Advanced Solid TumorPhase 2NCT07669415
A Study of LM-168 Combined With Other Anti-tumor Treatments in Participants With Advanced Solid Tumors
A Phase 2 study testing LM-168, Tislelizumab and Docetaxel injection in people with Advanced Solid Tumor, run by LaNova Medicines Limited at 1 site in China.
Trial summary
For Safety introduction phase，this study is to evaluate the safety and tolerability of LM-168 in combination with other anti-tumor treatment regimens in participants of advanced solid tumor trials, determine the maximum tolerated dose (MTD), and explore the recommended phase II dose (RP2D). 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-168, Tislelizumab and Docetaxel injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteChina
- Study dates
- 29 Jul 2026to 15 Dec 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants who are fully informed of the purpose, nature, method and possible adverse reactions of the study, and are willing to participate in the study and sign the informed consent document prior to any procedure.
- Aged ≥18 years old, male or female when sign the Informed consent form (ICF).
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1, and no deterioration within 2 weeks prior to the first dose.
- Life expectancy ≥ 3 months.
- In dose escalation stage, participants must have 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.
- In dose expansion stage, participants must have histological or cytological confirmation of selected advanced solid tumors.
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- Pre-treatment archived tumour tissue (within 5 years) or on treatment could be provided for biomarker analysis optionally.
- At least one measurable disease for expansion cohorts per Response Evaluation Criteria in Solid Tumours (RECIST) v1.1.
- Participants must show appropriate organ and marrow function in laboratory examinations within 7 days prior to the first dose.
- Participants who are able to communicate well with investigators and understand and adhere to the requirements of this study
Who cannot join
- Received any other investigational product or treatment within 28 days prior to the first dose of LM-168.
- Received anti-cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) agents, any other immunotherapy or oncology immune-oncology (IO) drugs within 28 days prior to the first dose of LM-168; or permanently discontinued prior immunotherapy due to immune-related adverse events (irAEs). All adverse events (AEs) from previous anti-tumor treatments have not fully resolved or resolved to Grade 1 prior to screening. Requirement for additional immunosuppressants (other than low-dose corticosteroids) to control irAEs.
- Received other anti-tumor treatments prior to the first dose of LM-168, as specified below:
- Received limited-field palliative radiotherapy within 14 days prior to the first dose (excluding radiotherapy solely for pain control of bone metastases).
- Received chemotherapy, small-molecule targeted agents (e.g., tyrosine kinase inhibitors) or hormonal therapies within 14 days prior to the first dose or within 5 half-lives of the respective agent (whichever is longer).
- Received biologic therapy or immunotherapy within 28 days prior to the first dose or within 5 half-lives of the respective agent (whichever is shorter).
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- Received traditional Chinese medicines with anti-tumor indications within 14 days prior to the first dose.
- Received nitrosoureas or mitomycin C within 42 days prior to the first dose.
- AEs from prior anti-tumor treatments have not recovered to Grade ≤ 1 per NCI CTCAE Version 6.0. Exceptions include: toxicities assessed by the Investigator to pose no safety risks (e.g., alopecia), long-term radiation-related toxicities with Grade ≤ 2, and hypothyroidism stabilized with hormonal replacement therapy.
- Uncontrolled tumor-related pain. Participants requiring analgesic treatment must have been on a stable analgesic dose prior to study entry.
- Known active brain metastases or leptomeningeal metastases.
- Uncontrolled pleural effusion, pericardial effusion or ascites requiring repeated drainage.
- Esophageal or gastric varices requiring immediate clinical intervention, or a history of variceal bleeding; except for participants with stable conditions confirmed by endoscopic evaluation within 3 months prior to the first study drug administration.
- History of hepatic encephalopathy, hepatorenal syndrome, or cirrhosis classified as Child-Pugh Class B or higher.
- Tumor invasion into adjacent vital organs (e.g., aorta, heart, pericardium, superior vena cava, trachea, esophagus, etc.), or at risk of developing esophagotracheal fistula or esophagopleural fistula.
- Active or prior history of inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis, chronic diarrhea).
- History of Grade ≥ 3 hypersensitivity reactions to monoclonal antibody-based therapies.
- Experienced Grade ≥ 3 irAEs during prior immunotherapy, or discontinued prior immunotherapy due to severe or life-threatening irAEs.
- Received systemic corticosteroids (prednisone equivalent > 10 mg daily) or other systemic immunosuppressive agents (including but not limited to prednisone, dexamethasone, cyclophosphamide, azathioprine, methotrexate, thalidomide, anti-tumor necrosis factor agents) within 2 weeks prior to the first dose of LM-168. Topical, ophthalmic, intra-articular, intranasal and inhaled corticosteroids are permitted.
