Solid TumorPhase 1NCT05390710
PhI to Solid Tumors and PhII to Locally Advanced or mTNBC
A Phase 1 study testing LAE005 + Afuresertib + Nab-Paclitaxel in people with Solid Tumor and TNBC - Triple-Negative Breast Cancer, run by Laekna Limited at 5 sites in China.
Trial summary
PhI Dose Escalation with BOIN design in advanced Solid Tumor with Triple combination therapy to determine MTD and RP2D Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor, TNBC - Triple-Negative Breast Cancer
- What is being tested?
- LAE005 + Afuresertib + Nab-Paclitaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 5 sitesChina
- Study dates
- 12 Jun 2021to 11 Dec 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
- Be ≥18 years of age on the day of signing the informed consent and be able to provide written informed consent for the trial.
- In Phase I, patients with histologically or cytologically confirmed advanced solid tumors are allowed to be enrolled in this study. mTNBC is a preferred cancer type to be enrolled although all solid tumors are qualified in phase I.
- In Phase I, patients with advanced solid tumors who have progressed after 0 to 3 lines of available standard of care (i.e. targeted therapy, immunotherapy and/or chemotherapy) are allowed to be enrolled in this study. If anti-cancer drugs have been used, the washout period is 4 weeks or 5 half-lives (whichever is longer).
- In phase I, there is no biomarker test required.
- Have measurable disease per RECIST 1.1 as assessed by local image study, that has not undergone radiotherapy.
- Patients must have an Eastern Cooperative Oncology Group (ECOG) Performance Score of 0 or 1 in both Phase I and II.
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- Have adequate organ function as defined below. If the specimens are collected within 10 days prior to the start of study treatment, the same tests in Day 1 can be waived to avoid redundancy.
- Hematological:
- Absolute neutrophil count (ANC) ≥1500/μL
- Platelets within the normal range in phase I, and platelet count ≥100,000/µl in phase II
- Hemoglobin ≥9.0 g/dL or ≥5.6 mmol/L
- Criteria must be met without erythropoietin dependency and without packed red blood cell (rRBC) transfusion within last 2 weeks.
- Renal
- Creatinine ≤1.5 × ULN OR
- Measured or calculated per institutional standard creatinine clearance (GFR can also be used in place of creatinine or creatinine clearance) ≥30 mL/min for participant with creatinine levels >1.5 × institutional ULN.
- Hepatic
- Total bilirubin ≤1.5 ×ULN OR direct bilirubin ≤1.0 ×ULN for participants with total bilirubin levels >1.5 × ULN.
- AST (SGOT) and ALT (SGPT) ≤2.5 × ULN (≤5 × ULN for participants with liver metastases).
- Coagulation
- International normalized ratio (INR) OR prothrombin time (PT)/Activated partial thromboplastin time (aPTT) ≤1.5 × ULN unless participant is receiving anticoagulant therapy, as long as PT or aPTT is within therapeutic range of intended use of anticoagulants.
- Fasting glucose ≤126 mg/dL or ≤7.0 mmol/L for patients without type 2 diabetes and ≤167 mg/dL or ≤9.3 mmol/L for patients with type 2 diabetes; or glycosylated hemoglobin (HbA1c) ≤8%.
- Life expectancy of 24 weeks or more based on investigator's assessment.
- Patients have recovered from adverse events associated with chemotherapy, radiation and surgical operation as pre-treatment to Grade 1 or lower with CTCAE v5.0 excluding stable symptoms (e.g. alopecia, skin hyperpigmentation).
- Patients must agree to use effective contraception during the study and for at least 90 days after discontinuation as following:
- Total abstinence (if it is their preferred and usual lifestyle)
- An intrauterine device (IUD) or hormone-releasing system (IUS)
- A contraceptive implant
- An oral contraceptive (with additional barrier method) OR
- Have a vasectomized partner with confirmed azoospermia
- Male patients must agree to use an adequate method of contraception from enrollment through 90 days after the last dose of study treatment.
- Patient is able to swallow and retain oral medication without gastrointestinal diseases to interfere with drug absorption.
