arms 1. Phase Ib: advanced or refractory solid tumors;

arms 2.Phase II: subjects with tumor of specific types

One course will last 28 days. CS1001 will be intravenously administered every 4 weeks (Q4W).

CS1001

One course will last 28 days. Administration will be orally (p.o.) taken at different dose schemes.

Regorafenib

This is a multicenter, open-label study of CS1001 in combination with regorafenib in participants with advanced or refractory cancers. There will be a dose escalation portion in "allcomers"to find a suitable dose of regorafenib for combination use with CS1001. This study will also enroll participants with specific tumor types in the phase II part of the study to assess the efficacy, pharmacokinetics and safety of the combined regimen (RP2D of regorafenib + CS 1001)

A Study of CS1001 in Combination With Regorafenib in Patients With Advanced or Refractory Solid Tumors

A Phase Ib/II, Multicenter Open-label Study of CS1001 in Combination With Regorafenib in Patients With Advanced or Refractory Solid Tumors

Bayer

CStone Pharmaceuticals

Neoplasms

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Rare Diseases

Lymphoma

Hodgkin Disease

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphosarcoma

Hodgkin Lymphoma

All Drugs and Chemicals

Antibodies

Antibodies, Monoclonal

Immunoglobulins

Participants will receive CS1001 1200 mg by intravenous infusion every three weeks

This is a multicenter, single-arm phase II study to evaluate the efficacy and safety of CS1001 monotherapy for relapsed/refractory classical Hodgkin Lymphoma (rr-cHL)

Eligible subjects with rr-cHL who failed at least two prior lines of therapies are planned to receive CS1001 1200 mg intravenous infusion every three weeks until progression of disease, intolerable toxicity, consent withdrawn or death.The primary endpoint of this trial is objective response rate (ORR), as assessed by independent radiological review committee (IRRC) based on Criteria for Response Assessment of Lymphoma: Lugano 2014 Classification.

A Study of CS1001 in Subjects With Relapsed or Refractory Classical Hodgkin Lymphoma

A Single-Arm, Multicenter, Phase II Clinical Trial of CS1001 in Subjects With Relapsed or Refractory Classical Hodgkin Lymphoma

The percentage of subjects whose best overall response is either complete response or partial response evaluated by IRRC according to Criteria for Response Assessment of Lymphoma: Lugano 2014 Classification

In the dose-escalation part, the dose levels will be escalated following a modified 3+3 dose escalation scheme. In the dose-expansion part, both dose levels will be expanded.

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

A Study of CS1001 in Subjects With Advanced Solid Tumors

A Phase I, Open-Label, Multiple-Dose, Dose-Escalation Study of an Anti-PD-L1 Monoclonal Antibody CS1001 in Subjects With Advanced Solid Tumors

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.

Lin Shen, MD

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.

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

A Phase Ia/Ib, Open-Label, Multiple-Dose, Dose-Escalation and Expansion Study of the Anti-PD-L1 Monoclonal Antibody CS1001 in Subjects With Advanced Solid Tumors

Respiratory Tract (Lung and Bronchial) Diseases

Small Cell Lung Carcinoma

Lung Neoplasms

Carcinoma

Carcinoma, Bronchogenic

Bronchial Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Small Cell Lung Cancer

low-dose radiation+CS1001 1200mg Q3W. In the dose escalation part, the dose levels will be escalated following a modified 3+3 dose escalation scheme.

Dose A: 3Gy/1f; Dose B: 9Gy/3f; Dose C: 15Gy/5f;

In the dose expansion part, more SCLC patients will be assigned.

You Lu, MD

A Phase Ia/Ib Safety and Tolerability Evaluation of Low-dose Radiation in Combination with CS1001 in relapsed SCLC patients

This is a dose-escalation study of Low-dose Radiation in combination with CS1001 in relapsed SCLC patients. Patients are assigned to 3 treatment groups received from 3 Gy to 15Gy, to determine the safety, tolerability and the maximal tolerant dose. Biomarkers and immunological markers are collected and analyzed as well.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study of CS1001 in Combination With Regorafenib in Patients With Advanced or Refractory Solid Tumors	NCT04200404	Advanced Refrac...	CS1001 Regorafenib	18 Years -	CStone Pharmaceuticals
A Study of CS1001 in Subjects With Relapsed or Refractory Classical Hodgkin Lymphoma	NCT03505996	Hodgkin Lymphom...	CS1001	18 Years - 75 Years	CStone Pharmaceuticals
A Study of CS1001 in Subjects With Advanced Solid Tumors	NCT03744403	Advanced Solid ...	CS1001	18 Years -	CStone Pharmaceuticals
A Study of CS1001 in Subjects With Advanced Solid Tumors	NCT03744403	Advanced Solid ...	CS1001	18 Years -	CStone Pharmaceuticals
A Study of CS1001 in Combination With Regorafenib in Patients With Advanced or Refractory Solid Tumors	NCT04200404	Advanced Refrac...	CS1001 Regorafenib	18 Years -	CStone Pharmaceuticals
A Study of CS1001 in Combination With Regorafenib in Patients With Advanced or Refractory Solid Tumors	NCT04200404	Advanced Refrac...	CS1001 Regorafenib	18 Years -	CStone Pharmaceuticals
A Phase Ia/Ib Study of CS1001 in Subjects With Advanced Solid Tumors	NCT03312842	Advanced Cancer	CS1001	18 Years - 75 Years	CStone Pharmaceuticals
Safety and Tolerability Evaluation of Low-dose Radiation in Combination With CS1001 in Relapsed SCLC Patients	NCT04421352	Relapsed Small ...	CS1001	18 Years - 75 Years	CStone Pharmaceuticals

Spots Global Cancer Trial Database for cs1001

Every month we try and update this database with for cs1001 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for cs1001

Every month we try and update this database with for cs1001 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for cs1001 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.