Solid Tumor Malignancies, CancerPhase 1NCT06883539
A Phase I Study of LXP1788 Injection with Advanced Solid Tumors.
A Phase 1 study testing LXP1788 is administered intravenously via Port-A in people with Solid Tumor Malignancies, Cancer and Solid Cancers, run by LaunXP Biomedical Co., Ltd. at 2 sites in Taiwan.
Trial summary
A Phase I, open-label, first-in-human study to determine the MTD, recommended phase 2 dose (RP2D), assess the safety, tolerability, pharmacokinetics and preliminary anti-tumor activity of LXP1788 Injection in patients with advanced solid tumor. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor Malignancies, Cancer, Solid Cancers, Solid Tumor Cancer
- What is being tested?
- LXP1788 is administered intravenously via Port-A
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 2 sitesTaiwan
- Study dates
- 31 Dec 2024to 30 Jun 2028
- Phase
- Phase 1
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written (signed) Informed Consent.
- Male or female ≥ 18 years old.
- Life expectancy > 8 weeks.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- A histologically or cytologically confirmed, advanced solid tumor that is refractory to currently available therapies or for which no effective treatment is available.
- Measurable disease per RECIST 1.1.
- Willing to have a tumor biopsy or having tissue sample from a previous biopsy available in the tissue bank for analysis that had been collected in the past 3 years.
Who cannot join
- Significant concurrent medical diseases, such as congestive heart failure, unstable angina, acute or recent myocardial infarction (< 6 months before enrollment), COPD with frequent exacerbations, uncontrolled hypertension (systemic blood pressure >= 160 mmHg and/or diastolic blood pressure >= 100 mmHg with or without anti-hypertensive medication), recent CVA (< 6 months before enrollment), or active infection which requires treatment withintravenous antibiotics.
- Patients with symptomatic CNS metastases who are neurologically unstable, receiving radiotherapy for the CNS lesion, or requiring increasing dose of steroids to control their CNS disease.
- Asymptomatic patients with metastatic brain disease who have been on a stable dose of steroids for less than 14 days prior to screening.
- Inadequate bone marrow reserve or organ function as demonstrated by any of the following laboratory values:
- Bone marrow:
- Absolute neutrophil count (ANC) < 1.5 x 10^9/L
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- Platelet count < 100 x 10^9/L
- Hemoglobin < 9 g/dL
- Having had a blood transfusion within 2 weeks of screening date is also not allowed.
- Hepatic:
- Total bilirubin > 1.5 x ULN
- AST and ALT > 3 x ULN if no liver metastases
- AST and ALT > 5 x ULN in the presence of liver metastases
- Renal:
- ⚫ Estimated creatinine clearance (CrCL) < 60 mL/min per the Cockcroft and Gault formula
- Known history of human immunodeficiency virus (HIV)-1 or -2 infection.
- Psychiatric disorders that would compromise the patient's compliance or ability to give consent.
- Major surgical intervention within 4 weeks of the first dose of LXP1788 Injection or with ongoing postoperative complications.
- Toxicities from any prior therapy, surgery, or radiotherapy that did not resolve to grade 0 or 1 as per the National Cancer Institute (NCI) - Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0, with the exception of alopecia, skin hyperpigmentation or hypopigmentation.
- Underlying medical conditions that, in the investigator's opinion, will make the administration of LXP1788 Injection hazardous or obscure the interpretation of toxicities or adverse events.
- Exposure to any other investigational or commercial anti-cancer agents or curative therapies within 28 days or 5 half-lives (whichever is shorter), before the first dose of LXP1788 Injection. Exposure to radiation therapy for non-curative purposes or pain control may be permitted under the judgement of the investigator.
- Judgment by the investigator that the patient should not participate in the study because the patient is unlikely to comply with study procedures, restrictions, or requirements.
- Pregnancy or breast feeding.
- Women or men of childbearing potential not willing to use effective means of contraception.
- Positive test for hepatitis B (HBsAg) or hepatitis C (positive HCV antibody with detectable HCV RNA).
- History of allergic reactions to any component of LXP1788 Injection.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan2 sites, 2 recruiting
- Recruiting
China Medical University Hospital
Taichung, 404
Li Yuan Bai Doctor, +886-4-2205-2121, lybai6@gmail.com
- Recruiting
National Cheng Kung University Hospital
Tainan, 704
Yu-Min Yeh Doctor, +886-6-232-3535, i5485111@gmail.com
About this study
Official title: A Phase I Open-label Dose-finding Study to Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of LXP1788 Injection in Patients with Advanced Solid Tumors.
