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Advanced Solid Tumor (Phase 1)Phase 1/2NCT06208124

A Study of IMM-6-415 in RAS/RAF Mutant Solid Tumors

A Phase 1/2 study testing IMM-6-415 in people with Advanced Solid Tumor (Phase 1) and Pancreas Adenocarcinoma, run by Immuneering Corporation at 5 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a FIH, ascending dose study to characterize the safety, tolerability, optimal dose and preliminary anti-tumor activity of IMM-6-415 in participants with advanced or metastatic solid tumors harboring RAS or RAF oncogenic mutations. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
IMM-6-415
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
5 sitesUnited States
Study dates
27 Feb 2024to 30 Apr 2025
Phase
Phase 1/2
Are there results?
None posted in the registry

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

  • Age ≥18 years
  • Life expectancy >16 weeks
  • Part 1: Histologically or cytologically confirmed diagnosis of a locally advanced unresectable or metastatic solid tumor malignancy harboring RAS (NRAS, KRAS, or HRAS)- or RAF- (ARAF, BRAF, RAF1) activating mutations, as documented by genomic analysis. Results of mutation analysis must be available prior to participant enrollment. A prior genomics report from archival tissues or liquid biopsy demonstrating mutation is acceptable
  • Part 2: Histologically or cytologically confirmed diagnosis of one of the following locally advanced unresectable or metastatic solid tumor malignancies: pancreatic adenocarcinoma, RASmut melanoma, Class I BRAFmut melanoma, RASmut NSCLC, other RASmut GI cancers (aside from CRC) or any other RAFmut solid tumor as documented by genomic analysis. Results of mutation analysis must be available prior to participant enrollment. A prior genomics report from archival tissues or liquid biopsy demonstrating mutation is acceptable
  • Participants must have received at least 1 line of systemic standard-of-care treatment for their advanced or metastatic disease and in the assessment of the Investigator, would be unlikely to tolerate or derive clinically meaningful benefit from other treatment options
  • Participants previously treated with codon-specific inhibitors of KRAS (including investigational agents) are eligible
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  • KRASG12C mutant participants must have received prior treatment with a KRASG12C inhibitor for any approved indication
  • Radiologic evidence of measurable disease (i.e., at least 1 target lesion) according to RECIST 1.1 criteria
  • ECOG performance status 0 or 1.
  • Participant has adequate organ function

Who cannot join

  • Inability to swallow oral medications.
  • Symptomatic, untreated, or actively progressing known central nervous system metastases.
  • Uncontrolled pleural or pericardial effusion or ascites requiring repeated drainage more than once every 28 days. In dwelling catheters are allowed.
  • History of severe COVID-19 infection resulting in current need of supplemental O2 therapy to maintain resting oxygen saturations ≥90%.
  • Presence of ongoing toxicities related to prior anticancer therapy that have not resolved to Grade ≤1 and are not otherwise allowed
  • Impaired cardiac function or clinically significant cardiac disease
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  • Uncontrolled intercurrent illness including but not limited to poorly controlled diabetes or any medical condition determined by the Investigator to be a risk
  • History or concurrent evidence of retinal vein occlusion (RVO) or current risk factors for RVO. History of clinically significant serous retinopathy, central serous chorioretinopathy or retinal edema.
  • History of rhabdomyolysis within 3 months prior to Study Day 1
  • HIV-infected participant must be on anti-retroviral therapy and have a well-controlled HIV infection/disease
  • Participants with a history of HBV infection no longer requiring treatment are eligible; participants with a history of HCV infection are eligible if HCV viral load is undetectable at screening.
  • 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

5 sites in 1 country.

5 sites in 1 country

United States5 sites

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Sarah Cannon Research Institute

    Denver, Colorado, 80218

  • City of Hope

    Duarte, California, 91010

  • MD Anderson Cancer Center

    Houston, Texas, 77030

  • Honor Health Research Institute

    Scottsdale, Arizona, 85258

Other trials in United States

About this study

Official title: A Phase 1/2a Study of IMM-6-415 in Participants With Advanced or Metastatic Malignancies Harboring RAS or RAF Oncogenic Mutations

This is a FIH, ascending dose study to characterize the safety, tolerability, optimal dose and preliminary anti-tumor activity of IMM-6-415 in participants with advanced or metastatic solid tumors harboring RAS or RAF oncogenic mutations.

