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Advanced Solid TumorPhase 1/2NCT05585320

A Phase 1/2a Study of IMM-1-104 in Participants With Advanced or Metastatic Solid Tumors

A Phase 1/2 study testing IMM-1-104 Monotherapy (Treatment Group A), IMM-1-104 + modified Gemcitabine/nab-Paclitaxel (Treatment Group B) and IMM-1-104 + modified FOLFIRINOX (Treatment Group C) in people with Advanced Solid Tumor and Pancreatic Adenocarcinoma, run by Immuneering Corporation at 20 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This is an open-label, dose-exploration and expansion study to determine the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of IMM-1-104 when administered as monotherapy or in combination with approved agents in participants with RAS-mutated or RAS/MAPK activated advanced… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
IMM-1-104 Monotherapy (Treatment Group A), IMM-1-104 + modified Gemcitabine/nab-Paclitaxel (Treatment Group B) and IMM-1-104 + modified FOLFIRINOX (Treatment Group C)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
209 participants
Where
20 sitesUnited States
Study dates
31 Oct 2022to Jun 2028
Phase
Phase 1/2
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

  • Must be ≥18 years of age
  • Must have histologically or cytologically confirmed diagnosis as follows:
  • Monotherapy Phase 1: A locally advanced unresectable or metastatic solid tumor malignancy that harbors a RAS (KRAS, NRAS, or HRAS) activating mutation.
  • 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)
  • Combination therapy (both phases): A locally advanced unresectable or metastatic PDAC
  • 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.
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  • 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:
  • Monotherapy Phase 1: received at least 1 line of systemic standard-of-care treatment for their advanced or metastatic disease
  • Monotherapy Phase 2a:
  • 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.
  • 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.
  • NSCLC participants will have received at least one and no more than two previous lines of systemic therapy.
  • 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

Who cannot join

  • 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
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  • 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.

Trial locations and contacts

20 sites in 1 country.

20 sites in 1 country

United States20 sites

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215

  • Levine Cancer Center

    Charlotte, North Carolina, 28204

  • Northwestern University

    Chicago, Illinois, 60611

  • University of Chicago

    Chicago, Illinois, 60637

  • Sarah Cannon Research Institute

    Denver, Colorado, 80218

  • City of Hope

    Duarte, California, 91010

  • Duke University Cancer Institute

    Durham, North Carolina, 27710

  • Hematology Oncology Associates of Central New York

    East Syracuse, New York, 13057

  • NEXT Oncology

    Fairfax, Virginia, 22031

  • MD Anderson Cancer Center

    Houston, Texas, 77030

  • Mayo Clinic

    Jacksonville, Florida, 32224

  • Florida Cancer Specialists and Research Institute

    Lake Mary, Florida, 32746

  • University of Wisconsin Clinical Science Center

    Madison, Wisconsin, 53792

  • SCRI Oncology Partners

    Nashville, Tennessee, 27203

  • Weill Cornell Medicine

    New York, New York, 10021

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • NEXT Oncology

    San Antonio, Texas, 78229

  • University of California San Diego

    San Diego, California, 92037

  • Sarcoma Oncology Center

    Santa Monica, California, 90403

  • Mayo Clinic

    Scottsdale, Arizona, 85259

Other trials in United States

About this study

Official title: A Phase 1/2a, Open-Label, Multicenter, Nonrandomized, Safety and Anti-tumor Activity Study of IMM-1-104, a Novel Oral Dual MEK1/2 Inhibitor in Participants With Advanced or Metastatic Solid Tumors

This is an open-label, dose-exploration and expansion study to determine the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of IMM-1-104 when administered as monotherapy or in combination with approved agents in participants with RAS-mutated or RAS/MAPK activated advanced or metastatic solid tumors. The dose exploration will identify the candidate recommended Phase 2 candidate optimal dose of IMM-1-104 to further explore the anti-tumor activity of IMM-1-104 as monotherapy and in combination with approved agents in multiple Phase 2a proof-of-concept cohorts in malignancies of interest.

