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DCC-2618

Phase 2

Gastrointestinal Stromal Tumors | Small molecule | Oncology |Zai Lab Limited|Trials Updated: Apr 3, 2026

DCC-2618 development status

Highest phase Phase 2
Registered trials 3 across 2 sponsors since Feb 2020

DCC-2618 target and mechanism

ModalitySmall molecule

Also known as Ripretinib

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials2
Total Enrollment147

FDA Designations

No designations recorded

DCC-2618 clinical trials

DCC-2618 · 2 trials · 2 indications

Phase 2 2
NCT04633122A Study to Assess DCC-2618 and Sunitinib in Patients With Advanced GIST After Treatment With ImatinibGastrointestinal Stromal Tumor(GIST)
COMPLETED108 Analytics
NCT04282980A Study of DCC-2618 (Ripretinib) In Patients With With Advanced Gastrointestinal Stromal Tumors (GIST)Gastrointestinal Stromal Tumors
COMPLETED39 Analytics
PHASE2COMPLETED
A Study to Assess DCC-2618 and Sunitinib in Patients With Advanced GIST After Treatment With Imatinib
Gastrointestinal Stromal Tumor(GIST)Unlock trial analytics
PHASE2COMPLETED
A Study of DCC-2618 (Ripretinib) In Patients With With Advanced Gastrointestinal Stromal Tumors (GIST)
Gastrointestinal Stromal TumorsUnlock trial analytics

Study Endpoints

Primary Endpoints

Progression-free Survival (PFS)
Approximately 12 months.

PFS is defined as the time interval from randomization to the first occurrence of progressive disease based on assessment of the independent radiology review (IRR) or death due to any causes.

Secondary Endpoints

Objective Response Rate (ORR)
Approximately 12 months.
Disease Control Rate (DCR)
Approximately 12 months.
Overall Survival (OS)
Approximately 28 months since the first subject enrolled.
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
RipretinibEXPERIMENTAL50mg/tablet,150 mg QD continuous administration, 6 weeks (42 days) for a cycle.
SunitinibACTIVE_COMPARATOR12.5mg/capsule, 50 mg QD, in 6 weeks (42 days) with 4 weeks continuous dosing followed by 2 weeks break.
DCC-2618EXPERIMENTALDCC-2618 drug is 50mg per tablet, 150mg once a day, with 28 days as a treatment cycle.

Interventions

NameTypeDescription
RipretinibDRUGOral kinase inhibitor
SunitinibDRUGsecond-line therapy in GIST patients who have progressed after imatinib treatment or are intolerant to imatinib
DCC-2618DRUGOral kinase inhibitor
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites18

Inclusion Criteria: * Male or female patients ≥18 years of age. * Histological diagnosis of advanced GIST and capability of providing tumor tissue sample (the interval between tumor tissue collection and signing of informed consent form should be less than 3 years). Otherwise, biopsy is required. *...

Countries:China
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Frequently asked questions about DCC-2618

What is DCC-2618 used for?

DCC-2618 is a small molecule being studied for the treatment of advanced gastrointestinal stromal tumors (GIST). It is an investigational drug currently in clinical development and has not been approved by regulatory authorities.

Who makes DCC-2618?

DCC-2618 is being developed by Zai Lab Limited, a biopharmaceutical company traded on the NASDAQ under the ticker symbol ZLAB. The company is conducting clinical research on this drug for gastrointestinal stromal tumors.

What phase is DCC-2618 in?

DCC-2618 is in Phase 2 clinical development. It is an investigational drug, meaning it has not yet received regulatory approval and is still being evaluated in clinical trials for safety and efficacy.

What clinical trials is DCC-2618 in?

DCC-2618 has been studied in one completed Phase 2 clinical trial with the identifier NCT04282980. This trial enrolled 39 participants with advanced gastrointestinal stromal tumors and was conducted in China.

Is DCC-2618 the same as ripretinib?

Yes, DCC-2618 is also known as ripretinib. The clinical trial NCT04282980 refers to the drug as DCC-2618 (Ripretinib), confirming that these names refer to the same investigational compound.