Solid TumorPhase 1NCT03844438
A Study Evaluating the Safety, Tolerability of LPM3480226 Tablets in Patients With Advanced Solid Tumors
A Phase 1 study testing LPM3480226 in people with Solid Tumor, run by Luye Pharma Group Ltd. at 1 site in China.
Trial summary
This study is a non-randomized, open, multiple administration and dose escalation phase 1 clinical trial evaluating the safety, tolerability, and pharmacokinetic/pharmacodynamics Characteristics of multiple oral administration of LPM3480226 in patients with advanced solid tumors., determine its dose-limiting toxicity… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Solid Tumor
- What is being tested?
- LPM3480226
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 18 Dec 2018to 1 Mar 2022
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The subject has voluntarily signed the written informed consent form (ICF)
- Male or female patients aged 18 to 75 years (18 years and 75 years are inclusive)
- Advanced solid tumors confirmed by histology or cytology (the following tumors may be preferred: melanoma, bladder cancer, kidney cancer, head and neck cancer, lung cancer, etc.);
- Standard treatment is ineffective, subjects refuse to accept or cannot tolerate standard treatment, or there is no standard effective treatment;
- The patient should have at least one measurable lesion as the target lesion (according to RECIST 1.1 criteria)
- The Eastern Cooperative Oncology Group (ECOG) performance status score is < 2 point.
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- The predictable survival duration is ≥ 3 months
- Laboratory results during screening: absolute neutrophil count ≥ 1.5× 109/L; platelet count≥ 90× 109/L; hemoglobin≥ 90 g/L; Total bilirubin ≤1.5×upper limit of normal (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <2.5×ULN for the subjects without liver metastasis and ALT and AST< 5×ULN for the subjects with liver metastasis.; creatinine clearance ≥ 50 mL/min （Cockcroft-Gault formula)
- QTc interval male ≤ 450 ms female≤ 470 ms；
- The female subjects and male subjects of childbearing age and the partners of the male subjects agree to take reliable contraceptive measures during the study period and within 6 months after infusion of the study drugs
Who cannot join
- There are any active autoimmune diseases or a history of autoimmune diseases [including but not limited to: rheumatoid arthritis, ankylosing spondylitis, autoimmune hemolytic anemia, interstitial pneumonia, uveitis, inflammation Intestinal disease, autoimmune hepatitis, autoimmune hypophysitis, glomerulonephritis, hyperthyroidism or decreased thyroid function (subclinical patients can be included), allergic asthma (where asthma in childhood has been completely relieved, and no intervention needed in adults can be included. Patients with asthma who need bronchodilators for medical intervention cannot be included.), and patients with vitiligo and type 1 diabetes can be included];
- Brain metastases, spinal cord compression, or cancerous meningitis, or brain CT or MRI scans confirmed brain metastases during screening period;
- have gastrointestinal diseases that may affect the absorption of the drug, or have undergone gastrointestinal surgery, which may affect the drug absorption by the investigator;
- Previously received radiotherapy, chemotherapy, surgery, or small molecule targeted therapy, less than 4 weeks prior to the first dose after treatment (if you had previously received nitrosourea or mitomycin chemotherapy, the time between the end of chemotherapy and the first dose Less than 6 weeks);
- Continue to use immunosuppressants (including but not limited to: tacrolimus, cyclosporine, etc.), systemic or topical hormonal therapy (dose > 10 mg / day prednisone or corresponding equivalent of other hormones)within 2 weeks prior to the first dose;
- Those who have received any vaccine within 28 days prior to the first dose;
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- Any drug that affects tryptophan metabolism is used within 28 days prior to the first dose, including but not limited to: serotonin reuptake inhibitors (eg, fluoxetine, paroxetine, fluvoxamine, sertraline, Citalopram, escitalopram, etc.), tryptophan hydroxylase inhibitors (eg, trossostat ethyl ester, p-chlorophenylalanine, etc.);
- Those who have used CYP3A4 strong inducers or strong inhibitors within 2 weeks before the first dose or within 5 half-life periods (for long periods of time) (see Annex V);
- Immunological "checkpoint" inhibitors (including but not limited to: anti-PD-1/PD-L1/PD-L2 monoclonal antibodies, anti-CTLA-4 monoclonal antibodies) were used within 42 days prior to the first dose;
- A monoamine oxidase inhibitor or a drug having a monoamine oxidase inhibitory action (eg, pethidine hydrochloride, linezolid, methylene blue, etc.) is used 3 weeks before the first administration or within 5 half-life periods (for long periods of time);
- Interferon-treated within 6 months prior to the first dose;
- Those who have used IDO/TDO inhibitors in the past;
- Active infections;
- Any of Hepatitis B virus surface antigen (HBsAg), hepatitis C virus antibody (HCV-Ab), acquired immunodeficiency syndrome antibody (Anti-HIV) or treponema pallidum antibody (TP-Ab) is positive;
- Those who received any other study drug or participated in another interventional clinical study 28 days before the first dose (42 days for mAbs);
- Other systemic anti-tumor therapists may be accepted during the study;
- Known to have a history of psychotropic substance abuse, alcohol abuse or drug abuse;
- Pregnant, lactating women or women with fertility test positive for pregnancy test;
- other important organ primary diseases (such as nervous system, cardiovascular system, urinary system, digestive system, respiratory system or metabolic endocrine system disease) or other reasons which are considered by the investigator that the subject is unsuitable to be enrolled.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Cancer Hospital
Beijing, 100000
Guo Jun, 010-88196348, guoj307@126.com
Guo Jun
About this study
Official title: A Non-randomized, Open, Dose Escalation Phase 1 Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LPM3480226 Tablets in Patients With Advanced Solid Tumors
This study is a non-randomized, open, multiple administration and dose escalation phase 1 clinical trial evaluating the safety, tolerability, and pharmacokinetic/pharmacodynamics Characteristics of multiple oral administration of LPM3480226 in patients with advanced solid tumors., determine its dose-limiting toxicity and maximum tolerated dose, and initially observe its clinical effectiveness, and explore the metabolites in plasma after administration.
