Advanced Solid Tumors
Conditions
Brief summary
This is a multicenter Phase I/II clinical trial. It aims to evaluate the safety, tolerability, efficacy and pharmacokinetics (PK) of GT201 in patients with advanced solid tumors.
Interventions
Sponsors
Grit Biotechnology
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* 1\. Voluntarily enroll in the study, sign the informed consent form (ICF), and be willing and able to comply with the study protocol. * 2\. Aged 18 to 70 years old. For subjects older than 70 years old, eligibility shall be jointly determined by the Investigator and the Sponsor's Medical Monitor. * 3\. Diagnosis: * Phase I trial: Patients with advanced solid tumors who have failed standard therapy, have no available standard therapy, or cannot tolerate standard therapy. * Phase II trial: Patients with the target indication who have progressed or are intolerant after receiving the specified treatment outlined in the protocol, and who meet the inclusion and
Exclusion criteria
for the target indication. * 4\. At least one lesion that is resectable for the preparation of autologous TIL cells. * 5\. At least one measurable lesion that meets the definition of RECIST v1.1 after tumor sampling. * 6\. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. * 7\. Estimated survival time ≥ 12 weeks. * 8\. Functions of major organs meet the requirements specified in the protocol. * 9\. Female or male subjects of childbearing potential who have not undergone surgical sterilization must agree to use at least one medically acceptable contraceptive method (e.g., intrauterine device, oral contraceptives, condoms) during study treatment and for 1 year after the end of study treatment. For female subjects of childbearing potential without surgical sterilization, serum human chorionic gonadotropin (hCG) test must be negative within 7 days prior to cell infusion. * 10\. Prior treatment related adverse events shall have recovered to Grade ≤ 1 per Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 before tumor sampling, or be judged by the investigator together with the sponsor's medical monitor not to interfere with the study. * 11\. For participants enrolled in this study due to disease progression, imaging documentation confirming disease progression following the prior therapy must be available before tumor sampling.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events (AEs) | Up to 2 years | Incidence and severity of AEs, SAEs and AE leading to treatment interruption and discontinuation will be graded per NCICTCAE v5.0 (Phase 1) |
| Changes in laboratory parameters | Up to 2 years | Evaluate the safety and tolerability based on changes in laboratory parameters before and after treatment. (Phase 1) |
| Objective Response Rate (ORR) | Up to 2 years | Proportion of participants achieving a Complete Response (CR) or Partial Response (PR) per RECIST 1.1 (Phase 2). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response Rate (ORR) | Up to 2 years | Proportion of participants achieving a Complete Response (CR) or Partial Response (PR) per RECIST 1.1 (Phase 1). |
| Disease control rate (DCR) | Up to 2 years | Proportion of participants achieving Complete Response (CR), Partial Response (PR), or Stable Disease (SD) per RECIST 1.1 (Phase 1 and Phase 2). |
| Progression free survival (PFS) | Up to 2 years | The time from GT201 infusion to the first documentation of progressive disease (PD) per RECIST 1.1 or death from any cause, whichever occurs first (Phase 1 and Phase 2). |
| Duration of Response (DOR) | Up to 2 years | The duration from the first confirmed objective response per RECIST 1.1 to the first documentation of progressive disease (PD) or death from any cause (Phase 1 and Phase 2). |
| Overall survival (OS) | Up to 2 years | The time from GT201 infusion to death from any cause (Phase 1 and Phase 2). |
| CD3+ T cell counts | Up to 2 years | To evaluate the persistence and expansion of TILs in participants by measuring CD3+ T cell counts in peripheral blood following infusion of GT201 Injection (Phase 1 and Phase 2). |
| GT201 gene copy numbers | Up to 2 years | To evaluate the persistence and expansion of TILs in participants by measuring GT201 gene copy numbers in peripheral blood following infusion of GT201 Injection (Phase 1 and Phase 2). |
| Adverse events (AEs) | Up to 2 years | Incidence and severity of AEs, SAEs and AE leading to treatment interruption and discontinuation will be graded per NCICTCAE v5.0 (Phase 2) |
| Anti-drug antibodies (ADA) | Up to 2 years | Incidence of anti-drug antibodies (ADA) and neutralizing antibodies (Nab) (Phase 1 and Phase 2). |
Countries
China
Contacts
CONTACTYue He, PhD
Outcome results
None listed