Trial studying safety and effects for KRAS G12C Mutation
Official title A Study to Investigate the Safety and Efficacy of KQB365 as Monotherapy and in Combination in Participants With Advanced Solid Malignancies
ClinicalTrials.gov ID: NCT06720987
What this study is testing
What is KQB365?
KQB365 is an investigational medicine, given as a once-weekly IV infusion (through a vein), being studied as a potential treatment for kras g12c mutation.
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
- This study is testing whether KQB365 works to shrink tumors. It also checks how safe the drug is and how the body handles it.
- Who it's for
- You may be able to join if you have advanced solid tumor cancer.
- What's involved
- You would get a weekly IV infusion of KQB365. You might also take other medicines like cetuximab or KQB198.
- Time commitment
- You would visit the clinic about nine times in the first six weeks. After that, you would visit once a week.
- Phase 1: an early, usually small safety 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
- PART 1 (monotherapy and combo therapy with KQB198): Histologically confirmed diagnosis of a solid tumor malignancy with either a KRAS G12C or KRAS...
- PART 1 (combo therapy with Cetuximab) \& PART 2: Histologically confirmed diagnosis of adenocarcinoma of the colon or rectum with either a KRAS G12C...
- PART 1 (monotherapy Non-Small Cell Lung Cancer Cohort): Histologically confirmed diagnosis of Non-Small Cell Lung Cancer with either a KRAS G12C or...
- Unresectable or metastatic disease
- No available treatment with curative intent
You likely can't join if
- Active primary central nervous system tumors
- Cardiac abnormalities
- Active interstitial lung disease
- Unable to swallow or GI condition that prevents absorption for patients in KQB198 combination cohorts
See the full eligibility criteria
- PART 1 (monotherapy and combo therapy with KQB198): Histologically confirmed diagnosis of a solid tumor malignancy with either a KRAS G12C or KRAS G12S mutation.
- PART 1 (combo therapy with Cetuximab) \& PART 2: Histologically confirmed diagnosis of adenocarcinoma of the colon or rectum with either a KRAS G12C or KRAS G12S mutation.
- PART 1 (monotherapy Non-Small Cell Lung Cancer Cohort): Histologically confirmed diagnosis of Non-Small Cell Lung Cancer with either a KRAS G12C or KRAS G12S mutation.
- Unresectable or metastatic disease
- No available treatment with curative intent
- Adequate organ function
- Measurable disease per RECIST v1.1
- Active primary central nervous system tumors
- Cardiac abnormalities
- Active interstitial lung disease
- Unable to swallow or GI condition that prevents absorption for patients in KQB198 combination cohorts
The study team makes the final eligibility decision.
Where it is enrolling
- Phoenix, Arizona, United States
- Denver, Colorado, United States
- Jacksonville, Florida, United States
- Boston, Massachusetts, United States
- Grand Rapids, Michigan, United States
- Rochester, Minnesota, United States
- Cleveland, Ohio, United States
- Oklahoma City, Oklahoma, United States
- Philadelphia, Pennsylvania, United States
- San Antonio, Texas, United States
- Fairfax, Virginia, United States
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; Denver, Colorado, United States; Jacksonville, Florida, United States; Boston, Massachusetts, United States; Grand Rapids, Michigan, United States; Rochester, Minnesota, United States and 5 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.