OLE Study Subsequent to Parent Study of Rilogrotug for the Treatment of Weight Loss and Anorexia in Patients With Cancer Cachexia and mCRC or mNSCLC

NCT07888075 — Phase 2 / Phase 3, Not yet recruiting, 400 participants, AVEO Pharmaceuticals, Inc.

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An Open-label Extension (OLE) Sub-Study Subsequent to the Phase 2/3 Randomized, Double-Blind Study of Rilogrotug Versus Placebo in the Treatment of Weight Loss and Anorexia in Patients With Cancer Cachexia and mCRC or mNSCLC

Registry	NCT07888075, acronym REACH-OLE
Status	Not yet recruiting
Phase	Phase 2 / Phase 3
Study type	Interventional; non randomized, parallel, masking: none, treatment
Enrollment	400 (Estimated)
Sponsor	AVEO Pharmaceuticals, Inc. (Industry)
Conditions	Cachexia; Cancer, Cachexia, Cachexia-Anorexia Syndrome, Metastatic Colorectal Cancer (CRC), Metastatic Non-small Cell Lung Cancer (NSCLC), Weight Loss, Anorexia
Interventions	Rilogrotug (Biological)
Dates	start 2027-02-01 (estimated), primary completion 2028-10-01 (estimated), completion 2031-01-01 (estimated), first posted 2026-10-22, last updated 2026-10-22

-Summary

The purpose of the OLE study is to evaluate the long-term safety and tolerability of rilogrotug treatment in participants who have completed the parent study and are eligible to receive continued treatment.

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+Detailed description

This multicenter, OLE study is designed to allow participants who have completed the parent study to continue receiving rilogrotug for up to an additional 6 months. The parent study is for treatment of weight loss and anorexia in participants with cachexia who have also been diagnosed with mCRC or mNSCLC and are receiving first line anticancer standard of care.

+Arms and interventions

Arm	Type	Interventions	Description
Rilogrotug - Phase 2 dose	Experimental	Biological: Rilogrotug	intravenous (IV) administration
Rilogrotug - Phase 3 dose	Experimental	Biological: Rilogrotug	IV administration

Rilogrotug (Biological): Rilogrotug (AV-380) is a humanized immunoglobulin G1 kappa monoclonal antibody that binds to growth differentiation factor-15 (GDF-15).

+Outcome measures

Primary outcomes

To evaluate the safety and tolerability of long-term rilogrotug administration [26 weeks]: Adverse events and Laboratory abnormalities

Secondary outcomes

To evaluate the long-term effect of rilogrotug on body weight [From enrollment to 26 weeks]: Change and percent change from baseline in body weight

+Eligibility

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* The patient completed double-blind treatment period
* The patient expressed interest in participating in the optional OLE sub-study and provided a signed informed consent form specific to the OLE.
* In the opinion of the Investigator, the patient continues to derive clinical benefit from study treatment, has not experienced any intolerable treatment-related toxicity of National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 6.0 Grade ≥ 2