Who cannot join
- A woman of child-bearing potential (WOCBP), who has a positive urine pregnancy test (e.g. within 72 hours) prior to treatment. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
- Has received a live vaccine within 30 days prior to the first dose of study drug. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., FluMist®) are live attenuated vaccines and are not allowed.
- Has a history of autoimmune diseases or diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study drug.
- Has a recent major surgery requiring hospitalization (<3 months from randomization) or use of IV antibiotics for systemic infection (< 2 months from randomization).
- Has a known additional malignancy that is progressing or has required active treatment within the past 3 years (Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, that have undergone potentially curative therapy are not excluded).
- History of seizure of condition that may predispose to seizure that needs anti-epileptic medications; brain arteriovenous malformation; or intracranial masses, such as schwannomas and meningiomas that are causing edema or mass effect.
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- Has known active CNS metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable, i.e., without evidence of progression for at least 4 weeks by repeat imaging (note that the repeat imaging should be performed during study screening), clinically stable and without requirement of steroid treatment for at least 14 days prior to first dose of study treatment.
- Has severe hypersensitivity (≥Grade 3) to LAE005 or afuresertib and/or any of their excipients.
- Has an active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed.
- Has a history of (non-infectious) pneumonitis that required steroids or has concurrent pneumonitis.
- New York Heart Association congestive heart failure of grade II or above, unstable angina, myocardial infarction within the past 6 months or serious cardiac arrhythmia associated with significant cardiovascular impairment within the past 6 months.
- Prolongation of corrected QTc interval, as corrected by the Frederica's correction formula to ≥450 msec for males and ≥470 msec for females; unless prolonged QTc interval due to right bundle branch block or left bundle branch block with a pacemaker.
- Presence of uncontrolled hypertension (systolic blood pressure >160 mmHg or diastolic BP>100 mmHg). Patients with a history of hypertension are allowed, provided that BP is controlled to within these limits by anti-hypertensive treatment.
- Has a known history of Hepatitis B (defined as HBsAg reactive) or known active Hepatitis C virus (defined as HCV RNA [qualitative] is detected) and HIV infection.
- Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator.
- Has a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study.
- Any medical contraindication to the use of nab-paclitaxel.
- Patients receiving a strong CYP3CA, OATP, BRCP substrate or inducer. Please see related section for a list of these prohibited medications.
- Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 90 days after the last dose of study treatment.
- Has had an allogenic tissue/solid organ transplant.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
China5 sites
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality
The first affiliated hopsital of bengbu medical college
Bengbu, Anhui
Sun Yat-sen Memorial Hospital
Guangzhou
Sir RunRun Shaw Hospital Zhejiang University School of Medicine
Hangzhou
Tianjin Medical University Cancer Institute & Hospital
Tianjin
About this study
Official title: A PhI Dose Escalation Study of LAE005+Afuresertib+Nab_Paclitaxel in Advanced Solid Tumors and PhII Study to Evaluate the Safety and Efficacy of LAE005+Afur+Nab_Paclitaxel or LAE005/Afur+Nab-Paclitaxel in Locally Advanced or mTNBC
PhI Dose Escalation with BOIN design in advanced Solid Tumor with Triple combination therapy to determine MTD and RP2D
Read the detailed description
Phase I dose escalation for triple combination therapy with BOINcomb design,The safety (including DLT), tolerability, and PK are the study endpoints of phase I and to determine MTD and RP2D.
- Conditions
- Solid Tumor, TNBC - Triple-Negative Breast Cancer
- Being tested
- LAE005 + Afuresertib + Nab-Paclitaxel
- Keywords
- TNBC
- Medical subject headings
- Triple Negative Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LAE005 + Afuresertib + Nab-PaclitaxelCombination product
LAE005: 1200 mg IV Q3W, Afuresertib: 125 mg QD, Nab paclitaxel:125 mg/m D1, D8 Q3W
| Study group | Role | What they receive |
|---|---|---|
| Triple combination | Experimental | LAE005+Afuresertib+Nab-Paclitaxel Receives: Combination Product: LAE005 + Afuresertib + Nab-Paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the safety.
Frequency and severity of AEs (including incidence rate of DLTs).
