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Head and Neck Squamous CarcinomaPhase 1NCT05552807

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

A Phase 1 study testing SCT-I10A, SCT200 and paclitaxel in people with Head and Neck Squamous Carcinoma, run by Sinocelltech Ltd. at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Head and Neck Squamous Carcinoma
What is being tested?
SCT-I10A, SCT200 and paclitaxel
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
1 siteChina
Study dates
15 Jun 2022to Sep 2023
Phase
Phase 1
Are there results?
None posted in the registry

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

  • 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

Who cannot join

  • 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;
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  • 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;
  • Subjects with known active, or with a history of autoimmune disease with a risk of relapse, or patients at high risk. However, the following patients are allowed to be enrolled: patients with type I diabetes who are stable with a fixed dose of insulin; autoimmune hypothyroidism who require only stable hormone replacement therapy; skin diseases that do not require systemic therapy;
  • Subjects with known history of interstitial lung disease, non-infectious pneumonia, or high suspicion of interstitial lung disease; subjects with previous drug-derived or radiological non-infectious pneumonia who are asymptomatic are allowed to be enrolled;
  • HIV positive, or other acquired or congenital immunodeficiency disease, or history of organ transplantation, or history of stem cell transplantation
  • HBsAg positive, and peripheral blood HBV DNA titer ≥ 2.5×10^3 copies/ml or ≥ 500 IU/ml; HCV antibody positive, and HCV-RNA above the lower limit of detection of the analytical method;
  • Active or uncontrollable infection requiring intravenous anti-infective therapy ≤ 2 weeks prior to the first dose;
  • Vaccination with live virus ≤ 4 weeks prior to first dose Seasonal influenza vaccine without live virus allowed;
  • Clinically uncontrollable third interstitial fluid that, in the judgment of the investigator, is not suitable for enrollment;
  • Known concomitant severe medical disease, such as NYHA III, IHD, or MI within 3 months prior to first dose, poorly controlled DM (fasting glucose ≥ 10 mmol/L) or poorly controlled hypertension despite drug therapy;
  • Medical or psychiatric history or history of laboratory abnormalities that may interfere with the interpretation of the results;
  • Subjects with alcohol or drug addiction;
  • Subjects deemed unsuitable for study participation by the investigator.

Trial locations and contacts

1 site in 1 country.

Fuqiang Chen contact

18510805834

fuqiang_chen@sinocelltech.com

China1 site, 1 recruiting

  • Shanghai East Hospital

    Shanghai

    Chaodan Tan, 021-38804518-28329, tanzhaodan@126.com

    Recruiting

Other trials in China

About this study

Official title: A Multicenter, Open Phase Ib Study to Evaluate the Efficacy and Safety of SCT-I10A in Combination With SCT200 or SCT200 in Combination With Paclitaxel/Docetaxel in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

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.

Read the detailed description

This multicenter, open phase Ib study focused on evaluating the objective response response rates of SCT200 in combination with SCT-I10A or SCT200 in combination with paclitaxel/docetaxel in patients with recurrent/metastatic head and neck squamous cell carcinoma who had previously received different treatments.

Being tested
SCT-I10A, SCT200, paclitaxel, docetaxel
Keywords
Carcinoma, Squamous Cell
Medical subject headings
Carcinoma, Squamous Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SCT-I10ADrug

    Administered intravenously

  • SCT200Drug

    Administered intravenously

  • paclitaxelDrug

    Administered intravenously

  • docetaxelDrug

    Administered intravenously

Study groups in NCT05552807
Study groupRoleWhat they receive
Cohort 1 SCT200+SCT-I10AExperimentalSCT200+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
Receives: Drug: SCT-I10A; Drug: SCT200
Cohort 2-1 SCT200+SCT-I10AExperimentalSCT200+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
Receives: Drug: SCT-I10A; Drug: SCT200
Cohort 2-2 SCT200+paclitaxel/docetaxelExperimentalSCT200+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
Receives: Drug: SCT200; Drug: paclitaxel; Drug: docetaxel
Cohort 3 SCT200+SCT-I10AExperimentalSCT200+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
Receives: Drug: SCT-I10A; Drug: SCT200

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: 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)

  1. Disease control rate(DCR)

    DCR is defined as the proportion of subjects who achieve best overall response of complete response (CR), partial response (PR) or stable disease (SD) according to RECIST version 1.1

    Measured: 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

  2. Duration of response(DOR)

    DOR is defined as the time from first response to first disease progression or death

    Measured: 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

  3. Progression-free survival(PFS)

    PFS is defined as the time between the date of first dose and the date of first documented disease progression (as assessed by RECIST version 1.1) or death from any cause.

    Measured: 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

  4. Overall survival(OS)

    OS is defined as the time from the date of first drug administration to death from any cause.

    Measured: 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

  5. Correlation of PD-L1 expression level with efficacy and prognosis

    For cohort1、2-1 and 3, evaluating correlation of PD-L1 expression level with efficacy and prognosis

    Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Sep 2022
  2. Study start15 Jun 2022
  3. Primary completionSep 2023 (estimated)
  4. Study completionSep 2023 (estimated)

Resources

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05552807
Sponsor's protocol ID
SCT-I10A-B101
Other IDs
CTR20220916, CTR20220917
Status last verified
Sep 2022
First submitted
22 Jun 2022
Last updated
23 Sep 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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, Wang Y, Chen X, Liu D, Guo Y. Phase Ib Trial of Finotonlimab Combined With SCT200 in Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma. Cancer Med. 2026 Sep;15(9):e72272. doi: 10.1002/cam4.72272.

    PubMed 42706605

  • 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.

    PubMed 39892704

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing SCT-I10A, SCT200 and paclitaxel in people with Head and Neck Squamous Carcinoma, run by Sinocelltech Ltd. 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 8 inclusion and 26 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: status not confirmed, as of the sponsor's last update on 23 Sep 2022. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Fuqiang Chen (18510805834, fuqiang_chen@sinocelltech.com), 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: 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). 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 NCT05552807, 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 23 Sep 2022.

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