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Cachexia; CancerPhase 2/3REACHNCT07888075

Master Protocol for the 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..

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

The purpose of this trial is to learn whether participants who take rilogrotug gain weight, have a better appetite, and have a better quality of life than participants who do not take rilogrotug (placebo arm). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Rilogrotug
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
950 participants
Where
No sites listed yet
Study dates
Nov 2026to Oct 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

Phase 2 (A), Phase 3 (B) \& (C) Inclusion Criteria (IC):

  • Documented histological or cytological confirmation of either mNSCLC or mCRC
  • For patients with mNSCLC, receiving first line (1L) systemic anticancer standard of care (SOC) treatment with standard approved regimens: the 1L systemic anticancer SOC treatments are a platinum-based doublet chemotherapy regimen, and an anti-PD-(L)1 immunotherapy
  • For patients with mCRC, receiving 1L systemic anticancer SOC treatment with standard approved regimens: fluorouracil-based regimens including oxaliplatin or irinotecan with or without biologics)
  • Documentation of informed consent by the patient or the patient's legally acceptable representative, indicating that the patient has been informed of and comprehended all pertinent aspects of the trial
  • Is willing and able to comply with the protocol tests and procedures
  • Age ≥18 years
  • Cachexia as defined by Fearon criteria for body weight and body mass index (BMI) (Fearon 2011)
  • Life expectancy ≥4months
  • Eastern Cooperative Oncology Group performance status 0 to 2

Phase 2 (A), Phase 3 (B) \& (C) Exclusion Criteria (EC):

  • Anorexia or cachexia caused by reasons other than cancer (for example, severe chronic obstructive pulmonary disease [COPD] with home oxygen support)
  • Reversible causes of reduced food intake, as determined by the Investigator.
  • Dysphagia, calorie-restricted diet within 6 months prior to first dose, or poor food digestion and absorption
  • Currently receiving tube feedings or parenteral nutrition (either total or partial)
  • Have received medications and/or herbal supplements to enhance appetite and/or intended to treat unintentional weight loss
  • Patients with uncontrolled or significant cardiovascular disease
  • Clinically significant recurrent ascites, pleural effusion, pericardial effusion and or significant edema
  • Creatinine clearance ≤30 mL/min (measured or calculated by Cockcroft and Gault equation)
  • Aspartate aminotransferase or alanine aminotransferase >5 × the upper limit of normal (ULN) OR total bilirubin >2 × ULN
  • Alkaline phosphatase (ALP) >3 x ULN (ALP >5× ULN if there is liver involvement by the tumor and/or in case of bone metastases)

OLE (D) IC:

  • 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

OLE (D) EC:

  • None

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Clinical Trial Office contact

+1-854-400-0101

clinical@aveooncology.com

About this study

Official title: A 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 this trial is to learn whether participants who take rilogrotug gain weight, have a better appetite, and have a better quality of life than participants who do not take rilogrotug (placebo arm). Adult participants with cachexia who have also been diagnosed with metastatic colorectal or non-small cell lung cancer will be enrolled.

The primary hypothesis is that after 12 weeks, rilogrotug will cause an increase from baseline in body weight and appetite (as measured by the Functional Assessment of Anorexia/Cachexia Therapy 5-item Anorexia Symptom Scale [FAACT-5IASS] questionnaire) compared to placebo.

Read the detailed description

This multicenter, randomized, double-blind, placebo-controlled Phase 2/3 study is designed to compare the efficacy and safety of rilogrotug to a control arm of placebo for treatment of weight loss and anorexia in participants with cachexia who have also been diagnosed with metastatic colorectal cancer (mCRC) or metastatic non-small cell lung cancer (mNSCLC) and are receiving first line anticancer standard of care. The master protocol is designed with 4 sub-studies:

The Phase 2 (A) sub-study is designed to compare the efficacy and safety of two dose levels of rilogrotug (Arm 1 or Arm 2) to a control arm of placebo (Arm 3) in a 1:1:1 allocation. It is anticipated that the sub-study will enroll approximately 150 participants across 3 arms.

The Phase 3 (B) sub-study is designed to assess safety and efficacy of the selected optimal dose versus placebo in patients with cancer cachexia and mCRC in a 1:1 allocation. It is anticipated that the sub-study will enroll approximately 400 participants across 2 arms.

The Phase 3 (C) sub-study is designed to assess safety and efficacy of the selected optimal dose versus placebo in patients with cancer cachexia and mNSCLC in a 1:1 allocation. It is anticipated that the sub-study will enroll approximately 400 participants across 2 arms.

The OLE (D) sub-study is designed to allow participants who have completed one of the parent sub-studies (A), (B), (C) to continue receiving rilogrotug for up to an additional 12 months.

Being tested
Rilogrotug, Placebo
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).

  • PlaceboBiological

    Placebo for this study will be normal saline.

Study groups in NCT07888075
Study groupRoleWhat they receive
Rilogrotug - high doseExperimentalintravenous (IV) administration
Receives: Biological: Rilogrotug
Rilogrotug - low doseExperimentalIV administration
Receives: Biological: Rilogrotug
PlaceboPlacebo comparatorIV administration
Receives: Biological: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Phase 2 (A): To evaluate the effect of rilogrotug compared to placebo on weight gain

    Percent change from baseline in body weight

    Measured: 12 weeks

  2. Phase 2 (A): Change from baseline in Functional Assessment of Anorexia/Cachexia Therapy- 5-Item Anorexia Symptom Scale score

    Scale has five items, each rated 0-4. Total score ranges from 0 (minimum) to 20 (maximum). Higher score is associated with a better outcome.

    Measured: 12 weeks

  3. Phase 3 (B): To evaluate the effect of rilogrotug compared to placebo on weight gain

    Percent change from baseline in body weight

    Measured: 12 weeks

  4. Phase 3 (B): Change from baseline in Functional Assessment of Anorexia/Cachexia Therapy- 5-Item Anorexia Symptom Scale score

    Scale has five items, each rated 0-4. Total score ranges from 0 (minimum) to 20 (maximum). Higher score is associated with a better outcome.

    Measured: 12 weeks

  5. Phase 3 (C): To evaluate the effect of rilogrotug compared to placebo on weight gain

    Percent change from baseline in body weight

    Measured: 12 weeks

  6. Phase 3 (C): Change from baseline in Functional Assessment of Anorexia/Cachexia Therapy- 5-Item Anorexia Symptom Scale score

    Scale has five items, each rated 0-4. Total score ranges from 0 (minimum) to 20 (maximum). Higher score is associated with a better outcome.

    Measured: 12 weeks

  7. OLE (D): To evaluate the safety and tolerability of long-term rilogrotug administration

    Adverse events and Laboratory abnormalities

    Measured: 52 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Oct 2026
  2. Study startNov 2026 (estimated)
  3. Primary completionMar 2030 (estimated)
  4. Study completionOct 2031 (estimated)

Resources

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
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
950 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07888075
Sponsor's protocol ID
AV-380-25-301
Other IDs
2026-527980-14-00
Acronym
REACH
Status last verified
Oct 2026
First submitted
15 Oct 2026
Last updated
28 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided

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?

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 28 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. Some participants in this study may receive a placebo. 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?

Phase 2 (A): To evaluate the effect of rilogrotug compared to placebo on weight gain (time frame: 12 weeks). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07888075.

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 28 Oct 2026.

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