Advanced Solid TumorPhase 1NCT06205082
A Phase I Clinical Trial to Evaluate LIT-00814 Tablets in Patients With Advanced Solid Tumor
A Phase 1 study testing LIT-00814 in people with Advanced Solid Tumor, run by LittDD Medicines Ltd at 1 site in China.
Trial summary
This study is a multi-center, open, dose-increasing and dose-expanding phase I clinical study, aiming at evaluating the safety, tolerability, pharmacokinetic characteristics and preliminary anti-tumor activity of LIT-00814 tablets with different doses in China, and preliminarily evaluating the relationship between… 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?
- LIT-00814
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 1 siteChina
- Study dates
- 14 Oct 2023to 30 Jun 2026
- 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
- The subject or legal representative shall voluntarily sign the informed consent approved by the Ethics Committee before starting any screening procedure.
- Male or female, age ≥18 years old.
- Unresectable locally advanced or metastatic solid tumor confirmed by histology or cytology.
- Subjects with relapsed and/or metastatic advanced solid tumors who have failed or have no standard treatment at present, or who are unable to accept standard treatment.
- At least one target lesion.
- ECOG score 0~1.
- Subjects must have sufficient organ function.
- Agree to use effective contraceptive measures within 3 months (about 90 days) from the signing of informed consent to the last administration of the study drug.
Who cannot join
- The toxicity caused by previous treatment did not recover to ≤1 grade before the first study administration;
- Known or symptomatic active central nervous system (CNS) metastasis or cancerous meningitis in the screening period;
- Patients who have undergone surgery within 28 days before the first administration and have not recovered yet;
- Suffering from uncontrolled or clinically significant cardiovascular diseases;
- Other malignant tumors occurred within 3 years before the first administration;
- Patients with active chronic hepatitis B, or patients with active hepatitis C, or patients with human immunodeficiency virus (HIV-Ab positive) or syphilis infection;
- There are circumstances that affect the subjects' compliance with the research plan;
- Other circumstances that the researcher thinks are not suitable for participating in this clinical study.
Trial locations and contacts
1 site in 1 country.
China1 site
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100000
About this study
Official title: A Multicenter, Open Phase I Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumor Activity of LIT-00814 Tablets in Patients With Advanced Solid Tumor/Esophageal Cancer.
This study is a multi-center, open, dose-increasing and dose-expanding phase I clinical study, aiming at evaluating the safety, tolerability, pharmacokinetic characteristics and preliminary anti-tumor activity of LIT-00814 tablets with different doses in China, and preliminarily evaluating the relationship between biomarkers and anti-tumor activity of LIT-00814 tablets.
This study includes two parts: Ia phase (i.e. dose escalation) and Ib phase (i.e. dose expansion).
- Conditions
- Advanced Solid Tumor
- Being tested
- LIT-00814
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LIT-00814Drug
LIT-00814 is an oral tablet.
| Study group | Role | What they receive |
|---|---|---|
| LIT-00814 20mg | Experimental | Take a fixed dose of LIT-00814 tablets orally once a day in the morning and evening, and take them orally continuously. Receives: Drug: LIT-00814 |
| LIT-00814 50mg | Experimental | Take a fixed dose of LIT-00814 tablets orally once a day in the morning and evening, and take them orally continuously. Receives: Drug: LIT-00814 |
| LIT-00814 100mg | Experimental | Take a fixed dose of LIT-00814 tablets orally once a day in the morning and evening, and take them orally continuously. Receives: Drug: LIT-00814 |
| LIT-00814 150mg | Experimental | Take a fixed dose of LIT-00814 tablets orally once a day in the morning and evening, and take them orally continuously. Receives: Drug: LIT-00814 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events
Measured: Up to 28 days post last drug administration
Determination of the MTD and RP2D of LIT-00814 monotherapy
Defined as the highest dose level at which no more than 1 of 6 subjects experience a DLT during the DLT assessment window（24days）
Measured: 24 days after the first dose
Secondary outcomes (8)
Objective remission rate (ORR)
according to the criterion of RECIST1.1, the proportion of subjects with complete remission (CR) and partial remission (PR) during the study period.
Measured: Until documented the disease progresses or informed consent is withdrawn
Disease control rate (DCR)
According to the criterion of RECIST1.1, the proportion of subjects with complete remission (CR), partial remission (PR) and stable disease (SD) during the study period.
Measured: Until documented the disease progresses or informed consent is withdrawn
Disease progression-free survival (PFS)
It is defined as the time between the first administration date of the study drug and the disease progression or death, whichever occurs first.
Measured: Until documented the disease progresses or informed consent is withdrawn
Treatment onset time (TTR)
It is defined as the time between the first administration date of the study drug and the first determination of complete remission (CR) and partial remission (PR).
Measured: Until documented the disease progresses or informed consent is withdrawn
Overall survival (OS)
The time from the first administration date of the study drug to the death (for any reason) of the subject.
