Advanced Solid TumorPhase 1/2NCT05161390
Study of LM-302 in Patients With Advance Solid Tumors
A Phase 1/2 study testing LM-302 Injection in people with Advanced Solid Tumor, run by LaNova Medicines Zhejiang Co., Ltd. at 1 site in China.
Trial summary
A Phase I/II Study of LM-302 in Patients with CLDN18.2-Positive Advanced Solid Tumors Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Advanced Solid Tumor
- What is being tested?
- LM-302 Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 153 participants
- Where
- 1 siteChina
- Study dates
- 26 Nov 2021to 10 Jan 2025
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects will be enrolled into the study only if they meet all of the following inclusion criteria:
- Subjects 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 between 18 to 80 years old, male or female when sign the Informed consent form (ICF);
- ECOG score 0-1;
- Life expectancy ≥ 3 months;
- Subjects have histological or cytological confirmation of advanced solid tumors, and are intolerable for available standard therapy, or there is no available standard therapy;
Show all 10Show fewer
- Claudin18.2(CLDN18.2) status will be tested by immunohistochemistry (IHC) by central lab, the result must be positive;
- At least one evaluable lesion for phase I and one measurable lesion for phase II according to RECIST v1.1;
- Subjects must have the following organ and marrow function in laboratory tests within 7 days prior to the first dose;
- Subjects who are able to well communicate with investigators as well as understand and adhere to the requirements of this study.
Who cannot join
- Subjects will be excluded from the study, if they meet any of the following criteria:
- Participate in any other clinical trial within 28 days prior to 1st dosing of LM-302;
- Subjects with anti-tumor treatment within 21 days prior to 1st dosing of LM-302, including radiotherapy, chemotherapy, biotherapy, endocrine therapy and immunotherapy, etc.
- Any adverse event from prior anti-tumor therapy has not yet recovered to ≤grade 1 of CTCAE v5.0;
- Peripheral sensory or motor neuropathy ≥ grade 2;
- Subjects with uncontrolled tumor-related pain;
Show all 27Show fewer
- Subjects with known central meningeal metastasis;
- Subjects with known brain metastasis, stable brain metastasis judged by investigator can be included;
- Subjects with uncontrolled third interstitial effusion judged by the investigator to be unsuitable for inclusion;
- Subjects with known antibody drug allergy ≥ grade 3;
- Subjects who have received the treatment with ADCs targeting to CLDN18.2;
- Subjects who were intolerable to the treatment with MMAE based ADCs or anti-CLDN18.2 antibodies are not eligible;
- Administrate strong inhibitors/strong inducers of CYP3A4 within 14 days prior to 1st dosing of LM-302;
- Use of any live vaccines within 28 days prior to 1st dosing of LM-302;
- Subjects with the history of interstitial lung disease or drug-induced interstitial lung disease/pneumonitis;
- Subjects who are taking therapeutic doses of anticoagulants such as heparin or vitamin K antagonists (except preventive treatment at a stable dose);
- Uncontrolled persistent and recurrent vomiting (e.g. due to gastric outlet obstruction);
- Subjects with uncontrolled/severe gastrointestinal hemorrhage, or ulcer within 28 days prior to 1st dosing of LM-302;
- Subjects who have received surgical or interventional treatment within 28 days prior to 1st dosing LM-302, with the exception for tumor biopsy,puncture, etc.;
- (Limited PhaseⅡ dose expansion)Subjects who have another active malignancy which is likely to require treatment, and have the history of another malignancy within 2 years before the 1st dosing LM-302;
- Subjects who have severe cardiovascular disease;
- Subjects who have uncontrolled or severe illness, including but not limited to ongoing or active infection requiring antibiotics administration;
- Subjects who have a history of immunodeficiency disease, including other acquired or congenital immunodeficiency diseases, or organ transplantation, or allogeneic bone marrow transplantation, or autologous hematopoietic stem cell transplantation;
- HIV infection, active HBV and HCV infection;
- Child-bearing potential female who have positive results in pregnancy test before the 1st dosing LM-302 or are lactating;
- Subjects who have psychiatric illness or social situations that would preclude study compliance;
- Subject who is determined as not eligible to participate in this study by the investigator.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I/II , Open, Multicentre, Dose-escalation and Expansion Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity and Antitumour Activity of LM-302 in Patients With CLDN18.2 Positive Advanced Solid Tumours
A Phase I/II Study of LM-302 in Patients with CLDN18.2-Positive Advanced Solid Tumors
Read the detailed description
A Phase I/II, First-in-Human, Open-Label, Dose Escalation and Expansion Study of LM-302 in Patients with CLDN18.2-Positive Advanced Solid Tumors The study includes phase I (dose escalation) to determine MTD/RP2D and phase II (dose expansion) to assess the preliminary anti-tumor activity, etc..
- Conditions
- Advanced Solid Tumor
- Being tested
- LM-302 Injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LM-302 InjectionDrug
LM-302 Injection with dose escalation stage of different dose levels, as well as dose expansion stage with recommended dose level from dose escalation stage.
| Study group | Role | What they receive |
|---|---|---|
| LM-302 Dose Escalation at different dose levels | Experimental | LM-302 Dose Escalation. 6 dose levels were pre-defined, and the initial accelerated titration followed by the i3+3 design was adopted during phase I. Receives: Drug: LM-302 Injection |
| LM-302(RP2D) Dose Expansion | Experimental | LM-302 Dose Expansion, RP2D will be selected for dose expansion, with the aim to further evaluate the preliminary anti-tumor activity, safety and tolerability, etc. Receives: Drug: LM-302 Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose limiting toxicity (DLT)
DLT is defined as a toxicity (adverse event at least possibly related to LM302) occurring during the DLT observation period
Measured: Cycle 1 of each cohort. Duration of one cycle is 21 days
Adverse Events and Serious Adverse Events
The safety profile of LM-302 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 signing the ICF until 28 days after EOT or accept other anti-cancer therapy
Recommended Phase II Dose (RP2D)
The RP2D will be determined during the dose expansion stage of the study. RP2D will be determined using available safety and efficacy data
Measured: up to 21 days following first dose
Maximum Tolerated Dose (MTD)
The MTD is defined as the dose of which the toxicity rate during the DLT observation period (21 days after the first administration in cycle 1 on day 1).
Measured: up to 21 days following first dose
Secondary outcomes (1)
Area under plasma concentration vs time curve (AUC) for LM-302
changes in AUC over time in participants with LM-302
Measured: Up to finished cycle 5 (each cycle is 21 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2021
- Study start26 Nov 2021
- Primary completion10 Jan 2025
- Study completion10 Jan 2025
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.
- 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
- 153 participants (actual)
Sponsor and investigators
- Lead sponsor
- LaNova Medicines Zhejiang Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jin Li, Principal investigator, Shanghai East HospitalWei Shen, Principal investigator, Xinhua Hospital, Shanghai Jiao Tong University School of MedicineYuping Sun, Principal investigator, Shandong Province Cancer HospitalYanqiao Zhang, Principal investigator, The Second Affiliated Hospital of Harbin Medical UniversityJianping Xiong, Principal investigator, The First Affiliated Hospital of Nanchang UniversityWenhui Lou, Principal investigator, Shanghai Zhongshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05161390
- Sponsor's protocol ID
- LM302-01-102
- Status last verified
- Sep 2025
- First submitted
- 5 Dec 2021
- Last updated
- 12 Sep 2025
- 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 12 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II , Open, Multicentre, Dose-escalation and Expansion Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity and Antitumour Activity of LM-302 in Patients With CLDN18.2 Positive Advanced Solid Tumours
- ClinicalTrials.gov ID
- NCT05161390
- Acronym / sponsor ID
- LM302-01-102
- Conditions
- Advanced Solid Tumor
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 153 participants (actual)
- Lead sponsor
- LaNova Medicines Zhejiang Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 26 Nov 2021 (actual)
- Primary completion
- 10 Jan 2025 (actual)
- Study completion
- 10 Jan 2025 (actual)
- First posted
- 17 Dec 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.