- Known history of autoimmune diseases, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, Guillain-Barré syndrome, multiple sclerosis and glomerulonephritis (see Appendix 3 for the complete list of autoimmune diseases). Exception: participants with autoimmune hypothyroidism maintained on a stable dose of thyroid replacement hormones.
- History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, idiopathic pneumonia, interstitial lung disease or severe radiation pneumonitis; or evidence of active pneumonia on chest CT scan during the screening period.
- Received any live vaccine within 28 days prior to the first dose.
- Underwent major surgery or interventional procedures within 28 days prior to the first dose of LM-168 (excluding tumor biopsy, puncture and other minor procedures).
- Severe cardiovascular and cerebrovascular diseases,
- Uncontrolled or severe concomitant diseases, including ongoing or active infections (e.g., active COVID-19/SARS-CoV-2 infection, syphilis) requiring therapeutic antibiotics and/or other medications. SARS-CoV-2 testing is not mandatory for study enrollment but shall comply with local clinical practice guidelines and standards.
- History of immunodeficiency disorders, including other acquired or congenital immunodeficiencies; or history of solid organ transplantation, allogeneic bone marrow transplantation or autologous hematopoietic stem cell transplantation.
- Human Immunodeficiency Virus (HIV) infection, or active hepatitis infection (including tuberculosis, Hepatitis B Virus [HBV] and Hepatitis C Virus [HCV] infection),
- History of other malignancies within 5 years prior to the first study drug administration. Exceptions include cured cutaneous squamous cell carcinoma, basal cell carcinoma, non-muscle invasive bladder cancer, localized low-risk prostate cancer (defined as Stage ≤ T2a, Gleason score ≤ 6, curatively treated at diagnosis with no biochemical recurrence of prostate-specific antigen [PSA; PSA ≤ 10 ng/mL if tested]), carcinoma in situ of cervix or breast, and other malignancies deemed appropriate for study participation by the Investigator.
- Females of childbearing potential with a positive pregnancy test or who are breastfeeding.
- Psychiatric illnesses or disorders that may interfere with study compliance.
- Any other conditions that render the participants unsuitable for study participation, as determined by the Investigator.
- Exclusion Criteria for the Combination cohort with Docetaxel
- Prior exposure to taxane-based therapies.
- Received strong CYP3A4 inhibitors or strong CYP3A4 inducers within 14 days prior to the first dose (see Appendix 5).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking University Cancer Hospital
Beijing, Beijing Municipality, 201210
ting lu, 010-88225151, luting_1010@163.com
lin shen
About this study
Official title: A Phase II，Open Label,Multicenter Study to Evaluate the Efficacy,Safety,and Tolerability of LM-168 Combined With Other Anti-tumor Therapies in Participants With Advanced Solid Tumor Trials
For Safety introduction phase，this study is to evaluate the safety and tolerability of LM-168 in combination with other anti-tumor treatment regimens in participants of advanced solid tumor trials, determine the maximum tolerated dose (MTD), and explore the recommended phase II dose (RP2D).
For Dose expansion phase，this study is to evaluate the preliminary antitumor activity of LM-168 in combination with other antitumor treatment regimens in participants of advanced solid tumor trials, measured by objective response rate (ORR)
- Conditions
- Advanced Solid Tumor
- Being tested
- LM-168, Tislelizumab, Docetaxel injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LM-168Drug
Q3W,Intravenous Drip
TislelizumabDrug
Q3W,Intravenous Drip
Docetaxel injectionDrug
Q3W,Intravenous Drip
| Study group | Role | What they receive |
|---|---|---|
| LM-168 + Tislelizumab Safety introduction | Experimental | Not described Receives: Drug: LM-168; Drug: Tislelizumab |
| LM-168 Dose Expansion | Experimental | Not described Receives: Drug: LM-168 |
| LM-168 + Tislelizumab Dose Expansion | Experimental | Not described Receives: Drug: LM-168; Drug: Tislelizumab |
| LM-168 + Tislelizumab +Other anti-tumor treatments Dose Expansion | Experimental | Not described Receives: Drug: LM-168; Drug: Tislelizumab; Drug: Docetaxel injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of dose-limiting toxicity (DLT)
Safety introduction phase
Measured: 78 Weeks
Objective response rate (ORR)
Dose expansion phase
Measured: From start of treatment to date of documented disease progression, up to approximately 42 months
Secondary outcomes (19)
Duration of response (DoR)
Dose expansion phase
Measured: Time from initial response (CR or PR) to date of documented disease progression or death (due to any cause) whichever occurs first, up to approximately 42 months
Disease control rate (DCR)
Dose expansion phase
Measured: From start of treatment to date of documented disease progression, up to approximately 42 months
Progression Free Survival (PFS)
Dose expansion phase
