KRAS-mutant Non-small Cell Lung Cancer (NSCLC)Phase 1NCT07458347
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
A Phase 1 study testing KST-6051, Gemcitabine/nab-paclitaxel and Cetuximab in people with KRAS-mutant Non-small Cell Lung Cancer (NSCLC) and KRAS-mutant Pancreatic Ductal Adenocarcinoma (PDAC), run by Kestrel Therapeutics, Inc. at 9 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- KRAS-mutant Non-small Cell Lung Cancer (NSCLC), KRAS-mutant Pancreatic Ductal Adenocarcinoma (PDAC), KRAS-mutant Colorectal Cancer (CRC)
- What is being tested?
- KST-6051, Gemcitabine/nab-paclitaxel and Cetuximab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 545 participants
- Where
- 9 sitesUnited States
- Study dates
- 21 Apr 2026to Apr 2029
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 join
- 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.
Trial locations and contacts
9 sites in 1 country. Contact the study team or a site near you to ask about taking part.
9 sites in 1 country
United States9 sites, 9 recruiting
- Recruiting
Mass General Brigham Cancer Institute at Massachusetts General Hospital
Boston, Massachusetts, 02114
- Recruiting
NEXT Virginia
Fairfax, Virginia, 22031
- Recruiting
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
- Recruiting
Cedars-Sinai Medical Center
Los Angeles, California, 90048
- Recruiting
Sidney Kimmel Cancer Center
Philadelphia, Pennsylvania, 19107
- Recruiting
Huntsman Cancer Institute, University of Utah
Salt Lake City, Utah, 84112
- Recruiting
NEXT Oncology
San Antonio, Texas, 78229
- Recruiting
Florida Cancer Specialists
Sarasota, Florida, 34232
- Recruiting
Moffitt Cancer Center
Tampa, Florida, 33612
About this study
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
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.
Read the detailed description
This is a first-in-human, phase 1, open-label, multicenter clinical trial designed to evaluate safety, tolerability, pharmacokinetics, biomarkers, pharmacodynamics and preliminary activity of orally administered KST-6051 as monotherapy or in combination with other anticancer agents. The trial seeks to enroll adults with advanced or metastatic KRAS mutant solid tumors including but not limited to pancreatic ductal adenocarcinoma, colorectal cancer, and non-small cell lung cancer whose cancers have progressed after prior therapy or in whom standard therapy was not tolerated. The trial includes a dose escalation phase in which higher doses of KST-6051 will be given in subsequent groups of participants. The trial also includes a dose expansion phase to further investigate KST-6051. Participants can stay in the trial as long as they benefit from the treatment and can tolerate it.
- 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
- Being tested
- KST-6051, Gemcitabine/nab-paclitaxel, Cetuximab, Pembrolizumab, mFOLFOX6
- Keywords
- Advanced Solid Tumors, Metastatic Solid Tumors, KRAS Mutation, KST-6051, KRAS, Lung Cancer, Pancreatic Cancer, Colorectal Cancer, Colon Cancer, Rectal Cancer, Endometrial Cancer, Cholangiocarcinoma, Metastatic Cancer, Pan KRAS, Biliary Tract Cancer, Post-RAS targeted therapies
- Medical subject headings
- Lung Neoplasms, Pancreatic Neoplasms, Colorectal Neoplasms, Colonic Neoplasms, Rectal Neoplasms, Endometrial Neoplasms, Cholangiocarcinoma, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KST-6051Drug
KST-6051 will be administered orally as a tablet.
Gemcitabine/nab-paclitaxelDrug
Gemcitabine/nab-paclitaxel will be administered intravenously (IV).
CetuximabDrug
Cetuximab will be administered IV.
PembrolizumabDrug
Pembrolizumab will be administered IV.
mFOLFOX6Drug
mFOLFOX6 will be administered IV.
FOLFIRIDrug
FOLFIRI will be administered IV.
PemetrexedDrug
Pemetrexed will be administered IV.
