Advanced Solid TumorPhase 1/2NCT05255484
Study of LM-108 as a Single Agent or in Combination With Pembrolizumab in Subjects With Advanced Solid Tumours
A Phase 1/2 study testing LM-108 and An Anti-PD-1 Antibody in people with Advanced Solid Tumor, run by LaNova Medicines Limited at 6 sites in United States.
Trial summary
A Phase I/II, Open-Label, Dose Escalation and Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of LM-108 as a Single Agent or in Combination with Pembrolizumab in Advanced Solid Tumors Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumor
- What is being tested?
- LM-108 and An Anti-PD-1 Antibody
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 6 sitesUnited States
- Study dates
- 26 May 2022to 6 Oct 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- Histological or cytological confirmation of recurrent or refractory advanced solid tumours, and have progressed on standard therapy, or are intolerable for available standard therapy, or there is no available standard therapy.
- At least one measurable disease for expansion cohorts per Response Evaluation Criteria in Solid Tumours (RECIST) v1.1.
- Subjects must show appropriate organ and marrow function in laboratory examinations within 7 days prior to the first dose
Who cannot join
- Any adverse event from prior anti-tumour therapy has not yet recovered to ≤grade 1 of CTCAE v5.0
- Uncontrolled tumour-related pain
- Known central nervous system (CNS)
- Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures
- Use of inhaled corticosteroids
- Known history of autoimmune disease
Show all 14Show fewer
- Use of any live attenuated vaccines within 28 days
- Have severe cardiovascular disease
- Uncontrolled or severe illness
- History of immunodeficiency disease
- Active malignancies which are likely to require the treatment.
- Child-bearing potential female
- Have psychiatric illness or disorders
- Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Gabrail Cancer and Research Center
Canton, Ohio, 44718
The Christ Hospital
Cincinnati, Ohio, 45219
Mary Crowley Cancer Research
Dallas, Texas, 75230
Indiana University Melvin and Bren Simon Comprehensive Cancer Center
Indianapolis, Indiana, 46202
University of Oklahoma
Norman, Oklahoma, 73104
Ocala Oncology Center
Ocala, Florida, 34474
About this study
Official title: A Phase I/II, Open-Label, Dose Escalation and Expansion Study of LM-108 as a Single Agent or in Combination With Pembrolizumab in Advanced Solid Tumors
A Phase I/II, Open-Label, Dose Escalation and Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of LM-108 as a Single Agent or in Combination with Pembrolizumab in Advanced Solid Tumors
Read the detailed description
A Phase I/II, Open-Label, Dose Escalation and Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of LM-108 as a Single Agent or in Combination with Pembrolizumab in Advanced Solid 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 Solid Tumor
- Being tested
- LM-108, An Anti-PD-1 Antibody
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LM-108Drug
Administered intravenously
An Anti-PD-1 AntibodyDrug
Administered intravenously
| Study group | Role | What they receive |
|---|---|---|
| LM-108 Dose Escalation | Experimental | Drug: LM-108 Administered intravenously Receives: Drug: LM-108 |
| LM-108 Dose Expansion | Experimental | Drug: LM-108 Administered intravenously Receives: Drug: LM-108 |
| LM-108 Combination Dose Escalation | Experimental | Drug: LM-108 Administered intravenously Drug: An Anti-PD-1 Antibody Administered intravenously Receives: Drug: LM-108; Drug: An Anti-PD-1 Antibody |
| LM-108 Combination Dose Expansion | Experimental | Drug: LM-108 Administered intravenously Drug: An Anti-PD-1 Antibody Administered intravenously Receives: Drug: LM-108; Drug: An Anti-PD-1 Antibody |
What is being measured
The primary outcome is the main question the study is designed to answer.
AEs
Incidence of adverse events
Measured: 126 weeks
DLT
Incidence of dose-limiting toxicity (DLT)
Measured: 21 days
SAE
Incidence of serious adverse event
Measured: 126 weeks
Incidence of clinical significant in laboratory examinations
Incidence of clinical significant in laboratory examinations, including hematology, urinalysis, blood biochemistry, coagulation tests and thyroid function.
