2023-07-27
2025-07-01
2026-01-01
276
NCT05934331
LaNova Medicines Limited
LaNova Medicines Limited
INTERVENTIONAL
A LM-302 Combined With Toripalimab Phase II Study
A Phase II, Open-Label, Multicenter Study Evaluating the Efficacy, Safety, and Tolerability of LM-302 Combined With Toripalimab in CLDN18.2 Positive Patients advanced gastro-Intestinal Cancer
Primary Objective: To evaluate the efficacy of the LM-302 + Toripalimab regimen in subjects with CLDN18.2-positive advanced gastro-Intestinal cancer Secondary Objectives: To evaluate the correlation between CLDN18.2 and PD-L1 expression levels and the antitumor activity of the LM-302 + Toripalimab regimen.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2023-06-19 | N/A | 2023-10-04 |
2023-06-28 | N/A | 2023-10-06 |
2023-07-06 | N/A | 2023-10 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
Na
Interventional Model:
Sequential
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| EXPERIMENTAL: LM-302 in combination with Toripalimab LM-302 (recombinant humanized anti-CLDN18.2 monoclonal antibody, MMAE conjugate), Toripalimab(recombinant humanized anti-PD1 monoclonal antibody) | DRUG: LM302+Toripalimab
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| PFS | Progression free survival according to the Response Evaluation Criteria in Solid Tumors (RECIST v1.1) | up to 6 weeks following first dose. |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| ORR | Objective response rate (ORR) | up to 6 weeks following first dose. |
| DOR | Duration of response (DOR) | up to 6 weeks following first dose. |
| DCR | Disease control rate (DCR = CR + PR + SD) | up to 6 weeks following first dose. |
| OS | Overall survival (OS) | up to 6 weeks following first dose. |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
|
Study Contact Name: Ginny Zhang Phone Number: 021-68889618 Email: ginnyzhang@lanovamed.com |
Study Contact Backup Name: Paul Kong Phone Number: 021-68889618 Email: paulkong@lanovamed.com |
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
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