CarboplatinDrug
Carboplatin will be administered IV.
| Study group | Role | What they receive |
|---|---|---|
| KST-6051 Dose Escalation Monotherapy | Experimental | Sequential cohorts with increasing doses of KST-6051 as monotherapy will be evaluated to determine recommended dose(s) for expansion (RDE[s]). Receives: Drug: KST-6051 |
| KST-6051 Dose Escalation Combination Therapy with Gemcitabine/Nab-paclitaxel | Experimental | 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. Receives: Drug: KST-6051; Drug: Gemcitabine/nab-paclitaxel |
| KST-6051 Dose Escalation Combination Therapy with Cetuximab | Experimental | 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. Receives: Drug: KST-6051; Drug: Cetuximab |
| KST-6051 Dose Escalation Combination Therapy with Pembrolizumab | Experimental | 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. Receives: Drug: KST-6051; Drug: Pembrolizumab |
| KST-6051 Dose Expansion Monotherapy in PDAC After 1 or 2 Prior Lines of Therapy | Experimental | Dose expansion cohorts will be evaluated to further investigate KST-6051 as monotherapy in PDAC after 1 or 2 prior lines of therapy. Receives: Drug: KST-6051 |
| KST-6051 Dose Expansion Monotherapy in mCRC After 1 or 2 prior Lines of Therapy | Experimental | Dose expansion cohorts will be evaluated to further investigate KST-6051 as monotherapy in mCRC after 1 or 2 prior lines of therapy. Receives: Drug: KST-6051 |
| KST-6051 Dose Expansion Monotherapy in NSCLC After 1 or 2 Prior Lines of Therapy | Experimental | Dose expansion cohorts will be evaluated to further investigate KST-6051 as monotherapy in NSCLC after 1 or 2 prior lines of therapy. Receives: Drug: KST-6051 |
| KST-6051 Dose Expansion Monotherapy in Prior RAS/KRAS Inhibitor-treated Solid Tumors | Experimental | Dose expansion cohorts will be evaluated to further investigate KST-6051 as monotherapy in prior RAS/KRAS inhibitor-treated solid tumors. Receives: Drug: KST-6051 |
| KST-6051 Dose Expansion Monotherapy in Later-line Settings | Experimental | 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. Receives: Drug: KST-6051 |
| KST-6051 Dose Expansion Combination Therapy with Gemcitabine/nab-paclitaxel | Experimental | Dose expansion cohorts will be evaluated to further investigate KST-6051 as combination therapy with gemcitabine/nab-paclitaxel in 1L PDAC. Receives: Drug: KST-6051; Drug: Gemcitabine/nab-paclitaxel |
| KST-6051 Dose Expansion Combination Therapy with Cetuximab | Experimental | Dose expansion cohorts will be evaluated to further investigate KST-6051 as combination therapy with cetuximab in 2L/3L CRC. Receives: Drug: KST-6051; Drug: Cetuximab |
| KST-6051 Dose Expansion Combination Therapy with Cetuximab and mFOLFOX6 or FOLFIRI | Experimental | Dose expansion cohorts will be evaluated to further investigate KST-6051 as combination therapy with cetuximab and mFOLFOX6 or FOLFIRI in 1L CRC. Receives: Drug: KST-6051; Drug: Cetuximab; Drug: mFOLFOX6; Drug: FOLFIRI |
| KST-6051 Dose Expansion Combination Therapy with Pembrolizumab and Pemetrexed/carboplatin | Experimental | Dose expansion cohorts will be evaluated to further investigate KST-6051 as combination therapy with pembrolizumab and pemetrexed/carboplatin in 1L NSCLC. Receives: Drug: KST-6051; Drug: Pembrolizumab; Drug: Pemetrexed; Drug: Carboplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose Escalation Cohorts: Number of Participants With Dose-limiting Toxicities (DLTs) at the end of Cycle 1 (Each Cycle is 21 Days)
Measured: Up to Day 21 of Treatment Cycle 1
Dose Escalation Cohorts: Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Clinically significant changes in safety assessments (vital signs, physical examinations, electrocardiograms, and clinical laboratory tests) are to be reported as adverse events.
Measured: Up to approximately 2 years
Dose Escalation Cohorts: Number of Participants With Treatment-related Adverse Events (TRAEs)
Clinically significant changes in safety assessments (vital signs, physical examinations, electrocardiograms, and clinical laboratory tests) are to be reported as adverse events.
