A Phase Ia/Ib Study of CS1001 in Subjects With Advanced Solid Tumors

Conditions

Advanced Cancer

Brief summary

This is a phase Ia/Ib, open-label, multiple-dose, dose-escalation and expansion study to evaluate the safety, tolerability, pharmacokinetics and anti-tumor activity of CS1001 in subjects with advanced solid tumors.

Gong J, Cao J, Zhang Q, Xu N, Zhao Y, Xing B, Miao Z, Wu Y, Pan H, Gao Q, Li X, Liu B, Li W, Pei Z, Xia H, Qi Q, Dai H, Shi Q, Yang J, Li J, Shen L.

2022-01-0513 citations

10.1007/s00262-021-03102-3

Platinum-based chemotherapy (chemo) with CS1001, an anti-PD-L1 antibody, for first-line advanced non-small cell lung cancer (NSCLC): Preliminary results from phase Ib cohorts of CS1001-101 study.

Qing Zhou, Qingyuan Zhang, Nong Xu, Yanqiu Zhao, Zhanhui Miao et al. (14 authors)

Journal of Clinical Oncology2020-05-20

10.1200/jco.2020.38.15_suppl.e21687

Gemstone-301: A phase III clinical trial of CS1001 as consolidation therapy in subjects with locally advanced/unresectable (stage III) non-small cell lung cancer (NSCLC) who have not progressed after prior concurrent/sequential chemoradiotherapy (CRT).

Yi‐Long Wu, Ming Chen, Qing Zhou, Hao Li, Wenyi Sun et al. (7 authors)

Journal of Clinical Oncology2019-05-202 citations

10.1200/jco.2019.37.15_suppl.tps8572

A phase Ia/Ib trial of the anti-PD-L1 human monoclonal antibody (mAb), CS1001, in patients (pts) with advanced solid tumors or lymphomas.

Lin Shen, Junning Cao, Jin Li, Hongming Pan, Nong Xu et al. (9 authors)

Journal of Clinical Oncology2019-05-201 citations

10.1200/jco.2019.37.15_suppl.2526

Preliminary safety, pharmacokinetics (PK) and efficacy results from a phase I study of CS1001, an anti-programmed death ligand-1 (PD-L1) monoclonal antibody (mAb) in patients (pts) with advanced tumors

Lin Shen, Junning Cao, J. Gong, Dongmei Ji, Zhen Qin et al. (9 authors)

Annals of Oncology2018-10-012 citations

10.1093/annonc/mdy288.038

Interventions

DRUGCS1001

In the dose escalation part, the dose levels will be escalated following a modified 3+3 dose escalation scheme. In the dose expansion part, patients will be assigned to different groups based on their tumor type.

Study design

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

No

Inclusion criteria

1. With advanced-stage or metastatic tumor (unresectable) and experienced progression since last anti-tumor treatment; standard therapy is not available or rejected. 2. ECOG performance status of 0 or 1. 3. Subjects must have at least one measurable lesion. 4. Patients with life expectancy ≥ 3 months. 5. Subject must have adequate organ function. 6. Fertile men and women of childbearing potential must agree to use an effective method of birth control from providing signed consent and for six months after last study drug administration.

Exclusion criteria

1. Known brain metastasis or other CNS metastasis that is either symptomatic or untreated. 2. Subjects with active autoimmune diseases or history of autoimmune diseases should be excluded. 3. Patients who have received immune checkpoint proteins/antibody/medicine (including PD-1, PD-L1, etc) for treatment. 4. Known history of HIV infection. 5. Hepatitis B surface antigen (HBsAg) and Hepatitis B core antibody (HBcAb) positive or Hepatitis C virus (HCV) antibody positive. 6. Patients who have serious hypersensitive reaction to monoclonal antibodies, and have history of uncontrolled allergic asthma. 7. Known history of alcoholism or drugs abuse. For more information regarding trial participation, please contact at cstonera@cstonepharma.com

Design outcomes

Primary

Measure	Time frame
To evaluate the safety and tolerability of CS1001	From first dose to 30 days after last dose of CS1001, up to 2 years
To determine the maximum tolerated dose (MTD) and/or recommended phase II dose (RP2D) of CS1001	From first dose to 30 days after last dose of CS1001, up to 2 years

Countries

China

Outcome results

None listed