Measured: up to 42 months
Overall Survival (OS)
Dose expansion phase
Measured: up to 42 months
AE and SAE
Safety introduction phase/Dose expansion phase
Measured: From signing the ICF until 28 days after EOT or accept other anti-cancer therapy,up to 40 days after last study dose
Pharmacokinetic (PK) Parameter: Area Under the Concentration-time Curve from time zero to the last quantifiable concentration (AUC last)
safety introduction phase/Dose expansion phase
Measured: up to 42 months
Pharmacokinetic (PK) Parameter：Area Under the Concentration-time Curve over a dosing interval (τ) at steady state(AUC tau)
safety introduction phase/Dose expansion phase
Measured: up to 42 months
Pharmacokinetic (PK) Parameter：Maximum Observed Concentration(Cmax)
safety introduction phase/Dose expansion phase
Measured: up to 42 months
Pharmacokinetic (PK) Parameter：Time to Reach Maximum Concentration(Tmax)
safety introduction phase/Dose expansion phase
Measured: up to 42 months
Pharmacokinetic (PK) Parameter：Elimination Half-life(T 1/2)
safety introduction phase/Dose expansion phase
Measured: up to 42 months
Pharmacokinetic (PK) Parameter：Maximum Steady-State Concentration(Cmax, ss)
safety introduction phase/Dose expansion phase
Measured: up to 42 months
Pharmacokinetic (PK) Parameter：Minimum Steady-State Concentration(Cmin, ss)
safety introduction phase/Dose expansion phase
Measured: up to 42 months
Pharmacokinetic (PK) Parameter：Clearance at Steady State(CLss)
safety introduction phase/Dose expansion phase
Measured: up to 42 months
Pharmacokinetic (PK) Parameter：Volume of Distribution at Steady State(Vss)
safety introduction phase/Dose expansion phase
Measured: up to 42 months
Pharmacokinetic (PK) Parameter：Accumulation Ratio based on AUC(Rac, AUC)
safety introduction phase/Dose expansion phase
Measured: up to 42 months
Pharmacokinetic (PK) Parameter：Accumulation Ratio based on Cmax(Rac, Cmax)
safety introduction phase/Dose expansion phase
Measured: up to 42 months
Pharmacokinetic (PK) Parameter：Fluctuation Index / Degree of Fluctuation
safety introduction phase/Dose expansion phase
Measured: up to 42 months
immunogenicity Parameter:Anti-Drug Antibody(ADA)
safety introduction phase/Dose expansion phase
Measured: up to 42 months
immunogenicity Parameter:Neutralizing Antibody(Nab)
safety introduction phase/Dose expansion phase
Measured: up to 42 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2026
- Study start29 Jul 2026
- Primary completion15 Dec 2027 (estimated)
- Study completion15 Dec 2028 (estimated)
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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- LaNova Medicines Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- lin shen, Principal investigator, Peking University Cancer Hospital & Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07669415
- Sponsor's protocol ID
- LM168-02-201
- Status last verified
- Jul 2026
- First submitted
- 10 Jun 2026
- Last updated
- 30 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II，Open Label,Multicenter Study to Evaluate the Efficacy,Safety,and Tolerability of LM-168 Combined With Other Anti-tumor Therapies in Participants With Advanced Solid Tumor Trials
- ClinicalTrials.gov ID
- NCT07669415
- Acronym / sponsor ID
- LM168-02-201
- Conditions
- Advanced Solid Tumor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- LaNova Medicines LimitedIndustry (pharma, biotech, devices)
- Study start
- 29 Jul 2026 (actual)
- Primary completion
- 15 Dec 2027 (estimated)
- Study completion
- 15 Dec 2028 (estimated)
- First posted
- 25 Jun 2026 (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.
For Safety introduction phase，this study is to evaluate the safety and tolerability of LM-168 in combination with other anti-tumor treatment regimens in participants of advanced solid tumor trials, determine the maximum tolerated dose (MTD), and explore the recommended phase II dose (RP2D).
For Dose expansion phase，this study is to evaluate the preliminary antitumor activity of LM-168 in combination with other antitumor treatment regimens in participants of advanced solid tumor trials, measured by objective response rate (ORR)
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| LM-168 + Tislelizumab Safety introduction | Experimental | Drug: LM-168, Drug: Tislelizumab |
| LM-168 Dose Expansion | Experimental | Drug: LM-168 |
| LM-168 + Tislelizumab Dose Expansion | Experimental | Drug: LM-168, Drug: Tislelizumab |
| LM-168 + Tislelizumab +Other anti-tumor treatments Dose Expansion | Experimental | Drug: LM-168, Drug: Tislelizumab, Drug: Docetaxel injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Participants who are fully informed of the purpose, nature, method and possible adverse reactions of the study, and are willing to participate in the study and sign the informed consent document prior to any procedure.
- Aged ≥18 years old, male or female when sign the Informed consent form (ICF).
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1, and no deterioration within 2 weeks prior to the first dose.
- Life expectancy ≥ 3 months.
