SCT200 in Combination With SCT-I10A/Paclitaxel/Docetaxel in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma

NCT05552807 | Unknown Phase 1

• 3 other identifiers: SCT-I10A-B101CTR20220916CTR20220917
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

The study is to explore the efficacy and safety of SCT200 with SCT-I10A or SCT200 combined with paclitaxel/docetaxel in the treatment of recurrent/metastatic head and neck squamous cell carcinoma.

Conditions

Head and Neck Squamous Carcinoma

Keywords

Carcinoma, Squamous Cell

Outcome Measures

Primary Outcomes (1)

• Objective response rate(ORR)

  ORR is defined as the proportion of subjects with complete response (CR) or partial response (PR) confirmed by the overall best response rate (assessed according to RECIST version 1.1).

  From date of the first dose until the date of first documented progression or date of receiving new antitumor therapy or date of withdraw informed consent or date of death from any cause, whichever came first，assessed up to 24 months

Secondary Outcomes (5)

• Disease control rate(DCR)

  From date of the first dose until the date of first documented progression or date of receiving new antitumor therapy or date of withdraw informed consent or date of death from any cause, whichever came first，assessed up to 24 months

• Duration of response(DOR)

  From date of the first dose until the date of first documented progression or date of receiving new antitumor therapy or date of withdraw informed consent or date of death from any cause, whichever came first，assessed up to 24 months

• Progression-free survival(PFS)

  From date of the first dose until the date of first documented progression or date of receiving new antitumor therapy or date of withdraw informed consent or date of death from any cause, whichever came first，assessed up to 24 months

• Overall survival(OS)

  From date of the first dose until the date of first documented progression or date of receiving new antitumor therapy or date of withdraw informed consent or date of death from any cause, whichever came first，assessed up to 24 months

• Correlation of PD-L1 expression level with efficacy and prognosis

  From date of the first dose until the date of first documented progression or date of receiving new antitumor therapy or date of withdraw informed consent or date of death from any cause, whichever came first，assessed up to 24 months

Other Outcomes (2)

• Occurrence of Study Treatment Related Adverse Events

  From date of the first dose until the date of first documented progression or date of receiving new antitumor therapy or date of withdraw informed consent or date of death from any cause, whichever came first，assessed up to 24 months

• Immunogenicity

  From date of the first dose until the date of first documented progression or date of receiving new antitumor therapy or date of withdraw informed consent or date of death from any cause, whichever came first，assessed up to 24 months

Study Arms (4)

Cohort 1 SCT200+SCT-I10A

EXPERIMENTAL

SCT200+SCT-I10A was given to patients who had failed previous platinum-based therapy. Among them, SCT200 was administered as 6 mg/kg/QW for 12 weeks and 8 mg/kg/Q2W maintenance by intravenous infusion; SCT-I10A was 200 mg/Q3W by intravenous infusion for no more than 2 years. Every 6 weeks is a treatment cycle. After the first dose, tumor assessment was performed every 6 weeks until the occurrence of PD, initiation of new antitumor therapy, withdrawal of informed consent, death, or loss of visit

Drug: SCT-I10A; Drug: SCT200

Cohort 2-1 SCT200+SCT-I10A

EXPERIMENTAL

SCT200+SCT-I10A was given to patients who had failed previous platinum-based and immune checkpoint inhibitor therapy. Among them, SCT200 was administered as 6 mg/kg/QW for 12 weeks and 8 mg/kg/Q2W maintenance by intravenous infusion; SCT-I10A was 200 mg/Q3W by intravenous infusion for no more than 2 years. Every 6 weeks is a treatment cycle. After the first dose, tumor assessment was performed every 6 weeks until the occurrence of PD, initiation of new antitumor therapy, withdrawal of informed

Drug: SCT-I10A; Drug: SCT200

Cohort 2-2 SCT200+paclitaxel/docetaxel

EXPERIMENTAL

SCT200+paclitaxel/docetaxel was given to patients who had failed previous platinum-based and immune checkpoint inhibitor therapy. Among them, SCT200 was administered as 6 mg/kg/QW for 12 weeks and 8 mg/kg/Q2W maintenance by intravenous infusion; paclitaxel was 80mg/m\^2/QW by intravenous infusion; docetaxel was 75mg/m\^2/Q3W. Every 6 weeks is a treatment cycle. After the first dose, tumor assessment was performed every 6 weeks until the occurrence of PD, initiation of new antitumor therapy, withdrawal of informed

