A Phase 1/2a Study of IMM-1-104 in Participants With Previously Treated, RAS-Mutant, Advanced or Metastatic Solid Tumors

Overview

About this study

The purpose of this study is to determine the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of IMM-1-104 when administered as monotherapy in participants with RAS-mutated advanced or metastatic solid tumors.  

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

- Must be ≥18 years of age

- Phase 1: Must have histologically or cytologically confirmed RAS-mutated (KRAS, NRAS,
or HRAS) solid tumor malignancy that is advanced and unresectable, or metastatic.

- Phase 2a: Must have histologically or cytologically confirmed diagnosis of one of the
following locally advanced unresectable or metastatic solid tumor malignancies:
NRAS-mutant melanoma, KRAS-mutant pancreatic ductal adenocarcinoma (PDAC), KRAS-mutant
non-small cell lung cancer (NSCLC), or KRAS-mutant and APC-wild-type colorectal cancer
(CRC)

- Must have received at least one prior systemic, standard-of-care therapy to treat
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

- Females who are pregnant, breastfeeding, or planning to become pregnant and males who
plan to father a child while enrolled in this study.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 7/21/23. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Ryan Carr, M.D., Ph.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Jacksonville, Fla.

Mayo Clinic principal investigator

Umair Majeed, M.B.B.S., M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Daniel Ahn, D.O.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available