Measured: Up to approximately 2 years
Dose Expansion Cohorts: Confirmed Objective Response Rate (ORR)
Measured: Up to approximately 2 years
Secondary outcomes (19)
Dose Escalation Cohorts: Maximum Observed Blood Concentration (Cmax) of KST-6051 Alone
Measured: Up to Week 6
Dose Escalation Cohorts: Cmax of KST-6051 in Combination with Other Agents
Measured: Up to Week 6
Dose Escalation Cohorts: Time to Achieve Cmax (Tmax) of KST-6051 Alone
Measured: Up to Week 6
Dose Escalation Cohorts: Tmax of KST-6051 in Combination with Other Agents
Measured: Up to Week 6
Dose Escalation Cohorts: Half-life (t1/2) of KST-6051 Alone
Measured: Up to Week 6
Dose Escalation Cohorts: t1/2 of KST-6051 in Combination with Other Agents
Measured: Up to Week 6
Dose Escalation Cohorts: Area Under the Blood Concentration-time Curve (AUC) of KST-6051 Alone
Measured: Up to Week 6
Dose Escalation Cohorts: AUC of KST-6051 in Combination with Other Agents
Measured: Up to Week 6
Dose Escalation Cohorts: ORR
Measured: Up to approximately 2 years
Dose Escalation and Dose Expansion Cohorts: Disease Control Rate (DCR)
Measured: Up to approximately 2 years
Dose Escalation and Dose Expansion Cohorts: Duration of Overall Response (DOR)
Measured: Up to approximately 2 years
Dose Escalation and Dose Expansion Cohorts: Progression-free Survival (PFS)
Measured: Up to approximately 2 years
Dose Escalation and Dose Expansion Cohorts: Overall Survival (OS)
Measured: Up to approximately 2 years
Dose Escalation Cohorts: Duration of Stable Disease
Measured: Up to approximately 2 years
Dose Expansion Cohorts: Time to Response (TTR)
Measured: Up to approximately 2 years
Dose Expansion Cohorts: Number of Participants With TEAEs
Measured: Up to approximately 2 years
Dose Expansion Cohorts: Number of Participants with Dose Interruptions, Dose Reductions, and Discontinuations
Measured: Up to approximately 2 years
Dose Expansion Cohorts: Relative Dose Intensity and Treatment Exposure
Measured: Up to approximately 2 years
Dose Expansion Cohorts: Concentration of KST-6051 in the Whole Blood After Multiple Dose Administration
Measured: Up to Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2026
- Study start21 Apr 2026
- Primary completionApr 2028 (estimated)
- Study completionApr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for KRAS-mutant Non-small Cell Lung Cancer (NSCLC)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 545 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kestrel Therapeutics, Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07458347
- Sponsor's protocol ID
- KST-6051-101
- Status last verified
- Oct 2026
- First submitted
- 3 Mar 2026
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07458347
- Acronym / sponsor ID
- KST-6051-101
- 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
- Keywords
- Advanced Solid Tumors, Metastatic Solid Tumors, KRAS Mutation, KST-6051, KRAS, Lung Cancer, Pancreatic Cancer, Colorectal Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 545 participants (estimated)
- Lead sponsor
- Kestrel Therapeutics, Inc.University, hospital or other
- Study start
- 21 Apr 2026 (actual)
- Primary completion
- Apr 2028 (estimated)
- Study completion
- Apr 2029 (estimated)
- First posted
- 9 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a first-in-human, phase 1, open-label, multicenter clinical trial designed to evaluate safety, tolerability, pharmacokinetics, biomarkers, pharmacodynamics and preliminary activity of orally administered KST-6051 as monotherapy or in combination with other anticancer agents. The trial seeks to enroll adults with advanced or metastatic KRAS mutant solid tumors including but not limited to pancreatic ductal adenocarcinoma, colorectal cancer, and non-small cell lung cancer whose cancers have progressed after prior therapy or in whom standard therapy was not tolerated. The trial includes a dose escalation phase in which higher doses of KST-6051 will be given in subsequent groups of participants. The trial also includes a dose expansion phase to further investigate KST-6051. Participants can stay in the trial as long as they benefit from the treatment and can tolerate it.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 13
