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Immunotoxin

Mesothelin Expression for Neoplasms

Phase 1

Waitlist Available

Led By Christine C Alewine, M.D.

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up pre-administration, end-of-infusion, then 1, 2, 4, 8-10, 12-16 hours post- lmb-100 during cycle 1 (each cycle = 21 days)

Awards & highlights

Study Summary

This trial is testing a combination of drugs to see if they are safe and effective for people with solid tumors that make the protein mesothelin.

Eligible Conditions

Mesothelin-Expressing Neoplasms
Pancreatic Adenocarcinoma
Epithelioid Mesothelioma
Bile Duct Cancer

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ pre-administration, end-of-infusion, then 1, 2, 4, 8-10, 12-16 hours post- lmb-100 during cycle 1 (each cycle = 21 days)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~pre-administration, end-of-infusion, then 1, 2, 4, 8-10, 12-16 hours post- lmb-100 during cycle 1 (each cycle = 21 days)

This trial's timeline: 3 weeks for screening, Varies for treatment, and pre-administration, end-of-infusion, then 1, 2, 4, 8-10, 12-16 hours post- lmb-100 during cycle 1 (each cycle = 21 days) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Maximum Tolerated Dose (MTD) of LMB-100 With Tofacitinib

Number of Participants With Serious Adverse Events Possibly, Probably, and/or Definitely Related to LMB-100 Treated in the Dose Escalation Group

Percentage of Participants With Pancreatobiliary Cancer and LMB-100 Plasma Drug Levels Above Threshold 600ng/mL During Cycle 2 Who Received LMB-100 at Maximum Tolerated Dose

Secondary outcome measures

Area Under the Plasma Concentration vs. Time Curve Extrapolated to Infinity (AUC(INF)) of LMB-100

Maximum Observed (Peak) Plasma Concentration (Cmax) of LMB-100

Number of Participants With Serious Adverse Events Possibly, Probably, and/or Definitely Related to LMB-100 Who Have Pancreatobiliary Cancer

+3 more

Other outcome measures

Number of Participants With Serious and/or Non-serious Adverse Events Regardless of Attribution Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0).

Number of Participants With a Dose-Limiting Toxicity (DLT)

Trial Design

2Treatment groups

Experimental Treatment

Group I: 2. Dose expansionExperimental Treatment2 Interventions

LMB-100 at optimal dose plus tofacitinib

Group II: 1. Dose escalationExperimental Treatment3 Interventions

LMB-100 at escalating doses plus tofacitinib

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Mesothelin Expression

2019

Completed Phase 2

~60

Tofacitinib

2018

Completed Phase 3

~39970

LMB-100

2019

Completed Phase 2

~80

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,657 Previous Clinical Trials

40,933,648 Total Patients Enrolled

1,358 Trials studying Neoplasms

5,192,353 Patients Enrolled for Neoplasms

Christine C Alewine, M.D.Principal InvestigatorNational Cancer Institute (NCI)

3 Previous Clinical Trials

115 Total Patients Enrolled

1 Trials studying Neoplasms

40 Patients Enrolled for Neoplasms

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research program still open to new participants?

"Clinicaltrials.gov confirms that, as of the last edit on January 18th 2022, this clinical trial is not enlisting new participants. Despite no longer recruiting patients for this study, 1135 other trials remain open to potential candidates across all specialties."

Answered by AI

How many participants is the clinical trial aiming to enroll?

"This research endeavour is no longer actively enlisting participants. It first appeared on August 29th 2019 and its entry was revised lastly on January 18th 2022. If you are searching for other clinical studies, there are currently 1101 trials recruiting patients with adenocarcinoma and 34 investigations seeking individuals expressing Mesothelin that need volunteers."

Answered by AI

Has the FDA sanctioned Mesothelin Expression as a viable treatment?

"Since it is still early in the research process, with limited data to support safety and efficacy, Mesothelin Expression was rated a 1 on our assessment scale."

Answered by AI

Have any other investigations explored Mesothelin Expression?

"Currently, 34 live clinical trials are studying Mesothelin Expression with seven of them in Phase 3. Of those studies, the majority is based out of Shanghai but there are 662 sites recruiting patients for this therapeutic approach worldwide."

Answered by AI

What are the desired end results of this experiment?

"This assessment is foremost judging the number of participants with serious adverse reactions related to LMB-100 treatment. Auxiliary objectives involve measuring Area Under Curve (AUC) Extrapolated to Infinity, Percentage without Delayed Neutralizing Anti-drug Antibodies formation, and Plasma Half-Life for the drug over a 21 day Cycle 2 period."

Answered by AI

How is Mesothelin Expression commonly utilized in therapeutic treatments?

"Juvenile arthritis is most effectively managed with Mesothelin Expression. Additionally, patients who are intolerant to methotrexate and those that have had an inadequate response to conventional therapy can benefit from this treatment."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Mesothelin-Targeted Immunotoxin LMB-100 in Combination With Tofacitinib in Persons With Previously Treated Pancreatic Adenocarcinoma, Cholangiocarcinoma and Other Mesothelin Expressing Solid Tumors

Christine Alewine, M.D. 2019. "Mesothelin-Targeted Immunotoxin LMB-100 in Combination With Tofacitinib in Persons With Previously Treated Pancreatic Adenocarcinoma, Cholangiocarcinoma and Other Mesothelin Expressing Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04034238.