<p>A First-in-Human Dose Finding Study of Camrelizumab in Patients with Advanced or Metastatic Cancer in Australia</p>

Abstract

Purpose: Camrelizumab inhibits PD-1 in non-clinical models and showed typical non-clinical pharmacokinetic (PK) and safety profiles for an IgG4 monoclonal antibody. We report results from the First-inHuman Phase 1 trial of camrelizumab in Australian population. Methods: Camrelizumab was administered to patients with advanced solid tumors who had failed standard therapies. In the dose-escalation phase (n=23), camrelizumab was administered intravenously at 1 mg/kg, 3 mg/kg, 6 mg/kg, and 10 mg/kg every 2 weeks. In dose expansion (n=26), camrelizumab was given at 200 mg or 600 mg every 4 weeks. Results: Two dose-limiting toxicities were observed during dose escalation: transaminase elevation and diarrhea (both grade 3). Overall, treatment-related adverse events were consistent with the expected toxicity profile of immune checkpoint inhibition, with the striking exception of the dose-related development of angiomatous skin lesions characterized as reactive cutaneous capillary endothelial proliferation. The PK profile showed a doseprogressive increase in half-life from 3 days at 1 mg/kg to 7 days at 10 mg/kg. Moreover, receptor occupancy assays showed a PD-1 occupancy of >50% in most patients out to 28 days post-dose. The objective response rate was 15.2% (95% CI 6.3-28.9). Conclusion: Camrelizumab has manageable toxicity and encouraging preliminary antitumor activity in advanced solid tumors in Australia. Clinical Trial Registration: ClinicalTrials.gov Identifier: NCT02492789.

The Safety and Efficacy of Camrelizumab and Its Combination With Apatinib in Various Solid Cancers

“…After carefully screening the full text or conference abstracts, 24 articles were eligible. Finally, 15 articles with 1,390 patients were included after removing nine articles with duplicate data (Fang et al, 2018;Huang et al, 2019a;Huang et al, 2019b;Liu et al, 2019;Qin et al, 2019;Shen et al, 2019;Wu et al, 2019;Xie et al, 2019;Xu et al, 2019;Zhang et al, 2019;Zhou et al, 2019a;Zhou et al, 2019b;Chen et al, 2020a;Lickliter et al, 2020;Qin et al, 2020). Trial NCT03121716 had both a single-agent cohort (camrelizumab alone) and a combination cohort (camrelizumab plus other therapies), and the two cohorts were enrolled separately as two studies (Fang et al, 2018).…”

Recent Advances in Monoclonal Antibody Therapy for Colorectal Cancers

“…The indications for camrelizumab are expanding through multiple ongoing clinical trials. A phase II clinical trial (NCT03912857) for treatment of patients with advanced mCRC, the combination of camrelizumab plus apatinib, a VEGFR2 inhibitor, is expected to increase the overall response rate of advanced mCRC after standard chemotherapy [183,184] (Table 1).…”

Anti‐PD‐1 antibody camrelizumab plus doxorubicin showed durable response in pulmonary sarcomatoid carcinoma: Case report and literature review

“…Camrelizumab (SHR‐1210), a PD‐1 inhibitor, is being investigated as a treatment option for non‐squamous NSCLC 12 . A recent study (NCT02492789) showed that camrelizumab had encouraging antitumour activity in advanced solid tumours 13 . To the best of our knowledge, the evidence regarding the efficacy of camrelizumab for PSC is lacking.…”