Advanced Solid Tumors Harboring NTRK FusionPhase 1/2NCT05745623

Study of ICP-723 in Patients With Advanced Solid Tumors or Primary Central Nervous System Tumors

A Phase 1/2 study testing ICP-723 in people with Advanced Solid Tumors Harboring NTRK Fusion and Primary Central Nervous System Tumors Harboring NTRK Fusion, run by Beijing InnoCare Pharma Tech Co., Ltd. at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial summary

A Multi-center, Non-Randomized, Open-Label Phase 2 Basket Clinical Trial to Evaluate ICP-723 in Patients with Advanced Solid Tumors or Primary Central Nervous System Tumors Read more about this study

Who is it for?: Ages 2 years and older
Conditions the study is for: Advanced Solid Tumors Harboring NTRK Fusion, Primary Central Nervous System Tumors Harboring NTRK Fusion
What is being tested?: ICP-723
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 70 participants
Where: 1 siteChina
Study dates: 27 Dec 2022to 25 Dec 2028
Phase: Phase 1/2
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 2 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;
Patients with advanced solid tumors or primary central nervous system (CNS) tumors harboring NTRK gene fusions as detected by the designated central laboratory, who received no previous NTRK inhibitor treatment;
At least one measurable lesion as per RECIST1.1 criteria, or for primary CNS tumors, at least one measurable lesion as per RANO or INRC criteria.
Organ functions meet the clinical criteria

Who cannot join

Patients with unstable primary central nervous system (CNS) tumors or CNS metastasis.
Patients with abnormal QTc interval at screening, or other clinically significant abnormalities in electrocardiographic examination at the discretion of the investigator.
Patient with recent anti-tumor and other treatment as stated in the protocol.
Grade 1 or higher toxicities attributed to any previous treatment not yet recovered.
Other conditions considered unsuitable for participation in this trial at the discretion of the investigator

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Ruihua Xu contact

020-87343333

xurh@sysucc.org.cn

Yuhong Li contact

liyh@sysucc.org.cn

China1 site, 1 recruiting

Sun Yat-Sen University Cancer Center
Guangzhou, Guangdong, 510060
RuiHua Xu
Recruiting

Other trials in China

About this study

Official title: A Multi-center, Non-Randomized, Open-Label Phase 2 Basket Clinical Trial to Evaluate ICP-723 in Patients With Advanced Solid Tumors or Primary Central Nervous System Tumors

A Multi-center, Non-Randomized, Open-Label Phase 2 Basket Clinical Trial to Evaluate ICP-723 in Patients with Advanced Solid Tumors or Primary Central Nervous System Tumors

Conditions: Advanced Solid Tumors Harboring NTRK Fusion, Primary Central Nervous System Tumors Harboring NTRK Fusion
Being tested: ICP-723

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ICP-723Drug
ICP-723 tablet administered orally，once a day，for every 28 days as one cycle

Study groups in NCT05745623
Study group	Role	What they receive
ICP-723	Experimental	Not described Receives: Drug: ICP-723

What is being measured

The primary outcome is the main question the study is designed to answer.

Objective response rate (ORR)
The objective response rate (ORR) evaluated by the Independent Center Review
Measured: Through study completion, an average of 4 years

Secondary outcomes (16)

ORR assessed by the investigator
Measured: Through study completion, an average of 4 years
DCR as assessed by the investigator and the IRC
Measured: Through study completion, an average of 4 years
Time to response (TTR) as assessed by the investigator and the IRC
Measured: Through study completion, an average of 4 years
Duration of response (DOR) as assessed by the investigator and the IRC
Measured: Through study completion, an average of 4 years
Progression-free survival (PFS) as assessed by the investigator and the IRC
Measured: Through study completion, an average of 4 years
Intracranial objective response rate (IC-ORR) as assessed by the investigator and IRC
Measured: Through study completion, an average of 4 years
central nervous system progression-free survival (CNS-PFS) as assessed by the investigator and IRC
Measured: Through study completion, an average of 4 years
Overall survival (OS)
Measured: Through study completion, an average of 4 years
The incidence, character and severity of adverse events as assessed per NCI-CTCAE v5.0 criteria
Measured: Through study completion, an average of 4 years
The maximum plasma concentration observed (Cmax)
Measured: Through study completion, an average of 4 years
Time of maximum observed plasma concentration (Tmax)
Measured: Through study completion, an average of 4 years
Elimination half-life (t1/2)
Measured: Through study completion, an average of 4 years
AUC0-∞
Measured: Through study completion, an average of 4 years
AUC0-t
Measured: Through study completion, an average of 4 years
Apparent clearance (CL/F)
Measured: Through study completion, an average of 4 years
Apparent volume of distribution (Vz/F)
Measured: Through study completion, an average of 4 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

