatment of Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, a Phase Ib Study
This is a single-arm, phase Ib study involving HNSCC patients who had received first-line treatment with either PD-1 combined with platinum-based drugs or PD-1 monotherapy. The aim of the study is to evaluate the safety and efficacy of Finotonlimab in combination with Stapokibart in the treatment of recurrent/metastatic HNSCC patients.
Read the detailed description
This study includes a total of 10 participants. Firstly, five participants will be enrolled to receive the combination therapy regimen. Safety observations will be conducted within 30 days after the third participant completes the third cycle of Stapokibart and Finotonlimab combination therapy. Based on the collected trial data, the investigators will evaluate and provide a safety report. If a major safety event or other factor affecting participant safety was identified, the treatment regimen will be re-evaluated before proceeding with further enrollment. Adjustments to administration frequency, dosage, and sample size can be made, or the trial can be terminated; If no safety concerns are identified, the remaining five participants will be enrolled according to the study protocol.
- Conditions
- HNSCC
- Being tested
- Stapokibart and Finotonlimab
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stapokibart and FinotonlimabCombination product
Receive the combination therapy with Stapokibart and Finotonlimab. Stapokibart, 600mg for the first cycle, 300mg for the second and subsequent cycles, administered subcutaneously every 3 weeks; Finotonlimab 200mg, administered intravenously every 3 weeks. Treatment with Stapokibart in combination with Finotonlimab was continued until confirmed disease progression occurs according to the RECIST 1.1 imaging criteria (if the researcher determines that the subject can benefit from continuing PD-1 drug treatment, and the subject can tolerate the study treatment and agree, PD-1 drug can be continued and recorded in the study records), unacceptable toxic side effects, initiation of new anti-tumor treatment, withdrawal from the study or death (whichever occurs first), or reaching a maximum treatment period of 2 years.
| Study group | Role | What they receive |
|---|---|---|
| Stapokibart and Finotonlimab | Experimental | Stapokibart, 600 mg for the first cycle, 300 mg for the second and subsequent cycles, administered subcutaneously every three weeks.
Finotonlimab 200 mg, administered intravenously once every three weeks, until disease progression or unacceptable toxicity. Receives: Combination Product: Stapokibart and Finotonlimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events (AEs)
Number of participants with AEs assessed by Common Terminology Criteria for Adverse Events v5.0.
Measured: Up to 2 years
Overall response rate (ORR)
Percentage of participants with a confirmed best overall complete response (CR) or partial response (PR) according to response evaluation criteria in solid tumors version 1.1 (RECIST 1.1).
Measured: Up to 2 years
Secondary outcomes (3)
Disease control rate (DCR)
The proportion of participants who achieve complete response (CR), partial response (PR), or stable disease (SD) as their best overall response, according to RECIST 1.1 criteria.
Measured: Up to 2 years
Progression free survival (PFS)
PFS will be calculated from the first administration of Stapokibart to the date of documented disease progression, or death from any cause.
Measured: Up to 2 years
Duration of response (DOR)
The time from the date of first response (CR or PR) to the date of progression of disease or death of any cause.
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2025
- Study start9 Oct 2025
- Primary completionJun 2027 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HNSCCStudies of the same condition, open and under way.
- More trials run by Beijing Tongren HospitalThe 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tongren Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Sinocelltech Ltd., Keymed Biosciences Co.Ltd
- Responsible party
- Sponsor
- Investigators
- Luo Zhang, Study chair, Beijing Tong-Ren hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07040072
- Sponsor's protocol ID
- TR Sta-Fin (LONG'E)
- Acronym
- LONG'E
- Status last verified
- Jun 2025
- First submitted
- 18 Apr 2025
- Last updated
- 4 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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
- The Safety and Efficacy of Finotonlimab Combined With Stapokibart in the Treatment of Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, a Phase Ib Study
- ClinicalTrials.gov ID
- NCT07040072
- Acronym / sponsor ID
- LONG'E / TR Sta-Fin (LONG'E)
- Conditions
- HNSCC
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Beijing Tongren HospitalUniversity, hospital or other
- Collaborators
- Sinocelltech Ltd., Keymed Biosciences Co.Ltd
- Study start
- 9 Oct 2025 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 26 Jun 2025 (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 is a single-arm, phase Ib study involving HNSCC patients who had received first-line treatment with either PD-1 combined with platinum-based drugs or PD-1 monotherapy. The aim of the study is to evaluate the safety and efficacy of Finotonlimab in combination with Stapokibart in the treatment of recurrent/metastatic HNSCC patients.
