Recruiting PHASE1 KRAS G12C Mutation

Tests treatment safety and results 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 an once-weekly infusion into 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
The goal of this clinical trial is to learn if KQB365 works to treat advanced solid tumor cancer in adults. It will also learn about the safety of KQB365.
  • 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...
  • Unresectable or metastatic disease
  • No available treatment with curative intent
  • Adequate organ function

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
Who can join
  • 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.
  • Unresectable or metastatic disease
  • No available treatment with curative intent
  • Adequate organ function
  • Measurable disease per RECIST v1.1
What rules you out
  • 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's taking place

  • 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 - 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?

Study sites include 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 location(s). Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.