Advanced TumoursPhase 1/2NCT04882176

A Clinical Study Preliminary Efficacy of LM-061 Tablet in Subjects With Advanced Tumours

A Phase 1/2 study testing LM-061 in people with Advanced Tumours, run by LaNova Medicines Limited at 1 site in China.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Trial summary

This is a phase I/II, open-label, dose escalation and dose extension study to evaluate the safety, tolerability, PK, and preliminary efficacy of LM-061 in subjects with advanced tumors. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Advanced Tumours
What is being tested?: LM-061
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 18 participants
Where: 1 siteChina
Study dates: 20 May 2021to 19 Jul 2023
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 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Volunteer to participate in clinical study, sign a written informed consent form, and be able to comply with clinical visits and study related procedures;
Male or female subjects 18 to 75 years old (both inclusive) when sign the informed consent;
Study population;
Dose Escalation the subjects with advanced malignant tumors confirmed by histology or cytology, and have failed standard treatment, or have no standard treatment, or not suitable for standard treatment at present;
Dose Extension patients with advanced solid tumors with abnormal c-Met, including EGFR-TKI-resistant non-small cell lung cancer and pulmonary sarcomatoid adenocarcinoma, diagnosed histologically or cytologically, who have failed standard therapy, or who do not have standard treatment regimens, or who are not suitable for standard therapy at this stage;Papillary renal cell carcinoma;Metastatic or locally advanced unresectable gastric adenocarcinoma with at least first-line standard treatment;
ECOG score 0-1;

Show all 11Show fewer

C-MET abnormalities are defined by central laboratory as the situation that meets one of the following: Abnormal expression of c-Met immunohistochemistry (IHC) : strong staining (2+ or above) in more than 50% of tumor cells; MET amplification positive: MET/CEP 7 ≥2 or GCN ≥5; MET exon14-skipping mutation;
The estimated survival time is not less than 3 months;
The functional of bone marrow reserve and organs must meet the following requirements (without ongoing continuous supportive treatment): Bone marrow reserve: Neutrophil count (NE#) ≥ 1.5×109/L, platelet count (PLT) ≥90 ×109/L; hemoglobin (HGB) > 9.0 g/dL (no blood transfusion or hematopoietic stimulating factor therapy within 14 days); Coagulation function: activated partial thromboplastin time (APTT) prolong ≤ 1.5× upper limit of normal (ULN), and international standard ratio (INR) ≤ 1.5; Liver function: total bilirubin (TBIL) ≤ 1.5×ULN, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5×ULN (if there is liver metastasis, ALT or AST≤ 5×ULN); Kidney function: Creatinine clearance rate ≥50 mL/min (using Cockcroft-Gault formula, see Appendix 1) or serum creatinine ≤1.5×ULN; qualitative urine protein ≤1+ or qualitative urine protein ≥2+, but 24-hour urine protein <1g; Cardiac function: left ventricular ejection fraction (LVEF) ≥ 50%; ECG is basically normal, and corrected QT interval (QTcF) ≤450 ms and 470 ms for male and female, respectively;
According to RECIST v1.1 criteria, there should be at least one evaluable tumor focus in the dose escalation phase;At least one measurable tumor was present during the dose expansion phase;
Eligible subjects with fertility (male and female) must agree to use reliable contraceptive methods (hormonal or barrier method or abstinence, etc.) with their partners during the trial period and at least 3 months after the last administration; women of childbearing age (Refer to Appendix 2 for definitions) The subject's serum pregnancy test must be negative within 7 days prior to the first administration.

Who cannot join

Have received chemotherapy, radiotherapy, biological therapy, endocrine therapy, immune checkpoint inhibitor therapy and other anti-tumour treatments within 4 weeks prior to first dose of IMP, except for the following items:
Subjects was diagnosed as acute promyelocytic leukemia (APL), breakpoint cluster region-abelson (BCR-ABL)-positive leukemia (i.e., chronic myelogenous leukemia in blast crisis), active central nervous system leukemia, or AML secondary to prior chemotherapy for other neoplasms;
Have used nitrosourea or Mitomycin C within 6 weeks prior to first dose of IMP;
Have used oral fluorouracil and small molecule targeted drugs within 2 weeks or 5 half-lives of the drugs prior to first dose of IMP (whichever is longer);
Have received other unmarketed clinical study drugs or treatments within 4 weeks prior to first dose of IMP;
Have undergone major organ surgery (excluding biopsy) or have had significant trauma or invasive dental procedures (such as tooth extraction, dental implant) within 4 weeks prior to first dose of IMP, or required elective surgery during the study period;

