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Alectinib

Phase 2

Cancer | Small molecule | Oncology |GSK plc|Last Updated: Jul 25, 2025

Target and mechanism

Molecular targetALK, EML4, RET
Target classInhibitor
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

CONTROLLEDBiomarker
Total Trials1
Total Enrollment300

FDA Designations

No designations recorded

Clinical trial landscape

Alectinib · 1 trial · 4 indications

Phase 2 1
NCT04341181ProTarget - A Danish Nationwide Clinical Trial on Targeted Cancer Treatment Based on Genomic ProfilingCancer
RECRUITING300 Analytics
PHASE2RECRUITING
ProTarget - A Danish Nationwide Clinical Trial on Targeted Cancer Treatment Based on Genomic Profiling
CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Response rate
16 weeks

Response according to RECIST

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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
AlectinibEXPERIMENTALAlectinib for patients with a molecular tumor profile that can potentially be targeted by Alectinib.
AtezolizumabEXPERIMENTALAtezolizumab for patients with a molecular tumor profile that can potentially be targeted by Atezolizumab.
AvelumabEXPERIMENTALAvelumab for patients with a molecular tumor profile that can potentially be targeted by Avelumab.
AxitinibEXPERIMENTALAxitinib for patients with a molecular tumor profile that can potentially be targeted by Axitinib.
ErlotinibEXPERIMENTALErlotinib for patients with a molecular tumor profile that can potentially be targeted by Erlotinib.
Vemurafenib plus Cobimetinib (combination)EXPERIMENTALVemurafenib plus Cobimetinib (combination treatment) for patients with a molecular tumor profile that can potentially be targeted by Vemurafenib plus Cobimetinib.
Trastuzumab plus Pertuzumab (combination)EXPERIMENTALTrastuzumab plus Pertuzumab (combination treatment) for patients with a molecular tumor profile that can potentially be targeted by Trastuzumab plus Pertuzumab.
Trastuzumab emtansinEXPERIMENTALTrastuzumab emtansin for patients with a molecular tumor profile that can potentially be targeted by Trastuzumab emtansin.
VismodegibEXPERIMENTALVismodegib for patients with a molecular tumor profile that can potentially be targeted by Vismodegib.
NiraparibEXPERIMENTALNiraparib for patients with a molecular tumor profile that can potentially be targeted by Niraparib.

Interventions

NameTypeDescription
AlectinibDRUGAlectinib treatment for patients with an advanced solid tumor, multiple myeloma or B cell non-Hodgkin lymphoma, who are not eligible for on-label treatment but for whom anti-tumor activity of Alectinib might be expected based on their molecular tumor profile.
AtezolizumabDRUGAtezolizumab treatment for patients with an advanced solid tumor, multiple myeloma or B cell non-Hodgkin lymphoma, who are not eligible for on-label treatment but for whom anti-tumor activity of Atezolizumab might be expected based on their molecular tumor profile.
AvelumabDRUGAvelumab treatment for patients with an advanced solid tumor, multiple myeloma or B cell non-Hodgkin lymphoma, who are not eligible for on-label treatment but for whom anti-tumor activity of Avelumab might be expected based on their molecular tumor profile.
AxitinibDRUGAxitinib treatment for patients with an advanced solid tumor, multiple myeloma or B cell non-Hodgkin lymphoma, who are not eligible for on-label treatment but for whom anti-tumor activity of Axitinib might be expected based on their molecular tumor profile.
ErlotinibDRUGErlotinib treatment for patients with an advanced solid tumor, multiple myeloma or B cell non-Hodgkin lymphoma, who are not eligible for on-label treatment but for whom anti-tumor activity of Erlotinib might be expected based on their molecular tumor profile.
Vemurafenib plus Cobimetinib (combination)DRUGVemurafenib plus Cobimetinib treatment for patients with an advanced solid tumor, multiple myeloma or B cell non-Hodgkin lymphoma, who are not eligible for on-label treatment but for whom anti-tumor activity of Vemurafenib plus Cobimetinib might be expected based on their molecular tumor profile.
Trastuzumab plus Pertuzumab (combination)DRUGTrastuzumab plus Pertuzumab treatment for patients with an advanced solid tumor, multiple myeloma or B cell non-Hodgkin lymphoma, who are not eligible for on-label treatment but for whom anti-tumor activity of Trastuzumab plus Pertuzumab might be expected based on their molecular tumor profile.
Trastuzumab emtansineDRUGTrastuzumab emtansine treatment for patients with an advanced solid tumor, multiple myeloma or B cell non-Hodgkin lymphoma, who are not eligible for on-label treatment but for whom anti-tumor activity of Trastuzumab emtansine might be expected based on their molecular tumor profile.
VismodegibDRUGVismodegib treatment for patients with an advanced solid tumor, multiple myeloma or B cell non-Hodgkin lymphoma, who are not eligible for on-label treatment but for whom anti-tumor activity of Vismodegib might be expected based on their molecular tumor profile.
NiraparibDRUGNiraparib treatment for patients with an advanced solid tumor, multiple myeloma or B cell non-Hodgkin lymphoma, who are not eligible for on-label treatment but for whom anti-tumor activity of Niraparib might be expected based on their molecular tumor profile.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites7

Inclusion Criteria: 1. Patient (age≥ 18 years) with a histologically-proven locally advanced or metastatic malignant disease who is no longer benefitting from standard anti-cancer treatment or for whom, in the opinion of the investigator, no such treatment is available or indicated. 2. ECOG perform...

Countries:Denmark
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Recent Changes (Last 90 Days)

LOWMay 24, 2026NCT04341181studyFirstPostDate: changed

Frequently asked questions about Alectinib

What is Alectinib used for in cancer?

Alectinib is an investigational small molecule being studied for the treatment of cancer, including tumors and neoplasms. It is currently in Phase 2 clinical development as part of a targeted cancer treatment approach based on genomic profiling. The drug is being evaluated in a controlled clinical trial in Denmark.

What does Alectinib target?

Alectinib targets ALK, EML4, and RET. It is an inhibitor of these molecular targets, which are relevant in certain cancers. By inhibiting these targets, Alectinib is being studied for its potential role in treating cancer, particularly in patients selected based on biomarker profiles.

Who is developing Alectinib?

Alectinib is being developed by GSK plc, a pharmaceutical company listed on the stock exchange under the ticker GSK. The drug is currently in Phase 2 clinical trials for cancer, with an active study recruiting participants in Denmark.

What phase is Alectinib in?

Alectinib is in Phase 2 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. The ongoing Phase 2 trial is actively recruiting patients with cancer, tumors, or neoplasms, and is designed as a controlled study.

What clinical trials is Alectinib in?

Alectinib is being studied in the clinical trial NCT04341181, titled 'ProTarget - A Danish Nationwide Clinical Trial on Targeted Cancer Treatment Based on Genomic Profiling.' This Phase 2 trial is recruiting 300 participants aged 18 years and older with cancer, tumors, or neoplasms in Denmark. The study is biomarker-selected and controlled.

Is Alectinib the same as any other drug?

Alectinib is also known by the ChEMBL identifier CHEMBL1738797. This identifier is used in chemical and biological databases to reference the compound. No other alternative names for Alectinib have been disclosed in the available information.