Cachexia; CancerPhase 2/3REACH-OLENCT07888075
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 study testing Rilogrotug in people with Cachexia; Cancer and Cachexia, run by AVEO Pharmaceuticals, Inc..
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cachexia; Cancer, Cachexia, Cachexia-Anorexia Syndrome
- What is being tested?
- Rilogrotug
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- No sites listed yet
- Study dates
- Feb 2027to Jan 2031
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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
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.
- Conditions
- Cachexia; Cancer, Cachexia, Cachexia-Anorexia Syndrome, Metastatic Colorectal Cancer (CRC), Metastatic Non-small Cell Lung Cancer (NSCLC), Weight Loss
- Being tested
- Rilogrotug
- Medical subject headings
- Cachexia, Neoplasms, Colorectal Neoplasms, Carcinoma, Non-Small-Cell Lung, Weight Loss, Anorexia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RilogrotugBiological
Rilogrotug (AV-380) is a humanized immunoglobulin G1 kappa monoclonal antibody that binds to growth differentiation factor-15 (GDF-15).
| Study group | Role | What they receive |
|---|---|---|
| Rilogrotug - Phase 2 dose | Experimental | intravenous (IV) administration Receives: Biological: Rilogrotug |
| Rilogrotug - Phase 3 dose | Experimental | IV administration Receives: Biological: Rilogrotug |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the safety and tolerability of long-term rilogrotug administration
Adverse events and Laboratory abnormalities
Measured: 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
Measured: From enrollment to 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2026
- Study startFeb 2027 (estimated)
- Primary completionOct 2028 (estimated)
- Study completionJan 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cachexia; CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AVEO Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07888075
- Sponsor's protocol ID
- AV-380-25-301(D)
- Other IDs
- 2026-527980-14-00
- Acronym
- REACH-OLE
- Status last verified
- Sep 2026
- First submitted
- 15 Oct 2026
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07888075
- Acronym / sponsor ID
- REACH-OLE / AV-380-25-301(D)
- Conditions
- Cachexia; Cancer, Cachexia, Cachexia-Anorexia Syndrome, Metastatic Colorectal Cancer (CRC), Metastatic Non-small Cell Lung Cancer (NSCLC), Weight Loss
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- AVEO Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2027 (estimated)
- Primary completion
- Oct 2028 (estimated)
- Study completion
- Jan 2031 (estimated)
- First posted
- 22 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rilogrotug - Phase 2 dose | Experimental | Biological: Rilogrotugintravenous (IV) administration |
| Rilogrotug - Phase 3 dose | Experimental | Biological: RilogrotugIV administration |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RilogrotugRilogrotug (AV-380) is a humanized immunoglobulin G1 kappa monoclonal antibody that binds to growth differentiation factor-15 (GDF-15). | Biological | Rilogrotug - Phase 2 dose, Rilogrotug - Phase 3 dose |
Primary outcome
To evaluate the safety and tolerability of long-term rilogrotug administration
Time frame: 26 weeks
Adverse events and Laboratory abnormalities
1 secondary outcome
To evaluate the long-term effect of rilogrotug on body weight
Time frame: From enrollment to 26 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Rilogrotug in people with Cachexia; Cancer and Cachexia, run by AVEO Pharmaceuticals, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Trial Office (+1-854-400-0101, clinical@aveooncology.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the safety and tolerability of long-term rilogrotug administration (time frame: 26 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.