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Advanced Solid Tumors With KRAS G12C MutationsPhase 1/2PROSPERNCT06244771

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

A Phase 1/2 study testing FMC-376 in people with Advanced Solid Tumors With KRAS G12C Mutations and Solid Tumor, Adult, run by Frontier Medicines Corporation at 26 sites in 3 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

The goal of this clinical trial is to evaluate FMC-376 monotherapy and in combination with pembrolizumab 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). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
FMC-376
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
293 participants
Where
26 sitesin 3 countries
Study dates
12 Feb 2024to Apr 2028
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
  • NSCLC Participants (in the first-line advanced or metastatic setting who refused standard therapy or standard therapy was considered inappropriate)
  • 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
  • For patients receiving FMC-376 in combination with pembrolizumab: No history of autoimmune disease, and no history of immune-related adverse events or hepatitis

Who cannot join

  • 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
  • For patients receiving FMC-376 in combination with pembrolizumab: Has severe hypersensitivity (≥ Grade 3) to pembrolizumab, history of radiation-related toxicities, or history of non-infectious pneumonitis.

Trial locations and contacts

26 sites in 3 countries. Contact the study team or a site near you to ask about taking part.

Medical Lead contact

+1 (650) 457-1005

clinicaltrials@frontiermeds.com

26 sites in 3 countries

United States15 sites, 11 recruiting

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215

    Study Coordinator, 877-338-7425, matthew_olszewski@dfci.harvard.edu

    Recruiting

  • Karmanos Cancer Institute

    Detroit, Michigan, 48201

    Study Coordinator, 313-576-9816, galiciv@karmanos.org

    Recruiting

  • Northwest Cancer Centers

    Dyer, Indiana, 46311

    Study Coordinator, 219-924-8178, karyn.burnworth@usoncology.com

    Recruiting

  • Virginia Cancer Specialists

    Fairfax, Virginia, 22031

    Clinical Trials Nurse Navigator, 703-636-1473, carrie.friedman@usoncology.com

    Recruiting

  • The University of Kansas Cancer Center

    Fairway, Kansas, 66205

    Study Coordinator, 913-945-7552, CTNurseNav@kumc.edu

    Recruiting

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030

    Study Coordinator, 1-888-513-6613, adeshmukh1@mdanderson.org

    Recruiting

  • Community Clinical Trials

    Kingwood, Texas, 77339

    Completed

  • University of California San Diego (UC San Diego) Health - Jacobs Medical Center - Moores Cancer Center

    La Jolla, California, 92037

    Study Coordinator, 858-822-5354, rrpatel@health.ucsd.edu

    Recruiting

  • Florida Cancer Specialists and Research Institute

    Lake Mary, Florida, 32746

    Completed

  • University of California Irvine (UCI) - Chao Family Comprehensive Cancer Center

    Orange, California, 92868

    Completed

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

    Program Manager, 267-414-6179, jennifer.louie2@pennmedicine.upenn.edu

    Recruiting

  • South Texas Accelerated Research Therapeutics, LLC

    San Antonio, Texas, 78229

    Physician Referral Coordinator, 210-593-5265, isabel.jimenez@startsa.com

    Recruiting

  • UT Health San Antonio

    San Antonio, Texas, 78229

    Clinical Trials Specialist, 210-450-5798, goodwine@uthscsa.edu

    Recruiting

  • University of California San Francisco (UCSF) - Helen Diller Family Comprehensive Cancer Center