Being tested
IMM-1-104 Monotherapy (Treatment Group A), IMM-1-104 + modified Gemcitabine/nab-Paclitaxel (Treatment Group B), IMM-1-104 + modified FOLFIRINOX (Treatment Group C), IMM-1-104 + dabrafenib (Treatment Group D), IMM-1-104 + pembrolizumab (Treatment Group E)
Keywords
pan-RAS, KRAS, NRAS, HRAS, Targeted therapy, Metastatic cancer, Advanced cancer, RAS, Adenocarcinoma, MEK, Dual MEK, MEK 1/2, Mitogen-Activated Protein Kinase (MAPK), G12A, G12C, G12D, G12F, G12R, G12S, G12V
Medical subject headings
Melanoma, Cutaneous Malignant, Carcinoma, Non-Small-Cell Lung, Neoplasm Metastasis, Adenocarcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IMM-1-104 Monotherapy (Treatment Group A)Drug

    Also called IMM-1-104

    Once-daily, oral IMM-1-104 dose administered in 28-day cycles until treatment discontinuation criteria are met

  • IMM-1-104 + modified Gemcitabine/nab-Paclitaxel (Treatment Group B)Drug

    Also called IMM-1-104 + mGnP

    Once-daily, oral IMM-1-104 dose administered in 28-day cycles in combination with intravenous infusions of gemcitabine and nab-paclitaxel until treatment discontinuation criteria are met.

    Gemcitabine will be administered at a dose of 1000 mg/m^2 nab-Paclitaxel will be administered at a dose of 125 mg/m^2

  • IMM-1-104 + modified FOLFIRINOX (Treatment Group C)Drug

    Also called IMM-1-104 + mFFX

    Once-daily, oral IMM-1-104 dose administered in 28-day cycles in combination with intravenous infusions of modified FOLFIRNOX until treatment discontinuation criteria are met.

    FOLFIRINOX will be administered as follows:

    Folinic Acid will be administered at 400 mg/m^2 Fluorouracil will be administered at 2400 mg/m^2 Irinotecan will be administered at 150 mg/m^2 Oxaliplatin will be administered at 85 mg/m^2

  • IMM-1-104 + dabrafenib (Treatment Group D)Drug

    Also called IMM-1-104 + dabrafenib

    Once-daily, oral IMM-1-104 dose administered in 28-day cycles in combination with twice daily oral dose of dabrafenib until treatment discontinuation criteria are met. Dabrafenib will be administered at a dose of 150mg daily (75mg twice daily).

  • IMM-1-104 + pembrolizumab (Treatment Group E)Drug

    Also called IMM-1-104 + pembro

    Once-daily, oral IMM-1-104 dose administered in 28-day cycles in combination with intravenous infusions of pembrolizumab in sequence or concurrently depending on the enrolled cohort (two sub cohorts) until treatment discontinuation criteria are met. Pembrolizumab will be administered at a dose of 400mg.

Study groups in NCT05585320
Study groupRoleWhat they receive
IMM-1-104 monotherapy (Treatment Group A)ExperimentalIMM-1-104 monotherapy for first/second line pancreatic adenocarcinoma; first/second/third line melanoma; or second/third line non small cell lung cancer
Receives: Drug: IMM-1-104 Monotherapy (Treatment Group A)
IMM-1-104 in combination with mGnP (Treatment Group B)ExperimentalIMM-1-104 in combination with modified gemcitabine and nab-paclitaxel (mGnP) for first line pancreatic adenocarcinoma
Receives: Drug: IMM-1-104 + modified Gemcitabine/nab-Paclitaxel (Treatment Group B)
IMM-1-104 in combination with mFFX (Treatment Group C)ExperimentalIMM-1-104 in combination with modified FOLFIRINOX (mFFX) for first line pancreatic adenocarcinoma
Receives: Drug: IMM-1-104 + modified FOLFIRINOX (Treatment Group C)
IMM-1-104 in combination with dabrafenib (Treatment Group D)ExperimentalIMM-1-104 in combination with dabrafenib for second/third line post-IO melanoma with BRAF mutation
Receives: Drug: IMM-1-104 + dabrafenib (Treatment Group D)
IMM-1-104 in combination with pembrolizumab (Treatment Group E)ExperimentalIMM-1-104 in combination with pembrolizumab for second/third line post-IO melanoma
Receives: Drug: IMM-1-104 + pembrolizumab (Treatment Group E)

