What this study is
The main purpose of the trial is to assess whether the trial drug, KST-6051, is safe and tolerable when administered orally, alone or in combination with other anticancer agents, to adults with advanced or metastatic solid tumors with certain KRAS mutations.
What's being tested
- KST-6051
Intervention · DRUG
KST-6051 will be administered orally as a tablet.
- Gemcitabine/nab-paclitaxel
Intervention · DRUG
Gemcitabine/nab-paclitaxel will be administered intravenously (IV).
- Cetuximab
Intervention · DRUG
Cetuximab will be administered IV.
- Pembrolizumab
Intervention · DRUG
Pembrolizumab will be administered IV.
- mFOLFOX6
Intervention · DRUG
mFOLFOX6 will be administered IV.
- FOLFIRI
Intervention · DRUG
FOLFIRI will be administered IV.
- Pemetrexed
Intervention · DRUG
Pemetrexed will be administered IV.
- Carboplatin
Intervention · DRUG
Carboplatin will be administered IV.
Study details
- Official title
- A First-in-human Phase 1 Dose Escalation and Dose Expansion Study Evaluating the Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of KST-6051 in Patients With Advanced or Metastatic Solid Tumors With a KRAS Mutation
- Sponsor
- Kestrel Therapeutics, Inc.
- Conditions
- KRAS-mutant Non-small Cell Lung Cancer (NSCLC) · KRAS-mutant Pancreatic Ductal Adenocarcinoma (PDAC) · KRAS-mutant Colorectal Cancer (CRC) · Other KRAS-mutant Solid Tumors
- Enrolling
- 545 people
- Starts
- 2026-04-21
- Est. completion
- 2029-04
- Design
- Open-label, non-randomized, sequential groups, Phase 1
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- Age ≥ 18 years.
- Willing and able to give written informed consent.
- Histologically documented locally advanced and unresectable or metastatic NSCLC, PDAC, CRC, or other solid tumor.
- Documentation of KRAS mutation prior to the first dose of trial drug(s).
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1.
- Adequate cardiovascular, hematological, liver, and renal function.
- Measurable disease at baseline per Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST 1.1).
You can't join if
- Central nervous system (CNS) tumors or untreated or unstable metastases.
- Inability to swallow oral medications.
- Pregnant, breastfeeding, or expecting to conceive or father children within the projected duration of the trial. Other inclusion/exclusion criteria are specified in the protocol.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (9)
9 openCedars-Sinai Medical Center
Los Angeles, California, United States
RecruitingFlorida Cancer Specialists
Sarasota, Florida, United States
RecruitingMoffitt Cancer Center
Tampa, Florida, United States
RecruitingMass General Brigham Cancer Institute at Massachusetts General Hospital
Boston, Massachusetts, United States
RecruitingSidney Kimmel Cancer Center
Philadelphia, Pennsylvania, United States
RecruitingThe University of Texas MD Anderson Cancer Center
Houston, Texas, United States
RecruitingNEXT Oncology
San Antonio, Texas, United States
RecruitingHuntsman Cancer Institute, University of Utah
Salt Lake City, Utah, United States
RecruitingNEXT Virginia
Fairfax, Virginia, United States
Recruiting
Study team
Sponsor
Kestrel Therapeutics, Inc.
Study ID KST-6051-101
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.