Measured: 1year
recommended Phase II dose (RP2D) of LAE005 and afuresertib and nab-paclitaxel as a combination treatment in patients with advanced solid tumours (including mTNBC)
Frequency and severity of AEs (including incidence rate of DLTs).
Measured: 1year
To evaluate the tolerability.
Frequency and severity of AEs (including incidence rate of DLTs).
Measured: 1year
To determine the maximum tolerated dose (MTD)
Frequency and severity of AEs (including incidence rate of DLTs).
Measured: 1year
Secondary outcomes (8)
To assess the preliminary anti-tumor activity of LAE005 and afuresertib and nab-paclitaxel via DCR
Disease Control Rate (DCR) base on RECIST 1.1;
Measured: 1 year
To characterize the AUC0-t of LAE005 and afuresertib in patients receiving combination treatment of LAE005 and afuresertib and nab-paclitaxel.
Plasma concentrations and PK parameters of LAE005 and afuresertib, AUC0-t of afuresertib following combination treatment, calculated from PK samples obtained at various time points.
Measured: 1 year
To characterize the AUC0-inf of LAE005 and afuresertib in patients receiving combination treatment of LAE005 and afuresertib and nab-paclitaxel.
Plasma concentrations and PK parameters of LAE005 and afuresertib, AUC0-inf of afuresertib following combination treatment, calculated from PK samples obtained at various time points.
Measured: 1 year
To characterize the Tmax of LAE005 and afuresertib in patients receiving combination treatment of LAE005 and afuresertib and nab-paclitaxel.
Plasma concentrations and PK parameters of LAE005 and afuresertib, Tmax of afuresertib following combination treatment, calculated from PK samples obtained at various time points.
Measured: 1 year
To characterize the T1/2 of LAE005 and afuresertib in patients receiving combination treatment of LAE005 and afuresertib and nab-paclitaxel.
Plasma concentrations and PK parameters of LAE005 and afuresertib, T1/2 of afuresertib following combination treatment, calculated from PK samples obtained at various time points.
Measured: 1 year
To assess the preliminary anti-tumor activity of LAE005 and afuresertib and nab-paclitaxel via BOR
Best Overall Response Rate (BOR) base on RECIST 1.1;
Measured: 1 year
To assess the preliminary anti-tumor activity of LAE005 and afuresertib and nab-paclitaxel via DOR
Duration of Response (DOR) base on RECIST 1.1;
Measured: 1 year
To assess the preliminary anti-tumor activity of LAE005 and afuresertib and nab-paclitaxel via PFS
Progression-Free Survival (PFS) base on RECIST 1.1;
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2022
- Study start12 Jun 2021
- Primary completion11 Dec 2023
- Study completion11 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Not applicable
- Intervention model
- Single group
- Model description
- BOIN for Phase I with 1 treatment arm
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laekna Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Binghe NA Xu, Principal investigator, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05390710
- Sponsor's protocol ID
- LAE203CN2101
- Status last verified
- Oct 2024
- First submitted
- 26 Jul 2021
- Last updated
- 10 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 10 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A PhI Dose Escalation Study of LAE005+Afuresertib+Nab_Paclitaxel in Advanced Solid Tumors and PhII Study to Evaluate the Safety and Efficacy of LAE005+Afur+Nab_Paclitaxel or LAE005/Afur+Nab-Paclitaxel in Locally Advanced or mTNBC
- ClinicalTrials.gov ID
- NCT05390710
- Acronym / sponsor ID
- LAE203CN2101
- Conditions
- Solid Tumor, TNBC - Triple-Negative Breast Cancer
- Keywords
- TNBC
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Laekna LimitedIndustry (pharma, biotech, devices)
- Study start
- 12 Jun 2021 (actual)
- Primary completion
- 11 Dec 2023 (actual)
- Study completion
- 11 Dec 2023 (actual)
- First posted
- 25 May 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.
PhI Dose Escalation with BOIN design in advanced Solid Tumor with Triple combination therapy to determine MTD and RP2D
Detailed description
Phase I dose escalation for triple combination therapy with BOINcomb design,The safety (including DLT), tolerability, and PK are the study endpoints of phase I and to determine MTD and RP2D.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- BOIN for Phase I with 1 treatment arm
| Arm | Type | Receives |
|---|---|---|
| Triple combination | Experimental | Combination Product: LAE005 + Afuresertib + Nab-PaclitaxelLAE005+Afuresertib+Nab-Paclitaxel |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (31 listed)
- Be ≥18 years of age on the day of signing the informed consent and be able to provide written informed consent for the trial.
