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.

NCT07791745 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: SIM0669-304
• Study Type: interventional
• Target: 362
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Head and Neck Squamous Cell Carcinoma (HNSCC) - Recurrent/Metastatic (R/M)

Outcome Measures

Primary Outcomes (2)

• Overall Survival (Phase 3)

  Up to 2 years.

• Objective Response Rate (Phase 2)

  Up to 2 years.

Secondary Outcomes (7)

• Duration of response

  Up to 2 years.

• Disease control rate

  Up to 2 years.

• Progression-Free Survival

  Up to 2 years.

• Objective Response Rate (Phase 3)

  Up to 2 years.

• Overall Survival (Phase 2)

  Up to 2 years.

Study Arms (2)

Enlituo®

EXPERIMENTAL

Drug: Enlituo® + Anyouping® + PBC

Placebo

PLACEBO COMPARATOR

Drug: Placebo-Enlituo + Anyouping® + PBC

Interventions

Enlituo® + Anyouping® + PBC DRUG

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.

Enlituo®

Placebo-Enlituo + Anyouping® + PBC DRUG

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.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Taizhou Mabtech Pharmaceutical Co.,Ltd: lead

Study Sites (1)

Shanghai East Hospital

Shanghai, Shanghai Municipality, 200120, China

Location

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck; Recurrence; Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplastic Processes

Central Study Contacts

Zheng Zhang

CONTACT

+86 25-85566666; zhangzheng1@zaiming.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2026
• First Posted: August 28, 2026
• Study Start: August 30, 2026
• Primary Completion (Estimated): August 30, 2032
• Study Completion (Estimated): August 30, 2032
• Last Updated: August 28, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)