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CS1001

Phase 1

Advanced Refractory Solid Tumors | Small molecule | Oncology |Bayer AG|Last Updated: May 6, 2022

Success Probability

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Market & Valuation

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Trial Design

CONTROLLEDBiomarker
Total Trials1
Total Enrollment19

FDA Designations

No designations recorded

Clinical trial landscape

CS1001 · 1 trial · 1 indication

Phase 1 1
NCT04200404A Study of CS1001 in Combination With Regorafenib in Patients With Advanced or Refractory Solid TumorsAdvanced Refractory Solid Tumors
COMPLETED19 Analytics
PHASE1COMPLETED
A Study of CS1001 in Combination With Regorafenib in Patients With Advanced or Refractory Solid Tumors
Advanced Refractory Solid TumorsUnlock trial analytics

Study Endpoints

Primary Endpoints

Phase Ib (Safety Evaluation): Number of participants with adverse events
Baseline up to 90 days post last dose, up to 2 years
Phase Ib (Safety Evaluation): Dose Limiting Toxicity (DLT)
Baseline up to 90 days post last dose, up to 2 years
Phase II (Efficacy Expansion): Objective response rate (ORR)
Up to 2 years

Secondary Endpoints

Phase Ib (Safety Evaluation): Objective response rate (ORR)
Up to 2 years
Phase Ib (Safety Evaluation) and/or Phase II (Efficacy Expansion): Disease control rate (DCR)
Up to 2 years
Phase Ib (Safety Evaluation) and/or Phase II (Efficacy Expansion): Progression Free Survival (PFS)
Up to 2 years
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Phase Ib armEXPERIMENTALarms 1. Phase Ib: advanced or refractory solid tumors;
Phase II armEXPERIMENTALarms 2.Phase II: subjects with tumor of specific types

Interventions

NameTypeDescription
CS1001DRUGOne course will last 28 days. CS1001 will be intravenously administered every 4 weeks (Q4W).
RegorafenibDRUGOne course will last 28 days. Administration will be orally (p.o.) taken at different dose schemes.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * All participants must have unresectable advanced or metastatic tumors that have histologic or cytologic documentation confirmed. * Participant must have at least one measurable lesion by CT or MRI per RECIST 1.1; radiographic tumor assessment should be performed within 28 days...

Countries:Australia
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Competitive Landscape -Other Solid Tumors 9 trials (matched to "Advanced Refractory Solid Tumors")

Frequently asked questions about CS1001

What is CS1001 used for?

CS1001 is an investigational small molecule being studied for the treatment of advanced refractory solid tumors. It is being evaluated in combination with regorafenib in patients with advanced or refractory solid tumors. The drug is in Phase 1 clinical development and is not yet approved.

What does CS1001 target?

The specific molecular target of CS1001 has not been disclosed. It is a small molecule being studied in oncology for advanced refractory solid tumors. The drug is being evaluated in combination with regorafenib in a Phase 1 clinical trial.

Who makes CS1001?

CS1001 is being developed by Bayer AG, a pharmaceutical company traded on the OTC market under the ticker BAYRY. The drug is currently in Phase 1 clinical development for advanced refractory solid tumors.

What phase is CS1001 in?

CS1001 is in Phase 1 clinical development. It is an investigational drug being studied for advanced refractory solid tumors. The drug is not approved and is still undergoing clinical trials to evaluate its safety and efficacy.

What clinical trials is CS1001 in?

CS1001 has one completed Phase 1 clinical trial, NCT04200404, which studied CS1001 in combination with regorafenib in patients with advanced or refractory solid tumors. The trial enrolled 19 participants in Australia and has been completed.

Is CS1001 the same as regorafenib?

No, CS1001 is not the same as regorafenib. CS1001 is an investigational small molecule being studied in combination with regorafenib, which is an approved drug, in a Phase 1 clinical trial for advanced refractory solid tumors.