Head and Neck Squamous Cell Carcinoma (HNSCC) - Recurrent/Metastatic (R/M)Phase 2/3NCT07791745
A Clinical Trial Comparing the Efficacy and Safety of Anyouping® and Platinum-based Chemotherapy With or Without Enlituo® in Advanced Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma.
A Phase 2/3 study testing Enlituo® + Anyouping® + PBC in people with Head and Neck Squamous Cell Carcinoma (HNSCC) - Recurrent/Metastatic (R/M), run by Taizhou Mabtech Pharmaceutical Co.,Ltd at 1 site in China.
Trial summary
A Clinical Trial Comparing the Efficacy and Safety of Anyouping® and Platinum-based Chemotherapy With Enlituo® in Advanced Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Squamous Cell Carcinoma (HNSCC) - Recurrent/Metastatic (R/M)
- What is being tested?
- Enlituo® + Anyouping® + PBC
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 362 participants
- Where
- 1 siteChina
- Study dates
- 16 Sep 2026to 30 Aug 2032
- Phase
- Phase 2/3
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
- Voluntarily sign the written informed consent form and be willing to comply with all requirements specified in the study protocol;
- Aged ≥ 18 years;
- Histologically or cytologically confirmed recurrent or metastatic squamous cell carcinoma of the head and neck (including oral cavity, oropharynx, hypopharynx, larynx), deemed incurable after local therapy;
- Have not received any systemic therapy for recurrent or metastatic disease. Note: If disease progression occurs during neoadjuvant/adjuvant therapy, concurrent radiotherapy, or within 6 months after treatment discontinuation, the anti-tumor therapy administered during neoadjuvant/adjuvant therapy or concurrent radiotherapy (including platinum-based chemotherapy, anti-EGFR monoclonal antibodies, PD-1/PD-L1 inhibitors, etc.) will be regarded as first-line systemic therapy, and such subjects will be excluded.
- (Remark: Subjects previously treated with PD-1/PD-L1 inhibitors may be enrolled provided a washout period of ≥ 12 months is met.)
- Have at least one measurable evaluable target lesion per RECIST v1.1, or a measurable lesion with definitive radiological progression following local therapy, and the lesion must be suitable for repeated precise measurement;
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, with no disease deterioration within 2 weeks prior to enrollment;
- For participants with oropharyngeal carcinoma, human papillomavirus (HPV) status test results based on tumor tissue samples must be available prior to enrollment.
Who cannot join
- Primary tumor site (any histologic type) located in nasopharynx, nasal cavity, paranasal sinus, salivary gland, thyroid or parathyroid gland, skin, or unknown primary origin;
- Participants who have been diagnosed with a malignancy other than squamous cell carcinoma of the head and neck within 3 years prior to enrollment. Exceptions include cured basal cell carcinoma of the skin, cutaneous squamous cell carcinoma, and/or carcinoma in situ of the cervix and/or breast cancer treated with curative resection;
- Participants with an expected survival of less than 6 months and/or rapidly progressive disease (e.g., participants experiencing rapid disease progression within 1-2 months during therapy planned prior to enrollment);
- Participants eligible for curative-intent local therapy;
- Pregnant or breastfeeding participants, or those planning pregnancy or conception during the anticipated study period (from screening visit through 180 days after the last dose);
- Known history of psychiatric disorder or substance abuse that would interfere with compliance with study requirements;
- Any other condition that renders the participant unsuitable for enrollment in the opinion of the investigator.
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
Shanghai East Hospital
Shanghai, Shanghai Municipality, 200120
Ye Guo, +86 21-38804518, pattrickguo@gmaiI.com
About this study
Official title: A Prospective, Multicenter, Randomized, Controlled Phase II/III Study to Evaluate the Efficacy and Safety of Enlituo® Plus Anyouping® and Platinum-Based Chemotherapy Versus Anyouping® Plus Platinum-Based Chemotherapy as First-Line Treatment for Advanced, Recurrent or Metastatic of the Head and Neck Squamous Cell Carcinoma
A Clinical Trial Comparing the Efficacy and Safety of Anyouping® and Platinum-based Chemotherapy With Enlituo® in Advanced Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma.
