Primary Completion Date Change

Endevica's cachexia trial pushes primary readout to October 2027, third delay

The Phase 2 mifomelatide study has slipped its completion date three times since 2025, an 760-day cumulative delay, while enrollment target and design stay unchanged.

By AppliedXLJuly 15, 2026Trial NCT06937177

Executive Summary

Endevica Bio pushed back the primary completion date on its Phase 2 mifomelatide trial for the third time since the study began, extending the expected readout well beyond the original target.
The delay coincides with a mid-trial expansion of the study design to add a second tumor type, which lengthens the path to the readout independent of enrollment pace.
The enrollment target and core dosing design have not changed, so the delay reflects protocol and scope changes rather than a struggle to recruit patients.
When it reads out, the trial will show whether mifomelatide can maintain body weight and muscle mass during chemotherapy without adding toxicity, the safety question the primary endpoints are built to answer.

The timing change

NCT06937177, a randomized, double-blind, placebo-controlled trial of mifomelatide (TCMCB07) in patients starting first-line chemotherapy for colorectal cancer or pancreatic ductal adenocarcinoma, moved its primary completion date from March 1, 2027 to October 1, 2027. That is the third revision to the primary completion date on record: the trial's original target of September 1, 2025 moved to June 1, 2026 in August 2025, then to March 1, 2027 in May 2026, and now to October 1, 2027. The cumulative delay since the original target runs 760 days. NCT06937177+1

Probability of Success

Endpoint Met34%

Completes48%

Clinical Significance4%

Regulatory53%

What changed alongside the date

The completion-date slip tracks a substantive change to the trial itself. The study was originally titled and designed around metastatic colorectal cancer alone; the July 2026 update renamed it to cover both colorectal cancer and pancreatic ductal adenocarcinoma, structuring the trial as a basket study with separate CRC and PDAC cohorts, each randomized 1:1:1:1 to placebo or one of three mifomelatide doses. The enrollment target held flat at 120 patients across both revisions, a change the operational model classifies as typical and not a recruitment concern. NCT06937177

The endpoint bar

The trial's three primary endpoints are the incidence of laboratory abnormalities, the incidence and severity of adverse events, and the incidence of vital-sign abnormalities over the 12-week dosing period, measured against placebo. This is a tolerability study, not an efficacy comparison: it will show whether adding daily subcutaneous mifomelatide to standard chemotherapy regimens such as FOLFOX, FOLFIRI, or gemcitabine-based combinations changes the safety profile patients already experience on chemotherapy alone. Secondary measures, including change in body weight, BMI, and quality-of-life scores on the FAACT and EORTC QLQ-C30 instruments, will describe the drug's effect on weight maintenance, the mechanism the trial is designed to test. NCT06937177

The competitive field

No competitor in the eight-trial colorectal cancer landscape reviewed shares mifomelatide's modality or mechanism class; the nearest entries are an antibody-drug conjugate, a bispecific antibody, a monoclonal antibody, and a cancer vaccine, all pursuing tumor-targeting mechanisms distinct from a weight-preservation approach layered onto chemotherapy. That leaves the trial without a same-modality precedent to benchmark against in this indication, so its safety and weight-maintenance signal will be read largely on its own terms rather than against a comparable class result.

This analysis was produced using AI-assisted reporting systems, AppliedXL data, and official public records. These systems undergo editorial review, quality checks, and regular audits by human experts. Errors may still occur, as with any automated system. Always consult the linked primary sources. Read our AI Editorial Policy.