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

Inclusion Criteria:

• Must be ≥18 years of age

• Must have histologically or cytologically confirmed diagnosis as follows:

1. Monotherapy Phase 1: A locally advanced unresectable or metastatic solid tumormalignancy that harbors a RAS (KRAS, NRAS, or HRAS) activating mutation.

2. Monotherapy Phase 2a: A locally advanced unresectable or metastatic solid tumormalignancies: pancreatic ductal adenocarcinoma (PDAC), RAS-mutant melanoma, orRAS-mutant non-small cell lung cancer (NSCLC)

3. Combination therapy (both phases): A locally advanced unresectable ormetastatic PDAC

4. Combination therapy Phase 2a, Treatment D: Second and third line participantswith unresectable stage III or stage IV cutaneous melanoma with BRAF mutation.Must have progressed on or after treatment with an anti-PD-(L)1 monoclonalantibody as the most recent therapy. First day of study treatment must be morethan 28 days but less than 12 weeks from the last dose of anti-PD-(L)1 mAb.

5. Combination therapy Phase 2a, Treatment E: Second and third line participantswith unresectable stage III or stage IV cutaneous melanoma. Must haveprogressed on or after treatment with an anti-PD-(L)1 monoclonal antibody asthe most recent therapy. First day of study treatment must be more than 28 daysbut 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-caretreatment as follows:

1. Monotherapy Phase 1: received at least 1 line of systemic standard-of-caretreatment for their advanced or metastatic disease

2. Monotherapy Phase 2a:

3. First-line PDAC participants will have received no previous systemicanti-cancer therapy. Second-line PDAC participants will have received nomore than one prior systemic anti-cancer therapy.

4. First-line melanoma participants will have received no previous systemicanti-cancer therapy. Second- and third-line participants will havereceived and failed one or two prior systemic anti-cancer therapies,respectively.

5. NSCLC participants will have received at least one and no more than twoprevious lines of systemic therapy.

6. Combination therapy (both phases): PDAC participants will have received noprevious systemic anti-cancer therapy for their advanced or metastatic disease.

• Must have evidence of measurable disease (at least one target lesion) per RECISTv1.1 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 riskfactors for RVO. History of serous retinopathy, retinal edema, or retinal pigmentepithelial 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 startof study treatment

• Participants with active, uncontrolled autoimmune disease or participants activelybeing treated with tumor necrosis factor-alpha (TNF-alpha) inhibitors for managementof their autoimmune disease are excluded

• Receipt of an allogeneic tissue/solid organ transplant

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