Übersicht

Eignung

Details zum Design

Arme & Interventionen

Ergebnismessungen

Studienzentren

Quelle: NCT05934331

Rekrutiert

A LM-302 Combination With Other Anti-Tumor Therapies Phase ll Study

Interventionsstudie

Phase 2

Shanghai East Hospital

Sponsor: LaNova Medicines Zhejiang Co., Ltd.

Zuletzt aktualisiert: 12. September 2025
Hinweis - Die Informationen stammen aus öffentlichen Registern und spiegeln möglicherweise nicht die Echtzeitänderungen am lokalen Studienzentrum wider.

This study is to evaluate the efficacy of the LM-302 Combination With Other Therapies in patients with CLDN18.2-positive Advanced Digestive Tract Tumor.

Behandlungskategorie

Andere Medikamente, Checkpoint-Inhibitoren, Chemotherapie, Zielgerichtete Therapie

Erforderliche Mutationen

Keine

Studie gestartet

27. Juli 2023

Zuletzt vom Sponsor aktualisiert

12. September 2025

Voraussichtlicher Abschluss

1. Juli 2026

Studienkontakt

Name:Alex Yuan

E-Mail:AlexYuan@Lanovamed.com

Telefon:021-68889618

Name:Paul Kong

E-Mail:paulkong@lanovamed.com

Telefon:021-68889618

Eignung

Einschlusskriterien

1. Subjects who are willing to participate in the study and sign the informed consent form (ICF) prior to any procedure.

2. Aged 18-80 years old (including boundary values) .

3. Eastern Cooperative Oncology Group (ECOG) performance status of0-1.

4. Life expectancy ≥ 3 months.

5. Subjects with advanced gastrointestinal tumors diagnosed histologically and/or cytologically and who have failed or are intolerant to prior standard first-line therapy (imaging confirmation required)

6. CLDN18.2-positive subjects.

7. At least one measurable lesion.

8. Subjects must show appropriate organ and marrow function in laboratory examinations within 7 days prior to the first dose.

9. Subjects who are able to communicate well with investigators and understand and adhere to the requirements of this study.

Ausschlusskriterien

1. Subjects with known HER2-positive gastric cancer/adenocarcinoma of the gastroesophageal junction

2. Subjects have participated in any other clinical trial within 28 days prior to 1st dosing of investigational medicinal product (IMP).

3. Subjects with anti-tumor treatment within 21 days prior to 1st dosing of IMP.

4. Previous immunotherapy and grade ≥3 irAE or grade ≥2 immune-related myocarditis. (for cohorts treated with combination PD-1).

5. Any adverse event from prior anti-tumor therapy has not yet recovered to ≤ grade 1 of CTCAE v5.0.

6. Present peripheral sensory or motor neuropathy ≥ grade 2.

7. Subjects with uncontrolled pain.

8. Subjects with symptomatic/active central nervous system(CNS)metastases.

9. Subject who have uncontrollable third space effusion.

10. Subjects with known hypersensitivity to antibody therapy.

11. Subjects have treated with the same target.

12. Subjects have received Strong inhibitor/strong inducer of CYP3A4 within 14 days prior to first dose.

13. Use of any live vaccines within 28 days prior to 1st dosing of IMP.

14. Subjects with current or previous interstitial lung diseases or pneumonia requiring oral or intravenous glucocorticoids for adjuvant therapy.

15. Subjects on anticoagulants, such as heparin and vitamin K antagonists.

16. Clinically uncontrollable persistent recurrent vomiting.

17. Uncontrollable/severe gastrointestinal bleeding, ulceration or diarrhea within 28 days prior to first dose of IMP.

18. Subjects who received major surgery or interventional treatment within28 days prior to the first dosing of IMP.

19. Subjects who have other cancers, other than the one treated in this trial, within 2 years prior to screening.

20. Subjects who have severe cardiovascular disease.

21. Subjects who have uncontrolled or severe illness.

22. Subjects who take systemic corticosteroids (> 10 mg daily prednisone equivalents) or other systemic immunosuppressive medications within 2 weeks prior to the first dosing of IMP.

