Advanced or Metastatic Solid Tumors With NTRK, ROS1 or ALK Gene FusionPhase 1NCT04671849

An Open Label, Multi-center, Phase I Clinical Study to Evaluate the Safety, Effectiveness and Pharmacokinetic Characteristics of SIM1803-1A in Patients With Locally Advanced/Metastatic Solid Tumors With NTRK, ROS1 or ALK Gene Fusion Mutations.

A Phase 1 study testing SIM1803-1A in people with Advanced or Metastatic Solid Tumors With NTRK, ROS1 or ALK Gene Fusion, run by Jiangsu Simcere Pharmaceutical Co., Ltd. at 1 site in China.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

This research study is done to test the safety, effectiveness and pharmacokinetic characteristics of SIM1803-1A in patients with locally advanced/metastatic solid tumors with NTRK, ROS1 or ALK gene fusion mutations. The cancer must have a change in a particular gene (NTRK1, NTRK2, NTRK3, ROS1 or ALK). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Advanced or Metastatic Solid Tumors With NTRK, ROS1 or ALK Gene Fusion
What is being tested?: SIM1803-1A
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 24 participants
Where: 1 siteChina
Study dates: 21 Dec 2020to 16 Mar 2023
Phase: Phase 1
Are there results?: None posted in the registry

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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Adult patients with a locally advanced or metastatic solid tumor that has progressed or was nonresponsive to available therapies, are unfit for standard chemotherapy or for which no standard or available curative therapy exists；Proof of a malignancy harboring a NTRK、ROS1 or ALK fusion；Eastern Cooperative Oncology Group (ECOG) score of 0 or 1 and a life expectancy of at least 3 month；Adequate hematologic, hepatic, and renal function；Signed informed consent form；

Who cannot join

Any contraindications as listed in the local approved product information；Patients with unstable primary central-nervous-system tumors or metastasis, exceptions possible；Pregnancy or lactation；Clinically significant active cardiovascular disease or history of myocardial infarction；Participation in an investigational program with interventions outside of routine clinical practice；Prior treatment with other kinase inhibitor with tropomyosin receptor kinase inhibition；Active uncontrolled systemic bacterial, viral, or fungal infection；Current treatment with a strong CYP3A4 inhibitor or inducer；

Trial locations and contacts

1 site in 1 country.

China1 site

Shanghai Chest Hospital
Shanghai

Other trials in China

About this study

Conditions: Advanced or Metastatic Solid Tumors With NTRK, ROS1 or ALK Gene Fusion
Being tested: SIM1803-1A

What participants receive

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

SIM1803-1ADrug
SIM1803-1A will be administered orally as tablets at a given dose once daily in continuing 21-days cycles.

Study groups in NCT04671849
Study group	Role	What they receive
adult patients_Dose 1	Experimental	Not described Receives: Drug: SIM1803-1A
adult patients_Dose 2	Experimental	Not described Receives: Drug: SIM1803-1A
adult patients_Dose 3	Experimental	Not described Receives: Drug: SIM1803-1A
adult patients_Dose 4	Experimental	Not described Receives: Drug: SIM1803-1A
adult patients_Dose 5	Experimental	Not described Receives: Drug: SIM1803-1A
adult patients_Dose 6	Experimental	Not described Receives: Drug: SIM1803-1A
adult patients_Dose 7	Experimental	Not described Receives: Drug: SIM1803-1A
adult patients_Dose 8	Experimental	Not described Receives: Drug: SIM1803-1A

