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New treatment option for Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma
Official title A Trial of SHR-A2102 With Adebrelimab With or Without Other Anti-tumor Therapies in Recurrent/MetastaticHead and Neck Squamous Cell Carcinoma Cancer
ClinicalTrials.gov ID: NCT07059221
What this study is testing
What is SHR-A2102?
SHR-A2102 is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for recurrent/metastatic head and neck squamous cell carcinoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study is being conducted to evaluate the safety, tolerability and efficacy of SHR-A2102/SHR-9839(sc) with Adebrelimab with or without other Antitumor Therapy in Subjects with Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma. To explore the reasonable dosage of SHR-A2102/SHR-9839（sc） for Subjects with Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Have the ability to give informed consent, have signed informed and able to comply with the treatment plan to visit the tests and other procedural...
- Subject with advanced or distant metastatic squamous cell carcinoma of the head and neck confirmed by histology or cytology.
- At least one measurable lesion according to RECIST v1.1 criteria.
- The ECOG score is 0 or 1.
- Expected survival ≥12 weeks.
You likely can't join if
- \- 1\. people will not be screened if they meet any of the following conditions:
- Primary tumor located in the nasopharynx, salivary glands, sinuses, skin, or squamous cell carcinoma of unknown primary origin;
- Locally advanced patients who are candidates for curative surgery or local therapy and have the intention to undergo such treatment; 2\. Known...
- Use of any investigational drug within 4 weeks before the first dose;
- Concurrent enrollment in another clinical trial, unless it is an observational (non-treatment) study or follow-up in an treatment study; 4. Active...
See the full eligibility criteria
- Have the ability to give informed consent, have signed informed and able to comply with the treatment plan to visit the tests and other procedural requirements.
- Subject with advanced or distant metastatic squamous cell carcinoma of the head and neck confirmed by histology or cytology.
- At least one measurable lesion according to RECIST v1.1 criteria.
- The ECOG score is 0 or 1.
- Expected survival ≥12 weeks.
- Male people whose partners are women of childbearing age and female people who are fertile are required to use highly effective contraceptive methods.
- \- 1\. people will not be screened if they meet any of the following conditions:
- Primary tumor located in the nasopharynx, salivary glands, sinuses, skin, or squamous cell carcinoma of unknown primary origin;
- Locally advanced patients who are candidates for curative surgery or local therapy and have the intention to undergo such treatment; 2\. Known hypersensitivity to the investigational drug or any of its excipients, or a...
- Use of any investigational drug within 4 weeks before the first dose;
- Concurrent enrollment in another clinical trial, unless it is an observational (non-treatment) study or follow-up in an treatment study; 4. Active autoimmune disease or a history of autoimmune disorders. 5. Residual...
The study team makes the final eligibility decision.
Where it's taking place
- Chongqing, Chongqing Municipality, China
- Chengdu, Sichuan, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chongqing, Chongqing Municipality, China; Chengdu, Sichuan, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.