Detailed description
This study includes a total of 10 participants. Firstly, five participants will be enrolled to receive the combination therapy regimen. Safety observations will be conducted within 30 days after the third participant completes the third cycle of Stapokibart and Finotonlimab combination therapy. Based on the collected trial data, the investigators will evaluate and provide a safety report. If a major safety event or other factor affecting participant safety was identified, the treatment regimen will be re-evaluated before proceeding with further enrollment. Adjustments to administration frequency, dosage, and sample size can be made, or the trial can be terminated; If no safety concerns are identified, the remaining five participants will be enrolled according to the study protocol.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stapokibart and Finotonlimab | Experimental | Combination Product: Stapokibart and FinotonlimabStapokibart, 600 mg for the first cycle, 300 mg for the second and subsequent cycles, administered subcutaneously every three weeks. Finotonlimab 200 mg, administered intravenously once every three weeks, until disease progression or unacceptable toxicity. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Voluntarily sign the ICF;
- Recurrent/metastatic HNSCC of the oral cavity, oropharyngeal, pharyngeal, and laryngeal regions;
- Male/female, ≥ 18 years old, ECOG 0~1;
- After PD-1 and platinum therapy, or PD-1 monotherapy, disease progression occurs within 24 weeks after the last ICI administration (as assessed by RECIST 1.1);
- Target lesion (RECIST 1.1);
Key exclusion criteria (20 listed)
- Suitable for local treatment;
- Merge with other malignant tumors;
- Brain metastasis;
- If the toxicity does not recover to level 0-1 after surgery/radiotherapy/drug treatment, excluding chronic toxicity;
- Allergic to known medication ingredients;
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 |
|---|---|---|
| Stapokibart and FinotonlimabReceive the combination therapy with Stapokibart and Finotonlimab. Stapokibart, 600mg for the first cycle, 300mg for the second and subsequent cycles, administered subcutaneously every 3 weeks; Finotonlimab 200mg, administered intravenously every 3 weeks. Treatment with Stapokibart in combination with Finotonlimab was continued until confirmed disease progression occurs according to the RECIST 1.1 imaging criteria (if the researcher determines that the subject can benefit from continuing PD-1 drug treatment, and the subject can tolerate the study treatment and agree, PD-1 drug can be continued and recorded in the study records), unacceptable toxic side effects, initiation of new anti-tumor treatment, withdrawal from the study or death (whichever occurs first), or reaching a maximum treatment period of 2 years. | Combination product | Stapokibart and Finotonlimab |
Primary outcome
Adverse events (AEs)
Time frame: Up to 2 years
Number of participants with AEs assessed by Common Terminology Criteria for Adverse Events v5.0.
Overall response rate (ORR)
Time frame: Up to 2 years
Percentage of participants with a confirmed best overall complete response (CR) or partial response (PR) according to response evaluation criteria in solid tumors version 1.1 (RECIST 1.1).
3 secondary outcomes
Disease control rate (DCR)
Time frame: Up to 2 years
Progression free survival (PFS)
Time frame: Up to 2 years
Duration of response (DOR)
Time frame: Up to 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 4 May 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.
Luo Zhang study chair
Beijing Tong-Ren hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Stapokibart and Finotonlimab in people with HNSCC, run by Beijing Tongren Hospital 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 9 inclusion and 20 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 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 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 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.
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 Luo Zhang ((86)13910830399, dr.luozhang@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events (AEs) (time frame: Up to 2 years). 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 4 May 2026.