Status:
COMPLETED
A Trial of SHR-1701 in Subjects With Advanced Solid Tumors
Lead Sponsor:
Atridia Pty Ltd.
Conditions:
Advanced Solid Tumor
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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-t...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 31 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2023
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT04324814
Start Date
March 31 2020
End Date
February 1 2023
Last Update
February 21 2023
Active Locations (4)
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1
Icon Cancer Care Centre
South Brisbane, New South Wales, Australia, 4101
2
Scientia Clinical research
Sydney, New South Wales, Australia
3
Sydney South West Private
Sydney, New South Wales, Australia
4
Linear Clinical Research
Perth, Western Australia, Australia