GKL-006Allo Injection in Patients With Advanced Solid Tumors
ConditionSolid Tumor Malignancies
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorBeijing Gene Key Life Technology Co., Ltd
About this trial
This is a Phase 1 study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and preliminary anti-tumor activity of GKL-006Allo Injection in participants with advanced solid tumors.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Able to understand and voluntarily sign the informed consent form.
Aged 18 to 75 years.
Histologically, cytologically or clinical confirmed unresectable locally advanced or metastatic solid tumor that has failed standard therapy.
At least one measurable tumor lesion during screening according to RECIST v1.1.
Disqualifiers
Recently received radical radiotherapy or other anti-tumor therapy.
Known hypersensitivity to any component of the study treatment.
Prior history or concurrent malignancy that has not been cured.
Active infection, known or suspected autoimmune disease.
Trial design
Design model
Sequential
Treatments tested in this trial
GKL-006Allo Injection
Biological/VaccineGKL-006Allo Injection is an allogeneic invariant natural killer T (iNKT) cell therapy. It will be administered according to the dose level, dosing schedule, and treatment stage specified in the protocol.
Treatment groups
27 Participants
are divided into 1 treatment groupGroup A: GKL-006Allo InjectionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Number of Participants With Dose-Limiting Toxicities (DLTs)
Dose-limiting toxicities will be assessed according to protocol-defined DLT criteria.
Time frame
From the first dose through the end of the DLT observation period, assessed up to 28 days.2
Incidence and Severity of Adverse Events
Safety will be assessed by the incidence and severity of adverse events, serious adverse events, laboratory abnormalities, electrocardiogram abnormalities, physical examination findings, and vital sign abnormalities.
Time frame
From the first dose of study treatment until 28 days after the pointed dose of study treatment. The safety monitor will be continued until the end of the study, up to 18 months.Secondary outcomes
1
Progression-Free Survival (PFS)
Progression-free survival is defined as the time from the first dose of study treatment to the first documented disease progression or death from any cause, whichever occurs first, according to RECIST v1.1.
Time frame
From the first dose of study treatment until disease progression or death from any cause, whichever occurs first, assessed up to 18 months.2
Overall Survival (OS)
Overall survival is defined as the time from the first dose of study treatment to death from any cause.
Time frame
From the first dose of study treatment until death from any cause, assessed up to 18 months.3
Change From Baseline in EORTC QLQ-C30 Scale Scores
Health-related quality of life will be assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30). Scores for each scale range from 0 to 100. Higher scores on the functional scales and global health status/quality-of-life scale indicate better functioning or quality of life.
Time frame
Baseline and scheduled post-baseline assessments, up to 18 months.4
Immunogenicity
GKL-006 Alloantibodies (ADA) and their titers, anti-GKL-006 Allo neutralizing antibodies (Nab) and their titers, anti-HLA antibodies, etc. will be tested.
Time frame
From baseline through protocol-specified immunogenicity sampling time points, assessed up to 180 days.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: