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Advanced Solid TumorPhase 1/2NCT05008445

Study of LM-102 in Patients With Advance Solid Tumors

A Phase 1/2 study testing LM-102 Injection and LM-102 Injection combined with SOC in people with Advanced Solid Tumor, run by LaNova Medicines Development Co., Ltd. at 1 site in China.

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 an open label Phase I/II trial of LM-102 injection, a recombinant humanized monoclonal antibody targeting Claudin 18.2 (CLDN18.2). It is being tested in advanced solid tumors including gastric cancer/gastroesophageal junction adenocarcinoma, Pancreatic Cancer, Biliary Tract Cancer, esophageal adenocarcinoma… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Advanced Solid Tumor
What is being tested?
LM-102 Injection and LM-102 Injection combined with SOC
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
11 participants
Where
1 siteChina
Study dates
6 Oct 2021to 28 Feb 2023
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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 75 years old, male or female when sign the Informed consent form (ICF);
  • Subjects who meet the criteria:
  • Phase I dose escalation:
  • Part Ia: Subjects have histological or cytological confirmation of recurrent or refractory advanced solid tumors, and are intolerable for available standard therapy, or there is no available standard therapy.
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  • Part Ib:Subjects have been histologically or cytologically confirmed advanced solid tumors and meet the criteria as follows: No previous systemic chemotherapy was given for the recurrent or metastatic disease or for the subjects who have received curative treatment (including neo-adjuvant or adjuvant chemotherapy /radiotherapy, etc.), the interval between recurrence and the last dose of previous anti-cancer treatment must be more than 6 months.
  • Phase II dose expansion: subjects with positive CLDN18.2 confirmed by central immunohistochemistry (IHC).
  • Part IIa: Subjects have histological or cytological confirmation of recurrent or refractory advanced solid tumors, and are intolerable for available standard therapy, or there is no available standard therapy.
  • Part IIb: Subjects have histological or cytological confirmation of advanced solid tumors and meet the criteria as follows: No previous systemic chemotherapy was given for the recurrent or metastatic disease, or for the subjects who have received curative treatment (including neo-adjuvant or adjuvant chemotherapy /radiotherapy, etc.), the interval between recurrence and the last dose of previous anti-cancer treatment must be more than 6 months;
  • At least one evaluable lesion for phase I and one measurable lesion for phase II according to RECIST v1.1;
  • ECOG score 0-1;
  • Life expectancy ≥ 3 months;
  • 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:
  • Child-bearing potential female who have positive results in pregnancy test or are lactating;
  • Subjects who known to be allergic to the similar products or any of its excipients;
  • Exposure to any IMP, or participate in any other clinical trial within 21 days prior to 1st dosing of LM-102;
  • Subjects with anti-tumor treatment within 28 days prior to 1st dosing of LM-302, including radiotherapy, chemotherapy, biotherapy, endocrine therapy and immunotherapy, etc.
  • Subjects who have received surgical or interventional treatment within 28 days prior to 1st dosing LM-102, with the exception for tumor biopsy, puncture, etc.;
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  • Subjects who have received the treatment targeting to CLDN18.2 or ADCs;
  • Use of any live vaccines (e.g., against infectious diseases such as influenza, varicella etc.) within 28 days prior to 1st dosing of LM-102;
  • 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 for preventive treatment at a stable dose);
  • Subjects with gastric outlet obstruction, persistent recurrent vomiting or uncontrolled/severe gastrointestinal hemorrhage, or ulcer within 28 days prior to 1st dosing;
  • Subjects who are unable to take the oral drugs, have the conditions that severely affect gastrointestinal absorption;
  • Subjects with known central nervous system (CNS) or meningeal metastasis;
  • Subjects who have uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures;
  • Subjects who have severe cardiovascular disease;
  • Any adverse event from prior anti-tumor therapy has not yet recovered to ≤ grade 1 of CTCAE v5.0;
  • Subjects with uncontrolled tumor-related pain.
  • 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;
  • Men and women who are unwilling to use appropriate contraceptive methods throughout the study period and for at least 6 months after the last use of LM-102;
  • Subjects who have psychiatric illness or social situations that would preclude study compliance;
  • Subjects who have another active malignancy which is likely to require treatment, and have the history of another malignancy within 2 years before the first dosing;
  • Subject who is determined as not eligible to participate in this study by the investigator.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Fudan Zhongshan Hospital