A Phase I, open-label, first-in-human study to determine the MTD, recommended phase 2 dose (RP2D), assess the safety, tolerability, pharmacokinetics and preliminary anti-tumor activity of LXP1788 Injection in patients with advanced solid tumor.
Patients with advanced solid tumors that are refractory to currently available therapies or for whom no effective treatment is available will be selected.
The main questions it aims to answer are:
- To determine the maximum tolerated dose (MTD) and the recommended phase 2 dose (RP2D) of LXP1788 Injection
- To evaluate the pharmacokinetics (PK) of LXP1788 Injection
- Conditions
- Solid Tumor Malignancies, Cancer, Solid Cancers, Solid Tumor Cancer, Solid Tumor, Unspecified, Adult, Solid Tumour, Solid Tumors Refractory to Standard Therapy
- Being tested
- LXP1788 is administered intravenously via Port-A
- Keywords
- Phase 1, LXP1788, LAUNXP, DBPR114-101, solid tumor, cancer, Hepatocellular carcinoma, Pancrease Cancer, Renal Cell Carcinoma, Tyrosine kinase inhibitor
- Medical subject headings
- Neoplasms, Carcinoma, Hepatocellular, Carcinoma, Renal Cell, Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LXP1788 is administered intravenously via Port-ADrug
LXP1788 Injection is formulated as a solution for injection and will be administered intravenously for 60 minutes on days 1, 8, 15, 22 of the cycle. Each cycle will be 28 days.
| Study group | Role | What they receive |
|---|---|---|
| LXP1788 Injection will be administered intravenously once a week in a 28-day treatment cycle. | Experimental | Not described Receives: Drug: LXP1788 is administered intravenously via Port-A |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the MTD and potential phase 2 dose regimen(s) of LXP1788 Injection
Measured: 2 years
To characterize the plasma PK profile of LXP1788 following IV administration of LXP1788 Injection
PK blood samples to determine plasma concentrations of LXP1788 will be collected at the time points listed in the schedule of events table. Where possible, the plasma concentration-time data will be used to calculate the following parameters for LXP1788 Injection by non-compartmental methods: Maximum plasma concentration (Cmax), dose-normalized Cmax (Cmax/D), area under the concentration-time curve from time 0 to 24 hours post-dose (AUC0-24), dose-normalized AUC0-24 (AUC0-24/D), AUC from time 0 to the last quantifiable concentration (AUC0-last), dose-normalized AUC0-last (AUC0-last/D), AUC from time 0 extrapolated to infinity (AUC0-inf), dose-normalized AUC0-inf (AUC0-inf/D), time to Cmax (tmax), plasma clearance (CL), volume of distribution (Vz), terminal rate constant (λz), and terminal elimination half-life (t1/2).
Measured: 2 years
Secondary outcomes (3)
To assess the safety, tolerability, and dose-limiting toxicity (DLT) of LXP1788 Injection
To assess the safety, tolerability, and dose-limiting toxicity (DLT) of LXP1788 Injection
Measured: 2 years
To assess exposure levels to LXP1788
To assess exposure levels to LXP1788
Measured: 2 years
To assess anti-tumor activity of LXP1788 Injection
To assess anti-tumor activity of LXP1788 Injection
- Objective response rate (ORR) using RECIST 1.1 for solid tumor
- Time to tumor progression (TTP)
- Disease control rate (DCR)
- Clinical benefit rate (CBR)
- Duration of response (DoR)
- Progression free survival (PFS)
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2025
- Study start31 Dec 2024
- Primary completion31 Dec 2027 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid Tumor Malignancies, CancerStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- LaunXP Biomedical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Efficient Pharma Management Corp.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06883539
- Sponsor's protocol ID
- DBPR114-101
- Status last verified
- Mar 2025
- First submitted
- 6 Mar 2025
- Last updated
- 19 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Open-label Dose-finding Study to Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of LXP1788 Injection in Patients with Advanced Solid Tumors.
- ClinicalTrials.gov ID
- NCT06883539
- Acronym / sponsor ID
- DBPR114-101
- Conditions
- Solid Tumor Malignancies, Cancer, Solid Cancers, Solid Tumor Cancer, Solid Tumor, Unspecified, Adult, Solid Tumour, Solid Tumors Refractory to Standard Therapy
- Keywords
- Phase 1, LXP1788, LAUNXP, DBPR114-101, solid tumor, cancer, Hepatocellular carcinoma, Pancrease Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- LaunXP Biomedical Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Efficient Pharma Management Corp.