What is being measured

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

Number of participants with adverse events
Number of participants with adverse events
Measured: 5 years
Severity of adverse events
Severity of adverse events
Measured: 5 years
Maximum tolerated dose
Maximum tolerated dose
Measured: 5 years
Recommended dose for dose expansion
Recommended dose for dose expansion
Measured: 5 years
Maximum concentration of SIM1803-1A in plasma (Cmax)
Maximum concentration of SIM1803-1A in plasma (Cmax)
Measured: Predose and 0.25, 0.5, 1, 2, 4, 8，12，24and 48 hours after drug administration on Days 1 and 8 of Cycle 1（each cycle is 21 days）
Area under the concentration-time curve of SIM1803-1A in plasma from time 0 to 24 hours in fasted state (AUC(0-24)_fasted)
Area under the concentration-time curve of SIM1803-1A in plasma from time 0 to 24 hours in fasted state (AUC(0-24)_fasted)
Measured: Up to 1 day
Area under the concentration-time curve of SIM1803-1A in plasma from time 0 to infinity in fasted state (AUC_fasted)
Area under the concentration-time curve of SIM1803-1A in plasma from time 0 to infinity in fasted state (AUC_fasted)
Measured: Up to 3 days
Number of participants with treatment-emergent adverse events (TEAEs)
Number of participants with treatment-emergent adverse events (TEAEs)
Measured: Up to 24 weeks
Time to maximum concentration of SIM1803-1A in plasma (Tmax)
Time to maximum concentration of SIM1803-1A in plasma (Tmax)
Measured: Predose and 0.25, 0.5, 1, 2, 4, 8，12，24and 48 hours after drug administration on Days 1 and 8 of Cycle 1（each cycle is 21 days)

Secondary outcomes (3)

Overall Response Rate (ORR)
Overall Response Rate (ORR)
Measured: Up to 60 months
Duration of Response (DOR)
Duration of Response (DOR)
Measured: Up to 60 months
progression-free survival（PFS）
progression-free survival（PFS）
Measured: Up to 60 months

Timeline

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

21 Dec 202016 Mar 2023

First posted17 Dec 2020
Study start21 Dec 2020
Primary completion16 Mar 2023
Study completion16 Mar 2023

Why it stopped: Business strategy

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Advanced or Metastatic Solid Tumors With NTRK, ROS1 or ALK Gene FusionStudies of the same condition, open and under way.
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
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Enrolment: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04671849
Sponsor's protocol ID: SIM1803-1A-NTRK-0101
Status last verified: Jan 2021
First submitted: 15 Dec 2020
Last updated: 24 Sep 2026
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Study at a glance

From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open Label, Multi-center, Phase I Clinical Study to Evaluate the Safety, Effectiveness and Pharmacokinetic Characteristics of SIM1803-1A in Patients With Locally Advanced/Metastatic Solid Tumors With NTRK, ROS1 or ALK Gene Fusion Mutations.
ClinicalTrials.gov ID: NCT04671849
Acronym / sponsor ID: SIM1803-1A-NTRK-0101
Conditions: Advanced or Metastatic Solid Tumors With NTRK, ROS1 or ALK Gene Fusion
Phase: Phase 1
Study type: Interventional
Recruitment status: TerminatedReason stopped: Business strategy
Enrolment: 24 participants (actual)
Lead sponsor: Jiangsu Simcere Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
Study start: 21 Dec 2020 (actual)
Primary completion: 16 Mar 2023 (actual)
Study completion: 16 Mar 2023 (actual)
First posted: 17 Dec 2020 (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.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Number of arms: 8

Arm	Type	Receives
adult patients_Dose 1	Experimental	Drug: SIM1803-1A
adult patients_Dose 2	Experimental	Drug: SIM1803-1A
adult patients_Dose 3	Experimental	Drug: SIM1803-1A
adult patients_Dose 4	Experimental	Drug: SIM1803-1A
adult patients_Dose 5	Experimental	Drug: SIM1803-1A
adult patients_Dose 6	Experimental	Drug: SIM1803-1A
adult patients_Dose 7	Experimental	Drug: SIM1803-1A
adult patients_Dose 8	Experimental	Drug: SIM1803-1A