Show all 24Show fewer

Have serious unhealable wounds/ulcers/bone fractures within 4 weeks prior to first dose of IMP;
Are taking (or cannot be stopped at least 1 week prior to first dose of IMP) any drug that is known to strongly inhibit or induce CYP3A4 (see Appendix 5 for details);
The histopathological type of the tumour is head and neck or lung squamous cell carcinoma, or other tumours with bleeding tendency as judged by the investigator;
Bleeding events of grade 3 or above occurred within 6 months before the first dose of IMP or currently ≥grade 2 bleeding or factors judged by the investigator to have a high risk of bleeding (such as active peptic ulcer or esophageal varices) at present;
The adverse reactions of previous anti-tumour treatments have not yet recovered to CTCAE 5.0 grade evaluation ≤1 (except for toxicity judged by the investigator to have no safety risk, such as hair loss, grade 2 peripheral neurotoxicity, etc.);
Central nervous system metastasis or meningeal metastasis with clinical symptoms, or other evidence that the subject's central nervous system metastasis or meningeal metastasis has not been controlled, and the investigator judges it to be unsuitable for inclusion;
Gastrointestinal perforation, abdominal fistula, or intra-abdominal abscess occurred within 6 months before the first dose of the IMP; or the investigator has determined that there are high-risk factors for the formation of cavity organ perforation/fistula (such as tumour infiltration in the cavity Outer layer of the wall); inflammatory bowel disease (including ulcerative colitis and Crohn's disease), diverticulitis, cholecystitis, symptomatic cholangitis or appendicitis;
Unable to be dosed orally, or there are conditions that have been judged by the investigators to seriously affect the absorption of the gastrointestinal tract, such as dysphagia, nausea and vomiting that are difficult to control, intestinal obstruction, and gastric outlet obstruction;
Have active infection 1 week before the first dose of IMP and currently need systemic anti-infective treatment;
HIV infection, active HBV infection (HBV DNA exceeds the ULN), active HCV infection (HCV RNA exceeds the ULN);
Have a history of serious cardiovascular and cerebrovascular diseases, including but not limited to: Severe heart rhythm or conduction abnormalities, such as ventricular arrhythmia that requires clinical intervention, grade Ⅱ-Ⅲ atrioventricular block, etc.; Thromboembolic events requiring therapeutic anticoagulation, or subjects with venous filters;According to the New York Heart Association (NYHA) standards, subjects with grade III~IV cardiac insufficiency;Acute coronary syndrome, congestive heart failure, aortic dissection, stroke or other cardiovascular and cerebrovascular events of grade 3 or above occurred within 6 months before the first administration of IMP;Clinically uncontrollable hypertension (blood pressure cannot be controlled at systolic blood pressure <140 mmHg and diastolic blood pressure <90 mmHg after standard antihypertensive treatment);Any factors that increase the risk of QTc prolongation or arrhythmia, such as heart failure, hypokalemia, congenital long QT syndrome, use of any concomitant drugs that are known or may prolong the QT interval (see Appendix 5 for details);
The third gap effusion that cannot be controlled clinically is not suitable for inclusion in the study judged by the investigator;
Known history of drug abuse;
Subjects with mental disorders or poor compliance;
Women who are pregnant or breastfeeding;
Cannot tolerate venous blood sampling;
Known to be allergic to LM-061 tablets or any of its excipients;
Has history of other serious systemic diseases judged by the investigator, or other reasons are not suitable for participating in the study.

Trial locations and contacts

1 site in 1 country.

China1 site

Shanghai East Hospital
Shanghai, Shanghai City, 310000

Other trials in China

About this study

Official title: A Phase I/II, First-in-Human, Open-Label, Dose-Escalation and Dose-Extension Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of LM-061 Tablet in Subjects With Advanced Tumours

This is a phase I/II, open-label, dose escalation and dose extension study to evaluate the safety, tolerability, PK, and preliminary efficacy of LM-061 in subjects with advanced tumors.