- Study start
- 31 Dec 2024 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 19 Mar 2025 (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 Phase I, open-label, first-in-human study to determine the MTD, recommended phase 2 dose (RP2D), assess the safety, tolerability, pharmacokinetics and preliminary anti-tumor activity of LXP1788 Injection in patients with advanced solid tumor.
Patients with advanced solid tumors that are refractory to currently available therapies or for whom no effective treatment is available will be selected.
The main questions it aims to answer are:
- To determine the maximum tolerated dose (MTD) and the recommended phase 2 dose (RP2D) of LXP1788 Injection
- To evaluate the pharmacokinetics (PK) of LXP1788 Injection
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LXP1788 Injection will be administered intravenously once a week in a 28-day treatment cycle. | Experimental | Drug: LXP1788 is administered intravenously via Port-A |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Written (signed) Informed Consent.
- Male or female ≥ 18 years old.
- Life expectancy > 8 weeks.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- A histologically or cytologically confirmed, advanced solid tumor that is refractory to currently available therapies or for which no effective treatment is available.
Key exclusion criteria (26 listed)
- Significant concurrent medical diseases, such as congestive heart failure, unstable angina, acute or recent myocardial infarction (< 6 months before enrollment), COPD with frequent exacerbations, uncontrolled hypertension (systemic blood pressure >= 160 mmHg and/or diastolic blood pressure >= 100 mmHg with or without anti-hypertensive medication), recent CVA (< 6 months before enrollment), or active infection which requires treatment withintravenous antibiotics.
- Patients with symptomatic CNS metastases who are neurologically unstable, receiving radiotherapy for the CNS lesion, or requiring increasing dose of steroids to control their CNS disease.
- Asymptomatic patients with metastatic brain disease who have been on a stable dose of steroids for less than 14 days prior to screening.
- Inadequate bone marrow reserve or organ function as demonstrated by any of the following laboratory values:
- ⚫ Estimated creatinine clearance (CrCL) < 60 mL/min per the Cockcroft and Gault formula
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 |
|---|---|---|
| LXP1788 is administered intravenously via Port-ALXP1788 Injection is formulated as a solution for injection and will be administered intravenously for 60 minutes on days 1, 8, 15, 22 of the cycle. Each cycle will be 28 days. | Drug | LXP1788 Injection will be administered intravenously once a week in a 28-day treatment cycle. |
Primary outcome
To determine the MTD and potential phase 2 dose regimen(s) of LXP1788 Injection
Time frame: 2 years
To characterize the plasma PK profile of LXP1788 following IV administration of LXP1788 Injection
Time frame: 2 years
PK blood samples to determine plasma concentrations of LXP1788 will be collected at the time points listed in the schedule of events table. Where possible, the plasma concentration-time data will be used to calculate the following parameters for LXP1788 Injection by non-compartmental methods: Maximum plasma concentration (Cmax), dose-normalized Cmax (Cmax/D), area under the concentration-time curve from time 0 to 24 hours post-dose (AUC0-24), dose-normalized AUC0-24 (AUC0-24/D), AUC from time 0 to the last quantifiable concentration (AUC0-last), dose-normalized AUC0-last (AUC0-last/D), AUC from time 0 extrapolated to infinity (AUC0-inf), dose-normalized AUC0-inf (AUC0-inf/D), time to Cmax (tmax), plasma clearance (CL), volume of distribution (Vz), terminal rate constant (λz), and terminal elimination half-life (t1/2).
3 secondary outcomes
To assess the safety, tolerability, and dose-limiting toxicity (DLT) of LXP1788 Injection
Time frame: 2 years
To assess exposure levels to LXP1788
Time frame: 2 years
To assess anti-tumor activity of LXP1788 Injection
Time frame: 2 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 19 Mar 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing LXP1788 is administered intravenously via Port-A in people with Solid Tumor Malignancies, Cancer and Solid Cancers, run by LaunXP Biomedical Co., Ltd. at 2 sites in Taiwan.
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 7 inclusion and 26 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 19 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Taiwan. 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?
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 Chin- Hua Lin Clinical Research Director (+886-4-2320-5691, rdjulialin@launxp.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine the MTD and potential phase 2 dose regimen(s) of LXP1788 Injection (time frame: 2 years). 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 19 Mar 2025.