Measured: date of death from any cause or withdrawal of informed consent
Pharmacokinetic parameters：Maximum observed concentration（Cmax）
Maximum concentration of LIT-00814 in blood after single dose and continuous multiple doses
Measured: C0D1-D3 0-72h（single dose），C1D1 0h、C1D8 0h、C2D1 0-8h（21days/cycle）
Pharmacokinetic parameters：Area under the concentration-time curve (AUC)
The concentration of LIT-00814 in blood after single dose and continuous multiple doses
Measured: C0D1-D3 0-72h（single dose），C1D1 0h、C1D8 0h、C2D1 0-8h（21days/cycle）
Pharmacokinetic parameters：Half-life (t1/2)
The concentration of LIT-00814 in blood after single dose and continuous multiple doses
Measured: C0D1-D3 0-72h（single dose），C1D1 0h、C1D8 0h、C2D1 0-8h（21days/cycle）
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2024
- Study start14 Oct 2023
- Primary completion30 Oct 2025 (estimated)
- Study completion30 Jun 2026 (estimated)
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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 81 participants (estimated)
Sponsor and investigators
- Lead sponsor
- LittDD Medicines Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jing Huang, Professor, Principal investigator, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06205082
- Sponsor's protocol ID
- LIT-00814-2023-CP101
- Status last verified
- Feb 2024
- First submitted
- 18 Dec 2023
- Last updated
- 1 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open Phase I Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumor Activity of LIT-00814 Tablets in Patients With Advanced Solid Tumor/Esophageal Cancer.
- ClinicalTrials.gov ID
- NCT06205082
- Acronym / sponsor ID
- LIT-00814-2023-CP101
- Conditions
- Advanced Solid Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 81 participants (estimated)
- Lead sponsor
- LittDD Medicines LtdIndustry (pharma, biotech, devices)
- Study start
- 14 Oct 2023 (actual)
- Primary completion
- 30 Oct 2025 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 12 Jan 2024 (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.
This study is a multi-center, open, dose-increasing and dose-expanding phase I clinical study, aiming at evaluating the safety, tolerability, pharmacokinetic characteristics and preliminary anti-tumor activity of LIT-00814 tablets with different doses in China, and preliminarily evaluating the relationship between biomarkers and anti-tumor activity of LIT-00814 tablets.
This study includes two parts: Ia phase (i.e. dose escalation) and Ib phase (i.e. dose expansion).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| LIT-00814 20mg | Experimental | Drug: LIT-00814Take a fixed dose of LIT-00814 tablets orally once a day in the morning and evening, and take them orally continuously. |
| LIT-00814 50mg | Experimental | Drug: LIT-00814Take a fixed dose of LIT-00814 tablets orally once a day in the morning and evening, and take them orally continuously. |
| LIT-00814 100mg | Experimental | Drug: LIT-00814Take a fixed dose of LIT-00814 tablets orally once a day in the morning and evening, and take them orally continuously. |
| LIT-00814 150mg | Experimental | Drug: LIT-00814Take a fixed dose of LIT-00814 tablets orally once a day in the morning and evening, and take them orally continuously. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- The subject or legal representative shall voluntarily sign the informed consent approved by the Ethics Committee before starting any screening procedure.
- Male or female, age ≥18 years old.
- Unresectable locally advanced or metastatic solid tumor confirmed by histology or cytology.
- Subjects with relapsed and/or metastatic advanced solid tumors who have failed or have no standard treatment at present, or who are unable to accept standard treatment.
- At least one target lesion.
Key exclusion criteria (8 listed)
- The toxicity caused by previous treatment did not recover to ≤1 grade before the first study administration;
- Known or symptomatic active central nervous system (CNS) metastasis or cancerous meningitis in the screening period;
- Patients who have undergone surgery within 28 days before the first administration and have not recovered yet;
- Suffering from uncontrolled or clinically significant cardiovascular diseases;
- Other malignant tumors occurred within 3 years before the first administration;
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 |
|---|---|---|
| LIT-00814LIT-00814 is an oral tablet. | Drug | LIT-00814 100mg, LIT-00814 150mg, LIT-00814 20mg, LIT-00814 50mg |
Primary outcome
Incidence of adverse events
Time frame: Up to 28 days post last drug administration
Determination of the MTD and RP2D of LIT-00814 monotherapy
Time frame: 24 days after the first dose
Defined as the highest dose level at which no more than 1 of 6 subjects experience a DLT during the DLT assessment window（24days）
8 secondary outcomes
Objective remission rate (ORR)
Time frame: Until documented the disease progresses or informed consent is withdrawn
Disease control rate (DCR)
Time frame: Until documented the disease progresses or informed consent is withdrawn
Disease progression-free survival (PFS)
Time frame: Until documented the disease progresses or informed consent is withdrawn
Treatment onset time (TTR)
Time frame: Until documented the disease progresses or informed consent is withdrawn
Overall survival (OS)
Time frame: date of death from any cause or withdrawal of informed consent
Pharmacokinetic parameters：Maximum observed concentration（Cmax）
Time frame: C0D1-D3 0-72h（single dose），C1D1 0h、C1D8 0h、C2D1 0-8h（21days/cycle）
Pharmacokinetic parameters：Area under the concentration-time curve (AUC)
Time frame: C0D1-D3 0-72h（single dose），C1D1 0h、C1D8 0h、C2D1 0-8h（21days/cycle）
Pharmacokinetic parameters：Half-life (t1/2)
Time frame: C0D1-D3 0-72h（single dose），C1D1 0h、C1D8 0h、C2D1 0-8h（21days/cycle）
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2024.
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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.
Jing Huang, Professor principal investigator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
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 LIT-00814 in people with Advanced Solid Tumor, run by LittDD Medicines 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 8 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: status not confirmed, as of the sponsor's last update on 1 Mar 2024. 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?
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?
Incidence of adverse events (time frame: Up to 28 days post last drug administration). 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 1 Mar 2024.