Read the detailed description

This is a phase I/II, open-label, dose escalation and dose extension study to evaluate the safety, tolerability, PK, and preliminary efficacy of LM-061 in subjects with advanced tumors.

The study schedule includes screening visit (28 days prior to accept the investigational medicinal product (IMP)), treatment visit (accept IMP for the first time to the end of treatment (EOT)/early withdrawal), and follow-up visit (28 days after the EOT/early withdrawal).

Conditions: Advanced Tumours
Being tested: LM-061

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

LM-061Drug
Also called Kinase inhibitor
The subjects in each dose level will be administered single oral dose of LM-061 tablet on C0D1, and washout for 5 days. After that, the subjects will be administered multiple oral doses once daily (QD) in continuous 28 days (4 weeks) per treatment cycle, until meet the treatment termination criteria, including disease progression or unaccepted toxicity, etc. After obtaining MTD/RP2D, the Safety Review Committee (SRC) may combine the data of safety, PK, and preliminary efficacy to explore other dosing schedules (such as 3 weeks on and 1 week off).

Study groups in NCT04882176
Study group	Role	What they receive
LM061 Dose Escalation Level 1, 2.5mg	Experimental	The dose escalation scheme using the the accelerated titration design for dose 1 and the i3+3 design for the remaining doses. first dose: 2.5mg QD, n=1; Receives: Drug: LM-061
LM061 Dose Escalation Level 2, 5mg	Experimental	The dose escalation scheme using the the accelerated titration design for dose 1 and the i3+3 design for the remaining doses. second dose: 5mg QD, n=3; Receives: Drug: LM-061
LM061 Dose Escalation Level 3, 10mg	Experimental	The dose escalation scheme using the the accelerated titration design for dose 1 and the i3+3 design for the remaining doses. third dose: 10mg QD, n=3; Receives: Drug: LM-061
LM061 Dose Escalation Level 4, 20mg	Experimental	The dose escalation scheme using the the accelerated titration design for dose 1 and the i3+3 design for the remaining doses. fourth dose: 20mg, n=3; Receives: Drug: LM-061
LM061 Dose Escalation Level 5, 30mg	Experimental	The dose escalation scheme using the the accelerated titration design for dose 1 and the i3+3 design for the remaining doses. fifth dose: 30mg, n=3; Receives: Drug: LM-061
LM061 Dose Escalation Level 6, 40mg	Experimental	The dose escalation scheme using the the accelerated titration design for dose 1 and the i3+3 design for the remaining doses. sixth dose: 40mg, n=9; Receives: Drug: LM-061
LM061 Dose Escalation Level 7, 60mg	Experimental	The dose escalation scheme using the the accelerated titration design for dose 1 and the i3+3 design for the remaining doses. seventh dose: 60mg, n=15; Receives: Drug: LM-061

