Clinical trial for Colon Adenocarcinoma
Official title A Clinical Study of Calderasib (MK-1084) With Targeted Therapy and Chemotherapy in People With Colorectal Cancer (MK-1084-012/KANDLELIT-012)
ClinicalTrials.gov ID: NCT06997497
What this study is testing
What is Calderasib?
An investigational oral tablet being studied for locally advanced or metastatic colorectal cancer with a KRAS G12C mutation.
Also referred to as MK-1084.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study aims to see if the new drug combination is safe and if it can keep cancer from growing or spreading longer than usual chemo alone.
- Who it's for
- It is looking for adults with advanced or metastatic colon or rectal cancer that has a KRAS G12C mutation and cannot be removed by surgery.
- What's involved
- Participants will receive the study drugs plus standard chemotherapy, have regular doctor visits, blood tests, and scans to monitor safety and cancer status.
- Time commitment
- The trial lasts about 2 years, with frequent visits during treatment and follow‑up appointments afterward.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Has a histologically confirmed diagnosis of locally advanced unresectable or metastatic (unresectable Stage III or Stage IV as defined by American...
- Part 2 only: Has not received systemic anticancer therapy for locally advanced unresectable or metastatic colorectal cancer
- Demonstrates presence of a Kirsten rat sarcoma viral oncogene homolog G12C (KRAS G12C) mutation
- Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy (ART)
- Participants who are Hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy and...
You likely can't join if
- Has active inflammatory bowel disease requiring immunosuppressive medication or previous clear history of inflammatory bowel disease (eg, Crohn's...
- Has uncontrolled, significant cardiovascular disease or cerebrovascular disease
- Has known partial or complete dihydropyrimidine dehydrogenase (DPD) deficiency
- HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
- Has received prior systemic anticancer therapy including investigational agents within 4 weeks before randomization, with the exception of the...
- Has 1 or more conditions that, in the opinion of the investigator, make the participant ineligible for treatment with bevacizumab
See the full eligibility criteria
- Has a histologically confirmed diagnosis of locally advanced unresectable or metastatic (unresectable Stage III or Stage IV as defined by American Joint Committee on Cancer [AJCC] eighth edition) colorectal...
- Part 2 only: Has not received systemic anticancer therapy for locally advanced unresectable or metastatic colorectal cancer
- Demonstrates presence of a Kirsten rat sarcoma viral oncogene homolog G12C (KRAS G12C) mutation
- Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy (ART)
- Participants who are Hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy and have undetectable HBV viral load
- Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable
- Has active inflammatory bowel disease requiring immunosuppressive medication or previous clear history of inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis, chronic diarrhea)
- Has uncontrolled, significant cardiovascular disease or cerebrovascular disease
- Has known partial or complete dihydropyrimidine dehydrogenase (DPD) deficiency
- HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
- Has received prior systemic anticancer therapy including investigational agents within 4 weeks before randomization, with the exception of the optional chemotherapy
- Has 1 or more conditions that, in the opinion of the investigator, make the participant ineligible for treatment with bevacizumab
- Has known additional malignancy that is progressing or has required active treatment within the past 3 years
- Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis or leptomeningeal disease
- Has active infection requiring systemic therapy
- Has not adequately recovered from major surgery or have ongoing surgical complications
- Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
The study team makes the final eligibility decision.
Where it is enrolling
- Phoenix, Arizona, United States
- Fountain Valley, California, United States
- Los Angeles, California, United States
- Sacramento, California, United States
- Santa Monica, California, United States
- Fort Collins, Colorado, United States
- Lone Tree, Colorado, United States
- Fort Myers, Florida, United States
- Jacksonville, Florida, United States
- Orlando, Florida, United States
- St. Petersburg, Florida, United States
- West Palm Beach, Florida, United States
- Atlanta, Georgia, United States
- Boise, Idaho, United States
- Evanston, Illinois, United States
- Lisle, Illinois, United States
- Indianapolis, Indiana, United States
- Iowa City, Iowa, United States
- Lexington, Kentucky, United States
- Louisville, Kentucky, United States
+ 198 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Phoenix, Arizona, United States; Fountain Valley, California, United States; Los Angeles, California, United States; Sacramento, California, United States; Santa Monica, California, United States; Fort Collins, Colorado, United States and 212 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.