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CS3007

Phase 1

Gastrointestinal Stromal Tumors | Small molecule | Oncology |Blueprint Medicines Corporation|Trials Updated: Apr 27, 2023

CS3007 target and mechanism

ModalitySmall molecule

Also known as CS3007 (BLU-285)

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment65

FDA Designations

No designations recorded

CS3007 clinical trials

CS3007 · 1 trial · 1 indication

Phase 1 1
NCT04254939A Study of CS3007 in Subjects With Gastrointestinal Stromal TumorGastrointestinal Stromal Tumors
COMPLETED65 Analytics
PHASE1COMPLETED
A Study of CS3007 in Subjects With Gastrointestinal Stromal Tumor
Gastrointestinal Stromal TumorsUnlock trial analytics

Study Endpoints

Primary Endpoints

Phase I: Recommended Phase II dose (RP2D), incidence of dose limiting toxicities (DLT) in Cycle 1, incidence and severity of adverse events and serious adverse events and changes in vital signs, clinical laboratory results and ECG findings
at the end of Cycle 1 (each cycle is 28 days) for RP2D and DLT; during every cycle through 30 days after the last dose of study drug, an average of approximately 24 months, for other measures
Phase II: ORR based on mRESIST 1.1
At Cycle 3 (each cycle is 28 days) Day 1, then every 2 cycles until Cycle 13, they every 3 cycles through study completion, disease progression or patient discontinuation from the study (whichever comes first), an average of approximately 24 months
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
CS3007(BLU-285)EXPERIMENTAL -

Interventions

NameTypeDescription
CS3007 (BLU-285)DRUGA modified "3+3" dose escalation design will be adopted. Each group will enroll 3-6 subjects. Avapritinib will be administered orally at the starting of 200 mg QD. A cycle consists of 28 consecutive days.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites16

Inclusion criteria: 1. For phase I study, the subject must have histologically or cytologically confirmed unresectable or metastatic GIST that progressed after imatinib and at least one additional TKI treatment, or who cannot tolerate the standard treatment or have D842V mutation in the PDGFRα gene...

Countries:China
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Frequently asked questions about CS3007

What is CS3007 used for?

CS3007 is being developed for the treatment of gastrointestinal stromal tumors, a type of cancer affecting the digestive tract. It is an investigational small molecule therapy being studied in patients with this condition. The clinical program has focused on evaluating the drug in adults with gastrointestinal stromal tumors.

Who is developing CS3007?

CS3007 is being developed by Blueprint Medicines Corporation, which trades on the Nasdaq under the ticker symbol BPMC. The company is responsible for the clinical development of the drug, including the Phase 1 study conducted in China.

What phase is CS3007 in?

CS3007 is in Phase 1 clinical development. The only reported trial for this drug was a Phase 1 study that has been completed. It is an investigational therapy and has not been approved for any indication.

What clinical trials is CS3007 in?

CS3007 has been evaluated in a single Phase 1 clinical trial, NCT04254939, titled A Study of CS3007 in Subjects With Gastrointestinal Stromal Tumor. The trial enrolled 65 participants, was conducted in China, and is now completed.

Is CS3007 the same as BLU-285?

Yes, CS3007 is also known as BLU-285. Both names refer to the same investigational small molecule developed by Blueprint Medicines Corporation for gastrointestinal stromal tumors.