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of participants with adverse events and serious adverse events
The safety profile of LM061 will be assessed by monitoring the adverse events (AE) per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
Measured: From screening up to 1.5 year
Dose-limiting toxicities (DLT)
DLT is defined as a toxicity (adverse event at least possibly related to LM061) occurring during the DLT observation period (the initial 21 days)
Measured: Cycle 1 of each cohort. Duration of one cycle is 28 days
Maximum tolerated dose (MTD)
MTD is defined as the dose for which the probability of DLT does not exceed the upper bound of the EI, 0.35, and is closest to the target toxicity probability p_T=0.3 during the DLT assessment period (from LM-061 single dose to the first treatment cycle of the multiple dose).
The i3+3 design does not select a dose as the MTD unless at least 3 subjects have completed the safety assessment.
Measured: Cycle 1 of each cohort. Duration of one cycle is 28 days
Change in Vital Signs-ear temperature
Change in vital signs-ear temperature will be measured after the subject has been fully rested.
Measured: Baseline (Week 0) through approximately 1 year after first administration of LM061
Change in Vital Signs-pulse rate
Change in vital signs-pulse rate will be measured after the subject has been fully rested.
Measured: Baseline (Week 0) through approximately 1 year after first administration of LM061
Change in Vital Signs-blood pressure
Change in vital signs-blood pressure will be measured after the subject has been fully rested.
Measured: Baseline (Week 0) through approximately 1 year after first administration of LM061
Change in Electrocardiogram (ECG)-RR interval
RR interval of 12-lead ECG will be performed in the supine position after the patients are fully rested at each timepoint for once. RR is the standard heart rate which calculated by 60 divided by heart rate.
Measured: Baseline (Week 0) through approximately 1 year after first administration of LM061
Change in Electrocardiogram (ECG)-QT interval
QT interval of 12-lead ECG will be performed in the supine position after the patients are fully rested at each timepoint for once.
Measured: Baseline (Week 0) through approximately 1 year after first administration of LM061
Change in Electrocardiogram (ECG)-QRS duration
QRS duration of 12-lead ECG will be performed in the supine position after the patients are fully rested at each timepoint for once.
Measured: Baseline (Week 0) through approximately 1 year after first administration of LM061
Incidence of Abnormal Clinical Laboratory Test Results-hematology
Number of participants with incidence of abnormal clinical lab test results like hematology will be assessed.
Measured: Baseline (Week 0) through approximately 1 year after first administration of LM061
Incidence of Abnormal Clinical Laboratory Test Results-Biochemistry
Number of participants with incidence of abnormal clinical lab test results like Biochemistry will be assessed.
Measured: Baseline (Week 0) through approximately 1 year after first administration of LM061
Incidence of Abnormal Clinical Laboratory Test Results-Urinalysis
Number of participants with incidence of abnormal clinical lab test results like Urinalysis will be assessed.
Measured: Baseline (Week 0) through approximately 1 year after first administration of LM061
Incidence of Abnormal Clinical Laboratory Test Results-Coagulation test
Number of participants with incidence of abnormal clinical lab test results like Coagulation test will be assessed.
Measured: Baseline (Week 0) through approximately 1 year after first administration of LM061

Secondary outcomes (12)

Area under the serum concentration versus time curve within one dosing interval (AUCtau)
To determine the pharmacokinetics (PK) profile of LM061 Single dose: pre-dose (within 30 minutes before administration), and 1 h, 3 h, 6 h, 8 h, 10 h, 12 h, 24 h, 36 h, 48 h, 72 h, 96 h after administration on C0D1; Multiple dose: pre-dose (within 30 minutes before administration) on C1D1, C1D8, and C1D15; pre-dose (within 30 minutes before administration), and 1 h, 3 h, 6 h, 8 h, 10 h, 12 h, 24 h after administration on C1D22;
The timepoints of PK sample may be adjusted base on the human PK data. The blood samples for PK analysis will be collected as much as possible if the subjects end of treatment/early withdraw.
Measured: Up to 1.5year
Volume of distribution (Vd)
To determine the pharmacokinetics (PK) profile of LM061 For AML, the efficacy will be evaluated by using the European LeukemiaNet (ELN) 2017 criteria. The complete blood count and bone marrow will be evaluated at screening visit and every 4 weeks ± 1 week (relative to C1D1) after the start of multiple administrations until the progressive disease judged by investigator or initiate new anti-tumour therapy or subject withdraw. The assessment results are divided into complete remission (CR), CR without minimal residual disease (CRMRD-)，CR with incomplete hematologic recovery (CRi), morphologic leukemia-free state (MFLS), partial remission (PR), stable disease (SD), progressive disease (PD).
Measured: Up to 1.5 year
Volume of distribution at steady state (Vss)
To determine the pharmacokinetics (PK) profile of LM061
Measured: Up to 1.5 year
Maximum serum concentration (Cmax)
To determine the pharmacokinetics (PK) profile of LM061
Measured: Up to 1.5 year
Trough concentration before the next dose is administered (Ctrough)
To determine the pharmacokinetics (PK) profile of LM061
Measured: Up to 1.5year
Time to reach maximum serum concentration (Tmax)
To determine the pharmacokinetics (PK) profile of LM061
Measured: Up to 1.5 year
Clearance (CL)
To determine the pharmacokinetics (PK) profile of LM061
Measured: Up to 1.5 year
Terminal half-life (T1/2)
To determine the pharmacokinetics (PK) profile of LM061
Measured: Up to 1.5 year
Dose proportionality
To determine the pharmacokinetics (PK) profile of LM061
Measured: Up to 1.5 year
Objective response rate (ORR)
To assess the preliminary antitumor activity of LM102,The ORR, using RECIST 1.1 criteria, was defined as the percentage of participants in the analysis population who had a confirmed Complete Response (CR; disappearance of all target lesions) or Partial Response (PR; at least a 30% decrease in the sum of diameters of target lesions) at any time during the study, based on Investigator assessment.
Measured: Up to 1.5 year
Best of response (BOR)
To assess the preliminary antitumor activity of LM061
Measured: Up to 1.5 year
Disease control rate (DCR)
To assess the preliminary antitumor activity of LM061
Measured: Up to 1.5 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 May 202119 Jul 2023

