CompletedPhase 1/2

Study of LM-302 in Patients With Advance Solid Tumors

China153 participantsStarted 2021-11-26

Plain-language summary

A Phase I/II Study of LM-302 in Patients with CLDN18.2-Positive Advanced Solid Tumors

Age range18 Years – 80 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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;
✓. 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;

✕. 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;
✕. 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;

Dose limiting toxicity (DLT)

Timeframe: Cycle 1 of each cohort. Duration of one cycle is 21 days

Adverse Events and Serious Adverse Events

Timeframe: From signing the ICF until 28 days after EOT or accept other anti-cancer therapy

Recommended Phase II Dose (RP2D)

Timeframe: up to 21 days following first dose

Maximum Tolerated Dose (MTD)

Timeframe: up to 21 days following first dose

NCT IDNCT05161390

SponsorLaNova Medicines Zhejiang Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-01-10

Who can participate

Age range18 Years – 80 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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;
✓. 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;

✕. 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;
✕. 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;

What they're measuring

Dose limiting toxicity (DLT)

Timeframe: Cycle 1 of each cohort. Duration of one cycle is 21 days

Adverse Events and Serious Adverse Events

Timeframe: From signing the ICF until 28 days after EOT or accept other anti-cancer therapy

Recommended Phase II Dose (RP2D)

Timeframe: up to 21 days following first dose

Maximum Tolerated Dose (MTD)

Timeframe: up to 21 days following first dose