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

Conditions

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

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• IMM-1-104 Monotherapy (Treatment Group A) — DRUG
  Once-daily, oral IMM-1-104 dose administered in 28-day cycles until treatment discontinuation criteria are met
• IMM-1-104 + modified Gemcitabine/nab-Paclitaxel (Treatment Group B) — DRUG
  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
• IMM-1-104 + modified FOLFIRINOX (Treatment Group C) — DRUG
  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
• IMM-1-104 + dabrafenib (Treatment Group D) — DRUG
  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).
• IMM-1-104 + pembrolizumab (Treatment Group E) — DRUG
  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.

Study Details

This is an open-label, dose-exploration and expansion study to determine the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of IMM-1-104 when administered as monotherapy or in combination with approved agents in participants with RAS-mutated or RAS/MAPK activated advanced or metastatic solid tumors. The dose exploration will identify the candidate recommended Phase 2 candidate optimal dose of IMM-1-104 to further explore the anti-tumor activity of IMM-1-104 as monotherapy and in combination with approved agents in multiple Phase 2a proof-of-concept cohorts in malignancies of interest.

Key Dates

Start date

Oct 31, 2022

Status verified

Aug 2025

Primary completion

Jun 30, 2026

Completion

Jun 30, 2027

Study Design

Enrollment

209 participants (actual)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

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
• Experimental: IMM-1-104 in combination with dabrafenib (Treatment Group D)
  IMM-1-104 in combination with dabrafenib for second/third line post-IO melanoma with BRAF mutation
• Experimental: IMM-1-104 in combination with pembrolizumab (Treatment Group E)
  IMM-1-104 in combination with pembrolizumab for second/third line post-IO melanoma

Primary Outcome Measure

Phase 1: Adverse Events [ Time Frame: From treatment initiation through 30 days following the last IMM-1-104 dose ]

Locations (20)

Find similar trials in Scottsdale, AZ

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