    Shanghai, Shanghai Municipality, Xuhui District

Other trials in China

About this study

Official title: A Phase I/II, Open-Label, Multiple Center Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity and Preliminary Efficacy of LM-102 Monotherapy or Combination Therapy in Patients With CLDN18.2-Positive Advanced Solid Tumors

This is an open label Phase I/II trial of LM-102 injection, a recombinant humanized monoclonal antibody targeting Claudin 18.2 (CLDN18.2). It is being tested in advanced solid tumors including gastric cancer/gastroesophageal junction adenocarcinoma, Pancreatic Cancer, Biliary Tract Cancer, esophageal adenocarcinoma and ovarian mucous carcinoma.

Read the detailed description

This study includes phase I dose escalation and phase II dose expansion.

Phase I dose escalation consists of LM-102 monotherapy dose escalation (Part Ia) and LM-102 combination dose escalation (Part Ib):

Part Ia is LM-102 monotherapy dose escalation, will be conducted among the subjects with recurrent or refractory advanced solid tumors to determine the RP2D of LM-102 monotherapy;Statistical designs include an initial accelerated titration at the first dose level followed by the i3+3 design at other four dose levels ; Part Ib is the dose escalation of LM-102 combined with SOC, will be conducted in the subjects with advanced gastric and gastroesophageal junction adenocarcinoma(GC/GEJ), pancreatic cancer (PC)and biliary tract carcinoma(BTC), respectively in first setting or second setting, to explore the recommended dose of LM-102 in combination SOC for dose expansion, 4 cohorts are planned;

Phase II dose expansion consists of LM-102 monotherapy dose escalation (Part IIa) and LM-102 combination dose escalation (Part IIb):

Part IIa is the dose expansion of LM-102 monotherapy, 3 cohorts are planned in the subjects with CLDN18.2 positive, recurrent or refractory advanced GC/GEJ , PC , BTC , to explore the preliminary efficacy of LM-102 monotherapy in the target tumor types； Part IIb is the dose expansion of LM-102 in combination with SOC, 4 cohorts are planned in the subjects with advanced, CLDN18.2 positive, treatment naïve GC/GEJ, PC, BTC, and in the subjects with GC/GEJ who have progressed on first line treatment, with the aim to to explore the preliminary efficacy of LM-102 monotherapy in the target tumor types;

Being tested
LM-102 Injection, LM-102 Injection combined with SOC

What participants receive

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

  • LM-102 InjectionBiological

    LM-102 Injection with dose escalation stage of 3mg/kg up to 40mg/kg, as well as dose expansion stage with recommended dose level from dose escalation stage.

  • LM-102 Injection combined with SOCCombination product

    LM-102 Injection with appropriate dose level(s), combined with SOC.

