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TCMCB07 for Cachexia

Phase 1
Recruiting
Led By Maria Bermudez, MD, CPI
Research Sponsored by Endevica Bio
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Body mass index 18.0 to 30.0 kg/m2 as measured at Screening or, if outside this range, considered not clinically significant by the investigator.
Weight ≥ 50 kg at Screening
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights

Study Summary

This trial will test whether the experimental drug TCMCB07 can help treat cancer cachexia, a syndrome that causes weight loss, anorexia, weakness, and anemia.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of participants with abnormal vital signs
Number of people with abnormal Electrocardiograms
Number of people with abnormal laboratory test results
+2 more
Secondary outcome measures
Area under the plasma concentration versus time curve (AUC)
Peak Plasma Concentration (Cmax)

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: TCMCB07Experimental Treatment1 Intervention
once daily subcutaneous injection
Group II: TCMCB07 Matching PlaceboPlacebo Group1 Intervention
once daily subcutaneous injection

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Endevica BioLead Sponsor
Maria Bermudez, MD, CPIPrincipal InvestigatorQuotient Sciences

Frequently Asked Questions

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

Is my profile suitable for participating in this research endeavor?

"Aspiring participants should possess cachexia and be between 18-55 years old to qualify for this medical trial. A total of 97 patients are needed in order to move forward with the study."

Answered by AI

What risks do patients face when taking TCMCB07?

"A lack of evidence for safety and efficacy implies that the score assigned to TCMCB07 by our team at Power is 1."

Answered by AI

What population is being examined in this clinical experiment?

"Affirmative. According to information on clinicaltrials.gov, this medical trial is still accepting applicants. It was initially posted on July 12th 2022 and the most recent update occurred on September 2nd 2022. 97 individuals need to be enrolled across a single site."

Answered by AI

Is it permissible for persons over the age of twenty to join this research endeavor?

"This trial is available for patients aged 18 to 55. Further, there are 3 trials specifically targeted at individuals younger than 18 and 23 additional studies dedicated to those over 65 years of age."

Answered by AI

Does this clinical investigation currently accept new participants?

"Affirmative. According to information on clinicaltrials.gov, this experimental protocol is currently looking for volunteers. It was published on the 12th of July 2022 and its most recent update occurred on the 2nd of September 2022 with 97 participants required at a single site."

Answered by AI
~38 spots leftby Feb 2025