Abstract 2110
Background
CS1001 is a first full-length, fully human anti-PD-L1 mAb developed by the OMT transgenic rat platform, which mirrors natural IgG4 human antibody with expected pharmacokinetics (PK) profiles, and may potentially reduce the risk of immunogenicity and toxicity in pts. This first-in-human Phase Ia/Ib study of CS1001 was conducted to evaluate the safety, tolerability, PK profile, and anti-tumor activity of CS1001 in pts with advanced solid tumors or lymphomas.
Methods
Pts with advanced solid tumors or lymphomas were enrolled in the dose escalation Phase Ia, receiving CS1001, Q3W, IV, at escalating doses from 3, to 10, 20, 40 mg/kg and 1200 mg fixed dose. Dose escalation followed a 3 + 3 dose escalation scheme. Dose-limiting toxicity (DLT) was evaluated within 3 weeks after the initial dose. Pts with various tumor types were enrolled in the dose expansion Phase Ib to assess anti-tumor activity and safety, including GC, cholangiocarcinoma, NSCLC, HCC, etc. Safety was assessed by monitoring the frequency and severity of adverse events (AEs) per NCI CTCAE v4.03, tumor response was assessed per RECIST v1.1 (solid tumors) or Lugano 2014 (lymphomas).
Results
As of 30 Nov 2018, 29 pts, median age of 53 (23-75) years, were enrolled in Phase Ia, 3 mg/kg (N = 3); 10 mg/kg (4); 20 mg/kg (3); 40 mg/kg (3) and 1200 mg fixed dose (16). 20 pts discontinued treatment, mostly due to disease progression (14). 2 pts discontinued treatment due to AEs (Grade [G] 4 hepatic function abnormal and G3 pulmonary tuberculosis, neither of which were related to CS1001). Median treatment duration was 126 (21-408+) days. No DLTs were observed. The most frequent TRAEs included anaemia (48.3%) and proteinuria (44.8%). SAEs were reported in 6 pts and they were not related to CS1001. irAEs occurred in 7 pts. Among the 29 pts, 7 (24%) pts had PR, mDoR was not reached. In Phase Ib, 162 pts were enrolled as of 15 Mar 2019.
Conclusions
CS1001 is well tolerated without DLT across the dose levels investigated. Evidence of anti-tumor activities was observed. Currently, 1200 mg fixed dose Q3W is being explored in various tumor types in Phase Ib, safety and efficacy results of selected Phase Ib expansion arms will be reported at the conference presentation.
Clinical trial identification
NCT03312842.
Editorial acknowledgement
Legal entity responsible for the study
CStone Pharmaceuticals (Su Zhou) Co., Ltd.
Funding
CStone Pharmaceuticals (Su Zhou) Co., Ltd.
Disclosure
J. Ding: Full / Part-time employment: CStone Pharmaceuticals. J. Wang: Full / Part-time employment: CStone Pharmaceuticals. Y. Wang: Full / Part-time employment: CStone Pharmaceuticals. H. Dai: Full / Part-time employment: CStone Pharmaceuticals. All other authors have declared no conflicts of interest.
Resources from the same session
4596 - A Phase 2, Open-Label, Randomized, Multicenter Trial of Encorafenib + Binimetinib Evaluating a Standard-dose and a High-dose Regimen in Patients With BRAFV600-Mutant Melanoma Brain Metastasis (MBM) (POLARIS)
Presenter: Michael Davies
Session: Poster Display session 3
Resources:
Abstract
1891 - Continuation of annual screening mammograms and breast-cancer mortality in women over 70
Presenter: Xabier Garcia De Albeniz
Session: Poster Display session 3
Resources:
Abstract
5587 - Introducing standardized medical procedure and dynamic decision support program in precision oncology for the community of practice
Presenter: Istvan Petak
Session: Poster Display session 3
Resources:
Abstract
4757 - Effectively using primary care givers in oncology care through capacity building, task sharing and techno-mentoring.
Presenter: Dinesh Pendharkar
Session: Poster Display session 3
Resources:
Abstract
4497 - A single institution review of capecitabine related acute admissions and cost analysis
Presenter: Gemma Dart
Session: Poster Display session 3
Resources:
Abstract
2187 - Health status of middle-aged and older cancer survivors in China: results from the China Health and Retirement Longitudinal Study (CHARLS)
Presenter: Jiarui Li
Session: Poster Display session 3
Resources:
Abstract
5101 - Crossed looks on lung cancer perception and knowledge from general public and physicians in France: results of a two-fold survey
Presenter: Céline Mascaux
Session: Poster Display session 3
Resources:
Abstract
4354 - Knowledge and perception of clinical trials (CTs) and attitude towards participation among Polish oncological patients - A pilot survey
Presenter: Artur Kotowski
Session: Poster Display session 3
Resources:
Abstract
3499 - Achieving best possible cancer treatment outcomes in care pathways through benchmarking; ABC-Benchmarking
Presenter: Anke Wind
Session: Poster Display session 3
Resources:
Abstract
2270 - Impact of 10-day Fulbright Specialist Program (FSP) and Project Pink Blue (PPB) Education Sessions on Medical Oncology knowledge among Doctors that treat cancer in Nigeria
Presenter: Mike Martin
Session: Poster Display session 3
Resources:
Abstract