Read the detailed description

The dose exploration will identify the candidate recommended Phase 2 dose (RP2D) of IMM-6-415 to further explore the anti-tumor activity of IMM-6-415 as monotherapy in Phase 2a tumor-specific cohorts. Patients will be self-administering IMM-6-415 on a daily basis for up to 16 cycles (21-day cycles). During the first 2 cycles, PK and PD will be assessed. Solid tumor types with RAS/RAF mutations are eligible.

Being tested
IMM-6-415
Keywords
pan-RAS, pan-RAF, KRAS, NRAS, HRAS, BRAF, targeted therapy, metastatic therapy, RAS, RAF, adenocarcinoma, MEK, dual MEK, G12A, G12C, G12D, G12F, G12V, Q61H, Q61K
Medical subject headings
Carcinoma, Non-Small-Cell Lung, Melanoma, Cutaneous Malignant, Adenocarcinoma

What participants receive

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

  • IMM-6-415Drug

    Twice daily, oral tablet administered in 21-day cycles until treatment discontinuation criteria are met.

Study groups in NCT06208124
Study groupRoleWhat they receive
IMM-6-415ExperimentalDose Escalation and Dose Expansion
Receives: Drug: IMM-6-415

What is being measured

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

  1. Phase 1/2a: Adverse Events

    Number of participants with adverse events

    Measured: From treatment initiation through 30 days following the last IMM-6-415 dose

  2. Phase 1: Dose-Limiting Toxicities (DLT)

    Number of participants with dose-limiting toxicities

    Measured: The first 21 days of study treatment

  3. Phase 1: Recommended Phase 2 Dose (RP2D) candidate

    Selection of candidate RP2D to take forward into Ph2a

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

  4. Phase 1: Maximum Observed Plasma Concentration of IMM-6-415

    Cmax

    Measured: After 9 weeks (3 Cycles) of study treatment

  5. Phase 1: Time to Reach Maximum Observed Plasma Concentration of IMM-6-415

    Tmax

    Measured: After 9 weeks (3 Cycles) of study treatment

  6. Phase 1: Area Under Plasma Concentration (AUC) Time Curve of IMM-6-415

    AUC0-t

    Measured: After 9 weeks (3 Cycles) of study treatment

  7. Phase 1: Pharmacodynamic (PD) Activity of IMM-6-415 Plasma Concentrations Over Time

    Surrogate PD Biomarker Assay, pERK

    Measured: After 9 weeks (3 Cycles) of study treatment

  8. Phase 2a: Overall Response Rate (ORR)

    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 (16 cycles) of study treatment

Secondary outcomes (9)

  1. Phase 2a: Maximum Observed Plasma Concentration of IMM-6-415

    Cmax

    Measured: After 9 weeks (3 Cycles) of study treatment

  2. Phase 2a: Time to Reach Maximum Observed Plasma Concentration of IMM-6-415

    Tmax

    Measured: After 9 weeks (3 Cycles) of study treatment

  3. Phase 2a: Area Under Plasma Concentration (AUC) Time Curve of IMM-6-415

    AUC0-t

    Measured: After 9 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 12 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 posted17 Jan 2024
  2. Study start27 Feb 2024
  3. Primary completion30 Apr 2025
  4. Study completion30 Apr 2025

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06208124
Sponsor's protocol ID
IMM6415-101
Status last verified
May 2025
First submitted
5 Jan 2024
Last updated
28 May 2025
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-6-415 in people with Advanced Solid Tumor (Phase 1) and Pancreas Adenocarcinoma, run by Immuneering Corporation at 5 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 10 inclusion and 12 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: finished, as of the sponsor's last update on 28 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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 1/2a: Adverse Events (time frame: From treatment initiation through 30 days following the last IMM-6-415 dose). The study lists 8 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 NCT06208124.

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 May 2025.

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