A Trial to Evaluate Safety and Tolerability of INCSHR01210 in Cancer Patients
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|ClinicalTrials.gov Identifier: NCT02492789|
Recruitment Status : Active, not recruiting
First Posted : July 9, 2015
Last Update Posted : May 23, 2018
|Condition or disease||Intervention/treatment||Phase|
|Solid Tumors and Hematologic Malignancy||Biological: INCSHR01210 injection||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||49 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-label, Multicenter, Non-randomized, Dose Escalation Phase 1 Trial to Evaluate Safety and Tolerability of INCSHR01210 in Subjects With Advanced Solid Tumors|
|Study Start Date :||September 2015|
|Estimated Primary Completion Date :||November 2018|
|Estimated Study Completion Date :||May 2019|
3 dose levels are designed in this study: 1, 3 and 10 mg/kg.3 to 6 patients (traditional "3+3" design) will be enrolled in each dose cohort. INCSHR01210 injection at a dose of 1, 3 or 10 mg/kg is administered every 2 weeks (q2w, except in the first cycle).
Biological: INCSHR01210 injection
Part1: INCSHR01210 injection at a dose of 1, 3 or 10 mg/kg is administered every 2 weeks (3+3,q2w, except in the first cycle, in which subjects will be only dosed once on Day 1 for PK samplings and dose limiting toxicity observation). Response is assessed by every 2 cycles (4 weeks each cycle) by using irRECIST.
Part2: Additional patients (200mg dose cohorts will be enrolled in Part 2, depending on the data outcomes in Part 1, to further explore preliminarily clinical benefits of INCSHR01210 as well as the other objectives of the study.
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 15 months ]Recommended phase II doses (RP2D) is 200 mg, and the only dose interval to be tested will be once every 4 weeks (Q4W).
- Pharmacokinetics (PK) profile of INCSHR01210 (Tmax) [ Time Frame: Day 1 of cycle 1 ]
- Maximum tolerated dose (MTD) of INCSHR01210 [ Time Frame: 6 months ]
- Incidence of anti-INCSHR01210 antibody in serum [ Time Frame: 15 months ]
- PD-1 receptor occupancy [ Time Frame: 15 months ]
- Duration of response [ Time Frame: 15 months ]
- Objective response rate [ Time Frame: 15 months ]
- Time to progression [ Time Frame: 15 months ]
- Pharmacokinetics (PK) profile of INCSHR01210 (Cmax) [ Time Frame: Day 1 of cycle 1 ]
- Pharmacokinetics (PK) profile of INCSHR01210 (AUC0-28day) [ Time Frame: Day 28 of cycle 1 ]
- Pharmacokinetics (PK) profile of INCSHR01210 (accumulation ratio R) [ Time Frame: Day 28 of each cycle ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02492789
|Austin Hospital/Olivia Newton-John Cancer Research Institute|
|Heidelberg, Victoria, Australia|
|Chris O'Brien Life House|
|Linear Clinical Research Limited|