Clinical trial · Interventional
A Study of IMM-6-415 in RAS/RAF Mutant Solid Tumors
A Phase 1/2a Study of IMM-6-415 in Participants With Advanced or Metastatic Malignancies Harboring RAS or RAF Oncogenic Mutations
NCT06208124CI-TRIAL-00090247completedPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a FIH, ascending dose study to characterize the safety, tolerability, optimal dose and preliminary anti-tumor activity of IMM-6-415 in participants with advanced or metastatic solid tumors harboring RAS or RAF oncogenic mutations.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Solid Tumor (Phase 1) | Solid Neoplasm | CURATED_BROADER | 0.80 |
| Malignant Melanoma (Cutaneous) | Melanoma | ALIAS | 0.85 |
| Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
| Pancreas Adenocarcinoma | Pancreatic Adenocarcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| IMM-6-415 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- IMM-6-415
- description
- Dose Escalation and Dose Expansion
- interventionNames
- Drug: IMM-6-415
Primary outcomes (8)
- measure
- Phase 1/2a: Adverse Events
- timeFrame
- From treatment initiation through 30 days following the last IMM-6-415 dose
- description
- Number of participants with adverse events
- measure
- Phase 1: Dose-Limiting Toxicities (DLT)
- timeFrame
- The first 21 days of study treatment
- description
- Number of participants with dose-limiting toxicities
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age ≥18 years * Life expectancy \>16 weeks * Part 1: Histologically or cytologically confirmed diagnosis of a locally advanced unresectable or metastatic solid tumor malignancy harboring RAS (NRAS, KRAS, or HRAS)- or RAF- (ARAF, BRAF, RAF1) activating mutations, as documented by genomic analysis. Results of mutation analysis must be available prior to participant enrollment. A prior genomics report from archival tissues or liquid biopsy demonstrating mutation is acceptable * Part 2: Histologically or cytologically confirmed diagnosis of one of the following locally advanced unresectable or metastatic solid tumor malignancies: pancreatic adenocarcinoma, RASmut melanoma, Class I BRAFmut melanoma, RASmut NSCLC, other RASmut GI cancers (aside from CRC) or any other RAFmut solid tumor as documented by genomic analysis. Results of mutation analysis must be available prior to participant enrollment. A prior genomics report from archival tissues or liquid biopsy demonstrating mutation is acceptable * Participants must have received at least 1 line of systemic standard-of-care treatment for their advanced or metastatic disease and in the assessment of the Investigator, would be unlikely to tolerate or derive clinically meaningful benefit from other treatment options * Participants previously treated with codon-specific inhibitors of KRAS (including investigational agents) are eligible * KRASG12C mutant participants must have received prior treatment with a KRASG12C inhibitor for any approved indication * Radiologic evidence of measurable disease (i.e., at least 1 target lesion) according to 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 system metastases. * Uncontrolled pleural or pericardial effusion or ascites requiring repeated drainage more than once every 28 days. In dwelling catheters are allowed. * History of severe COVID-19 infection resulting in current need of supplemental O2 therapy to maintain resting oxygen saturations ≥90%. * Presence of ongoing toxicities related to prior anticancer therapy that have not resolved 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 controlled diabetes or any medical condition determined by the Investigator to be a risk * History or concurrent evidence of retinal vein occlusion (RVO) or current risk factors for RVO. History of clinically significant serous retinopathy, central serous 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 a well-controlled HIV infection/disease * Participants with a history of HBV infection no longer requiring treatment are eligible; participants with a history of HCV infection are eligible if HCV viral load is undetectable at screening. * Females who are pregnant, breastfeeding, or planning to become pregnant and males who plan to father a child while enrolled in this study.
References
Publications (0)
Data not yet available
No reference posted for this study.