| Arm | Type | Receives |
|---|---|---|
| KST-6051 Dose Escalation Monotherapy | Experimental | Drug: KST-6051Sequential cohorts with increasing doses of KST-6051 as monotherapy will be evaluated to determine recommended dose(s) for expansion (RDE[s]). |
| KST-6051 Dose Escalation Combination Therapy with Gemcitabine/Nab-paclitaxel | Experimental | Drug: KST-6051, Drug: Gemcitabine/nab-paclitaxelSequential 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. |
| KST-6051 Dose Escalation Combination Therapy with Cetuximab | Experimental | Drug: KST-6051, Drug: CetuximabSequential 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. |
| KST-6051 Dose Escalation Combination Therapy with Pembrolizumab | Experimental | Drug: KST-6051, Drug: PembrolizumabSequential 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. |
| KST-6051 Dose Expansion Monotherapy in PDAC After 1 or 2 Prior Lines of Therapy | Experimental | Drug: KST-6051Dose expansion cohorts will be evaluated to further investigate KST-6051 as monotherapy in PDAC after 1 or 2 prior lines of therapy. |
| KST-6051 Dose Expansion Monotherapy in mCRC After 1 or 2 prior Lines of Therapy | Experimental | Drug: KST-6051Dose expansion cohorts will be evaluated to further investigate KST-6051 as monotherapy in mCRC after 1 or 2 prior lines of therapy. |
| KST-6051 Dose Expansion Monotherapy in NSCLC After 1 or 2 Prior Lines of Therapy | Experimental | Drug: KST-6051Dose expansion cohorts will be evaluated to further investigate KST-6051 as monotherapy in NSCLC after 1 or 2 prior lines of therapy. |
| KST-6051 Dose Expansion Monotherapy in Prior RAS/KRAS Inhibitor-treated Solid Tumors | Experimental | Drug: KST-6051Dose expansion cohorts will be evaluated to further investigate KST-6051 as monotherapy in prior RAS/KRAS inhibitor-treated solid tumors. |
| KST-6051 Dose Expansion Monotherapy in Later-line Settings | Experimental | Drug: KST-6051Dose 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. |
| KST-6051 Dose Expansion Combination Therapy with Gemcitabine/nab-paclitaxel | Experimental | Drug: KST-6051, Drug: Gemcitabine/nab-paclitaxelDose expansion cohorts will be evaluated to further investigate KST-6051 as combination therapy with gemcitabine/nab-paclitaxel in 1L PDAC. |
| KST-6051 Dose Expansion Combination Therapy with Cetuximab | Experimental | Drug: KST-6051, Drug: CetuximabDose expansion cohorts will be evaluated to further investigate KST-6051 as combination therapy with cetuximab in 2L/3L CRC. |
| KST-6051 Dose Expansion Combination Therapy with Cetuximab and mFOLFOX6 or FOLFIRI | Experimental | Drug: KST-6051, Drug: Cetuximab, Drug: mFOLFOX6, Drug: FOLFIRIDose expansion cohorts will be evaluated to further investigate KST-6051 as combination therapy with cetuximab and mFOLFOX6 or FOLFIRI in 1L CRC. |
| KST-6051 Dose Expansion Combination Therapy with Pembrolizumab and Pemetrexed/carboplatin | Experimental | Drug: KST-6051, Drug: Pembrolizumab, Drug: Pemetrexed, Drug: CarboplatinDose expansion cohorts will be evaluated to further investigate KST-6051 as combination therapy with pembrolizumab and pemetrexed/carboplatin in 1L NSCLC. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KST-6051KST-6051 will be administered orally as a tablet. | Drug | KST-6051 Dose Escalation Combination Therapy with Cetuximab, KST-6051 Dose Escalation Combination Therapy with Gemcitabine/Nab-paclitaxel, KST-6051 Dose Escalation Combination Therapy with Pembrolizumab, KST-6051 Dose Escalation Monotherapy, KST-6051 Dose Expansion Combination Therapy with Cetuximab, KST-6051 Dose Expansion Combination Therapy with Cetuximab and mFOLFOX6 or FOLFIRI, KST-6051 Dose Expansion Combination Therapy with Gemcitabine/nab-paclitaxel, KST-6051 Dose Expansion Combination Therapy with Pembrolizumab and Pemetrexed/carboplatin, KST-6051 Dose Expansion Monotherapy in Later-line Settings, KST-6051 Dose Expansion Monotherapy in NSCLC After 1 or 2 Prior Lines of Therapy, KST-6051 Dose Expansion Monotherapy in PDAC After 1 or 2 Prior Lines of Therapy, KST-6051 Dose Expansion Monotherapy in Prior RAS/KRAS Inhibitor-treated Solid Tumors, KST-6051 Dose Expansion Monotherapy in mCRC After 1 or 2 prior Lines of Therapy |
