Advanced TumoursPhase 1NCT04737122

Study of LM-061 in Subjects in Advanced Tumors

A Phase 1 study testing LM-061 and Toripalimab in people with Advanced Tumours, run by LaNova Medicines Limited at 1 site in Australia.

Terminated

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

Official record

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Trial summary

This is a phase I, open-label, dose escalation 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 and Toripalimab
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 18 participants
Where: 1 siteAustralia
Study dates: 6 May 2021to 1 Dec 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

Volunteer to participate in clinical trial, 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: 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;
ECOG score 0-1;
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):

Show all 12Show fewer

Bone marrow reserve: Neutrophil count (NE#) ≥ 1.5×109/L, platelet count (PLT) ≥ 759 0 ×109/L; for patients with hematologic malignancies, platelet count ≥ 75 × 109/L, and 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;
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-tumor treatments within 4 weeks prior to first dose of IMP, except for the following items:
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 prior to first dose of IMP or 5 half-lives of the IMP (whichever is longer);
Have used herbal therapy with anti-tumor indications are within 2 weeks prior to first dose of IMP;
Have received other Non-approved clinical trial 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 trial period;

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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 3 for details);
The histopathological type of the tumor is head and neck or lung squamous cell carcinoma, or other tumors 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-tumor 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 tumor 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 3 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.
（Combination escalation levels only ) Known history of intolerable to any prior anti-PD-1/PD-L1 or CTLA-4 therapy;
(Combination escalation levels only) Known to take systemic corticosteroids (> 10 mg daily prednisone equivalents) or other systemic immunosuppressive medications (including, but not limited to, prednisone, dexamethasone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor agents) within 2 weeks prior to the first dosing of LM-061 and toripalimab. Usage of topical, ocular, intra-articular, intranasal, and inhalational corticosteroids is allowed;
(Combination escalation levels only) Have a known or suspected history of an autoimmune disorder;
(Combination escalation levels only) Have a history of primary immunodeficiency;
(Combination escalation levels only) Subjects from endemic area will be specifically screened for tuberculosis. Subjects with activetuberculosis are excluded;
(Combination escalation levels only) History of (non-infectious) pneumonitis that required corticosteroids or current pneumonitis, or history of interstitial lung disease.

Trial locations and contacts

1 site in 1 country.

Australia1 site

St George Private Hospital
Kogarah, New South Wales, 2217

Other trials in Australia

About this study

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

This is a phase I, open-label, dose escalation 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, open-label, dose escalation 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, Toripalimab

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
Oral dose with approximately 240 mL water in the fasting condition, and food will be forbidden 1 h prior to administration and 2h after dose. QD for continuous 28 days, and 4 weeks as one treatment cycle.
ToripalimabDrug
For subjects in combination escalation levels, toripalimab will be administered 240mg, IV, every 3 weeks

Study groups in NCT04737122
Study group	Role	What they receive
LM-061 single agent escalation	Experimental	The dose escalation scheme using the the accelerated titration design for dose 1 and the i3+3 design for the remaining doses. The subject in single agent dose levels will be administered multiple oral doses of LM-061 once daily. Receives: Drug: LM-061
LM-061 combination escalation	Experimental	The dose escalation scheme using the the accelerated titration design for dose 1 and the i3+3 design for the remaining doses. The subjects in combination dose levels will be administered multiple oral doses once daily of LM-061 and Toripalimab fixed dose injections every 3 weeks Receives: Drug: LM-061; Drug: Toripalimab

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 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
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-pluse rate
Change in vital signs-pluse 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)

7. 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 year
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 year
Volume of distribution at steady state (Vss)
To determine the pharmacokinetics (PK) profile of LM061
Measured: Up to 1 year
Maximum serum concentration (Cmax)
To determine the pharmacokinetics (PK) profile of LM061
Measured: Up to 1 year
Trough concentration before the next dose is administered (Ctrough)
To determine the pharmacokinetics (PK) profile of LM061
Measured: Up to 1 year
Time to reach maximum serum concentration (Tmax)
To determine the pharmacokinetics (PK) profile of LM061
Measured: Up to 1 year
Clearance (CL)
To determine the pharmacokinetics (PK) profile of LM061
Measured: Up to 1 year
Terminal half-life (T1/2)
To determine the pharmacokinetics (PK) profile of LM061
Measured: Up to 1 year
Dose proportionality
To determine the pharmacokinetics (PK) profile of LM061
Measured: Up to 1 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 year
Best of response (BOR)
To assess the preliminary antitumor activity of LM061
Measured: Up to 1 year
Disease control rate (DCR)
To assess the preliminary antitumor activity of LM061
Measured: Up to 1 year

