Advanced Malignant Cancer
Conditions
Brief summary
This is an, open-label, multi-center, three-part phase I trial to evaluate the safety, pharmacokinetics and immunogenicity of SHR-1909 and preliminary anti-tumor efficacy of SHR-1909 in advanced malignant cancer.
Interventions
DRUGSHR-1909 injection
SHR-1909 for intravenous injection;Strength:6ml:0.3g/vial. Dose escalation (non randomized, 6 dose-levels); Dose-expansion and efficacy-expansion(non-randomized,1-3 dose-level(s)).
Sponsors
Shanghai Hengrui Pharmaceutical Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Dose escalation (non randomized， 6 arms); Dose-expansion and efficacy-expansion(non-randomized,1-3 arms)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; * Patients must have cytologically or histologically confirmed advanced malignant tumor, and must have failed standard treatment; * Toxicities caused by prior anti-tumor treatments must have resolved to CTCAE Grade ≤ 1 prior to the first dose (except for alopecia or hypothyroidism treated with hormone replacement therapy or diabetes controlled with insulin); * Adequate organ function.
Exclusion criteria
* With CNS infiltration, or ascites requiring paracentesis or symptomatic pleural effusion; * Received prior CAR T-cell therapy; * Received allogeneic hematopoietic stem cell transplantation within 3 months prior to the start of study treatment, or with acute/chronic graft versus host disease; * With active infection or fever of unknown origin (\> 38.5 °C).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| MTD of SHR-1909 | From Day 1 to 4 weeks | Maximum tolerated dose (MTD) based on dose-limiting toxicities (DLTs) |
| RP2D of SHR-1909 | From Day 1 to 90 days after last dose | Recommended Phase 2 Dose(RP2D) of SHR-1909 will be determined during the dose-escalation and dose-expansion parts of the study. RP2D will be determined using available safety, pharmacokinetics and pharmacodynamics data. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events | 90 days after the last dose | Adverse Events documented by CTCAE 5.0 |
| Objective Response Rate (ORR) | Up to approximately 2 years | Baseline to documented disease progression or study discontinuation |
| Progression-Free Survival (PFS) | Up to approximately 2 years | From Day 1 to Radiographic Progression or Death Due to Any Cause |
Countries
China
Outcome results
None listed