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

Inclusion Criteria:

• Age ≥18 years

• Life expectancy >16 weeks

• Part 1: Histologically or cytologically confirmed diagnosis of a locally advancedunresectable or metastatic solid tumor malignancy harboring RAS (NRAS, KRAS, orHRAS)- or RAF- (ARAF, BRAF, RAF1) activating mutations, as documented by genomicanalysis. Results of mutation analysis must be available prior to participantenrollment. A prior genomics report from archival tissues or liquid biopsydemonstrating mutation is acceptable

• Part 2: Histologically or cytologically confirmed diagnosis of one of the followinglocally advanced unresectable or metastatic solid tumor malignancies: pancreaticadenocarcinoma, RASmut melanoma, Class I BRAFmut melanoma, RASmut NSCLC, otherRASmut GI cancers (aside from CRC) or any other RAFmut solid tumor as documented bygenomic analysis. Results of mutation analysis must be available prior toparticipant enrollment. A prior genomics report from archival tissues or liquidbiopsy demonstrating mutation is acceptable

• Participants must have received at least 1 line of systemic standard-of-caretreatment for their advanced or metastatic disease and in the assessment of theInvestigator, would be unlikely to tolerate or derive clinically meaningful benefitfrom other treatment options

• Participants previously treated with codon-specific inhibitors of KRAS (includinginvestigational agents) are eligible

• KRASG12C mutant participants must have received prior treatment with a KRASG12Cinhibitor for any approved indication

• Radiologic evidence of measurable disease (i.e., at least 1 target lesion) accordingto 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 systemmetastases.

• Uncontrolled pleural or pericardial effusion or ascites requiring repeated drainagemore than once every 28 days. In dwelling catheters are allowed.

• History of severe COVID-19 infection resulting in current need of supplemental O2therapy to maintain resting oxygen saturations ≥90%.

• Presence of ongoing toxicities related to prior anticancer therapy that have notresolved 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 controlleddiabetes or any medical condition determined by the Investigator to be a risk

• History or concurrent evidence of retinal vein occlusion (RVO) or current riskfactors for RVO. History of clinically significant serous retinopathy, centralserous 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 awell-controlled HIV infection/disease

• Participants with a history of HBV infection no longer requiring treatment areeligible; participants with a history of HCV infection are eligible if HCV viralload is undetectable at screening.

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