Clinical trial NCT04324814: A Trial of SHR-1701 in Subjects With Advanced Solid Tumors
Official title: A Phase 1, Open-Label, Multi-Center, Non-Randomized, Dose Escalation/Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Immunogenicity of SHR-1701 in Subjects With Advanced Solid Tumors.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Advanced Solid Tumor
Lead sponsor: Atridia Pty Ltd.
Sponsor class: INDUSTRY
First posted: 2020-03-27
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Dose escalation is designed according to a modified 3+3 scheme, in which 3 to 6 subjects will be enrolled in each dose group. Four dose levels of SHR-1701 are planned. After completion of dose escalation, selected cohort(s) will be expanded.
Primary purpose: TREATMENT

Brief summary: This is a dose-escalation and dose-expansion Phase 1 trial to evaluate the safety and tolerability of SHR-1701 in subjects with advanced solid tumors.

Detailed description: This is a two-part, open-label, multicenter, non-randomized, dose escalation, Phase 1 study of repeated doses of SHR-1701 in subjects with advanced solid tumors who have failed current standard anti-tumor therapies.

Eligibility criteria: Inclusion Criteria:

* Diagnosed (histologically or cytologically) with solid tumors
* ECOG Performance Status of 0 or 1 at both the screening and baseline visits
* Life expectancy ≥12 weeks
* Adequate laboratory parameters
* Willing and able to comply with clinic visits and study-related procedures
* Provide signed informed consent

Exclusion Criteria:

* Known history of hypersensitivity to the study drug
* Prior malignancy active within the previous 2 years
* Any investigational or concurrent cancer therapy
* History of immunodeficiency including seropositivity
* Systemic antibiotics treatment for ≥ 7 days before the first dose
* A known history of allogeneic organ transplantation

Primary outcomes:
measure: Adverse events
timeFrame: Screening up to study completion, an average of 1 year
measure: Laboratory results
timeFrame: Screening up to study completion, an average of 1 year
measure: Vital signs
timeFrame: Screening up to study completion, an average of 1 year
measure: Electrocardiogram
timeFrame: Screening up to study completion, an average of 1 year
Secondary outcomes:
measure: Pharmacokinetic - Cmax
timeFrame: Pre-dose, 10min(±2min), 1h(±5min), 2h(±5min), 6h(±10min) Post-dose on Cycle1 Day 1, pre-dose on Day 2, 3, 4, 8, 15
measure: Pharmacokinetic - AUC∞
timeFrame: Pre-dose, 10min(±2min), 1h(±5min), 2h(±5min), 6h(±10min) Post-dose on Cycle1 Day 1, pre-dose on Day 2, 3, 4, 8, 15
measure: Pharmacokinetic - Tmax
timeFrame: Pre-dose, 10min(±2min), 1h(±5min), 2h(±5min), 6h(±10min) Post-dose on Cycle1 Day 1, pre-dose on Day 2, 3, 4, 8, 15
measure: Pharmacokinetic - CL/F
timeFrame: Pre-dose, 10min(±2min), 1h(±5min), 2h(±5min), 6h(±10min) Post-dose on Cycle1 Day 1, pre-dose on Day 2, 3, 4, 8, 15
measure: Pharmacokinetic - Vz/F
timeFrame: Pre-dose, 10min(±2min), 1h(±5min), 2h(±5min), 6h(±10min) Post-dose on Cycle1 Day 1, pre-dose on Day 2, 3, 4, 8, 15
measure: Pharmacokinetic - t1/2
timeFrame: Pre-dose, 10min(±2min), 1h(±5min), 2h(±5min), 6h(±10min) Post-dose on Cycle1 Day 1, pre-dose on Day 2, 3, 4, 8, 15
measure: Pharmacodynamics- ADA
timeFrame: Pre-dose on Day1 of cycle 2,3,4,5,7,9,13,17
Other outcomes:
Locations:
city: South Brisbane
country: Australia
facility: Icon Cancer Care Centre
state: New South Wales
city: Sydney
country: Australia
facility: Scientia Clinical research
state: New South Wales
city: Sydney
country: Australia
facility: Sydney South West Private
state: New South Wales
city: Perth
country: Australia
facility: Linear Clinical Research
state: Western Australia
Study officials:
References: