Clinical Trial Finder

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 tumor malignancy that harbors a RAS (KRAS, NRAS, or HRAS) activating mutation. 2. Monotherapy Phase 2a: A locally advanced unresectable or metastatic solid tumor malignancies: pancreatic ductal adenocarcinoma (PDAC), RAS-mutant melanoma, or RAS-mutant non-small cell lung cancer (NSCLC) 3. Combination therapy (both phases): A locally advanced unresectable or metastatic PDAC.

• - Participants must be treatment naive or received prior systemic standard-of-care treatment as follows: 1.

Monotherapy Phase 1: received at least 1 line of systemic standard-of-care treatment for their advanced or metastatic disease. 2. Monotherapy Phase 2a: 1. First-line PDAC participants will have received no previous systemic anti-cancer therapy. Second-line PDAC participants will have received no more than one prior systemic anti-cancer therapy. 2. First-line melanoma participants will have received no previous systemic anti-cancer therapy. Second- and third-line participants will have received and failed one or two prior systemic anti-cancer therapies, respectively. 3. NSCLC participants will have received at least one and no more than two previous lines of systemic therapy. 3. Combination therapy (both phases): PDAC participants will have received no previous systemic anti-cancer therapy for 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.

Arms

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

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

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

Interventions

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

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-Paclitaxel will be administered at a dose of 125 mg/m^2

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 at 400 mg/m^2 Fluorouracil will be administered at 2400 mg/m^2 Irinotecan will be administered at 150 mg/m^2 Oxaliplatin will be administered at 85 mg/m^2