Read the detailed description
The primary objective of this study was to assess the safety and tolerability of LPM3480226 tablets after oral administration to patients with advanced solid tumors, and to determine the dose-limiting toxicity (DLT) and maximum tolerated dose (MTD) of LPM3480226.
A non-randomized, open, multiple dose escalation design was used with a total of five dose groups. The starting dose was 50 mg and the subsequent dose was increased according to the protocol of 100 mg , 200 mg , 400 mg , 600mg. Starting from the low-dose group, each subject received only one dose of the drug, and the next dose group study could only be performed if the previous dose group was completed and safe tolerance was confirmed.
Subjects were given the corresponding doses in the order，bid，28 days as a cycle, to evaluate the safety and tolerability of multiple doses. After confirming the safety and tolerance of the dose group in the first administration cycle, the administration was continued for another cycle according to the dose, and the subjects were evaluated for the efficacy after the two-cycle administration, and the subjects who did not have disease progression and is well tolerated and the investigator believes that continued treatment can benefit, the patient may continue to receive the dose of the drug on a voluntary basis, with a maximum dose of no more than one year.
- Conditions
- Solid Tumor
- Being tested
- LPM3480226
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LPM3480226Drug
The starting dose was 50 mg and the subsequent dose was increased according to the protocol of 100 mg, 200 mg, 400 mg, 600mg.
| Study group | Role | What they receive |
|---|---|---|
| LPM3480226 | Experimental | LPM3480226 tablet will be orally administered，bid，28 days are considered as 1 cycle. The starting dose was 50 mg and the subsequent dose was increased according to the protocol of 100 mg,200 mg,400 mg,600mg. Receives: Drug: LPM3480226 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerability of LPM3480226 assessed by adverse events
Collection of adverse events throughout the study as a measure of safety and tolerability.
Measured: 1 cycle (28 days)
Secondary outcomes (2)
AUC
Area under the concentration-time curve (AUC) Assessment Area under the concentration-time curve (AUC) for the Pharmacokinetics (PK) of
Measured: 1 cycle (28 days)
CMax
Maximum concentration (Cmax) Assessment Maximum concentration (Cmax) for the Pharmacokinetics (PK) of
Measured: 1 cycle (28 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2019
- Study start18 Dec 2018
- Primary completion28 Oct 2020 (estimated)
- Study completion1 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Solid TumorStudies of the same condition, open and under way.
- More trials run by Luye Pharma Group 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Luye Pharma Group Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Nanjing Bangnuo Biotechnology Co. Ltd
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03844438
- Sponsor's protocol ID
- LY01013-CHN -101
- Status last verified
- Feb 2019
- First submitted
- 14 Feb 2019
- Last updated
- 20 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Al-Zoubi RM, Elaarag M, Al-Qudimat AR, Al-Hurani EA, Fares ZE, Farhan A, Al-Zoubi SR, Khan A, Agouni A, Shkoor M, Bawadi H, Zakaria ZZ, Al Zoubi M, Alrumaihi K. IDO and TDO inhibitors in cancer immunotherapy: mechanisms, clinical development, and future directions. Front Pharmacol. 2025 Sep 16;16:1632446. doi: 10.3389/fphar.2025.1632446. eCollection 2025.
PubMed 41035912
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Non-randomized, Open, Dose Escalation Phase 1 Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LPM3480226 Tablets in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT03844438
- Acronym / sponsor ID
- LY01013-CHN -101
- Conditions
- Solid Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Luye Pharma Group Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Nanjing Bangnuo Biotechnology Co. Ltd
- Study start
- 18 Dec 2018 (actual)
- Primary completion
- 28 Oct 2020 (estimated)
- Study completion
- 1 Mar 2022 (estimated)
- First posted
- 18 Feb 2019 (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 non-randomized, open, multiple administration and dose escalation phase 1 clinical trial evaluating the safety, tolerability, and pharmacokinetic/pharmacodynamics Characteristics of multiple oral administration of LPM3480226 in patients with advanced solid tumors., determine its dose-limiting toxicity and maximum tolerated dose, and initially observe its clinical effectiveness, and explore the metabolites in plasma after administration.
