Head and Neck Squamous Cell CarcinomaPhase 2NCT04146181
Safety and Efficacy of SCT-I10A in Head and Neck Squamous Cell Carcinoma
A Phase 2 study testing PD-1 in people with Head and Neck Squamous Cell Carcinoma, run by Sinocelltech Ltd. at 1 site in China.
Trial summary
The objective of this study is to evaluate the efficacy and safety of SCT-I10A for Recurrent/ Metastatic Head and Neck Squamous cell Carcinoma who progressed on or after platinum-based chemotherapy 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
- What is being tested?
- PD-1
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 103 participants
- Where
- 1 siteChina
- Study dates
- 31 Oct 2019to 30 Sep 2021
- Phase
- Phase 2
- 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
- Voluntarily participate in this clinical trial and sign an informed consent form;
- Male or female, age ≥ 18 years old;
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
- Has histologically- or cytologically-confirmed recurrent or metastatic (disseminated) head and neck squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, and larynx;
- Is considered incurable by local therapies;
- Have measurable disease based on RECIST1.1. tumor lesions, situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesion after 3 months of radiotherapy;
Show all 14Show fewer
- Have provided tissue for PD-L1 biomarker analysis
- The estimated survival period is ≥ 3 months;
- Patients who have been treated with platinum (cisplatin/carboplatin/nidaplatin) and have clear disease progression during treatment (at least 2 cycles) or after treatment (see RECIST version 1.1) or side effects Intolerance, and the minimum dose of platinum drugs must meet:
- Minimum dose of cisplatin: ≥60mg/m2 per cycle, or ≥120mg/m2 in 8 weeks; The minimum dose of carboplatin: AUC ≥ 4 / cycle, or total AUC ≥ 8 within 8 weeks.
- If cisplatin is converted to platinum, the platinum dosage can be calculated using the following formula: carboplatin 1AUC = cisplatin 15mg/m2; The minimum dose of nedaplatin: ≥80mg/m2 per cycle, or ≥160mg/m2 in 8 weeks; Note: Platinum drugs can be used as adjuvant therapy for postoperative patients (synchronous radiotherapy), for palliative chemotherapy in patients with advanced stage or in patients with recurrent and/or metastatic disease.
- Laboratory inspection:
- Blood routine: neutrophils ≥1.5×l09/L, platelets≥75×109/L, hemoglobin≥80g/L; Liver function: alanine aminotransferase (ALT) and aspartate aminotransferase (AST), ALT and AST ≤ upper limit of normal value × 3 for liver metastasis, ALT and AST ≤ upper limit of normal value for liver metastases × 5; total bilirubin ( TBIL) ≤ upper limit of normal value × 1.5; Renal function: creatinine (Cr) ≤ normal upper limit × 1.5; Coagulation: Activated Partial Thromboplastin Time (aPTT), International Normalized Ratio (INR), Prothrombin Time (PT) ≤1.5xULN Echocardiogram: LVEF≥50%
- Subjects should agree to use an adequate method of contraception starting with the first dose of study medication through 6 months after the last dose of study therapy. Female subjects of childbearing potential should have a negative blood pregnancy test within 7 days prior to receiving the first dose of study medication, and should be non-breastfeeding;
Who cannot join
- Disease is suitable for local therapy administered with curative intent
- Prior therapy with an anti-PD-1 or anti-PD1-L1 or -L2 therapy, or anti-CD137, or anti-CTLA-4 therapy
- Diagnosed and/or treated additional malignancy within 5 years of randomization, with the exception of curatively-treated basal cell or squamous cell carcinoma of the skin, and/or curatively-resected in situ cervical cancers;
- NCI CTCAE v5.0 Grading of Peripheral Neuropathy≥2;
- Active central nervous system (CNS) metastases and/or carcinomatous meningitis; subjects with previous treated brain metastases may participate provided they are stable for at least 2 weeks prior to the first dose of study medication, have no evidence of new or enlarging brain metastases, and are not using steroids for at least 14 days prior to trial treatment. Subjects with asymptomatic BM (without neurological symptoms, not using steroids, tumor lesions≤1.5cm) may participate in condition that the tumor lesion should be regularly evaluated using identical imaging modality for each assessment, either MRI or CT scans;
- At the time of enrollment, patients still had ≥2 toxic side effects (except for hair loss, hearing loss, tinnitus, dry mouth or platinum-induced grade 2 neurotoxicity) caused by previous anti-tumor treatment;
Show all 24Show fewer
- Has known serious allergic reaction to study medication or any component of the product, and has known serious allergic reaction to other monoclonal antibodies (NCI CTCAE v5.0≥3);