What is being measured

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

  1. Phase 1: Adverse Events

    Number of participants with adverse events

    Measured: From treatment initiation through 30 days following the last IMM-1-104 dose

  2. Phase 1: Dose-Limiting Toxicities

    Number of participants with dose-limiting toxicities

    Measured: The first 21 days of study treatment

  3. Phase 1: Recommended Phase 2 Candidate Optimal Dose

    Selection of candidate optimal dose to take forward into Ph2a

    Measured: Initiation of study treatment through 21 days (up to approximately 18 months)

  4. Phase 2a: Overall Response Rate

    The proportion of participants who achieve a best overall response (BOR) of complete response (CR) or partial response (PR), based on RECIST 1.1 criteria

    Measured: After up to 48 weeks (12 cycles) of study treatment

Secondary outcomes (9)

  1. Phase 1/2a: Maximum Observed Plasma Concentration of IMM-1-104

    Cmax

    Measured: After 12 weeks (3 Cycles) of study treatment

  2. Phase 1/2a: Time to Reach Maximum Plasma Concentration of IMM-1-104

    Tmax

    Measured: After 12 weeks (3 Cycles) of study treatment

  3. Phase 1/2a: Area Under Plasma Concentration (AUC) Time Curve of IMM-1-104

    AUC0-t

    Measured: After 12 weeks (3 Cycles) of study treatment

  4. Phase 2a: Disease Control Rate (DCR)

    The proportion of participants who have a best overall response (BOR) of stable disease (SD) or better

    Measured: After 16 weeks (4 Cycles) of study treatment

  5. Phase 2a: Progression Free Survival (PFS)

    The time interval between study treatment start and disease progression or death due to any cause.

    Measured: Up to approximately 2 years

  6. Phase 2a: Duration of Response (DOR)

    The time interval between an assessment of partial response (PR) or better and disease progression or death due to any cause.

    Measured: Up to approximately 2 years.

  7. Phase 2a: Landmark 3-Month Survival

    The proportion of participants who are still alive after three months on study.

    Measured: After 3 months of study participation.

  8. Phase 2a: Landmark 6-Month Survival

    The proportion of participants who are still alive after six months on study.

    Measured: After 6 months of study participation.

  9. Phase 2a: Overall Survival (OS)

    The time interval between study treatment start and death due to any cause.

    Measured: Up to approximately 2 Years

Timeline

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

  1. First posted18 Oct 2022
  2. Study start31 Oct 2022
  3. Primary completionJun 2027 (estimated)
  4. Study completionJun 2028 (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 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
209 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05585320
Sponsor's protocol ID
IMM1104-101
Status last verified
Oct 2026
First submitted
14 Oct 2022
Last updated
20 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing IMM-1-104 Monotherapy (Treatment Group A), IMM-1-104 + modified Gemcitabine/nab-Paclitaxel (Treatment Group B) and IMM-1-104 + modified FOLFIRINOX (Treatment Group C) in people with Advanced Solid Tumor and Pancreatic Adenocarcinoma, run by Immuneering Corporation at 20 sites in United States.

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 17 inclusion and 9 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: under way, not looking for participants, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Phase 1: Adverse Events (time frame: From treatment initiation through 30 days following the last IMM-1-104 dose). The study lists 4 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 NCT05585320.

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 20 Oct 2026.

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