A Phase 1/2a, Open-Label, Multicenter, Nonrandomized, Safety and Anti-tumor Activity Study of IMM-1-104, a Novel Oral Dual MEK1/2 Inhibitor in Participants With Advanced or Metastatic Solid Tumors

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Record identity and dates

Source

ClinicalTrials.gov

Source record ID

NCT05585320

Title field or adapter rule

{'original_value': 'A Phase 1/2a, Open-Label, Multicenter, Nonrandomized, Safety and Anti-tumor Activity Study of IMM-1-104, a Novel Oral Dual MEK1/2 Inhibitor in Participants With Advanced or Metastatic Solid Tumors', 'source_field': 'protocolSection.identificationModule.officialTitle'}

Ingested At

2026-10-31T23:27:22.909503+00:00

Published At

2026-10-20T00:00:00+00:00

Record Updated At

2026-10-20

Source Retrieved At

2026-10-31T22:19:02.163121+00:00

Timestamp Basis

ClinicalTrials.gov API/RSS response retrieval timestamp recorded by Dossier adapter

Date limitation

ClinicalTrials.gov API/RSS response retrieval timestamp recorded by Dossier adapter

Fields recorded by this source

protocolSection.conditionsModule.conditions

["Advanced Solid Tumor", "Pancreatic Adenocarcinoma", "Malignant Melanoma (Cutaneous)", "Non-small Cell Lung Cancer (NSCLC)"]

protocolSection.statusModule.lastUpdatePostDateStruct

{"date": "2026-10-20", "type": "ACTUAL"}

protocolSection.identificationModule.nctId

"NCT05585320"

protocolSection.identificationModule.officialTitle

"A Phase 1/2a, Open-Label, Multicenter, Nonrandomized, Safety and Anti-tumor Activity Study of IMM-1-104, a Novel Oral Dual MEK1/2 Inhibitor in Participants With Advanced or Metastatic Solid Tumors"

protocolSection.statusModule.overallStatus

"ACTIVE_NOT_RECRUITING"

protocolSection.designModule.phases

["PHASE1", "PHASE2"]

protocolSection.statusModule.resultsFirstPostDateStruct

null

Study condition terms

• Advanced Solid Tumor (protocolSection.conditionsModule.conditions)
• Pancreatic Adenocarcinoma (protocolSection.conditionsModule.conditions)
• Malignant Melanoma (Cutaneous) (protocolSection.conditionsModule.conditions)
• Non-small Cell Lung Cancer (NSCLC) (protocolSection.conditionsModule.conditions)

Interventions recorded in this study

• {'armGroupLabels': ['IMM-1-104 monotherapy (Treatment Group A)'], 'description': 'Once-daily, oral IMM-1-104 dose administered in 28-day cycles until treatment discontinuation criteria are met', 'name': 'IMM-1-104 Monotherapy (Treatment Group A)', 'type': 'DRUG'} (protocolSection.armsInterventionsModule.interventions[])
• {'armGroupLabels': ['IMM-1-104 in combination with mGnP (Treatment Group B)'], 'description': '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.\n\nGemcitabine will be administered at a dose of 1000 mg/m\\^2 nab-Paclitaxel will be administered at a dose of 125 mg/m\\^2', 'name': 'IMM-1-104 + modified Gemcitabine/nab-Paclitaxel (Treatment Group B)', 'type': 'DRUG'} (protocolSection.armsInterventionsModule.interventions[])
• {'armGroupLabels': ['IMM-1-104 in combination with mFFX (Treatment Group C)'], 'description': '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.\n\nFOLFIRINOX will be administered as follows:\n\nFolinic 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', 'name': 'IMM-1-104 + modified FOLFIRINOX (Treatment Group C)', 'type': 'DRUG'} (protocolSection.armsInterventionsModule.interventions[])
• {'armGroupLabels': ['IMM-1-104 in combination with dabrafenib (Treatment Group D)'], 'description': 'Once-daily, oral IMM-1-104 dose administered in 28-day cycles in combination with twice daily oral dose of dabrafenib until treatment discontinuation criteria are met. Dabrafenib will be administered at a dose of 150mg daily (75mg twice daily).', 'name': 'IMM-1-104 + dabrafenib (Treatment Group D)', 'type': 'DRUG'} (protocolSection.armsInterventionsModule.interventions[])
• {'armGroupLabels': ['IMM-1-104 in combination with pembrolizumab (Treatment Group E)'], 'description': 'Once-daily, oral IMM-1-104 dose administered in 28-day cycles in combination with intravenous infusions of pembrolizumab in sequence or concurrently depending on the enrolled cohort (two sub cohorts) until treatment discontinuation criteria are met. Pembrolizumab will be administered at a dose of 400mg.', 'name': 'IMM-1-104 + pembrolizumab (Treatment Group E)', 'type': 'DRUG'} (protocolSection.armsInterventionsModule.interventions[])

An intervention appearing in a study record does not establish an effect or an approved use.

Drug names recorded in this source

• IMM-1-104 Monotherapy (Treatment Group A) (protocolSection.armsInterventionsModule.interventions[].name)
• IMM-1-104 + modified Gemcitabine/nab-Paclitaxel (Treatment Group B) (protocolSection.armsInterventionsModule.interventions[].name)
• IMM-1-104 + modified FOLFIRINOX (Treatment Group C) (protocolSection.armsInterventionsModule.interventions[].name)
• IMM-1-104 + dabrafenib (Treatment Group D) (protocolSection.armsInterventionsModule.interventions[].name)
• IMM-1-104 + pembrolizumab (Treatment Group E) (protocolSection.armsInterventionsModule.interventions[].name)

A recorded drug name is not by itself an indication or a condition-specific relationship.

This index keeps the source fields it imported; it may not contain the complete original record. Verify wording and context in the linked source.