Measured: 126 weeks
Secondary outcomes (12)
Incidence of anti-drug antibodies to LM-108
Incidence of anti-drug antibodies to LM-108
Measured: 126 weeks
Cmax
Pharmacokinetic (PK) Parameter: Maximum Observed Concentration (Cmax) for LM-108
Measured: 126 weeks
Cmin
PK Parameter: Minimum Observed Concentration (Cmin) for LM-108
Measured: 126 weeks
Tmax
PK Parameter: Time of Maximum Observed Concentration (Tmax) for LM-108
Measured: 126 weeks
AUC
PK Parameter: Area Under the Concentration-time Curve (AUC) for LM-108
Measured: 126 weeks
Cmax,ss
PK Parameter: Steady State Maximum Concentration (Cmax,ss)
Measured: 126 weeks
Cmin, ss
PK Parameter: Steady State Minimum Concentration (Cmin, ss)
Measured: 126 weeks
CLss
PK Parameter: Systemic Clearance at Steady State (CLss)
Measured: 126 weeks
Rac
PK Parameter: Accumulation Ratio (Rac)
Measured: 126 weeks
t 1/2
PK Parameter: Elimination Half-life (t 1/2)
Measured: 126 weeks
Vss
PK Parameter: Volume of Distribution at Steady-State (Vss)
Measured: 126 weeks
DF
PK Parameter: Degree of Fluctuation (DF)
Measured: 126 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2022
- Study start26 May 2022
- Primary completion6 Oct 2023
- Study completion6 Oct 2023
Why it stopped: Completed primary objective.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorStudies 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
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- LaNova Medicines Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05255484
- Sponsor's protocol ID
- LM108-01-102
- Status last verified
- Oct 2023
- First submitted
- 14 Feb 2022
- Last updated
- 25 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II, Open-Label, Dose Escalation and Expansion Study of LM-108 as a Single Agent or in Combination With Pembrolizumab in Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT05255484
- Acronym / sponsor ID
- LM108-01-102
- Conditions
- Advanced Solid Tumor
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Completed primary objective.
- Enrolment
- 24 participants (actual)
- Lead sponsor
- LaNova Medicines LimitedIndustry (pharma, biotech, devices)
- Study start
- 26 May 2022 (actual)
- Primary completion
- 6 Oct 2023 (actual)
- Study completion
- 6 Oct 2023 (actual)
- First posted
- 24 Feb 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.
A Phase I/II, Open-Label, Dose Escalation and Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of LM-108 as a Single Agent or in Combination with Pembrolizumab in Advanced Solid Tumors
Detailed description
A Phase I/II, Open-Label, Dose Escalation and Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of LM-108 as a Single Agent or in Combination with Pembrolizumab in Advanced Solid 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).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| LM-108 Dose Escalation | Experimental | Drug: LM-108Drug: LM-108 Administered intravenously |
| LM-108 Dose Expansion | Experimental | Drug: LM-108Drug: LM-108 Administered intravenously |
| LM-108 Combination Dose Escalation | Experimental | Drug: LM-108, Drug: An Anti-PD-1 AntibodyDrug: LM-108 Administered intravenously Drug: An Anti-PD-1 Antibody Administered intravenously |
| LM-108 Combination Dose Expansion | Experimental | Drug: LM-108, Drug: An Anti-PD-1 AntibodyDrug: LM-108 Administered intravenously Drug: An Anti-PD-1 Antibody Administered intravenously |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- Histological or cytological confirmation of recurrent or refractory advanced solid tumours, and have progressed on standard therapy, or are intolerable for available standard therapy, or there is no available standard therapy.
- At least one measurable disease for expansion cohorts per Response Evaluation Criteria in Solid Tumours (RECIST) v1.1.
- Subjects must show appropriate organ and marrow function in laboratory examinations within 7 days prior to the first dose
Key exclusion criteria (14 listed)
- Any adverse event from prior anti-tumour therapy has not yet recovered to ≤grade 1 of CTCAE v5.0
- Uncontrolled tumour-related pain
- Known central nervous system (CNS)
- Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures
- Use of inhaled corticosteroids
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-108Administered intravenously | Drug | LM-108 Combination Dose Escalation, LM-108 Combination Dose Expansion, LM-108 Dose Escalation, LM-108 Dose Expansion |
| An Anti-PD-1 AntibodyAdministered intravenously | Drug | LM-108 Combination Dose Escalation, LM-108 Combination Dose Expansion |
Primary outcome
AEs
Time frame: 126 weeks
Incidence of adverse events
DLT
Time frame: 21 days
Incidence of dose-limiting toxicity (DLT)
SAE
Time frame: 126 weeks
Incidence of serious adverse event
Incidence of clinical significant in laboratory examinations
Time frame: 126 weeks
Incidence of clinical significant in laboratory examinations, including hematology, urinalysis, blood biochemistry, coagulation tests and thyroid function.
12 secondary outcomes
Incidence of anti-drug antibodies to LM-108
Time frame: 126 weeks
Cmax
Time frame: 126 weeks
Cmin
Time frame: 126 weeks
Tmax
Time frame: 126 weeks
AUC
Time frame: 126 weeks
Cmax,ss
Time frame: 126 weeks
Cmin, ss
Time frame: 126 weeks
CLss
Time frame: 126 weeks
Rac
Time frame: 126 weeks
t 1/2
Time frame: 126 weeks
Vss
Time frame: 126 weeks
DF
Time frame: 126 weeks
Results and safety
The study was stopped early (reason given: Completed primary objective.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 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.
The record lists no contact. Use the official record to reach the sponsor.
6 sites 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-108 and An Anti-PD-1 Antibody in people with Advanced Solid Tumor, run by LaNova Medicines Limited at 6 sites in United States.
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 4 inclusion and 14 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 25 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 6 sites in United States. 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: Completed primary objective.). 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?
AEs (time frame: 126 weeks). 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 25 Oct 2023; AzTrials last refreshed its copy on 6 Nov 2026.