Advanced Solid TumorPhase 1/2NCT05451602
HEC169096 in Participants With Advanced Solid Tumors
A Phase 1/2 study testing HEC169096 in people with Advanced Solid Tumor, run by Sunshine Lake Pharma Co., Ltd. at 1 site in China.
Trial summary
An Open, Multi-Center Phase I/II Clinical Study To Evaluate The Safety, Tolerability, Pharmacokinetic Characteristics And Effectiveness Of HEC169096 In Patients With Thyroid Cancer, Non-Small Cell Lung Cancer, and Other Advanced Solid Tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumor
- What is being tested?
- HEC169096
- 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 Oct 2022to 23 Sep 2025
- Phase
- Phase 1/2
- 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
- Phase 1：Pathologically documented, definitively diagnosed non-resectable advanced solid tumor.
- Phase 2： All participants must have an oncogenic RET-rearrangement/fusion or mutation (excluding synonymous, frameshift, and nonsense mutations) solid tumor.
- Participants has Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-2.
- Measurable or non-measurable disease as determined by RECIST 1.1;
- Adequate hematologic, hepatic and renal function;
- Life expectancy of at least 12 weeks;
- Negative pregnancy test (urine or serum) for female patients of childbearing potential;
- Participants agrees to provide tumor tissue (archived, if available or a fresh biopsy).
Who cannot join
- Participant's cancer has a known primary driver alteration other than RET.
- Nitrosourea, anthracyclines and mitomycin chemotherapy within 6 weeks prior to study treatment;
- Chemotherapy, immunotherapy, radiotherapy, or major surgery within 4 weeks or 5 half-lives (whichever is longer) prior to study treatment;
- Those who have received more than 30% of bone marrow radiation or wide-range radiotherapy within 4 weeks before the first study drug treatment (the patients receiving palliative radiotherapy are within 2 weeks before receiving study drug treatment);
- Had received traditional Chinese medicine for anti-tumor within a week before receiving study drug treatment;
- Had received live vaccine within 4 weeks prior to study treatment;
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- Had received any investigational agent from other clinical study within 4 weeks or 5 half-lives (whichever is longer) prior to study treatment or are currently participating in other clinical trials;
- Any unresolved toxicities from prior therapy greater than Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 at the time of starting study treatment .
- Central nervous system (CNS) metastases or a primary CNS tumor that is associated with progressive neurological symptoms.
- Patients with other malignant tumors within 5 years before the first use of drugs
- Patients have a history of severe cardiovascular disease;
- Active hepatitis (Hepatitis B: HBsAg-positive and HBV-DNA ≥ 2000 IU/ mL or ≥ 10^4 cps/ mL; Hepatitis B: HCV antibody-positive and HCV-RNA positive), HIV antibody-positive.
- Patients with clinically active interstitial lung disease, active pneumonia, and radiation pneumonia requiring treatment;
- Poorly controlled pleural effusion, abdominal effusion, or pericardial effusion after intervention (such as drainage);
- Clinically significant active malabsorption syndrome or other diseases that may affect study drug administration and gastrointestinal absorption;
- Patients have been treated with any strong CYP3A inhibitors or inducers within 2 weeks prior to the first dose or PPIs in the first week before the first dose.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 1/2 Study of the Highly-selective RET Inhibitor,HEC169096 in Participants With Thyroid Cancer, Non-Small Cell Lung Cancer, and Other Advanced Solid Tumors
An Open, Multi-Center Phase I/II Clinical Study To Evaluate The Safety, Tolerability, Pharmacokinetic Characteristics And Effectiveness Of HEC169096 In Patients With Thyroid Cancer, Non-Small Cell Lung Cancer, and Other Advanced Solid Tumors.
Read the detailed description
This is an open-label, multi-center Phase 1/2 study in participants with advanced solid tumors, including RET fusion-positive NSCLC, MTC, and other tumors with RET activation. Phase I of this study includes a dose-escalation phase and a dose-expansion phase , which will focus on exploring MTD and/or RP2D of HEC169096 in patients with advanced solid tumours; Phase II will assess the efficacy and safety of HEC169096 at the RP2D dose.