- Has received anti-tumor therapy, including chemotherapy, hormonal therapy, immunotherapy, radiotherapy, and etc. within 4 weeks of the first dose of treatment, except palliative radiotherapy for bone pain;
- Has received any Chinese traditional medicine for anti-cancer purpose within 1 week of the first dose of treatment;
- Has undergone important surgery within 4 weeks prior to first dose of treatment or has scheduled an important surgery during the study;
- Has received immunosuppressive drugs during the study or within 2 weeks prior to first dose of treatment, except for the following situations:
- Intranasal, inhaled, topical corticosteroids (e.g. intra-articular injections); Physiological dose for systemic prednisolone (≤10mg/d or equivalent); Short-term administration (≤7days) of corticosteroids for prophylaxis or treatment against non-autoimmune allergic disease
- Has known active, and/ or history of autoimmune disease (systemic lupus erythematous, rheumatoid arthritis, inflammatory bowel disease, AITD, multiple sclerosis, vasculitis, glomerulonephritis), and is likely to get a recurrence, or is at high-risk (organ-transplanted patients need immunotherapy), except those with stable type 1 DM after fixed dose of insulin administration , or those with autoimmune hypothyroidism only require HRT, or those with skin disorders that does not require systemic treatment (e.g. eczema, rash <10% BSA, psoriasis without symptoms around eyes)
- Has known interstitial lung disease, such as interstitial pneumonia, pulmonary fibrosis, except asymptomatic drug-induced pneumonitis or radiation pneumonitis
- Has a known history of HIV
- Has known active Hepatitis B (e.g. HBsAg reactive) or Hepatitis C(e.g. HCV RNA [quantitative] is detected)
- has uncontrolled active infections within 2 weeks before enrollment
- Has received a live vaccine within 4 weeks prior to first dose of study treatment, except
- Is with clinical symptoms, required clinical intervention or stable time less than 4 weeks of serous cavity effusion (such as pleural effusion and ascites);
- Has severe conditions, including NYHA III heart failure, IHD, history of MI within 3 months prior to first dose of study treatment, poorly controlled DM (FBS≥10mmol/L) or poorly controlled hypertension (SBP≥160mmHg and/ or DBP≥100mmHg)
- Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
- Is currently participating in other clinical trials, or has participated in a study of an investigational agent and received study therapy, or used an investigational device, any of whose end date is within 4 weeks prior to the first dose of study medication
- has alcohol or drug addiction;
- Subjects who are considered unsuitable for participating in this study for various reasons at the discretion of the investigator，such as inability to comply with study and/or follow-up procedures.
Trial locations and contacts
1 site in 1 country.
Yuankai Shi, MD contact
China1 site, 1 recruiting
- Recruiting
Guangxi Medical University Affiliated Tumour Hospital
Nanning, Guangxi
Song Qu, PhD, 13607887386@163.com
About this study
Official title: A Phase II, Multicenter, Single-arm, Open-label Study of SCT-I10A in Patients With Recurrent/ Metastatic Head and Neck Squamous Cell Carcinoma Who Progressed on or After Platinum-based Chemotherapy
The objective of this study is to evaluate the efficacy and safety of SCT-I10A for Recurrent/ Metastatic Head and Neck Squamous cell Carcinoma who progressed on or after platinum-based chemotherapy
Read the detailed description
This is an open label, single-arm and multicenter phase II study designed to evaluate Objective Response Rate (ORR) of SCT-I10A for Recurrent/ Metastatic Head and Neck Squamous cell Carcinoma who progressed on or after platinum-based chemotherapy.
- Conditions
- Head and Neck Squamous Cell Carcinoma
- Being tested
- PD-1
- 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.
PD-1Drug
Also called SCT-I10A
SCT-I10A, 200 mg intravenous (IV) on Day 1 of each 3-week cycle.
| Study group | Role | What they receive |
|---|---|---|
| SCT-I10A | Experimental | SCT-I10A, 200 mg intravenous (IV) on Day 1 of each 3-week cycle. Receives: Drug: PD-1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR
ORR is defined as proportion of patients achieving complete response (CR) or partial response (PR) according to RECIST v1.1 during trial treatment
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2019
- Study start31 Oct 2019
- Primary completion30 Jun 2021 (estimated)
- Study completion30 Sep 2021 (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 CarcinomaStudies of the same condition, open and under way.
