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Clinical Trial Record

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

2024-02-27

2025-04-30

2025-04-30

30

Study Overview

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

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.

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.

  • Advanced Solid Tumor (Phase 1)
  • Pancreas Adenocarcinoma
  • Non-small Cell Lung Cancer
  • Malignant Melanoma (Cutaneous)
  • DRUG: IMM-6-415
  • IMM6415-101

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates Results Reporting Dates Study Record Updates

2024-01-05  

N/A  

2025-05-27  

2024-01-05  

N/A  

2025-05-28  

2024-01-17  

N/A  

2025-05  

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/ArmIntervention/Treatment
EXPERIMENTAL: IMM-6-415

Dose Escalation and Dose Expansion

DRUG: IMM-6-415

  • Twice daily, oral tablet administered in 21-day cycles until treatment discontinuation criteria are met.
Primary Outcome MeasuresMeasure DescriptionTime Frame
Phase 1/2a: Adverse EventsNumber of participants with adverse eventsFrom treatment initiation through 30 days following the last IMM-6-415 dose
Phase 1: Dose-Limiting Toxicities (DLT)Number of participants with dose-limiting toxicitiesThe first 21 days of study treatment
Phase 1: Recommended Phase 2 Dose (RP2D) candidateSelection of candidate RP2D to take forward into Ph2aInitiation of study treatment through 21 days (up to approximately 18 months)
Phase 1: Maximum Observed Plasma Concentration of IMM-6-415CmaxAfter 9 weeks (3 Cycles) of study treatment
Phase 1: Time to Reach Maximum Observed Plasma Concentration of IMM-6-415TmaxAfter 9 weeks (3 Cycles) of study treatment
Phase 1: Area Under Plasma Concentration (AUC) Time Curve of IMM-6-415AUC0-tAfter 9 weeks (3 Cycles) of study treatment
Phase 1: Pharmacodynamic (PD) Activity of IMM-6-415 Plasma Concentrations Over TimeSurrogate PD Biomarker Assay, pERKAfter 9 weeks (3 Cycles) of study treatment
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 criteriaAfter up to 48 weeks (16 cycles) of study treatment
Secondary Outcome MeasuresMeasure DescriptionTime Frame
Phase 2a: Maximum Observed Plasma Concentration of IMM-6-415CmaxAfter 9 weeks (3 Cycles) of study treatment
Phase 2a: Time to Reach Maximum Observed Plasma Concentration of IMM-6-415TmaxAfter 9 weeks (3 Cycles) of study treatment
Phase 2a: Area Under Plasma Concentration (AUC) Time Curve of IMM-6-415AUC0-tAfter 9 weeks (3 Cycles) of study treatment
Phase 2a: Disease Control Rate (DCR)The proportion of participants who have a best overall response (BOR) of stable disease (SD) or betterAfter 12 weeks (4 Cycles) of study treatment
Phase 2a: Progression Free Survival (PFS)The time interval between study treatment start and disease progression or death due to any cause.Up to approximately 2 years
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.Up to approximately 2 years
Phase 2a: Landmark 3-Month SurvivalThe proportion of participants who are still alive after three months on studyAfter 3 months of study participation.
Phase 2a: Landmark 6-Month SurvivalThe proportion of participants who are still alive after six months on studyAfter 6 months of study participation
Phase 2a: Overall Survival (OS)The time interval between study treatment start and death due to any causeUp to approximately 2 Years

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

    Inclusion Criteria:

  • 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
  • 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

    • Exclusion Criteria:

  • 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
  • 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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

    • STUDY_DIRECTOR: Vinny Hayreh, MD, Immuneering Corporation

    Publications

    The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

    General Publications

    No publications available

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