Drug: SCT200; Drug: paclitaxel; Drug: docetaxel

Cohort 3 SCT200+SCT-I10A

EXPERIMENTAL

SCT200+SCT-I10A was given to patients who have not received prior systemic chemotherapy. Among them, SCT200 was administered as 6 mg/kg/QW for 12 weeks and 8 mg/kg/Q2W maintenance by intravenous infusion; SCT-I10A was 200 mg/Q3W by intravenous infusion for no more than 2 years. Every 6 weeks is a treatment cycle. After the first dose, tumor assessment was performed every 6 weeks until the occurrence of PD, initiation of new antitumor therapy, withdrawal of informed

Drug: SCT-I10A; Drug: SCT200

Interventions

SCT-I10A DRUG

Administered intravenously

Cohort 1 SCT200+SCT-I10A; Cohort 2-1 SCT200+SCT-I10A; Cohort 3 SCT200+SCT-I10A

SCT200 DRUG

Administered intravenously

Cohort 1 SCT200+SCT-I10A; Cohort 2-1 SCT200+SCT-I10A; Cohort 2-2 SCT200+paclitaxel/docetaxel; Cohort 3 SCT200+SCT-I10A

paclitaxel DRUG

Administered intravenously

Cohort 2-2 SCT200+paclitaxel/docetaxel

docetaxel DRUG

Administered intravenously

Cohort 2-2 SCT200+paclitaxel/docetaxel

Eligibility Criteria

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

You may qualify if:

• Subjects voluntarily signed a written informed consent prior to screening;
• Male or female, age ≥ 18 years old;
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
• Has histologically or cytologically confirmed head and neck squamous cell carcinoma;
• Recurrent and/or metastatic HNSCC without indications for local radical treatment; Cohort 1: Patients who have received previous platinum-based therapy and experienced disease progression or toxic intolerance during or after treatment; Cohort 2: Patients who have received prior platinum-based therapy and immune checkpoint inhibitors and experienced disease progression or toxic intolerance during or after treatment; Cohort 3: Patients who have not received prior systemic chemotherapy but can receive chemotherapy as part of a multimodality treatment for patients with locally advanced HNSCC;
• According to RECIST 1.1, there is at least one measurable lesion, for lesions previously treated with radiotherapy, may be selected as a target lesion only if the lesion has shown definite disease progression or persists more than 3 months after the end of radiotherapy;
• The estimated survival period is ≥ 3 months;
• Laboratory inspection: Blood test: neutrophils ≥1.5×10\^9/L, hemoglobin ≥90g/L, platelets ≥75×10\^9/L for cohort 1 and cohort 3, and platelets ≥100×10\^9/L for cohort 2; liver function: Serum alanine transaminase (ALT) and serum aspartate aminotransferase (AST), ALT and AST ≤ 3 × ULN for those without liver metastases, ALT and AST ≤ 5 × ULN for those with liver metastases; total bilirubin (TBIL) ≤ 1.5 × ULN (Gilbert syndrome patients, ≤ 3 × ULN); Renal function: serum creatinine (Cr) ≤ 1.5×ULN or creatinine clearance (Ccr) ≥ 50 ml/min; Coagulation: activated partial thromboplastin time (APTT), international normalized ratio (INR), prothrombin time (PT) ≤ 1.5×ULN; Cardiac echocardiography: left ventricular ejection fraction (LVEF) ≥ 50%; Men and women of childbearing potential must agree that they must use contraception during the study period and for 6 months after the last study treatment; have a negative blood pregnancy test within 7 days prior to study enrollment and must non-breastfeeding

You may not qualify if:

