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3 dose levels are designed in this study.3 to 6 patients (traditional "3+3" design) will be enrolled in each dose cohort. INCSHR01210 injection at each dose level is administered every 2 weeks (q2w, except in the first cycle).

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.

INCSHR01210 injection

This is an open-label, multicenter, non-randomized, dose escalation and tumor-expansion phase I trial to evaluate safety and tolerability of INCSHR01210 in patients with advanced solid tumors. The trial will enroll subjects with advanced solid tumor who have failed current standard anti-tumor therapies.

A Trial to Evaluate Safety and Tolerability of INCSHR01210 in Cancer Patients

An Open-Label, Multicenter, Nonrandomized, Dose-Escalation and Tumor-Expansion Phase 1 Study to Evaluate the Safety and Tolerability of INCSHR01210 (Formerly SHR-1210) in Subjects With Advanced Solid Tumors

Recommended phase II doses (RP2D) is 200 mg, and the only dose interval to be tested will be once every 4 weeks (Q4W).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Trial to Evaluate Safety and Tolerability of INCSHR01210 in Cancer Patients	NCT02492789	Solid Tumors an...	INCSHR01210 inj...	18 Years -	Atridia Pty Ltd.
A Trial to Evaluate Safety and Tolerability of INCSHR01210 in Cancer Patients	NCT02492789	Solid Tumors an...	INCSHR01210 inj...	18 Years -	Atridia Pty Ltd.

Spots Global Cancer Trial Database for incshr01210 injection