Advanced Solid Tumors Cancer
Conditions
Keywords
Tumor Infiltrating Lymphocyte, TIL
Brief summary
This is a multicenter, single-arm phase 1/2 clinical trial to evaluate the safety and tolerability of GT201 as a monotherapy or in combination with anti-PD-1 therapy in patients with advanced solid tumors, and to evaluate the efficacy of this therapy.
Interventions
BIOLOGICALGT201
A tumor sample from individual participant is collected through a surgical resection for ex vivo manufacturing of GT201 TIL cell product.
BIOLOGICALIL-2 and PD-1
Participants tandemly receives a lymphodepleting regimen, GT201 TIL product, and IL-2. Some participants may also receive a PD-1 inhibitor following GT201 infusion
Sponsors
Gritbio Medicine, Inc.
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
Key eligibility criteria for inclusion in the study: * 1 Age 18\~70 years old; * 2 Diagnosed with: Phase 1 part: Patients with advanced solid tumors who have failed all standard therapy, have no standard therapy, or are intolerant of standard therapy Phase 2a part: Patients with an advanced or metastatic solid tumor enrolled in one of three (3) indications selected for dose expansion based on Phase 1 safety and preliminary activity. Patients must have progressed on or after standard-of-care therapy, or for whom no suitable standard therapy is available; * 3 At least one lesion that is resectable for the preparation of autologous TIL cells; * 4 At least one measurable lesion that meets the definition of RECIST v1.1 after tumor sampling; * 5 Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1; * 6 Expected survival ≥ 12 weeks; * 7 Non-surgically sterilized women of reproductive age who agree to use at least one medically recognized method of contraception during the study treatment period and for 1 year after the end of the study treatment period; and must have a negative serum test at screening, prior NMA-LD and cell infusion.
Exclusion criteria
Subjects will be excluded from the study for one or more of the following conditions: * 1 Patients with spinal cord compression that has failed to resolve after surgery and/or radiotherapy (patients with clinical evidence that symptoms have resolved after surgery or radiation therapy for ≥ 1 week prior to surgical sampling are eligible for enrollment); * 2 Bleeding events within 3 months prior to screening * 3 Patients with arterio-venous thrombotic events that occurred within 3 months prior to screening * 4 Have interstitial pneumonia or active pneumonia that is clinically significant at screening, or other respiratory conditions that severely affect lung function; * 5 Patients who have a left ventricular ejection fraction (LVEF) \< 45% or who are New York Heart Association (NYHA) Class grade \> grade 2; * 6 Participants with ≥ 3 untreated central nervous system (CNS) metastases; * 7 Have any historical or active autoimmune disease requiring systemic steroids, or immunosuppressive therapy (\> 10 mg/day of prednisone or equivalent); * 8 Malignant tumors other than the target indication within 5 years; * 9 The presence of refractory or intractable epilepsy, large amounts of pleural effusion, ascites, pericardial effusion, etc. that cannot be controlled by drugs, or other contraindications to IL-2 use; * 10 Patients with infectious diseases, will be excluded from the study; with some exceptions for HBV and HCV. * 11 Previous allogeneic bone marrow transplantation or solid organ transplantation;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To assess the safety of GT201 in the treatment of recurrent or metastatic solid tumors | Upto 2 years | Incidence and severity of AEs will be graded per NCICTCAE v5.0 (Phase 1) |
| To assess the tolerance of GT201 and decide on the recommended Phase 2 dose. | Upto 2 years | The safest combination will be used to determine recommended dose for Phase 2 (RP2D) (Phase 1) |
| To assess the Objective Response Rate (ORR) of GT201 infusion in accordance with RECIST v1.1 | Upto 2 years | To evaluate the proportion of participants who have a confirmed complete response (CR) or partial response (PR) (Phase 2) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To assess efficacy of GT201 in the treatment of recurrent or metastatic solid tumors: Objective response rate (ORR) | Upto 2 years | Proportion of participants achieving a Complete Response (CR) or Partial Response (PR) per RECIST v1.1 (Phase 1 and Phase 2) |
| To assess efficacy of GT201 in the treatment of recurrent or metastatic solid tumors: duration of response (DOR) | Upto 2 years | The duration from the first confirmed objective response per RECIST v1.1 to the first documentation of progressive disease (PD) or death from any cause (Phase 1 and Phase 2) |
| To assess efficacy of GT201 in the treatment of recurrent or metastatic solid tumors: disease control rate (DCR) | Upto 2 years | Proportion of participants achieving Complete Response (CR), Partial Response (PR), or Stable Disease (SD) per RECIST v1.1 (Phase 1 and Phase 2). |
| To assess efficacy of GT201 in the treatment of recurrent or metastatic solid tumors: progression free survival (PFS) | Upto 2 years | The time from GT201 infusion to the first documentation of progressive disease (PD) per RECIST v1.1 or death from any cause, whichever occurs first (Phase 1 and Phase 2) |
| To assess efficacy of GT201 in the treatment of recurrent or metastatic solid tumors: overall survival (OS) | Upto 2 years | The time from GT201 infusion to death from any cause (Phase 1 and Phase 2) |
Contacts
CONTACTGritbio Study Team
Outcome results
None listed