- In dose escalation stage, participants must have 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.
Key exclusion criteria (34 listed)
- Received any other investigational product or treatment within 28 days prior to the first dose of LM-168.
- Received anti-cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) agents, any other immunotherapy or oncology immune-oncology (IO) drugs within 28 days prior to the first dose of LM-168; or permanently discontinued prior immunotherapy due to immune-related adverse events (irAEs). All adverse events (AEs) from previous anti-tumor treatments have not fully resolved or resolved to Grade 1 prior to screening. Requirement for additional immunosuppressants (other than low-dose corticosteroids) to control irAEs.
- Received other anti-tumor treatments prior to the first dose of LM-168, as specified below:
- AEs from prior anti-tumor treatments have not recovered to Grade ≤ 1 per NCI CTCAE Version 6.0. Exceptions include: toxicities assessed by the Investigator to pose no safety risks (e.g., alopecia), long-term radiation-related toxicities with Grade ≤ 2, and hypothyroidism stabilized with hormonal replacement therapy.
- Uncontrolled tumor-related pain. Participants requiring analgesic treatment must have been on a stable analgesic dose prior to study entry.
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-168Q3W,Intravenous Drip | Drug | LM-168 + Tislelizumab +Other anti-tumor treatments Dose Expansion, LM-168 + Tislelizumab Dose Expansion, LM-168 + Tislelizumab Safety introduction, LM-168 Dose Expansion |
| TislelizumabQ3W,Intravenous Drip | Drug | LM-168 + Tislelizumab +Other anti-tumor treatments Dose Expansion, LM-168 + Tislelizumab Dose Expansion, LM-168 + Tislelizumab Safety introduction |
| Docetaxel injectionQ3W,Intravenous Drip | Drug | LM-168 + Tislelizumab +Other anti-tumor treatments Dose Expansion |
Primary outcome
Incidence of dose-limiting toxicity (DLT)
Time frame: 78 Weeks
Safety introduction phase
Objective response rate (ORR)
Time frame: From start of treatment to date of documented disease progression, up to approximately 42 months
Dose expansion phase
19 secondary outcomes
Duration of response (DoR)
Time frame: Time from initial response (CR or PR) to date of documented disease progression or death (due to any cause) whichever occurs first, up to approximately 42 months
Disease control rate (DCR)
Time frame: From start of treatment to date of documented disease progression, up to approximately 42 months
Progression Free Survival (PFS)
Time frame: up to 42 months
Overall Survival (OS)
Time frame: up to 42 months
AE and SAE
Time frame: From signing the ICF until 28 days after EOT or accept other anti-cancer therapy,up to 40 days after last study dose
Pharmacokinetic (PK) Parameter: Area Under the Concentration-time Curve from time zero to the last quantifiable concentration (AUC last)
Time frame: up to 42 months
Pharmacokinetic (PK) Parameter：Area Under the Concentration-time Curve over a dosing interval (τ) at steady state(AUC tau)
Time frame: up to 42 months
Pharmacokinetic (PK) Parameter：Maximum Observed Concentration(Cmax)
Time frame: up to 42 months
Pharmacokinetic (PK) Parameter：Time to Reach Maximum Concentration(Tmax)
Time frame: up to 42 months
Pharmacokinetic (PK) Parameter：Elimination Half-life(T 1/2)
Time frame: up to 42 months
Pharmacokinetic (PK) Parameter：Maximum Steady-State Concentration(Cmax, ss)
Time frame: up to 42 months
Pharmacokinetic (PK) Parameter：Minimum Steady-State Concentration(Cmin, ss)
Time frame: up to 42 months
Pharmacokinetic (PK) Parameter：Clearance at Steady State(CLss)
Time frame: up to 42 months
Pharmacokinetic (PK) Parameter：Volume of Distribution at Steady State(Vss)
Time frame: up to 42 months
Pharmacokinetic (PK) Parameter：Accumulation Ratio based on AUC(Rac, AUC)
Time frame: up to 42 months
Pharmacokinetic (PK) Parameter：Accumulation Ratio based on Cmax(Rac, Cmax)
Time frame: up to 42 months
Pharmacokinetic (PK) Parameter：Fluctuation Index / Degree of Fluctuation
Time frame: up to 42 months
immunogenicity Parameter:Anti-Drug Antibody(ADA)
Time frame: up to 42 months
immunogenicity Parameter:Neutralizing Antibody(Nab)
Time frame: up to 42 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2026.
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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.
lin shen principal investigator
Peking University Cancer Hospital & Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing LM-168, Tislelizumab and Docetaxel injection in people with Advanced Solid Tumor, 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 10 inclusion and 34 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Jul 2026. 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 phase mean?
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact wei wang (021-68889618, weiwang@Lanovamed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of dose-limiting toxicity (DLT) (time frame: 78 Weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2026.