• Patients suitable for local radical treatment;
• Histologically or cytologically confirmed nasopharyngeal or cutaneous squamous carcinoma;
• Cohorts 1 and 3 previously treated with immune checkpoint inhibitors or treated with EGFR monoclonal antibodies (Immune-checkpoint inhibitors or EGFR monoclonal antibodies as multimodal therapy for locally advanced HNSCC were eligible if the last treatment was more than 6 months after disease progression);
• Cohort 2 previously received EGFR monoclonal antibody (EGFR monoclonal antibodies as multimodal therapy for locally advanced HNSCC were eligible if the last treatment was more than 6 months after disease progression);
• Cohort 2 previously received paclitaxel, albumin paclitaxel or paclitaxel liposomes, and received docetaxel, and both of these drugs failed to treat;
• Previous immunotherapy with grade ≥3 irAE or grade ≥2 immune-associated myocarditis;
• Other malignant neoplasm present within 5 years or concurrent with the current period, except cured cervical carcinoma in situ, non-melanoma skin cancer or other radically treated tumor/cancer with no signs of disease for at least 5 years;
• Known peripheral neuropathy ≥ grade 2 according to the Common Terminology Criteria forAdverse Events(CTCAE v5.0) published by the National Cancer Institute (NCI);
• Active central nervous system (CNS) metastases and/or carcinomatous meningitis;subjects with previously treated brain metastases may be enrolled in the study provided they are clinically stable for at least 2 weeks, have no evidence of new or expanding brain metastases, and have discontinued steroids at least 14 days prior to study drug administration. Stable brain metastases in this definition should be determined before the first dose of study drug. Subjects with asymptomatic brain metastases (i.e., no neurological symptoms, no need for corticosteroids, and no lesions \>1.5 cm) may participate, but require periodic brain imaging at the the tumor lesion ;;
• Subjects (except alopecia and hypothyroidism stabilized by hormone replacement therapy) who have not recovered from any toxicity and/or complications of previous surgery, chemotherapy or radiotherapy, i.e., who have not dropped to ≤ grade 1 (NCI CTCAE v5.0);
• Any component of the study drug or formulation that has caused an allergic reaction, including a known grade ≥3 allergic reaction to other monoclonal antibody-based drugs;
• Received chemotherapy, radiotherapy, biological therapy, endocrine therapy, immunotherapy and other anti-tumor therapy ≤ 4 weeks before the first dose, except palliative radiotherapy to the bone for pain relief; received nitrosourea or mitomycin C ≤ 6 weeks before the first dose; received fluorouracil and small molecule targeted drugs ≤ 2 weeks or ≤ 5 half-lives of the drug before the first dose; received Chinese medicine with anti-tumor indications ≤ 2 weeks before the first dose;
• Received another unlisted clinical study drug or treatment ≤ 4 weeks prior to the first dose;
• Major surgery ≤4 weeks prior to first dose or expected during this study;
• Immunosuppressive drugs required ≤ 2 weeks prior to first dose or during the study period, excluding: a) intranasal, inhaled, topical glucocorticoids or topical glucocorticoid injections ; b) physiological doses of systemic glucocorticoids (≤ 10 mg/day prednisone or equivalent); c) short-term use of glucocorticoids for prophylaxis or treatment of non-autoimmune allergic diseases;

Sponsors & Collaborators

• Sinocelltech Ltd.: lead

Study Sites (1)

Shanghai East Hospital

Shanghai, China

RECRUITING

Related Publications (1)

• Lin J, Qu S, Yang K, Zhang T, Bai Y, Wu J, Huang Y, Fang M, Liu X, Huang X, Chen N, Li Z, Li W, Zhang S, Zhang S, Hu G, Sun Y, Chen X, Liu Y, Jing S, Shen L, Chang Z, Xie L, Gai W, Zhou Q, Chen X, Yi J, Guo Y. Phase Ib study of SCT200 combined with paclitaxel or docetaxel in patients with recurrent or metastatic head and neck squamous cell carcinoma following platinum-based chemotherapy and PD-1 antibody. Cancer Lett. 2025 Mar 31;613:217513. doi: 10.1016/j.canlet.2025.217513. Epub 2025 Jan 30.

  PMID: 39892704 DERIVED

MeSH Terms

Conditions

Carcinoma, Squamous Cell

Interventions

Paclitaxel; Docetaxel

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Squamous Cell

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Ye Guo, Ph.D

  Shanghai East Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fuqiang Chen

CONTACT

18510805834; fuqiang_chen@sinocelltech.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2022
• First Posted: September 23, 2022
• Study Start: June 15, 2022
• Primary Completion: September 1, 2023
• Study Completion: September 1, 2023
• Last Updated: September 23, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)