First posted11 May 2021
Study start20 May 2021
Primary completion7 Feb 2023
Study completion19 Jul 2023

Why it stopped: Not meeting expected endpoints

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Advanced TumoursStudies of the same condition, open and under way.
More trials run by LaNova Medicines LimitedThe 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 1/2
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Model description: Arm1: LM-061 2.5mg P.O QD Arm2: LM-061 5mg, P.O QD Arm3: LM-061 10mg, P.O QD Arm4: LM-061 20mg, P.O QD Arm5: LM-061 30mg, P.O QD Arm6: LM-061 40mg, P.O QD Arm7: LM-061 60mg, P.O QD
Masking: None (open label)
Enrolment: 18 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04882176
Sponsor's protocol ID: LM061-01-101
Status last verified: Apr 2021
First submitted: 22 Apr 2021
Last updated: 27 Jul 2023
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 3
A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)
Carcinoma, Renal Cell
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms

All Advanced Tumours trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase I/II, First-in-Human, Open-Label, Dose-Escalation and Dose-Extension Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of LM-061 Tablet in Subjects With Advanced Tumours
ClinicalTrials.gov ID: NCT04882176
Acronym / sponsor ID: LM061-01-101
Conditions: Advanced Tumours
Phase: Phase 1/2
Study type: Interventional
Recruitment status: TerminatedReason stopped: Not meeting expected endpoints
Enrolment: 18 participants (actual)
Lead sponsor: LaNova Medicines LimitedIndustry (pharma, biotech, devices)
Study start: 20 May 2021 (actual)
Primary completion: 7 Feb 2023 (actual)
Study completion: 19 Jul 2023 (actual)
First posted: 11 May 2021 (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 is a phase I/II, open-label, dose escalation and dose extension study to evaluate the safety, tolerability, PK, and preliminary efficacy of LM-061 in subjects with advanced tumors.

Detailed description

This is a phase I/II, open-label, dose escalation and dose extension study to evaluate the safety, tolerability, PK, and preliminary efficacy of LM-061 in subjects with advanced tumors.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Number of arms: 7
Model description: Arm1: LM-061 2.5mg P.O QD Arm2: LM-061 5mg, P.O QD Arm3: LM-061 10mg, P.O QD Arm4: LM-061 20mg, P.O QD Arm5: LM-061 30mg, P.O QD Arm6: LM-061 40mg, P.O QD Arm7: LM-061 60mg, P.O QD