Read the detailed description
This study is a Phase II/III clinical trial, aimed to evaluate the efficacy and safety of Enlituo® combined with Anyouping® plus platinum and nab-paclitaxel chemotherapy as first-line therapy for advanced, recurrent or metastatic HNSCC.
Phase II Part Approximately 60 participants will be enrolled and randomly assigned at a 1:1 ratio to the experimental group.
Phase III Part Approximately 302 participants will be enrolled and randomly assigned in a 1:1 double-blind manner to the experimental group.
- Being tested
- Enlituo® + Anyouping® + PBC, Placebo-Enlituo + Anyouping® + PBC
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck, Recurrence, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enlituo® + Anyouping® + PBCDrug
Enlituo®：Enlituo® is administered according to the protocol. Anyouping®：Anyouping® is administered according to the protocol. Platinum-based chemotherapy (PBC)：Cisplatin (DDP) or Carboplatin (CBP) plus Albumin-bound Paclitaxel (nab-paclitaxel) are administered according to the protocol.
Placebo-Enlituo + Anyouping® + PBCDrug
Comparator in Phase 2 is Anyouping® + PBC. Comparator in Phase 3 is Placebo-Enlituo + Anyouping® + PBC. Placebo-Enlituo (only in Phase 3)：Placebo-Enlituo is administered according to the protocol.
Anyouping®：Anyouping® is administered according to the protocol. Platinum-based chemotherapy (PBC)：Cisplatin (DDP) or Carboplatin (CBP) plus Albumin-bound Paclitaxel (nab-paclitaxel) are administered according to the protocol.
| Study group | Role | What they receive |
|---|---|---|
| Enlituo® | Experimental | Not described Receives: Drug: Enlituo® + Anyouping® + PBC |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo-Enlituo + Anyouping® + PBC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival (Phase 3)
Measured: Up to 2 years.
Objective Response Rate (Phase 2)
Measured: Up to 2 years.
Secondary outcomes (7)
Duration of response
The Blinded Independent Imaging Review Committee (BIRC) and Investigators will evaluated，respectively in Phase 3.
Measured: Up to 2 years.
Disease control rate
The Blinded Independent Imaging Review Committee (BIRC) and Investigators will evaluated，respectively in Phase 3.
Measured: Up to 2 years.
Progression-Free Survival
The Blinded Independent Imaging Review Committee (BIRC) and Investigators will evaluated，respectively in Phase 3.
Measured: Up to 2 years.
Objective Response Rate (Phase 3)
The Blinded Independent Imaging Review Committee (BIRC) and Investigators will evaluated，respectively.
Measured: Up to 2 years.
Overall Survival (Phase 2)
Measured: Up to 2 years.
Time to Progression
The Blinded Independent Imaging Review Committee (BIRC) and Investigators will evaluated，respectively in Phase 3.
Measured: Up to 2 years.
Number of participants with treatment-related adverse events as assessed by CTCAE v6.0
Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) as assessed by CTCAE V6.0.
Incidence of AE leading to dose interruption, dose delay and treatment discontinuation.
Measured: From the date of informed consent signature until 28 days after the last dose (each cycle is 21 days, up to 35 cycles or 2 years).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2026
- Study start16 Sep 2026
- Primary completion30 Aug 2032 (estimated)
- Study completion30 Aug 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck Squamous Cell Carcinoma (HNSCC) - Recurrent/Metastatic (R/M)Studies of the same condition, open and under way.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 362 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taizhou Mabtech Pharmaceutical Co.,Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07791745
- Sponsor's protocol ID
- SIM0669-304
- Status last verified
- Sep 2026
- First submitted
- 19 Aug 2026
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No