27 Dec 202225 Dec 2028

First posted27 Feb 2023
Study start27 Dec 2022
Primary completion25 Dec 2027 (estimated)
Study completion25 Dec 2028 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Advanced Solid Tumors Harboring NTRK FusionStudies of the same condition, open and under way.
More trials run by Beijing InnoCare Pharma Tech Co., Ltd.The sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1/2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 70 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05745623
Sponsor's protocol ID: ICP-CL-00505
Status last verified: Sep 2025
First submitted: 16 Feb 2023
Last updated: 11 Sep 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Interested in taking part?

Ruihua Xu

020-87343333

xurh@sysucc.org.cn

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

Active, not recruitingObservational study
Study to Learn More About the Safety and Effectiveness of the Drug VITRAKVI During Routine Use in Patients With TRK Fusion Cancer Which is Locally Advanced or Spread From the Place Where it Started to Other Places in the Body
Locally Advanced or Metastatic Solid Tumor Harboring an NTRK Gene Fusion
Not yet recruitingObservational study
Repotrectinib Post-Marketing Surveillance in Korean Patients With ROS1-Positive Non-Small Cell Lung Cancer (NSCLC) or Solid Tumors Harboring a Neurotrophic Tyrosine Receptor Kinase (NTRK) Gene Fusion
Non-Small Cell Lung Cancer
Active, not recruitingPhase 2
Basket Study of Entrectinib (RXDX-101) for the Treatment of Patients With Solid Tumors Harboring NTRK 1/2/3 (Trk A/B/C), ROS1, or ALK Gene Rearrangements (Fusions)
Breast Cancer, Cholangiocarcinoma
RecruitingObservational study
NTRK Gene Fusion - Positive Advanced or Recurrent Solid Tumors, a Rare Cancer Caused by Specific Changes in the Genes
Advanced or Recurrent Solid Tumor Harboring an NTRK Gene Fusion
Active, not recruitingPhase 2
Larotrectinib in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With NTRK Fusions (A Pediatric MATCH Treatment Trial)
Advanced Malignant Solid Neoplasm, Recurrent Ependymoma

All Advanced Solid Tumors Harboring NTRK Fusion trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multi-center, Non-Randomized, Open-Label Phase 2 Basket Clinical Trial to Evaluate ICP-723 in Patients With Advanced Solid Tumors or Primary Central Nervous System Tumors
ClinicalTrials.gov ID: NCT05745623
Acronym / sponsor ID: ICP-CL-00505
Conditions: Advanced Solid Tumors Harboring NTRK Fusion, Primary Central Nervous System Tumors Harboring NTRK Fusion
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 70 participants (estimated)
Lead sponsor: Beijing InnoCare Pharma Tech Co., Ltd.Industry (pharma, biotech, devices)
Study start: 27 Dec 2022 (actual)
Primary completion: 25 Dec 2027 (estimated)
Study completion: 25 Dec 2028 (estimated)
First posted: 27 Feb 2023 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

A Multi-center, Non-Randomized, Open-Label Phase 2 Basket Clinical Trial to Evaluate ICP-723 in Patients with Advanced Solid Tumors or Primary Central Nervous System Tumors

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
ICP-723	Experimental	Drug: ICP-723

Who may qualify

Ages: 2 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (4 listed)

Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;
Patients with advanced solid tumors or primary central nervous system (CNS) tumors harboring NTRK gene fusions as detected by the designated central laboratory, who received no previous NTRK inhibitor treatment;
At least one measurable lesion as per RECIST1.1 criteria, or for primary CNS tumors, at least one measurable lesion as per RANO or INRC criteria.
Organ functions meet the clinical criteria

Key exclusion criteria (5 listed)