Timeline

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

6 May 20211 Dec 2022

First posted3 Feb 2021
Study start6 May 2021
Primary completion19 Jul 2022
Study completion1 Dec 2022

Why it stopped: Failure to achieve expected outcomes

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
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Model description: Arm1: LM-061 single agent escalation Arm2: LM-061 combination escalation
Masking: None (open label)
Enrolment: 18 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04737122
Sponsor's protocol ID: LM061-01-102
Status last verified: Jan 2022
First submitted: 26 Nov 2020
Last updated: 10 Oct 2023
Results posted: No
Data monitoring committee: 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

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Study at a glance

From the registry record, last updated by the sponsor on 10 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase I, First-in-Human, Open-Label, Dose Escalation Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of LM-061 Tablet in Subjects With Advanced Tumors
ClinicalTrials.gov ID: NCT04737122
Acronym / sponsor ID: LM061-01-102
Conditions: Advanced Tumours
Phase: Phase 1
Study type: Interventional
Recruitment status: TerminatedReason stopped: Failure to achieve expected outcomes
Enrolment: 18 participants (actual)
Lead sponsor: LaNova Medicines LimitedIndustry (pharma, biotech, devices)
Study start: 6 May 2021 (actual)
Primary completion: 19 Jul 2022 (actual)
Study completion: 1 Dec 2022 (actual)
First posted: 3 Feb 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, open-label, dose escalation 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, open-label, dose escalation 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: 2
Model description: Arm1: LM-061 single agent escalation Arm2: LM-061 combination escalation

Arm	Type	Receives
LM-061 single agent escalation	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. The subject in single agent dose levels will be administered multiple oral doses of LM-061 once daily.
LM-061 combination escalation	Experimental	Drug: LM-061, Drug: ToripalimabThe dose escalation scheme using the the accelerated titration design for dose 1 and the i3+3 design for the remaining doses. The subjects in combination dose levels will be administered multiple oral doses once daily of LM-061 and Toripalimab fixed dose injections every 3 weeks

Who may qualify

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

Key inclusion criteria (12 listed)

Volunteer to participate in clinical trial, 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: 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;
ECOG score 0-1;
The estimated survival time is not less than 3 months;

Key exclusion criteria (36 listed)

Have received chemotherapy, radiotherapy, biological therapy, endocrine therapy, immune checkpoint inhibitor therapy and other anti-tumor treatments within 4 weeks prior to first dose of IMP, except for the following items:
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 prior to first dose of IMP or 5 half-lives of the IMP (whichever is longer);
Have used herbal therapy with anti-tumor indications are within 2 weeks prior to first dose of IMP;
Have received other Non-approved clinical trial 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 inhibitorOral dose with approximately 240 mL water in the fasting condition, and food will be forbidden 1 h prior to administration and 2h after dose. QD for continuous 28 days, and 4 weeks as one treatment cycle.	Drug	LM-061 combination escalation, LM-061 single agent escalation
ToripalimabFor subjects in combination escalation levels, toripalimab will be administered 240mg, IV, every 3 weeks	Drug	LM-061 combination escalation

Primary outcome

Number of participants with adverse events and serious adverse events
Time frame: : From screening up to 1 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)
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-pluse rate
Time frame: Baseline (Week 0) through approximately 1 year after first administration of LM061
Change in vital signs-pluse 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

7. Area under the serum concentration versus time curve within one dosing interval (AUCtau)
Time frame: Up to 1 year
Volume of distribution (Vd)
Time frame: Up to 1 year
Volume of distribution at steady state (Vss)
Time frame: Up to 1 year
Maximum serum concentration (Cmax)
Time frame: Up to 1 year
Trough concentration before the next dose is administered (Ctrough)
Time frame: Up to 1 year
Time to reach maximum serum concentration (Tmax)
Time frame: Up to 1 year
Clearance (CL)
Time frame: Up to 1 year
Terminal half-life (T1/2)
Time frame: Up to 1 year
Dose proportionality
Time frame: Up to 1 year
Objective response rate (ORR)
Time frame: Up to 1 year
Best of response (BOR)
Time frame: Up to 1 year
Disease control rate (DCR)
Time frame: Up to 1 year

Results and safety

The study was stopped early (reason given: Failure to achieve expected outcomes). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2023.
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.

Vinod Ganju principal investigator

Peninsula & South Eastern Hematology and Oncology group

Ganessan Kichenadasse principal investigator

Southern Oncology Clinical Research Unit

Paul De Souza principal investigator

St George Private Hospital

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 LM-061 and Toripalimab in people with Advanced Tumours, run by LaNova Medicines Limited at 1 site in Australia.

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 12 inclusion and 36 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 10 Oct 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 Australia. 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 was stopped early (reason given: Failure to achieve expected outcomes). 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 year). The study lists 12 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 NCT04737122.

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 2023.