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CS3007

Phase 1

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

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment65

FDA Designations

No designations recorded

Clinical trial landscape

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 Tumors
NCT0425493965
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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 an investigational small molecule being developed for the treatment of gastrointestinal stromal tumors (GIST). It is currently in clinical development and has not been approved by regulatory authorities. The drug is being studied in patients with this type of cancer.

Who is developing CS3007?

CS3007 is being developed by Blueprint Medicines Corporation, a biopharmaceutical company traded on the NASDAQ under the ticker symbol BPMC. The company is conducting clinical research to evaluate the safety and efficacy of this investigational drug in patients with gastrointestinal stromal tumors.

What phase is CS3007 in?

CS3007 is in Phase 1 clinical development. A Phase 1 study of the drug has been completed. The drug remains investigational and has not received approval from the FDA or other regulatory agencies for any use.

What clinical trials is CS3007 in?

CS3007 has been studied in a Phase 1 clinical trial with the identifier NCT04254939, titled "A Study of CS3007 in Subjects With Gastrointestinal Stromal Tumor." This trial enrolled 65 participants in China and has been completed. The study was open-label and did not use a control group.

Is CS3007 being studied in a randomized trial?

No, the completed Phase 1 trial of CS3007 was not randomized and did not use a control group. It was an uncontrolled, open-label study. The trial enrolled 65 patients with gastrointestinal stromal tumors and included biomarker-selected participants.