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NCT Number: NCT06244771

A Study Evaluating FMC-376 in Participants With KRAS G12C Mutated Solid Tumors

The goal of this clinical trial is to evaluate FMC-376 in participants with advanced solid tumors with KRAS G12C mutations. This clinical trial will be conducted in 3 parts: Phase 1A (Dose Escalation), Phase 1B (Dose Expansion), and Phase 2 (Cohort Expansion). Multiple dose levels in participants with advanced solid tumors will be evaluated.

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Key information

Conditions

Advanced Solid Tumors With KRAS G12C Mutations Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Colonic Diseases Colorectal Cancer Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms KRAS G12C Lung Diseases Lung Neoplasms Metastatic Solid Tumor Neoplasm Metastasis Neoplasms Neoplasms by Site Neoplastic Processes Non Small Cell Lung Cancer Pancreatic Cancer Pancreatic Diseases Pancreatic Neoplasms Pathologic Processes Pathological Conditions, Signs and Symptoms Rectal Diseases Respiratory Tract Diseases Respiratory Tract Neoplasms Solid Tumor, Adult Thoracic Neoplasms Unresectable Solid Tumor

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Macquarie University, Macquarie Park, New South Wales, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Histologically or cytologically confirmed locally advanced unresectable or metastatic solid tumors with KRAS G12C mutation
  • Received and progressed or been intolerant to prior standard therapy OR standard therapy is considered inappropriate OR an investigational agent is considered standard of care
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
  • Adequate hematological, renal, and hepatic function
  • Agrees not to participate in another interventional study while receiving study drug

Exclusion criteria

  • Leptomeningeal disease or carcinomatous meningitis
  • Clinically significant toxicity resulting from prior cancer therapies
  • Known or suspected hypersensitivity to FMC-376 or any components of the study drug
  • Condition that would interfere with study drug absorption
  • Any illness or medical history that would impact safety or compliance with study requirements or impact ability to interpret study data

Treatment and study plan

FMC-376

Drug

Oral Capsule Daily

Primary outcomes

  1. Dose Limiting Toxicities

    Time frame: Up to 21 Days

    Number of participants with Dose Limiting Toxicities (DLTs)

  2. Adverse Events (AEs)

    Time frame: Approximately 24 Months

    Number of participants with treatment-emergent adverse events (TEAEs)

Secondary outcomes

  1. Maximum Observed Plasma Concentration (Cmax) of FMC-376

    Time frame: Approximately 24 Months

    Cmax

  2. Time to Reach Maximum Blood Concentration (Tmax) of FMC-376

    Time frame: Approximately 24 Months

    Tmax

  3. Minimum Observed Plasma Concentration (Cmin) of FMC-376

    Time frame: Approximately 24 Months

    Cmin

  4. Elimination Half-life (t1/2) of FMC-376

    Time frame: Approximately 24 Months

    t1/2

  5. Area Under Blood Concentration-Time Curve (AUC) of FMC-376

    Time frame: Approximately 24 Months

    AUC

  6. Volume of Distribution (Vd) of FMC-376

    Time frame: Approximately 24 Months

    Vd

  7. Clearance (CL) of FMC-376 from Blood Plasma

    Time frame: Approximately 24 Months

    CL

  8. Overall Response Rate (ORR)

    Time frame: Approximately 24 Months

    Assess per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

  9. Duration of Response (DOR)

    Time frame: Approximately 24 Months

    Assess per RECIST v1.1

  10. Disease Control Rate (DCR)

    Time frame: Approximately 24 Months

    Assess per RECIST v1.1

  11. Progression-Free Survival (PFS)

    Time frame: Approximately 24 Months

    Assess per RECIST v1.1

  12. Overall Survival (OS)

    Time frame: Approximately 24 Months

Study contacts

Contact information is provided by the study sponsor or research team.

Medical Lead

CONTACT

[email protected]

+1 (650) 457-1005

Sponsors and collaborators

Lead sponsor

Frontier Medicines Corporation

Industry

Registry information

Official study title

An Open-Label, Phase 1/2 Dose Escalation, Dose Expansion and Cohort Expansion Study Evaluating the Safety, PK and Clinical Activity of FMC-376 in Participants With KRAS G12C Mutated Locally Advanced Unresectable or Metastatic Solid Tumors

Acronym: PROSPER

Important dates

Study start
2024
Primary completion
2027
Study completion
2028
First posted
Feb 6, 2024
Registry last updated
Mar 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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