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Adult patients with a locally advanced or metastatic solid tumor that has progressed or was nonresponsive to available therapies, are unfit for standard chemotherapy or for which no standard or available curative therapy exists；Proof of a malignancy harboring a NTRK、ROS1 or ALK fusion；Eastern Cooperative Oncology Group (ECOG) score of 0 or 1 and a life expectancy of at least 3 month；Adequate hematologic, hepatic, and renal function；Signed informed consent form；

Key exclusion criteria (1 listed)

Any contraindications as listed in the local approved product information；Patients with unstable primary central-nervous-system tumors or metastasis, exceptions possible；Pregnancy or lactation；Clinically significant active cardiovascular disease or history of myocardial infarction；Participation in an investigational program with interventions outside of routine clinical practice；Prior treatment with other kinase inhibitor with tropomyosin receptor kinase inhibition；Active uncontrolled systemic bacterial, viral, or fungal infection；Current treatment with a strong CYP3A4 inhibitor or inducer；

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
SIM1803-1ASIM1803-1A will be administered orally as tablets at a given dose once daily in continuing 21-days cycles.	Drug	adult patients_Dose 1, adult patients_Dose 2, adult patients_Dose 3, adult patients_Dose 4, adult patients_Dose 5, adult patients_Dose 6, adult patients_Dose 7, adult patients_Dose 8

Primary outcome

Number of participants with adverse events
Time frame: 5 years
Number of participants with adverse events
Severity of adverse events
Time frame: 5 years
Severity of adverse events
Maximum tolerated dose
Time frame: 5 years
Maximum tolerated dose
Recommended dose for dose expansion
Time frame: 5 years
Recommended dose for dose expansion
Maximum concentration of SIM1803-1A in plasma (Cmax)
Time frame: Predose and 0.25, 0.5, 1, 2, 4, 8，12，24and 48 hours after drug administration on Days 1 and 8 of Cycle 1（each cycle is 21 days）
Maximum concentration of SIM1803-1A in plasma (Cmax)
Area under the concentration-time curve of SIM1803-1A in plasma from time 0 to 24 hours in fasted state (AUC(0-24)_fasted)
Time frame: Up to 1 day
Area under the concentration-time curve of SIM1803-1A in plasma from time 0 to 24 hours in fasted state (AUC(0-24)_fasted)
Area under the concentration-time curve of SIM1803-1A in plasma from time 0 to infinity in fasted state (AUC_fasted)
Time frame: Up to 3 days
Area under the concentration-time curve of SIM1803-1A in plasma from time 0 to infinity in fasted state (AUC_fasted)
Number of participants with treatment-emergent adverse events (TEAEs)
Time frame: Up to 24 weeks
Number of participants with treatment-emergent adverse events (TEAEs)
Time to maximum concentration of SIM1803-1A in plasma (Tmax)
Time frame: Predose and 0.25, 0.5, 1, 2, 4, 8，12，24and 48 hours after drug administration on Days 1 and 8 of Cycle 1（each cycle is 21 days)
Time to maximum concentration of SIM1803-1A in plasma (Tmax)

3 secondary outcomes

Overall Response Rate (ORR)
Time frame: Up to 60 months
Duration of Response (DOR)
Time frame: Up to 60 months
progression-free survival（PFS）
Time frame: Up to 60 months

Results and safety

The study was stopped early (reason given: Business strategy). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
Individual participant dataSharing planned: No

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. This study is not recruiting at the moment.

shun lu, Ph.D principal investigator

Shanghai Chest Hospital

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

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing SIM1803-1A in people with Advanced or Metastatic Solid Tumors With NTRK, ROS1 or ALK Gene Fusion, run by Jiangsu Simcere Pharmaceutical Co., Ltd. at 1 site in China.

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 1 inclusion and 1 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: stopped early, as of the sponsor's last update on 24 Sep 2026. 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 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.

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

Are results available for this study?

The study was stopped early (reason given: Business strategy). Results are not available in the source record.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants with adverse events (time frame: 5 years). The study lists 9 primary outcomes in all. 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 NCT04671849.

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 24 Sep 2026.