Patients with unstable primary central nervous system (CNS) tumors or CNS metastasis.
Patients with abnormal QTc interval at screening, or other clinically significant abnormalities in electrocardiographic examination at the discretion of the investigator.
Patient with recent anti-tumor and other treatment as stated in the protocol.
Grade 1 or higher toxicities attributed to any previous treatment not yet recovered.
Other conditions considered unsuitable for participation in this trial at the discretion of the investigator

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ICP-723ICP-723 tablet administered orally，once a day，for every 28 days as one cycle	Drug	ICP-723

Primary outcome

Objective response rate (ORR)
Time frame: Through study completion, an average of 4 years
The objective response rate (ORR) evaluated by the Independent Center Review

16 secondary outcomes

ORR assessed by the investigator
Time frame: Through study completion, an average of 4 years
DCR as assessed by the investigator and the IRC
Time frame: Through study completion, an average of 4 years
Time to response (TTR) as assessed by the investigator and the IRC
Time frame: Through study completion, an average of 4 years
Duration of response (DOR) as assessed by the investigator and the IRC
Time frame: Through study completion, an average of 4 years
Progression-free survival (PFS) as assessed by the investigator and the IRC
Time frame: Through study completion, an average of 4 years
Intracranial objective response rate (IC-ORR) as assessed by the investigator and IRC
Time frame: Through study completion, an average of 4 years
central nervous system progression-free survival (CNS-PFS) as assessed by the investigator and IRC
Time frame: Through study completion, an average of 4 years
Overall survival (OS)
Time frame: Through study completion, an average of 4 years
The incidence, character and severity of adverse events as assessed per NCI-CTCAE v5.0 criteria
Time frame: Through study completion, an average of 4 years
The maximum plasma concentration observed (Cmax)
Time frame: Through study completion, an average of 4 years
Time of maximum observed plasma concentration (Tmax)
Time frame: Through study completion, an average of 4 years
Elimination half-life (t1/2)
Time frame: Through study completion, an average of 4 years
AUC0-∞
Time frame: Through study completion, an average of 4 years
AUC0-t
Time frame: Through study completion, an average of 4 years
Apparent clearance (CL/F)
Time frame: Through study completion, an average of 4 years
Apparent volume of distribution (Vz/F)
Time frame: Through study completion, an average of 4 years

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2025.
Individual participant dataSharing planned: No

Related trials for Advanced Solid Tumors Harboring NTRK Fusion

Active, not recruitingObservational study
Study to Learn More About the Safety and Effectiveness of the Drug VITRAKVI During Routine Use in Patients With TRK Fusion Cancer Which is Locally Advanced or Spread From the Place Where it Started to Other Places in the Body
Locally Advanced or Metastatic Solid Tumor Harboring an NTRK Gene Fusion
Not yet recruitingObservational study
Repotrectinib Post-Marketing Surveillance in Korean Patients With ROS1-Positive Non-Small Cell Lung Cancer (NSCLC) or Solid Tumors Harboring a Neurotrophic Tyrosine Receptor Kinase (NTRK) Gene Fusion
Non-Small Cell Lung Cancer
Active, not recruitingPhase 2
Basket Study of Entrectinib (RXDX-101) for the Treatment of Patients With Solid Tumors Harboring NTRK 1/2/3 (Trk A/B/C), ROS1, or ALK Gene Rearrangements (Fusions)
Breast Cancer, Cholangiocarcinoma
RecruitingObservational study
NTRK Gene Fusion - Positive Advanced or Recurrent Solid Tumors, a Rare Cancer Caused by Specific Changes in the Genes
Advanced or Recurrent Solid Tumor Harboring an NTRK Gene Fusion
Active, not recruitingPhase 2
Larotrectinib in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With NTRK Fusions (A Pediatric MATCH Treatment Trial)
Advanced Malignant Solid Neoplasm, Recurrent Ependymoma

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Ruihua Xu contact

020-87343333

xurh@sysucc.org.cn

Yuhong Li contact

liyh@sysucc.org.cn

Ruihua Xu principal investigator

Sun Yat-Sen University Cancer Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 11 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Ruihua Xu (020-87343333, xurh@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective response rate (ORR) (time frame: Through study completion, an average of 4 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05745623.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2025.