Arm	Type	Receives
LM061 Dose Escalation Level 1, 2.5mg	Experimental	Drug: LM-061The dose escalation scheme using the the accelerated titration design for dose 1 and the i3+3 design for the remaining doses. first dose: 2.5mg QD, n=1;
LM061 Dose Escalation Level 2, 5mg	Experimental	Drug: LM-061The dose escalation scheme using the the accelerated titration design for dose 1 and the i3+3 design for the remaining doses. second dose: 5mg QD, n=3;
LM061 Dose Escalation Level 3, 10mg	Experimental	Drug: LM-061The dose escalation scheme using the the accelerated titration design for dose 1 and the i3+3 design for the remaining doses. third dose: 10mg QD, n=3;
LM061 Dose Escalation Level 4, 20mg	Experimental	Drug: LM-061The dose escalation scheme using the the accelerated titration design for dose 1 and the i3+3 design for the remaining doses. fourth dose: 20mg, n=3;
LM061 Dose Escalation Level 5, 30mg	Experimental	Drug: LM-061The dose escalation scheme using the the accelerated titration design for dose 1 and the i3+3 design for the remaining doses. fifth dose: 30mg, n=3;
LM061 Dose Escalation Level 6, 40mg	Experimental	Drug: LM-061The dose escalation scheme using the the accelerated titration design for dose 1 and the i3+3 design for the remaining doses. sixth dose: 40mg, n=9;
LM061 Dose Escalation Level 7, 60mg	Experimental	Drug: LM-061The dose escalation scheme using the the accelerated titration design for dose 1 and the i3+3 design for the remaining doses. seventh dose: 60mg, n=15;

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (11 listed)

Volunteer to participate in clinical study, sign a written informed consent form, and be able to comply with clinical visits and study related procedures;
Male or female subjects 18 to 75 years old (both inclusive) when sign the informed consent;
Study population;
Dose Escalation the subjects with advanced malignant tumors confirmed by histology or cytology, and have failed standard treatment, or have no standard treatment, or not suitable for standard treatment at present;
Dose Extension patients with advanced solid tumors with abnormal c-Met, including EGFR-TKI-resistant non-small cell lung cancer and pulmonary sarcomatoid adenocarcinoma, diagnosed histologically or cytologically, who have failed standard therapy, or who do not have standard treatment regimens, or who are not suitable for standard therapy at this stage;Papillary renal cell carcinoma;Metastatic or locally advanced unresectable gastric adenocarcinoma with at least first-line standard treatment;

Key exclusion criteria (24 listed)

Have received chemotherapy, radiotherapy, biological therapy, endocrine therapy, immune checkpoint inhibitor therapy and other anti-tumour treatments within 4 weeks prior to first dose of IMP, except for the following items:
Subjects was diagnosed as acute promyelocytic leukemia (APL), breakpoint cluster region-abelson (BCR-ABL)-positive leukemia (i.e., chronic myelogenous leukemia in blast crisis), active central nervous system leukemia, or AML secondary to prior chemotherapy for other neoplasms;
Have used nitrosourea or Mitomycin C within 6 weeks prior to first dose of IMP;
Have used oral fluorouracil and small molecule targeted drugs within 2 weeks or 5 half-lives of the drugs prior to first dose of IMP (whichever is longer);
Have received other unmarketed clinical study drugs or treatments within 4 weeks prior to first dose of IMP;

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
LM-061Also: Kinase inhibitorThe subjects in each dose level will be administered single oral dose of LM-061 tablet on C0D1, and washout for 5 days. After that, the subjects will be administered multiple oral doses once daily (QD) in continuous 28 days (4 weeks) per treatment cycle, until meet the treatment termination criteria, including disease progression or unaccepted toxicity, etc. After obtaining MTD/RP2D, the Safety Review Committee (SRC) may combine the data of safety, PK, and preliminary efficacy to explore other dosing schedules (such as 3 weeks on and 1 week off).	Drug	LM061 Dose Escalation Level 1, 2.5mg, LM061 Dose Escalation Level 2, 5mg, LM061 Dose Escalation Level 3, 10mg, LM061 Dose Escalation Level 4, 20mg, LM061 Dose Escalation Level 5, 30mg, LM061 Dose Escalation Level 6, 40mg, LM061 Dose Escalation Level 7, 60mg

