Clinical Study of GT201 in Combination with PD-1 Inhibitor for Advanced Head and Neck Tumors

Launched by GRIT BIOTECHNOLOGY · Dec 19, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called GT201, used together with another medication known as a PD-1 inhibitor, for adults with advanced head and neck cancer. The goal is to see how safe and effective this combination is for patients who have recurrent or metastatic head and neck squamous cell carcinoma (HNSCC), which is a type of cancer affecting the mouth, throat, or nose. The trial has two phases: first, researchers will gradually increase the dose of GT201 to find the best amount to give, and then they will expand the study to include more participants.

To be eligible for this trial, participants need to be between 18 and 70 years old, have a diagnosis of advanced HNSCC, and have had no more than two previous treatments for their cancer. They should also be in relatively good health, with a performance status that allows them to care for themselves. Participants can expect to have regular check-ups and tests throughout the study to monitor their health and how well the treatment is working. It's important to note that certain patients, such as those with uncontrolled pain or significant mental health issues, may not be able to participate. If you or a loved one is considering joining this trial, it’s a great opportunity to potentially access a new treatment while contributing to important cancer research.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Voluntarily join the study, signed informed consent form,, willing and able to comply with the study protocol;
• • 2. Age 18 to 70 years old;
• • 3. Diagnosis with recurrent or metastatic head and neck malignant tumors and received≤2 lines of systemic therapy;
• • 4. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;
• • 5. Expected survival time of ≥ 12 weeks;
• • 6. Good function of vital organs;
• • 7. Subjects who enter this study due to poor treatment efficacy or intolerance must have medical records describing their condition after previous treatment or imaging records of lesion evaluation before tumor sampling;
• • 8. At least one measurable target lesion that meets the definition of RECIST v1.1 after tumor sampling.
• Exclusion Criteria:
• • 1.Patients with uncontrollable tumor-related pain as judged by the investigator; participants requiring analgesic medication must already have a stable analgesic regimen at the time of study entry; symptomatic lesions suitable for palliative radiotherapy should be completed prior to study entry;
• • 2.Known mental illness, alcoholism, drug use or substance abuse;
• • 3.Pregnant or lactating women; or women who are pregnant, breastfeeding, or planning to become pregnant within 1 year after cell infusion;
• • 4.Those who have received other clinical trial drug treatment within 4 weeks before NMA-LD chemotherapy or plan to participate in other clinical trial drug treatment during the study;
• • 5.The investigators determine that other conditions that make the patient not suitable for enrollment.