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New pill shows promise against Hard-to-Treat cancers

NCT ID NCT05585320

Disease control Sponsor: Immuneering Corporation Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study tests an experimental oral drug called IMM-1-104, which blocks certain cancer-driving proteins. It is given alone or with standard chemotherapy to people with advanced solid tumors that have RAS mutations, including pancreatic, melanoma, and lung cancers. The trial aims to find the safest dose and see if the drug can shrink tumors. About 209 adults are participating across multiple centers.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
IMM-1-104 (an oral MEK1/2 inhibitor), given alone or with gemcitabine and nab-paclitaxel
What this could lead to
If successful, this could provide a new oral treatment option for people with certain advanced cancers that have RAS mutations, potentially shrinking tumors or slowing their growth.
What could go wrong
This is an early-phase trial (Phase 1/2a) with a small number of participants, so the drug may not prove effective or safe enough for wider use. Side effects from the drug or chemotherapy are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

209 people

The number who actually took part.

Started

Oct 2022

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Must be ≥18 years of age * Must have histologically or cytologically confirmed diagnosis as follows: 1. Monotherapy Phase 1: A locally advanced unresectable or metastatic solid tumor malignancy that harbors a RAS (KRAS, NRAS, or HRAS) activating mutation. 2. Monotherapy Phase 2a: A locally advanced unresectable or metastatic solid tumor malignancies: pancreatic ductal adenocarcinoma (PDAC), RAS-mutant melanoma, or RAS-mutant non-small cell lung cancer (NSCLC) 3. Combination therapy (both phases): A locally advanced unresectable or metastatic PDAC 4. Combination therapy Phase 2a, Treatment D: Second and third line participants with unresectable stage III or stage IV cutaneous melanoma with BRAF mutation. Must have progressed on or after treatment with an anti-PD-(L)1 monoclonal antibody as the most recent therapy. First day of study treatment must be more than 28 days but less than 12 weeks from the last dose of anti-PD-(L)1 mAb. 5. Combination therapy Phase 2a, Treatment E: Second and third line participants with unresectable stage III or stage IV cutaneous melanoma. Must have progressed on or after treatment with an anti-PD-(L)1 monoclonal antibody as the most recent therapy. First day of study treatment must be more than 28 days but less than 12 weeks from the last dose of anti-PD-(L)1 mAb. * Participants must be treatment naive or received prior systemic standard-of-care treatment as follows: 1. Monotherapy Phase 1: received at least 1 line of systemic standard-of-care treatment for their advanced or metastatic disease 2. Monotherapy Phase 2a: 1. First-line PDAC participants will have received no previous systemic anti-cancer therapy. Second-line PDAC participants will have received no more than one prior systemic anti-cancer therapy. 2. First-line melanoma participants will have received no previous systemic anti-cancer therapy. Second- and third-line participants will have received and failed one or two prior systemic anti-cancer therapies, respectively. 3. NSCLC participants will have received at least one and no more than two previous lines of systemic therapy. 3. Combination therapy (both phases): PDAC participants will have received no previous systemic anti-cancer therapy for their advanced or metastatic disease. * Must have evidence of measurable disease (at least one target lesion) per RECIST v1.1 criteria * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Adequate organ function Exclusion Criteria: * Inability to swallow oral medications * Symptomatic, untreated, or actively progressing known central nervous system (CNS) metastases * History or concurrent evidence of retinal vein occlusion (RVO) or current risk factors for RVO. History of serous retinopathy, retinal edema, or retinal pigment epithelial detachment (RPED) * Impaired cardiovascular function or clinically significant cardiac disease * History of rhabdomyolysis within 3 months prior to start of study treatment * Active skin disorder requiring systemic treatment within 3 months prior to the start of study treatment * Participants with active, uncontrolled autoimmune disease or participants actively being treated with tumor necrosis factor-alpha (TNF-alpha) inhibitors for management of their autoimmune disease are excluded * Receipt of an allogeneic tissue/solid organ transplant * Females who are pregnant, breastfeeding, or planning to become pregnant and males who plan to father a child while enrolled in this study.

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Conditions

The condition(s) this trial relates to.

adenocarcinoma cutaneous melanoma melanoma Melanoma, Cutaneous Malignant metastatic malignant neoplasm Neoplasm Metastasis non-small cell lung carcinoma pancreatic adenocarcinoma pancreatic ductal adenocarcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Advanced solid tumor Malignant melanoma (cutaneous) Non-small cell lung cancer (NSCLC) Pancreatic adenocarcinoma

Contacts and locations

Locations

  • City of Hope

    Duarte, California, 91010, United States

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215, United States

  • Duke University Cancer Institute

    Durham, North Carolina, 27710, United States

  • Florida Cancer Specialists and Research Institute

    Lake Mary, Florida, 32746, United States

  • Hematology Oncology Associates of Central New York

    East Syracuse, New York, 13057, United States

  • Levine Cancer Center

    Charlotte, North Carolina, 28204, United States

  • MD Anderson Cancer Center

    Houston, Texas, 77030, United States

  • Mayo Clinic

    Scottsdale, Arizona, 85259, United States

  • Mayo Clinic

    Jacksonville, Florida, 32224, United States

  • Mayo Clinic

    Rochester, Minnesota, 55905, United States

  • NEXT Oncology

    San Antonio, Texas, 78229, United States

  • NEXT Oncology

    Fairfax, Virginia, 22031, United States

  • Northwestern University

    Chicago, Illinois, 60611, United States

  • SCRI Oncology Partners

    Nashville, Tennessee, 27203, United States

  • Sarah Cannon Research Institute

    Denver, Colorado, 80218, United States

  • Sarcoma Oncology Center

    Santa Monica, California, 90403, United States

  • University of California San Diego

    San Diego, California, 92037, United States

  • University of Chicago

    Chicago, Illinois, 60637, United States

  • University of Wisconsin Clinical Science Center

    Madison, Wisconsin, 53792, United States

  • Weill Cornell Medicine

    New York, New York, 10021, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.