- More trials run by Sinocelltech Ltd.The 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 103 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sinocelltech Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yuankai Shi, MD, Principal investigator, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04146181
- Sponsor's protocol ID
- SCT-I10A-B201
- Status last verified
- Dec 2019
- First submitted
- 28 Oct 2019
- Last updated
- 12 Dec 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Multicenter, Single-arm, Open-label Study of SCT-I10A in Patients With Recurrent/ Metastatic Head and Neck Squamous Cell Carcinoma Who Progressed on or After Platinum-based Chemotherapy
- ClinicalTrials.gov ID
- NCT04146181
- Acronym / sponsor ID
- SCT-I10A-B201
- Conditions
- Head and Neck Squamous Cell Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 103 participants (estimated)
- Lead sponsor
- Sinocelltech Ltd.Industry (pharma, biotech, devices)
- Study start
- 31 Oct 2019 (actual)
- Primary completion
- 30 Jun 2021 (estimated)
- Study completion
- 30 Sep 2021 (estimated)
- First posted
- 31 Oct 2019 (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.
The objective of this study is to evaluate the efficacy and safety of SCT-I10A for Recurrent/ Metastatic Head and Neck Squamous cell Carcinoma who progressed on or after platinum-based chemotherapy
Detailed description
This is an open label, single-arm and multicenter phase II study designed to evaluate Objective Response Rate (ORR) of SCT-I10A for Recurrent/ Metastatic Head and Neck Squamous cell Carcinoma who progressed on or after platinum-based chemotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SCT-I10A | Experimental | Drug: PD-1SCT-I10A, 200 mg intravenous (IV) on Day 1 of each 3-week cycle. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Voluntarily participate in this clinical trial and sign an informed consent form;
- Male or female, age ≥ 18 years old;
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
- Has histologically- or cytologically-confirmed recurrent or metastatic (disseminated) head and neck squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, and larynx;
- Is considered incurable by local therapies;
Key exclusion criteria (24 listed)
- Disease is suitable for local therapy administered with curative intent
- Prior therapy with an anti-PD-1 or anti-PD1-L1 or -L2 therapy, or anti-CD137, or anti-CTLA-4 therapy
- Diagnosed and/or treated additional malignancy within 5 years of randomization, with the exception of curatively-treated basal cell or squamous cell carcinoma of the skin, and/or curatively-resected in situ cervical cancers;
- NCI CTCAE v5.0 Grading of Peripheral Neuropathy≥2;
- Active central nervous system (CNS) metastases and/or carcinomatous meningitis; subjects with previous treated brain metastases may participate provided they are stable for at least 2 weeks prior to the first dose of study medication, have no evidence of new or enlarging brain metastases, and are not using steroids for at least 14 days prior to trial treatment. Subjects with asymptomatic BM (without neurological symptoms, not using steroids, tumor lesions≤1.5cm) may participate in condition that the tumor lesion should be regularly evaluated using identical imaging modality for each assessment, either MRI or CT scans;
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 |
|---|---|---|
| PD-1Also: SCT-I10ASCT-I10A, 200 mg intravenous (IV) on Day 1 of each 3-week cycle. | Drug | SCT-I10A |
Primary outcome
ORR
Time frame: 1 year
ORR is defined as proportion of patients achieving complete response (CR) or partial response (PR) according to RECIST v1.1 during trial treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2019.
- Individual participant dataSharing planned: No
Related trials for Head and Neck Squamous Cell Carcinoma
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 2
Proton Spatially Fractionated Radiotherapy or Photon Stereotactic Body Radiotherapy in Combination With Pembrolizumab Before Surgery for the Treatment of Locally Advanced and Radiation-Naive Locoregionally Recurrent Oral Cavity Cancer, OSPRI Trial
Locally Advanced Oral Cavity Squamous Cell Carcinoma, Locally Recurrent Oral Cavity Squamous Cell Carcinoma
RecruitingObservational study
Multicenter Prospective Cohort on Esophageal Endoscopic Submucosal Dissection
Superficial Esophageal Cancer, Oesophageal Adenocarcinoma
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
Not yet recruiting
Tumoral Versus Luminal Microbiome in Head and Neck Squamous Cell Carcinoma
Squamous Cell Cancer of Head and Neck (SCCHN)
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. This study is not recruiting at the moment.
Yuankai Shi, MD contact
Yuankai Shi, MD principal investigator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PD-1 in people with Head and Neck Squamous Cell 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 14 inclusion and 24 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 12 Dec 2019. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Yan Wang, MD (15201286305, SCT-CT@sinocelltech.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ORR (time frame: 1 year). 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 12 Dec 2019.