TCMCB07 for Cachexia

Overseen By Chief Commercialization Officer

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Endevica Bio

Disqualifiers: Hypersensitivity, Covid-19, Abnormal labs, others

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new drug called TCMCB07, which might help treat cancer cachexia. Cancer cachexia causes weight loss, lack of appetite, weakness, and anemia, often seen in advanced cancer stages. The trial aims to determine if TCMCB07 is safe and how the body processes it. Healthy individuals with no serious allergies to certain substances and weighing at least 50 kg might be suitable for this trial. Participants will receive either the experimental drug or a placebo (inactive substance) through a daily injection.

As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding how it works in people.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinator or your doctor.

Is there any evidence suggesting that TCMCB07 is likely to be safe for humans?

Research has shown that TCMCB07, the new treatment being tested for cancer-related weight loss, has undergone thorough animal studies. In these studies, TCMCB07 proved safe and effective in reversing weight loss symptoms in rodents. Early results from a human study revealed that 40 participants completed the trial, which focused mainly on safety and tolerability. These findings suggest that TCMCB07 is generally well-tolerated in healthy individuals, but further research is needed to fully understand its safety in humans. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for cancer cachexia?

Researchers are excited about TCMCB07 because it offers a new approach with its daily subcutaneous injection method, which could enhance the convenience and adherence for patients compared to other treatments that might require less comfortable or more frequent administration. TCMCB07's unique formulation is being explored for its potential to provide effective results while ensuring safety and tolerability, which are crucial factors in early-stage trials. This treatment could represent a significant advancement in terms of ease of use and patient experience, setting it apart from existing therapies.

What evidence suggests that TCMCB07 might be an effective treatment for cancer cachexia?

Research shows that TCMCB07, which participants in this trial may receive, may help with cancer-related weight loss. Studies have found that TCMCB07 can boost appetite, leading to increased food consumption. It also helps stabilize body weight and preserves both fat and heart muscle, crucial for patients experiencing weight loss and weakness. The drug blocks a specific receptor in the body that affects appetite and weight. While early studies in healthy individuals focused on safety, TCMCB07 has been suggested to improve appetite and help maintain muscle and fat in cancer patients. ^{4 6 7 8 9}

Who Is on the Research Team?

Maria Bermudez, MD, CPI

Principal Investigator

Quotient Sciences

Are You a Good Fit for This Trial?

Inclusion Criteria

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 for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive once daily subcutaneous injections of TCMCB07 or placebo

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• TCMCB07

How Is the Trial Designed?

Group I: TCMCB07 Experimental Treatment 1 Intervention

once daily subcutaneous injection

Group II: Placebo Placebo Group 1 Intervention

once daily subcutaneous injection

Who Is Running the Clinical Trial?

Endevica Bio

Lead Sponsor

Trials

1

Recruited

80+

Published Research Related to This Trial

In a study involving 45 patients with mild-to-moderate chronic congestive heart failure, short-term oral dosing of mibefradil did not worsen cardiac function or clinical variables, indicating its safety in this population.

While 23.3% of patients taking mibefradil reported adverse events compared to 13.3% in the placebo group, the incidence of these events was not related to the dose, suggesting that mibefradil may be well-tolerated at various levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating the safety of mibefradil, a selective T-type calcium antagonist, in patients with chronic congestive heart failure. van der Vring, JA., Bernink, PJ., van der Wall, EE., et al.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7456235/

Melanocortin-4 receptor antagonist TCMCB07 ameliorates ... Our data demonstrate that both central and peripheral administration of TCMCB07 effectively stimulated appetite, leading to a remarkable increase in food intake ...

2. ascopubs.org ascopubs.org/doi/10.1200/JCO.2023.41.16_suppl.e15195

Preliminary data from the phase I study of TCMCB07, a ... Conclusions: CB07 was well tolerated by normal healthy volunteers. Though the Phase 1 study was not designed to study efficacy, a modest ...

3. jci.org jci.org/articles/view/181305

Melanocortin-4 receptor antagonist TCMCB07 alleviates ... Our results indicate that peripheral administration of TCMCB07 improved appetite, stabilized body weight, preserved fat and heart mass, and ...

4. biorxiv.org biorxiv.org/content/10.1101/2024.09.14.613069v1.full.pdf

Melanocortin-4 receptor antagonist TCMCB07 401. Our assessment of the effectiveness of TCMCB07 in reversing chemotherapy-induced. 402 adverse effects, including anorexia and weight loss, ...

5. targetedonc.com targetedonc.com/view/tcmcb07-enters-phase-2-for-weight-loss-in-stage-iv-colorectal-cancer

TCMCB07 Enters Phase 2 for Weight Loss in Stage IV ... In the study, TCMCB07 showed strong safety and efficacy, including improved appetite and preserved lean mass and fat mass. TCMCB07 also showed ...

6. cdn.caymanchem.com cdn.caymanchem.com/cdn/msds/41545m.pdf

Safety Data Sheet Safety Data Sheet acc. to OSHA HCS. Printing date 06/19/2024. Revision date 06/19/2024. Trade name: TCMCB07 (trifluoroacetate salt). (Contd ...

7. abmole.com abmole.com/literature/tcmcb07-msds.html?srsltid=AfmBOoofPkYah09QfXY28TybYLMPSb9ZKjaWyKa_0pEvIaDmSUVhvwWX

Material Safety Data Sheet of TCMCB07 Use full personal protective equipment. Avoid breathing vapors, mist, dust or gas. Ensure adequate ventilation. Evacuate personnel to safe areas. Refer to ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10658582/

Safety of TCMCB07, a melanocortin‐4 antagonist peptide, in ... The melanocortin 4 antagonist TCMCB07 is safe and effective in reversing cachexia caused by sepsis or cancer in rodents.

9. clinicaltrials.gov clinicaltrials.gov/study/NCT05529849

NCT05529849 | A Study to Assess the Safety, Tolerability ... This study tests TCMCB07 for cancer cachexia, assessing safety, tolerability, and pharmacokinetics in healthy subjects, with a placebo comparator.