A Phase I/II Study of LM-302 in Patients with CLDN18.2-Positive Advanced Solid Tumors
Detailed description
A Phase I/II, First-in-Human, Open-Label, Dose Escalation and Expansion Study of LM-302 in Patients with CLDN18.2-Positive Advanced Solid Tumors The study includes phase I (dose escalation) to determine MTD/RP2D and phase II (dose expansion) to assess the preliminary anti-tumor activity, etc..
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LM-302 Dose Escalation at different dose levels | Experimental | Drug: LM-302 InjectionLM-302 Dose Escalation. 6 dose levels were pre-defined, and the initial accelerated titration followed by the i3+3 design was adopted during phase I. |
| LM-302(RP2D) Dose Expansion | Experimental | Drug: LM-302 InjectionLM-302 Dose Expansion, RP2D will be selected for dose expansion, with the aim to further evaluate the preliminary anti-tumor activity, safety and tolerability, etc. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Subjects will be enrolled into the study only if they meet all of the following inclusion criteria:
- Subjects 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 between 18 to 80 years old, male or female when sign the Informed consent form (ICF);
- ECOG score 0-1;
- Life expectancy ≥ 3 months;
Key exclusion criteria (27 listed)
- Participate in any other clinical trial within 28 days prior to 1st dosing of LM-302;
- Subjects with anti-tumor treatment within 21 days prior to 1st dosing of LM-302, including radiotherapy, chemotherapy, biotherapy, endocrine therapy and immunotherapy, etc.
- Any adverse event from prior anti-tumor therapy has not yet recovered to ≤grade 1 of CTCAE v5.0;
- Peripheral sensory or motor neuropathy ≥ grade 2;
- Subjects with uncontrolled tumor-related pain;
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-302 InjectionLM-302 Injection with dose escalation stage of different dose levels, as well as dose expansion stage with recommended dose level from dose escalation stage. | Drug | LM-302 Dose Escalation at different dose levels, LM-302(RP2D) Dose Expansion |
Primary outcome
Dose limiting toxicity (DLT)
Time frame: Cycle 1 of each cohort. Duration of one cycle is 21 days
DLT is defined as a toxicity (adverse event at least possibly related to LM302) occurring during the DLT observation period
Adverse Events and Serious Adverse Events
Time frame: From signing the ICF until 28 days after EOT or accept other anti-cancer therapy
The safety profile of LM-302 will be assessed by monitoring the adverse events (AE) per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
Recommended Phase II Dose (RP2D)
Time frame: up to 21 days following first dose
The RP2D will be determined during the dose expansion stage of the study. RP2D will be determined using available safety and efficacy data
Maximum Tolerated Dose (MTD)
Time frame: up to 21 days following first dose
The MTD is defined as the dose of which the toxicity rate during the DLT observation period (21 days after the first administration in cycle 1 on day 1).
1 secondary outcome
Area under plasma concentration vs time curve (AUC) for LM-302
Time frame: Up to finished cycle 5 (each cycle is 21 days)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2025.
Related trials for Advanced Solid Tumor
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 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
RecruitingPhase 1/2
A Study of Neladalkib (NVL-655) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ALK Rearrangement or Activating ALK Mutation (ALKOVE-1)
Locally Advanced Solid Tumor, Metastatic Solid Tumor
Active, not recruitingPhase 2
Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
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.
Jin Li principal investigator
Shanghai East Hospital
Wei Shen principal investigator
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Yuping Sun principal investigator
Shandong Province Cancer Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing LM-302 Injection in people with Advanced Solid Tumor, run by LaNova Medicines Zhejiang Co., Ltd. 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 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Sep 2025. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose limiting toxicity (DLT) (time frame: Cycle 1 of each cohort. Duration of one cycle is 21 days). 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 12 Sep 2025; AzTrials last refreshed its copy on 6 Nov 2026.