23. Subjects with a known history of autoimmune diseases.

24. Subjects who have a history of immunodeficiency disease.

25. Subjects with HIV infection, active HBV or HCV infection.

26. Child-bearing potential female who have positive results in pregnancy test within 7 days before the first dose or are lactating.

27. Subject who have a known psychiatric diseases or disorders that may affect compliance with the trial.

28. Subject who is judged as not eligible to participate in this study by the investigator.

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Design-Details

ZuteilungNon-Randomized

InterventionsmodellSequential Assignment

MaskierungNone (Open Label)

Anzahl der Teilnehmer276

Arme & Interventionen

Arme

Interventionen

Typ: Experimental

Beschreibung:

Interventionen:

LM-302
Toripalimab
Capecitabine
Tegafur, Gimeracil and Oteracil Potassium Capsules
Nivolumab
Apatinib
Gemcitabine

Ergebnismessungen

Primäre Ergebnismessungen

PFS112 weeks

Progression free survival according to the Response Evaluation Criteria in Solid Tumors (RECIST v1.1)

Sekundäre Ergebnismessungen

ORR112 weeks

Objective response rate (ORR)

DOR112 weeks

Duration of response (DOR)

DCR112 weeks

Disease control rate (DCR = CR + PR + SD)

OS112 weeks

Overall survival (OS)

AEs112 weeks

Incidence of adverse events

SAEs112 weeks

Incidence of serious adverse events

Temperatures112 weeks

Temperatures

Pulse in BPM112 weeks

Beat per Minute

Blood Pressure112 weeks

Blood Pressure in mmHg

Weight112 weeks

Weight in Kg

Height112 weeks

Height in centimeter

Blood Routine examination112 weeks

Laboratory tests-Blood Routine examination

Urine Routine test112 weeks

Laboratory tests-Urine Routine test

Blood biochemistry112 weeks

Laboratory tests-Blood biochemistry

Coagulation function112 weeks

Laboratory tests- Coagulation function

LVEF112 weeks

Echocardiography- LVEF(Left Ventricular Ejection Fraction) in percentage

HR112 weeks

12-lead electrocardiogram (ECG) in HR

RR112 weeks

12-lead electrocardiogram (ECG) in RR

PR112 weeks

12-lead electrocardiogram (ECG) in PR

QRS112 weeks

12-lead electrocardiogram (ECG) in QRS

QT112 weeks

12-lead electrocardiogram (ECG) in QT

QTcF112 weeks

12-lead electrocardiogram (ECG) in QTcF

ECOG score112 weeks

Eastern Cooperative Oncology Group score

PK Parameter:Cmax112 weeks

Pharmacokinetic (PK) Parameter: Maximum Observed Concentration (Cmax)

PK Parameter：Tmax112 weeks

PK Parameter:Time of Maximum Observed Concentration (Tmax)

PK Parameter: AUC112 weeks

PK Parameter: Area Under the Concentration-time Curve(AUC)

PK Parameter: Cmax,ss112 weeks

PK Parameter: Steady State Maximum Concentration(Cmax,ss)

PK Parameter: Cmin,ss112 weeks

PK Parameter: Steady State Minimum Concentration(Cmin,ss)

PK Parameter: CLss112 weeks

PK Parameter: Systemic Clearance at Steady State (CLss)

PK Parameter:Rac112 weeks

PK Parameter: Accumulation Ratio (Rac)

PK Parameter: t1/2112 weeks

PK Parameter: Elimination Half-life (t1/2)

PK Parameter: Vss112 weeks

PK Parameter: Volume of Distribution at Steady-State (Vss)

PK Parameter: DF112 weeks

PK Parameter: Degree of Fluctuation (DF)

Immunogenicity of LM-302112 weeks

Anti-Drug antibody and Nab (if neccessary) will be tested.

Biomarker correlation112 weeks

For the detection of CLDN18.2 and PD-L1

AE/SAE112 weeks

Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

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Studienzentren

Diese Studie hat 1 Studienzentrum

Shanghai East Hospital

Shanghai, CN

Name:Jin Li

Rekrutierend

Shanghai, CN

Shanghai East Hospital

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