- In Phase I, patients with histologically or cytologically confirmed advanced solid tumors are allowed to be enrolled in this study. mTNBC is a preferred cancer type to be enrolled although all solid tumors are qualified in phase I.
- In Phase I, patients with advanced solid tumors who have progressed after 0 to 3 lines of available standard of care (i.e. targeted therapy, immunotherapy and/or chemotherapy) are allowed to be enrolled in this study. If anti-cancer drugs have been used, the washout period is 4 weeks or 5 half-lives (whichever is longer).
- In phase I, there is no biomarker test required.
- Have measurable disease per RECIST 1.1 as assessed by local image study, that has not undergone radiotherapy.
Key exclusion criteria (20 listed)
- A woman of child-bearing potential (WOCBP), who has a positive urine pregnancy test (e.g. within 72 hours) prior to treatment. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
- Has received a live vaccine within 30 days prior to the first dose of study drug. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., FluMist®) are live attenuated vaccines and are not allowed.
- Has a history of autoimmune diseases or diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study drug.
- Has a recent major surgery requiring hospitalization (<3 months from randomization) or use of IV antibiotics for systemic infection (< 2 months from randomization).
- Has a known additional malignancy that is progressing or has required active treatment within the past 3 years (Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, that have undergone potentially curative therapy are not excluded).
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 |
|---|---|---|
| LAE005 + Afuresertib + Nab-PaclitaxelLAE005: 1200 mg IV Q3W, Afuresertib: 125 mg QD, Nab paclitaxel:125 mg/m D1, D8 Q3W | Combination product | Triple combination |
Primary outcome
To evaluate the safety.
Time frame: 1year
Frequency and severity of AEs (including incidence rate of DLTs).
recommended Phase II dose (RP2D) of LAE005 and afuresertib and nab-paclitaxel as a combination treatment in patients with advanced solid tumours (including mTNBC)
Time frame: 1year
Frequency and severity of AEs (including incidence rate of DLTs).
To evaluate the tolerability.
Time frame: 1year
Frequency and severity of AEs (including incidence rate of DLTs).
To determine the maximum tolerated dose (MTD)
Time frame: 1year
Frequency and severity of AEs (including incidence rate of DLTs).
8 secondary outcomes
To assess the preliminary anti-tumor activity of LAE005 and afuresertib and nab-paclitaxel via DCR
Time frame: 1 year
To characterize the AUC0-t of LAE005 and afuresertib in patients receiving combination treatment of LAE005 and afuresertib and nab-paclitaxel.
Time frame: 1 year
To characterize the AUC0-inf of LAE005 and afuresertib in patients receiving combination treatment of LAE005 and afuresertib and nab-paclitaxel.
Time frame: 1 year
To characterize the Tmax of LAE005 and afuresertib in patients receiving combination treatment of LAE005 and afuresertib and nab-paclitaxel.
Time frame: 1 year
To characterize the T1/2 of LAE005 and afuresertib in patients receiving combination treatment of LAE005 and afuresertib and nab-paclitaxel.
Time frame: 1 year
To assess the preliminary anti-tumor activity of LAE005 and afuresertib and nab-paclitaxel via BOR
Time frame: 1 year
To assess the preliminary anti-tumor activity of LAE005 and afuresertib and nab-paclitaxel via DOR
Time frame: 1 year
To assess the preliminary anti-tumor activity of LAE005 and afuresertib and nab-paclitaxel via PFS
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2024.
- 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.
Binghe NA Xu principal investigator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
5 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 LAE005 + Afuresertib + Nab-Paclitaxel in people with Solid Tumor and TNBC - Triple-Negative Breast Cancer, run by Laekna Limited at 5 sites 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 31 inclusion and 20 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: finished, as of the sponsor's last update on 10 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To evaluate the safety. (time frame: 1year). The study lists 4 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 10 Oct 2024; AzTrials last refreshed its copy on 26 Oct 2026.