Detailed description
The primary objective of this study was to assess the safety and tolerability of LPM3480226 tablets after oral administration to patients with advanced solid tumors, and to determine the dose-limiting toxicity (DLT) and maximum tolerated dose (MTD) of LPM3480226.
A non-randomized, open, multiple dose escalation design was used with a total of five dose groups. The starting dose was 50 mg and the subsequent dose was increased according to the protocol of 100 mg , 200 mg , 400 mg , 600mg. Starting from the low-dose group, each subject received only one dose of the drug, and the next dose group study could only be performed if the previous dose group was completed and safe tolerance was confirmed.
Subjects were given the corresponding doses in the order，bid，28 days as a cycle, to evaluate the safety and tolerability of multiple doses. After confirming the safety and tolerance of the dose group in the first administration cycle, the administration was continued for another cycle according to the dose, and the subjects were evaluated for the efficacy after the two-cycle administration, and the subjects who did not have disease progression and is well tolerated and the investigator believes that continued treatment can benefit, the patient may continue to receive the dose of the drug on a voluntary basis, with a maximum dose of no more than one year.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LPM3480226 | Experimental | Drug: LPM3480226LPM3480226 tablet will be orally administered，bid，28 days are considered as 1 cycle. The starting dose was 50 mg and the subsequent dose was increased according to the protocol of 100 mg,200 mg,400 mg,600mg. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- The subject has voluntarily signed the written informed consent form (ICF)
- Male or female patients aged 18 to 75 years (18 years and 75 years are inclusive)
- Advanced solid tumors confirmed by histology or cytology (the following tumors may be preferred: melanoma, bladder cancer, kidney cancer, head and neck cancer, lung cancer, etc.);
- Standard treatment is ineffective, subjects refuse to accept or cannot tolerate standard treatment, or there is no standard effective treatment;
- The patient should have at least one measurable lesion as the target lesion (according to RECIST 1.1 criteria)
Key exclusion criteria (19 listed)
- There are any active autoimmune diseases or a history of autoimmune diseases [including but not limited to: rheumatoid arthritis, ankylosing spondylitis, autoimmune hemolytic anemia, interstitial pneumonia, uveitis, inflammation Intestinal disease, autoimmune hepatitis, autoimmune hypophysitis, glomerulonephritis, hyperthyroidism or decreased thyroid function (subclinical patients can be included), allergic asthma (where asthma in childhood has been completely relieved, and no intervention needed in adults can be included. Patients with asthma who need bronchodilators for medical intervention cannot be included.), and patients with vitiligo and type 1 diabetes can be included];
- Brain metastases, spinal cord compression, or cancerous meningitis, or brain CT or MRI scans confirmed brain metastases during screening period;
- have gastrointestinal diseases that may affect the absorption of the drug, or have undergone gastrointestinal surgery, which may affect the drug absorption by the investigator;
- Previously received radiotherapy, chemotherapy, surgery, or small molecule targeted therapy, less than 4 weeks prior to the first dose after treatment (if you had previously received nitrosourea or mitomycin chemotherapy, the time between the end of chemotherapy and the first dose Less than 6 weeks);
- Continue to use immunosuppressants (including but not limited to: tacrolimus, cyclosporine, etc.), systemic or topical hormonal therapy (dose > 10 mg / day prednisone or corresponding equivalent of other hormones)within 2 weeks prior to the first dose;
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 |
|---|---|---|
| LPM3480226The starting dose was 50 mg and the subsequent dose was increased according to the protocol of 100 mg, 200 mg, 400 mg, 600mg. | Drug | LPM3480226 |
Primary outcome
Safety and Tolerability of LPM3480226 assessed by adverse events
Time frame: 1 cycle (28 days)
Collection of adverse events throughout the study as a measure of safety and tolerability.
2 secondary outcomes
AUC
Time frame: 1 cycle (28 days)
CMax
Time frame: 1 cycle (28 days)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2019.
- Derived from this study: PubMed 41035912Al-Zoubi RM, Elaarag M, Al-Qudimat AR, Al-Hurani EA, Fares ZE, Farhan A, Al-Zoubi SR, Khan A, Agouni A, Shkoor M, Bawadi H, Zakaria ZZ, Al Zoubi M, Alrumaihi K. IDO and TDO inhibitors in cancer immunotherapy: mechanisms, clinical development, and future directions. Front Pharmacol. 2025 Sep 16;16:1632446. doi: 10.3389/fphar.2025.1632446. eCollection 2025.
- Individual participant dataSharing planned: No
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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.
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 LPM3480226 in people with Solid Tumor, run by Luye Pharma Group 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 10 inclusion and 19 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 20 Feb 2019. 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?
Contact Yuli Sun (010 5281 9375, sunyuli@luye.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and Tolerability of LPM3480226 assessed by adverse events (time frame: 1 cycle (28 days)). 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 NCT03844438, which also lists 1 linked publication.
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 20 Feb 2019.