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

Launched by IMMUNEERING CORPORATION · Oct 14, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called IMM-1-104 for patients with specific types of advanced or metastatic solid tumors, particularly those with mutations in a gene called RAS. The trial aims to find out how safe the treatment is, how it works in the body, and whether it can help shrink tumors when used alone or with other approved treatments. It is currently recruiting adult participants who have previously received treatment for their cancer and have measurable disease, meaning there is at least one tumor that can be tracked.

To be eligible for the trial, participants must be at least 18 years old and have a confirmed diagnosis of certain types of cancer, such as pancreatic cancer, melanoma, or lung cancer, all of which have the RAS mutation. Participants should have already undergone some standard cancer treatments but may not have received many prior therapies, depending on the specific cancer type. Throughout the trial, participants will receive regular check-ups to monitor their health and the treatment's effects. It's important to note that the study cannot accept individuals with certain medical conditions or those who are pregnant or breastfeeding.

Gender

ALL

Eligibility criteria

• 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
• • 4. Combination therapy Phase 2a, Treatment D: Second and third line participants with unresectable stage III or stage IV cutaneous melanoma with BRAF mutation. Must have progressed on or after treatment with an anti-PD-(L)1 monoclonal antibody as the most recent therapy. First day of study treatment must be more than 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 participants with unresectable stage III or stage IV cutaneous melanoma. Must have progressed on or after treatment with an anti-PD-(L)1 monoclonal antibody as the most recent therapy. First day of study treatment must be more than 28 days but 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-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
• • Participants with active, uncontrolled autoimmune disease or participants actively being treated with tumor necrosis factor-alpha (TNF-alpha) inhibitors for management of their autoimmune disease are excluded
• • Receipt of an allogeneic tissue/solid organ transplant
• • Females who are pregnant, breastfeeding, or planning to become pregnant and males who plan to father a child while enrolled in this study.