Study groups in NCT05008445
Study groupRoleWhat they receive
LM-102 Dose Escalation Level 1, 3mg/kgExperimentalThe dose escalation scheme using the the accelerated titration design for dose 1 and the i3+3 design for the remaining doses. first dose: 3mg/kg, Q3W;
Receives: Biological: LM-102 Injection
LM-102 Dose Escalation Level 2, 10mg/kgExperimentalThe dose escalation scheme using the the accelerated titration design for dose 1 and the i3+3 design for the remaining doses. Second dose: 10mg/kg, Q3W;
Receives: Biological: LM-102 Injection
LM-102 Dose Escalation Level 3, 20mg/kgExperimentalThe dose escalation scheme using the the accelerated titration design for dose 1 and the i3+3 design for the remaining doses. Third dose: 20mg/kg, Q3W;
Receives: Biological: LM-102 Injection
LM-102 Dose Escalation Level 4, 30mg/kgExperimentalThe dose escalation scheme using the the accelerated titration design for dose 1 and the i3+3 design for the remaining doses. Four dose: 30mg/kg, Q3W;
Receives: Biological: LM-102 Injection
LM-102 Dose Escalation Level 5, 40mg/kgExperimentalThe dose escalation scheme using the the accelerated titration design for dose 1 and the i3+3 design for the remaining doses. Five dose: 40mg/kg, Q3W;
Receives: Biological: LM-102 Injection
LM-102 (RP2D-1) combined with SOC Dose EscalationExperimentalDuring the dose escalation of LM-102 combined with SOC,the next lower dose groups (RP2D-1) of LM-102 monotherapy's RP2D will be adopted as the starting dose.
Receives: Combination Product: LM-102 Injection combined with SOC
LM-102 (RP2D) combined with SOC Dose EscalationExperimentalDuring the dose escalation of LM-102 combined with SOC,(If applicable) LM-102 monotherapy's RP2D will be adopted as the starting dose.
Receives: Combination Product: LM-102 Injection combined with SOC

What is being measured

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

  1. The incidence and case number of DLT (Dose Limiting Toxicity) during observation period

    DLT is short for Dose Limiting Toxicity. dose-limiting describes side effects of a drug or other treatment that are serious enough to prevent an increase in dose or level of that treatment.

    Measured: up to 21 days following first dose

  2. Participant Safety as characterized by frequency and severity of adverse events(according to NCI CTCAE 5.0)

    An AE is any untoward medical occurrence in a subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.

    Measured: up to 31 days following last dose or other anti-cancer therapy

  3. 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

  4. Maximum Tolerated Dose (MTD）

    The MTD is defined as the dose of which the toxicity rate is lower than the upper bound of EI p_T+ϵ_1= 0.35 and closest to the target toxicity rate of p_T= 0.3 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 (8)

  1. Area under plasma concentration vs time curve (AUC) for LM-102

    changes in AUC over time in participants with LM-102

    Measured: Up to finished circle 5 (each cycle is 21 days)

  2. Peak plasma concentration (Cmax) for LM-102

    Cmax is the maximum plasma concentration.

    Measured: Up to finished circle 5 (each cycle is 21 days)

  3. Time to maximum observed plasma concentration (Tmax)

    Tmax is the time in hrs/days it takes to reach Cmax after dosing with LM-102

    Measured: Up to finished circle 5 (each cycle is 21 days)

  4. Terminal elimination half life (t1/2)

    Time for the plasma level of LM-102 to decrease by 1/2 during the terminal elimination phase

    Measured: Up to finished circle 5 (each cycle is 21 days)

  5. Immunogenicity

    by measurement of Incidence of anti-drug antibodies (ADA)

    Measured: up to 31 days following last dose

  6. Disease Control Rate(DCR )

    as measured by RECIST v1.1

    Measured: through study completion, an average of 8 months.

  7. Duration of Response (DOR)

    as measured by RECIST v1.1

    Measured: through study completion, an average of 8 months.

  8. Progression free survival (PFS)

    as measured by RECIST v1.1

    Measured: through study completion, an average of 8 months.

Timeline

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

  1. First posted17 Aug 2021
  2. Study start6 Oct 2021
  3. Primary completion8 Feb 2023
  4. Study completion28 Feb 2023

Why it stopped: company adjusted strategy

Resources

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
11 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05008445
Sponsor's protocol ID
LM102-01-102
Status last verified
Mar 2023
First submitted
27 Jul 2021
Last updated
9 Mar 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing LM-102 Injection and LM-102 Injection combined with SOC in people with Advanced Solid Tumor, run by LaNova Medicines Development 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 15 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 9 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: company adjusted strategy). 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?

The incidence and case number of DLT (Dose Limiting Toxicity) during observation period (time frame: up to 21 days following first dose). 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?

On the ClinicalTrials.gov record for NCT05008445.

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 9 Mar 2023.

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