Phase I/II Clinical Study of GT201 Injection as Monotherapy or in Combination With PD-1 Inhibitor for Advanced Solid Tumors

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorGrit Biotechnology

About this trial

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.

Eligibility criteria

Qualifiers

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.

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

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • GT201
  • IL-2
  • PD-1 inhibitor

Treatment groups

78 Participants
are divided into 1 treatment group

Sponsors and collaborators