Testing KST-6051 in advanced cancers with a KRAS mutation
Tests the safety of KST-6051 in adults with KRAS-mutant advanced solid tumors.
Key facts
- Who runs it
- Kestrel Therapeutics, Inc.
- Where
- Boston, Fairfax, Houston, Los Angeles, Philadelphia, Salt Lake City, San Antonio, Sarasota, and Tampa, United StatesSee the 9 sites
- Trial code
- Registry title
- A Phase 1 Dose Escalation and Dose Expansion Trial of KST-6051 in Participants With Advanced Solid Tumors With Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) Mutation
- Status
- Recruiting
- Phase
- Phase 1
- People taking part
- 545 people, planned
- Started
- 21 Apr 2026
- Expected to end
- Apr 2029
- Type of study
- Interventional, 13 groups
- Treatments tested
- KST-6051
- Gemcitabine/nab-paclitaxel
- Cetuximab
- Pembrolizumab
- mFOLFOX6
- FOLFIRI
- Pemetrexed
- Carboplatin
- Record updated
- 12 November 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with advanced or metastatic solid tumors that carry a KRAS mutation, such as lung, pancreatic or colorectal cancer.
- Age
- 18 years or older.
- Sex
- All sexes can join.
- Disease stage
- Locally advanced tumor that cannot be removed by surgery, or metastatic tumor (lung cancer NSCLC, pancreatic cancer PDAC, colorectal cancer CRC, or another solid tumor). Disease that can be measured at the start (RECIST 1.1).
- Biomarker or test result
- A documented KRAS mutation before the first dose of trial drug.
Main reasons for not taking part
- Brain or spinal cord (CNS) tumors, or untreated or unstable metastases
- Cannot swallow oral medications
- Pregnant, breastfeeding, or planning to conceive or father children during the trial
The registry criteria, word for word
Show all 10 criteriaShow less
Who can take part
- 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)
Who cannot take part
- Inability to swallow oral medications
- Central nervous system (CNS) tumors or untreated or unstable metastases
- 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
Where in United States
- Mass General Brigham Cancer Institute at Massachusetts General HospitalBoston, United StatesContact: Kestrel Therapeutics, Inc.Taking people
- NEXT VirginiaFairfax, United StatesContact: Carrie Friedman, RN, BSN, OCNTaking people
- The University of Texas MD Anderson Cancer CenterHouston, United StatesContact: David Hong, MDTaking people
- Cedars-Sinai Medical CenterLos Angeles, United StatesContact: Kestrel Therapeutics, Inc.Taking people
- Sidney Kimmel Cancer CenterPhiladelphia, United StatesContact: Ask Phase 1 (central mailbox)Taking people
- Huntsman Cancer Institute/University of UtahSalt Lake City, United StatesContact: Susan Sharry, CCRPTaking people
- NEXT OncologySan Antonio, United StatesContact: Kestrel Therapeutics, Inc.Taking people
- Florida Cancer SpecialistsSarasota, United StatesContact: Kestrel Therapeutics, Inc.Taking people
- Moffitt Cancer CenterTampa, United StatesContact: Kestrel Therapeutics, Inc.Taking people
About the trial
What the trial wants to find out
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.
The 13 groups in the trial
- KST-6051 Dose Escalation MonotherapyTreatment being tested
Sequential cohorts with increasing doses of KST-6051 as monotherapy will be evaluated to determine recommended dose(s) for expansion (RDE\[s\]).
Treatment: KST-6051
- KST-6051 Dose Escalation Combination Therapy with Gemcitabine/Nab-paclitaxelTreatment being tested
Sequential cohorts with increasing doses of KST-6051 as combination therapy with a standard dose of gemcitabine/nab-paclitaxel will be evaluated in participants with previously treated PDAC.
Treatment: KST-6051 and Gemcitabine/nab-paclitaxel
- KST-6051 Dose Escalation Combination Therapy with CetuximabTreatment being tested
Sequential cohorts with increasing doses of KST-6051 as combination therapy with a standard dose of cetuximab will be evaluated in participants with previously treated KRAS-mutant mCRC.
Treatment: KST-6051 and Cetuximab
- KST-6051 Dose Escalation Combination Therapy with PembrolizumabTreatment being tested
Sequential cohorts with increasing doses of KST-6051 as combination therapy with a standard dose of pembrolizumab will be evaluated in participants with first- or second-line KRAS-mutant NSCLC.
Treatment: KST-6051 and Pembrolizumab
- KST-6051 Dose Expansion Monotherapy in PDAC After 1 or 2 Prior Lines of TherapyTreatment being tested
Dose expansion cohorts will be evaluated to further investigate KST-6051 as monotherapy in PDAC after 1 or 2 prior lines of therapy.
Treatment: KST-6051
- KST-6051 Dose Expansion Monotherapy in mCRC After 1 or 2 prior Lines of TherapyTreatment being tested
Dose expansion cohorts will be evaluated to further investigate KST-6051 as monotherapy in mCRC after 1 or 2 prior lines of therapy.
Treatment: KST-6051
- KST-6051 Dose Expansion Monotherapy in NSCLC After 1 or 2 Prior Lines of TherapyTreatment being tested
Dose expansion cohorts will be evaluated to further investigate KST-6051 as monotherapy in NSCLC after 1 or 2 prior lines of therapy.
Treatment: KST-6051
- KST-6051 Dose Expansion Monotherapy in Prior RAS/KRAS Inhibitor-treated Solid TumorsTreatment being tested
Dose expansion cohorts will be evaluated to further investigate KST-6051 as monotherapy in prior RAS/KRAS inhibitor-treated solid tumors.
Treatment: KST-6051
- KST-6051 Dose Expansion Monotherapy in Later-line SettingsTreatment being tested
Dose expansion cohorts will be evaluated to further investigate KST-6051 as monotherapy in selected KRAS-mutant biliary tract cancer, endometrial cancer (EC), or other solid tumors in later-line settings.
Treatment: KST-6051
- KST-6051 Dose Expansion Combination Therapy with Gemcitabine/nab-paclitaxelTreatment being tested
Dose expansion cohorts will be evaluated to further investigate KST-6051 as combination therapy with gemcitabine/nab-paclitaxel in 1L PDAC.
Treatment: KST-6051 and Gemcitabine/nab-paclitaxel
- KST-6051 Dose Expansion Combination Therapy with CetuximabTreatment being tested
Dose expansion cohorts will be evaluated to further investigate KST-6051 as combination therapy with cetuximab in 2L/3L CRC.
Treatment: KST-6051 and Cetuximab
- KST-6051 Dose Expansion Combination Therapy with Cetuximab and mFOLFOX6 or FOLFIRITreatment being tested
Dose expansion cohorts will be evaluated to further investigate KST-6051 as combination therapy with cetuximab and mFOLFOX6 or FOLFIRI in 1L CRC.
Treatment: KST-6051, Cetuximab, mFOLFOX6, and FOLFIRI
- KST-6051 Dose Expansion Combination Therapy with Pembrolizumab and Pemetrexed/carboplatinTreatment being tested
Dose expansion cohorts will be evaluated to further investigate KST-6051 as combination therapy with pembrolizumab and pemetrexed/carboplatin in 1L NSCLC.
Treatment: KST-6051, Pembrolizumab, Pemetrexed, and Carboplatin
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- 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
- Plain-language title
- Testing KST-6051 in advanced cancers with a KRAS mutationGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 12 November 2026