- Conditions
- Advanced Solid Tumor
- Being tested
- HEC169096
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HEC169096Drug
Multiple doses of HEC169096 during Phase 2；Oral dose of HEC169096 as determined during Phase 2.
| Study group | Role | What they receive |
|---|---|---|
| HEC169096 | Experimental | Multiple doses of HEC169096 Receives: Drug: HEC169096 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase 1: MTD and RP2D of HEC169096
Determination of Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) of HEC169096
Measured: Cycle 1 (28 days) of treatment for MTD and at the end of every 2 cycle for RP2D for approximately 12 months or earlier if participant terminates from the study
Phase 2: Overall Response Rate
As assessed by Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2022
- Study start21 Oct 2022
- Primary completion23 Sep 2025
- Study completion23 Sep 2025
Why it stopped: Sponsor strategic decision; the study will not continue.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sunshine Lake Pharma Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05451602
- Sponsor's protocol ID
- HEC169096-ST-101
- Status last verified
- Apr 2026
- First submitted
- 3 Jul 2022
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1/2 Study of the Highly-selective RET Inhibitor,HEC169096 in Participants With Thyroid Cancer, Non-Small Cell Lung Cancer, and Other Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT05451602
- Acronym / sponsor ID
- HEC169096-ST-101
- Conditions
- Advanced Solid Tumor
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor strategic decision; the study will not continue.
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Sunshine Lake Pharma Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 21 Oct 2022 (actual)
- Primary completion
- 23 Sep 2025 (actual)
- Study completion
- 23 Sep 2025 (actual)
- First posted
- 11 Jul 2022 (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.
An Open, Multi-Center Phase I/II Clinical Study To Evaluate The Safety, Tolerability, Pharmacokinetic Characteristics And Effectiveness Of HEC169096 In Patients With Thyroid Cancer, Non-Small Cell Lung Cancer, and Other Advanced Solid Tumors.
Detailed description
This is an open-label, multi-center Phase 1/2 study in participants with advanced solid tumors, including RET fusion-positive NSCLC, MTC, and other tumors with RET activation. Phase I of this study includes a dose-escalation phase and a dose-expansion phase , which will focus on exploring MTD and/or RP2D of HEC169096 in patients with advanced solid tumours; Phase II will assess the efficacy and safety of HEC169096 at the RP2D dose.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HEC169096 | Experimental | Drug: HEC169096Multiple doses of HEC169096 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Phase 1：Pathologically documented, definitively diagnosed non-resectable advanced solid tumor.
- Phase 2： All participants must have an oncogenic RET-rearrangement/fusion or mutation (excluding synonymous, frameshift, and nonsense mutations) solid tumor.
- Participants has Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-2.
- Measurable or non-measurable disease as determined by RECIST 1.1;
- Adequate hematologic, hepatic and renal function;
Key exclusion criteria (16 listed)
- Participant's cancer has a known primary driver alteration other than RET.
- Nitrosourea, anthracyclines and mitomycin chemotherapy within 6 weeks prior to study treatment;
- Chemotherapy, immunotherapy, radiotherapy, or major surgery within 4 weeks or 5 half-lives (whichever is longer) prior to study treatment;
- Those who have received more than 30% of bone marrow radiation or wide-range radiotherapy within 4 weeks before the first study drug treatment (the patients receiving palliative radiotherapy are within 2 weeks before receiving study drug treatment);
- Had received traditional Chinese medicine for anti-tumor within a week before receiving study drug treatment;
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 |
|---|---|---|
| HEC169096Multiple doses of HEC169096 during Phase 2；Oral dose of HEC169096 as determined during Phase 2. | Drug | HEC169096 |
Primary outcome
Phase 1: MTD and RP2D of HEC169096
Time frame: Cycle 1 (28 days) of treatment for MTD and at the end of every 2 cycle for RP2D for approximately 12 months or earlier if participant terminates from the study
Determination of Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) of HEC169096
Phase 2: Overall Response Rate
Time frame: through study completion, an average of 1 year
As assessed by Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)
Results and safety
The study was stopped early (reason given: Sponsor strategic decision; the study will not continue.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing HEC169096 in people with Advanced Solid Tumor, run by Sunshine Lake Pharma 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 8 inclusion and 16 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 14 Oct 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 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?
The study was stopped early (reason given: Sponsor strategic decision; the study will not continue.). 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?
Phase 1: MTD and RP2D of HEC169096 (time frame: Cycle 1 (28 days) of treatment for MTD and at the end of every 2 cycle for RP2D for approximately 12 months or earlier if participant terminates from the study). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Oct 2026.