    San Francisco, California, 94158

    Project Manager, 415-344-8642, Lauren.Helwig@ucsf.edu

    Recruiting

  • START Mountain Region

    West Valley City, Utah, 84119

    Completed

Other trials in United States

Australia6 sites, 4 recruiting

  • Eastern Health - Box Hill Hospital

    Box Hill, Victoria, 3128

    Completed

  • Icon Cancer Centre Kurralta Park

    Kurralta Park, South Australia, 5037

    Sue Yeend, +61 8 84740240, adelaideresearch@icon.team

    Recruiting

  • Macquarie University

    Macquarie Park, New South Wales, 2109

    Study Contact, +61 2 9812 2956, clinicaltrials@mq.edu.au

    Recruiting

  • Linear Clinical Research Ltd

    Nedlands, Western Australia, 6009

    Head of Project Operations, 61 (08) 6382 5100, actcmanagement@linear.org.au

    Recruiting

  • GenesisCare North Adelaide

    North Adelaide, South Australia, 5006

    Completed

  • Tasman Health Care

    Southport, Queensland, 4215

    Study Contact, (07) 5613 2480, research@tasmanhealthcare.com.au

    Recruiting

Other trials in Australia

South Korea5 sites, 5 recruiting

  • Seoul National University Bundang Hospital

    Gyeonggi-do, Seongnam-si, 13620

    International Healthcare Center, +82-31-787-2034, ihsi@snubh.org

    Recruiting

  • The Catholic University of Korea, St. Vincent's Hospital

    Gyeonggi-do, Suwon-si, 16247

    International Health Care Center, +82-31-249-8016

    Recruiting

  • Seoul National University Hospital

    Seoul, Jongno-gu, 03080

    Medical Service, +82-2-2072-2890, international@snuh.org

    Recruiting

  • Severance Hospital

    Seoul, Seodaemun-gu, 03722

    International Health Care Center, +82-2-2228-5800, ihcc@yuhs.ac

    Recruiting

  • Korea University Anam Hospital

    Seoul, Seongbuk-gu, 02841

    International Healthcare Center, +82-2-920-5677, kumcihc@kumc.or.kr

    Recruiting

Other trials in South Korea

About this study

Official 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 Monotherapy and in Combination With Pembrolizumab in Participants With KRAS G12C Mutated Advanced Solid Tumors

The goal of this clinical trial is to evaluate FMC-376 monotherapy and in combination with pembrolizumab 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.

Being tested
FMC-376
Keywords
Lung Cancer, KRAS, G12C
Medical subject headings
Neoplasm Metastasis, Carcinoma, Non-Small-Cell Lung, Lung Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FMC-376Drug

    Oral Daily

Study groups in NCT06244771
Study groupRoleWhat they receive
FMC-376ExperimentalDose Escalation, Dose Expansion, and Cohort Expansion; Administered for 21-day cycle
Receives: Drug: FMC-376

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Ph 1a: Dose Limiting Toxicities

    Number of participants with Dose Limiting Toxicities (DLTs)

    Measured: Up to 21 Days

  2. Ph 1a: Adverse Events (AEs)

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

    Measured: Approximately 24 Months

  3. Ph 1b/Ph2: Overall Response Rate (ORR)

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

    Measured: Approximately 24 Months

Secondary outcomes (12)

  1. Ph1a/Ph1b/Ph2: Maximum Observed Plasma Concentration (Cmax) of FMC-376

    Cmax

    Measured: Approximately 24 Months

  2. Ph1a/Ph1b/Ph2: Time to Reach Maximum Blood Concentration (Tmax) of FMC-376

    Tmax

    Measured: Approximately 24 Months

  3. Ph1a/Ph1b/Ph2: Minimum Observed Plasma Concentration (Cmin) of FMC-376

    Cmin

    Measured: Approximately 24 Months

  4. Ph1a/Ph1b/Ph2: Elimination Half-life (t1/2) of FMC-376

    t1/2

    Measured: Approximately 24 Months

  5. Ph1a/Ph1b/Ph2: Area Under Blood Concentration-Time Curve (AUC) of FMC-376

    AUC

    Measured: Approximately 24 Months

  6. Ph1a/Ph1b/Ph2: Volume of Distribution (Vd) of FMC-376

    Vd

    Measured: Approximately 24 Months

  7. Ph1a/Ph1b/Ph2: Clearance (CL) of FMC-376 from Blood Plasma

    CL

    Measured: Approximately 24 Months

  8. Ph1a: Overall Response Rate (ORR)

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

    Measured: Approximately 24 Months

  9. Ph1a/Ph1b/Ph2: Duration of Response (DOR)

    Assess per RECIST v1.1

    Measured: Approximately 24 Months

  10. Ph1a/Ph1b/Ph2: Disease Control Rate (DCR)

    Assess per RECIST v1.1

    Measured: Approximately 24 Months

  11. Ph1a/Ph1b/Ph2: Progression-Free Survival (PFS)

    Assess per RECIST v1.1

    Measured: Approximately 24 Months

  12. Ph1a/Ph1b/Ph2: Overall Survival (OS)

    Measured: Approximately 24 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Feb 2024
  2. Study start12 Feb 2024
  3. Primary completionOct 2027 (estimated)
  4. Study completionApr 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential
Model description
Phase 1A: sequential; Phase 1B and Phase 2: parallel
Masking
None (open label)
Enrolment
293 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06244771
Sponsor's protocol ID
FMC-376-CL101
Acronym
PROSPER
Status last verified
Oct 2026
First submitted
19 Jan 2024
Last updated
19 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing FMC-376 in people with Advanced Solid Tumors With KRAS G12C Mutations and Solid Tumor, Adult, run by Frontier Medicines Corporation at 26 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 26 sites in United States, Australia, South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Medical Lead (+1 (650) 457-1005, clinicaltrials@frontiermeds.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Ph 1a: Dose Limiting Toxicities (time frame: Up to 21 Days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06244771.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2026.

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