Primary outcome

Number of participants with adverse events and serious adverse events
Time frame: From screening up to 1.5 year
The safety profile of LM061 will be assessed by monitoring the adverse events (AE) per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
Dose-limiting toxicities (DLT)
Time frame: Cycle 1 of each cohort. Duration of one cycle is 28 days
DLT is defined as a toxicity (adverse event at least possibly related to LM061) occurring during the DLT observation period (the initial 21 days)
Maximum tolerated dose (MTD)
Time frame: Cycle 1 of each cohort. Duration of one cycle is 28 days
MTD is defined as the dose for which the probability of DLT does not exceed the upper bound of the EI, 0.35, and is closest to the target toxicity probability p_T=0.3 during the DLT assessment period (from LM-061 single dose to the first treatment cycle of the multiple dose). The i3+3 design does not select a dose as the MTD unless at least 3 subjects have completed the safety assessment.
Change in Vital Signs-ear temperature
Time frame: Baseline (Week 0) through approximately 1 year after first administration of LM061
Change in vital signs-ear temperature will be measured after the subject has been fully rested.
Change in Vital Signs-pulse rate
Time frame: Baseline (Week 0) through approximately 1 year after first administration of LM061
Change in vital signs-pulse rate will be measured after the subject has been fully rested.
Change in Vital Signs-blood pressure
Time frame: Baseline (Week 0) through approximately 1 year after first administration of LM061
Change in vital signs-blood pressure will be measured after the subject has been fully rested.
Change in Electrocardiogram (ECG)-RR interval
Time frame: Baseline (Week 0) through approximately 1 year after first administration of LM061
RR interval of 12-lead ECG will be performed in the supine position after the patients are fully rested at each timepoint for once. RR is the standard heart rate which calculated by 60 divided by heart rate.
Change in Electrocardiogram (ECG)-QT interval
Time frame: Baseline (Week 0) through approximately 1 year after first administration of LM061
QT interval of 12-lead ECG will be performed in the supine position after the patients are fully rested at each timepoint for once.
Change in Electrocardiogram (ECG)-QRS duration
Time frame: Baseline (Week 0) through approximately 1 year after first administration of LM061
QRS duration of 12-lead ECG will be performed in the supine position after the patients are fully rested at each timepoint for once.
Incidence of Abnormal Clinical Laboratory Test Results-hematology
Time frame: Baseline (Week 0) through approximately 1 year after first administration of LM061
Number of participants with incidence of abnormal clinical lab test results like hematology will be assessed.
Incidence of Abnormal Clinical Laboratory Test Results-Biochemistry
Time frame: Baseline (Week 0) through approximately 1 year after first administration of LM061
Number of participants with incidence of abnormal clinical lab test results like Biochemistry will be assessed.
Incidence of Abnormal Clinical Laboratory Test Results-Urinalysis
Time frame: Baseline (Week 0) through approximately 1 year after first administration of LM061
Number of participants with incidence of abnormal clinical lab test results like Urinalysis will be assessed.
Incidence of Abnormal Clinical Laboratory Test Results-Coagulation test
Time frame: Baseline (Week 0) through approximately 1 year after first administration of LM061
Number of participants with incidence of abnormal clinical lab test results like Coagulation test will be assessed.

12 secondary outcomes

Area under the serum concentration versus time curve within one dosing interval (AUCtau)
Time frame: Up to 1.5year
Volume of distribution (Vd)
Time frame: Up to 1.5 year
Volume of distribution at steady state (Vss)
Time frame: Up to 1.5 year
Maximum serum concentration (Cmax)
Time frame: Up to 1.5 year
Trough concentration before the next dose is administered (Ctrough)
Time frame: Up to 1.5year
Time to reach maximum serum concentration (Tmax)
Time frame: Up to 1.5 year
Clearance (CL)
Time frame: Up to 1.5 year
Terminal half-life (T1/2)
Time frame: Up to 1.5 year
Dose proportionality
Time frame: Up to 1.5 year
Objective response rate (ORR)
Time frame: Up to 1.5 year
Best of response (BOR)
Time frame: Up to 1.5 year
Disease control rate (DCR)
Time frame: Up to 1.5 year

Results and safety

The study was stopped early (reason given: Not meeting expected endpoints). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2023.
Individual participant dataSharing planned: No

Related trials for Advanced Tumours

Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 3
A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)
Carcinoma, Renal Cell
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms

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 LM-061 in people with Advanced Tumours, run by LaNova Medicines Limited 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 11 inclusion and 24 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 27 Jul 2023. 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: Not meeting expected endpoints). 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?

Number of participants with adverse events and serious adverse events (time frame: From screening up to 1.5 year). The study lists 13 primary outcomes in all. 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 NCT04882176.

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 27 Jul 2023.