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Not yet recruitingNCT07888075REACH-OLEUpdated Oct 22, 2026

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

A Phase 2/3 interventional study of Rilogrotug in Cachexia; Cancer, Cachexia and Cachexia-Anorexia Syndrome, sponsored by AVEO Pharmaceuticals, Inc.. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-22.

Sponsored by AVEO Pharmaceuticals, Inc. (part of LG Chem) · Phase 2/3, Interventional, and Treatment

Updated Oct 22, 2026Newly registeredGo to Updates ↓
Phase
Phase 2/3
Study type
Interventional
Enrollment
400
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Cachexia; Cancer
  • Cachexia
  • Cachexia-Anorexia Syndrome
  • Metastatic Colorectal Cancer (CRC)
  • Metastatic Non-small Cell Lung Cancer (NSCLC)
  • Weight Loss
  • Anorexia
03

In context

Cachexia

336 studies on the registry are indexed under Cachexia; 76 are open to participants now.

This study's planned enrollment of 400 is above the median of 66 across 226 interventional studies indexed under Cachexia.

Browse Cachexia studies →

Lead sponsor

AVEO Pharmaceuticals, Inc. is the lead sponsor of 35 studies on the registry; 3 are open to participants now.

First submitted after AVEO Pharmaceuticals, Inc. became part of LG Chem.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

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
05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
400 participants (estimated)

Study arms

  • Experimental
    Rilogrotug - Phase 2 dose

    intravenous (IV) administration

    Biological: Rilogrotug

  • Experimental
    Rilogrotug - Phase 3 dose

    IV administration

    Biological: Rilogrotug

Interventions

  • BiologicalRilogrotug

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

06

What researchers measure

Primary outcomes

  1. To evaluate the safety and tolerability of long-term rilogrotug administration

    Adverse events and Laboratory abnormalities

    Time frame: 26 weeks

Secondary outcomes

  1. To evaluate the long-term effect of rilogrotug on body weight

    Change and percent change from baseline in body weight

    Time frame: From enrollment to 26 weeks

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Oct 22, 2026
Show all 1 update
  1. Oct 22, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07888075
Responsible party
Sponsor
First posted
Oct 22, 2026
Start date
Feb 2027 (estimated)
Primary completion
Oct 2028 (estimated)
Completion
Jan 2031 (estimated)
Last update
Oct 22, 2026

Study contacts

Clinical Trial Office
Contact
clinical@aveooncology.com
+1-854-400-0101

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Rilogrotug

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