A Study to Investigate the Safety and Efficacy of KQB198 as Monotherapy and in Combination in Par… (NCT06507306) | Clinical Trial Compass
Active — Not RecruitingPhase 1
A Study to Investigate the Safety and Efficacy of KQB198 as Monotherapy and in Combination in Participants With Advanced Solid Malignancies
United States, France, Italy92 participantsStarted 2024-06-03
Plain-language summary
The goal of this clinical trial is to learn if KQB198 works to treat advanced solid tumor cancer in adults. It will also learn about the safety of KQB198. The main questions it aims to answer are:
* What is the safe dose of KQB198 by itself or in combination with other anti-cancer drugs?
* Does KQB198 alone or in combination with other anti-cancer drugs decrease the size of the tumor?
* What happens to KQB198 in the body?
Participants will:
* Take KQB198 daily, alone or in combination with another anti-cancer drug
* Visit the clinic about 8 times in the first 8 weeks, and then once every 4 weeks after that
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* PART 1 - Histologically confirmed diagnosis of a solid tumor malignancy with any of the following oncogenic mutations: EGFR, RAS, PTPN11, or SOS1 mutations, or inactivating mutations of NF1.
* PART 1 - (Osimertinib and Amivantamab arms) and Part 2 Cohort A and Cohort B: Histologically confirmed diagnosis of NSCLC with activating EGFR mutation and progression on osimertinib
* Part 3 - Cohort A: Histologically confirmed diagnosis of NSCLC with exon 20 insertion EGFR mutation
* Unresectable or metastatic disease
* No available treatment with curative intent
* Adequate organ function
* Measurable disease per RECIST 1.1.
Exclusion Criteria:
* Prior therapy with a similar mechanism of action to KQB198
* History of intestinal disease, inflammatory bowel disease, major gastric surgery, or other gastrointestinal conditions likely to alter absorption of study treatment or result in inability to swallow
* History of interstitial lung disease
* Cardiac abnormalities
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since KQB198 is in Phase 1 and the main goal right now is figuring out a safe dose and identifying serious side effects, what does that mean for how much is actually known about whether this drug works for my specific type of solid tumor?
2The trial is listed as 'active not recruiting,' which means they're no longer enrolling new patients — is there any chance I could still be considered for participation, or are there related trials with KQB198 that are still open?
3Part 1 of this trial is specifically tracking dose-limiting toxicities — what kinds of side effects have been observed so far with KQB198, and how would those compare to what I might experience with standard treatment options for my cancer?
4This trial tests KQB198 both as a standalone therapy and in combination with other treatments — if my doctor thought I might benefit from a study like this, which approach would likely apply to my situation, and what would the combination drug be?
5Given that this is an early-phase trial still working out the recommended dose, would it make more sense for me to try an established standard-of-care treatment first, or is there a reason my doctor might consider a Phase 1 trial like this one a reasonable path at this stage?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of patients who experience treatment-emergent adverse events, serious adverse events, and dose-limiting toxicities (Part 1)
Timeframe: 28 Days
2
Recommended Phase 2 Dose (RP2D) (Part 1)
Timeframe: up to 30 months
3
Efficacy and Optimal Biologic Dose of study treatment, as measured by Objective Response Rate (ORR) (Parts 2 and 3)