A Phase 1/2a Study Of IMM-1-104 In Participants With Previously Treated, RAS-Mutant, Advanced Or Metastatic Solid Tumors

Study Overview

A Phase 1/2a Study of IMM-1-104 in Participants With Previously Treated, RAS-Mutant, 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 dose (RP2D) 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.

N/A

Advanced Solid Tumor
Pancreatic Adenocarcinoma
Malignant Melanoma (Cutaneous)
Non-small Cell Lung Cancer (NSCLC)

DRUG: IMM-1-104 Monotherapy (Treatment Group A)
DRUG: IMM-1-104 + modified Gemcitabine/nab-Paclitaxel (Treatment Group B)
DRUG: IMM-1-104 + modified FOLFIRINOX (Treatment Group C)

IMM1104-101

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
First Submitted 2022-10-14	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2025-02-18
First Submitted that Met QC Criteria 2022-10-14	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2025-03-25
First Posted (ACTUAL) 2022-10-18	Results First Posted N/A	Last Verified 2025-02

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:
Non Randomized

Interventional Model:
Parallel

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: IMM-1-104 monotherapy (Treatment Group A) IMM-1-104 monotherapy for first/second line pancreatic adenocarcinoma; first/second/third line melanoma; or second/third line non small cell lung cancer	DRUG: IMM-1-104 Monotherapy (Treatment Group A) Once-daily, oral IMM-1-104 dose administered in 28-day cycles until treatment discontinuation criteria are met
EXPERIMENTAL: IMM-1-104 in combination with mGnP (Treatment Group B) IMM-1-104 in combination with modified gemcitabine and nab-paclitaxel (mGnP) for first line pancreatic adenocarcinoma	DRUG: IMM-1-104 + modified Gemcitabine/nab-Paclitaxel (Treatment Group B) 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-Pacl
EXPERIMENTAL: IMM-1-104 in combination with mFFX (Treatment Group C) IMM-1-104 in combination with modified FOLFIRINOX (mFFX) for first line pancreatic adenocarcinoma	DRUG: IMM-1-104 + modified FOLFIRINOX (Treatment Group C) 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

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: IMM-1-104 monotherapy (Treatment Group A)

IMM-1-104 monotherapy for first/second line pancreatic adenocarcinoma; first/second/third line melanoma; or second/third line non small cell lung cancer

DRUG: IMM-1-104 Monotherapy (Treatment Group A)

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

EXPERIMENTAL: IMM-1-104 in combination with mGnP (Treatment Group B)

IMM-1-104 in combination with modified gemcitabine and nab-paclitaxel (mGnP) for first line pancreatic adenocarcinoma

DRUG: IMM-1-104 + modified Gemcitabine/nab-Paclitaxel (Treatment Group B)

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-Pacl

EXPERIMENTAL: IMM-1-104 in combination with mFFX (Treatment Group C)

IMM-1-104 in combination with modified FOLFIRINOX (mFFX) for first line pancreatic adenocarcinoma

DRUG: IMM-1-104 + modified FOLFIRINOX (Treatment Group C)

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

Primary Outcome Measures	Measure Description	Time Frame
Phase 1: Adverse Events	Number of participants with adverse events	From treatment initiation through 30 days following the last IMM-1-104 dose
Phase 1: Dose-Limiting Toxicities	Number of participants with dose-limiting toxicities	The first 21 days of study treatment
Phase 1: Recommended Phase 2 Dose (RP2D) candidate	Selection of candidate RP2D to take forward into Ph2a	Initiation of study treatment through 21 days (up to approximately 18 months)
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	After up to 48 weeks (12 cycles) of study treatment

Secondary Outcome Measures	Measure Description	Time Frame
Phase 1/2a: Maximum Observed Plasma Concentration of IMM-1-104	Cmax	After 12 weeks (3 Cycles) of study treatment
Phase 1/2a: Time to Reach Maximum Plasma Concentration of IMM-1-104	Tmax	After 12 weeks (3 Cycles) of study treatment
Phase 1/2a: Area Under Plasma Concentration (AUC) Time Curve of IMM-1-104	AUC0-t	After 12 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 better	After 16 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 Survival	The proportion of participants who are still alive after three months on study.	After 3 months of study participation.
Phase 2a: Landmark 6-Month Survival	The proportion of participants who are still alive after six months on study.	After 6 months of study participation.
Phase 2a: Overall Survival (OS)	The time interval between study treatment start and death due to any cause.	Up 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.

Study Contact

Name: IMM1104-101 Study Team

Phone Number: (860) 321-1302

Email: clinicaltrials@immuneering.com

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:

Must be ≥18 years of age
Must have histologically or cytologically confirmed diagnosis as follows:

Participants must be treatment naive or received prior systemic standard-of-care treatment as follows:

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

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
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.

Investigators

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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Resources

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Clinical Trial Record