TCMCB07 for Cachexia

Recruiting at 11 trial locations

Overseen By Lynette Aleman, RN, BSN

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Endevica Bio

Must not be taking: THC, Glucocorticoids, Androgenics, others

Disqualifiers: Second line treatment, Weight loss, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

100 Participants Needed

Trial Summary

What is the purpose of this trial?

This is a randomized, double-blind, placebo-controlled study of B07, administered daily by subcutaneous (SC) injection, in up to 100 patients with newly diagnosed metastatic colorectal cancer. This study will evaluate different doses of B07 on weight, body composition and BMI in patients with sub-optimal BMIs (18 to ≤ 29 kg/m2). Treatment will begin on the same day as the start of cancer chemotherapy and continue during the first 28 days of cytotoxic therapy with a goal of preserving muscle and fat mass, relative to placebo control.

Do I need to stop my current medications to join the trial?

The trial does not specify if you need to stop your current medications. However, you cannot use new agents designed to affect weight, certain THC agents, or high-dose corticosteroids. Stable, low-dose corticosteroids are allowed.

What data supports the effectiveness of the drug TCMCB07 for treating cachexia?

TCMCB07 is a promising drug for cachexia because it can cross the blood-brain barrier, which is a major challenge for many treatments. It works by blocking the melanocortin-4 receptor (MC4R), which is involved in the process of cachexia, and has shown effectiveness in animal models. ^{1 2 3 4 5}

Is TCMCB07 safe for humans?

TCMCB07 has been shown to be safe in animal studies, including dogs, where it was well-tolerated at both low and high doses with no significant side effects, except for temporary darkening of the coat. ^{4 6 7 8 9}

Eligibility Criteria

This trial is for up to 100 patients with newly diagnosed metastatic colorectal cancer who have a BMI between 18 and ≤29 kg/m2. Participants will receive treatment alongside their first round of chemotherapy, aiming to preserve muscle and fat mass.

Inclusion Criteria

Fertile men and women must agree to use adequate contraception for the duration of the trial

I am 18 years old or older.

I can eat and digest food without issues.

Exclusion Criteria

I have had weight loss surgery, such as gastric stapling or bypass.

I am undergoing my second or later round of treatment for stage IV disease.

Nothing is stopping me from participating in the study.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive TCMCB07 or placebo daily by subcutaneous injection during the first 28 days of chemotherapy

4 weeks

Daily administration

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Regular clinic visits

Treatment Details

Interventions

• TCMCB07

Trial Overview The study tests TCMCB07, given daily by injection, against a placebo. It's randomized and double-blind, meaning neither the researchers nor participants know who gets the real drug or placebo. The focus is on how different doses affect weight and body composition.

Participant Groups

Group I: TCMCB07 50 mg administered subcutaneously daily for 28 days Experimental Treatment 1 Intervention

Group II: TCMCB07 25 mg administered subcutaneously daily for 28 days Experimental Treatment 1 Intervention

Group III: TCMCB07 12.5 mg administered subcutaneously daily for 28 days Experimental Treatment 1 Intervention

Group IV: Placebo Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Endevica Bio

Lead Sponsor

Trials

1

Recruited

80+

References

1. United States pubmed.ncbi.nlm.nih.gov

Cancer-Mediated Muscle Cachexia: Etiology and Clinical Management. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Appraisal of current and experimental approaches to the treatment of cachexia. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Emerging signaling mediators in the anorexia-cachexia syndrome of cancer. [2023]

4. Germany pubmed.ncbi.nlm.nih.gov

Characterization of the cellular transport mechanisms for the anti-cachexia candidate compound TCMCB07. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Cachexia: A systemic consequence of progressive, unresolved disease. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Melanocortin-4 receptor antagonist TCMCB07 ameliorates cancer- and chronic kidney disease-associated cachexia. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Safety of TCMCB07, a melanocortin-4 antagonist peptide, in dogs with naturally occurring cachexia. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Pharmacokinetics and safety of TCMCB07, a melanocortin-4 antagonist peptide in dogs. [2022]

9. Germany pubmed.ncbi.nlm.nih.gov

The orally active melanocortin-4 receptor antagonist BL-6020/979: a promising candidate for the treatment of cancer cachexia. [2021]