| Gemcitabine/nab-paclitaxelGemcitabine/nab-paclitaxel will be administered intravenously (IV). | Drug | KST-6051 Dose Escalation Combination Therapy with Gemcitabine/Nab-paclitaxel, KST-6051 Dose Expansion Combination Therapy with Gemcitabine/nab-paclitaxel |
| CetuximabCetuximab will be administered IV. | Drug | KST-6051 Dose Escalation Combination Therapy with Cetuximab, KST-6051 Dose Expansion Combination Therapy with Cetuximab, KST-6051 Dose Expansion Combination Therapy with Cetuximab and mFOLFOX6 or FOLFIRI |
| PembrolizumabPembrolizumab will be administered IV. | Drug | KST-6051 Dose Escalation Combination Therapy with Pembrolizumab, KST-6051 Dose Expansion Combination Therapy with Pembrolizumab and Pemetrexed/carboplatin |
| mFOLFOX6mFOLFOX6 will be administered IV. | Drug | KST-6051 Dose Expansion Combination Therapy with Cetuximab and mFOLFOX6 or FOLFIRI |
| FOLFIRIFOLFIRI will be administered IV. | Drug | KST-6051 Dose Expansion Combination Therapy with Cetuximab and mFOLFOX6 or FOLFIRI |
| PemetrexedPemetrexed will be administered IV. | Drug | KST-6051 Dose Expansion Combination Therapy with Pembrolizumab and Pemetrexed/carboplatin |
| CarboplatinCarboplatin will be administered IV. | Drug | KST-6051 Dose Expansion Combination Therapy with Pembrolizumab and Pemetrexed/carboplatin |
Primary outcome
Dose Escalation Cohorts: Number of Participants With Dose-limiting Toxicities (DLTs) at the end of Cycle 1 (Each Cycle is 21 Days)
Time frame: Up to Day 21 of Treatment Cycle 1
Dose Escalation Cohorts: Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Time frame: Up to approximately 2 years
Clinically significant changes in safety assessments (vital signs, physical examinations, electrocardiograms, and clinical laboratory tests) are to be reported as adverse events.
Dose Escalation Cohorts: Number of Participants With Treatment-related Adverse Events (TRAEs)
Time frame: Up to approximately 2 years
Clinically significant changes in safety assessments (vital signs, physical examinations, electrocardiograms, and clinical laboratory tests) are to be reported as adverse events.
Dose Expansion Cohorts: Confirmed Objective Response Rate (ORR)
Time frame: Up to approximately 2 years
19 secondary outcomes
Dose Escalation Cohorts: Maximum Observed Blood Concentration (Cmax) of KST-6051 Alone
Time frame: Up to Week 6
Dose Escalation Cohorts: Cmax of KST-6051 in Combination with Other Agents
Time frame: Up to Week 6
Dose Escalation Cohorts: Time to Achieve Cmax (Tmax) of KST-6051 Alone
Time frame: Up to Week 6
Dose Escalation Cohorts: Tmax of KST-6051 in Combination with Other Agents
Time frame: Up to Week 6
Dose Escalation Cohorts: Half-life (t1/2) of KST-6051 Alone
Time frame: Up to Week 6
Dose Escalation Cohorts: t1/2 of KST-6051 in Combination with Other Agents
Time frame: Up to Week 6
Dose Escalation Cohorts: Area Under the Blood Concentration-time Curve (AUC) of KST-6051 Alone
Time frame: Up to Week 6
Dose Escalation Cohorts: AUC of KST-6051 in Combination with Other Agents
Time frame: Up to Week 6
Dose Escalation Cohorts: ORR
Time frame: Up to approximately 2 years
Dose Escalation and Dose Expansion Cohorts: Disease Control Rate (DCR)
Time frame: Up to approximately 2 years
Dose Escalation and Dose Expansion Cohorts: Duration of Overall Response (DOR)
Time frame: Up to approximately 2 years
Dose Escalation and Dose Expansion Cohorts: Progression-free Survival (PFS)
Time frame: Up to approximately 2 years
Dose Escalation and Dose Expansion Cohorts: Overall Survival (OS)
Time frame: Up to approximately 2 years
Dose Escalation Cohorts: Duration of Stable Disease
Time frame: Up to approximately 2 years
Dose Expansion Cohorts: Time to Response (TTR)
Time frame: Up to approximately 2 years
Dose Expansion Cohorts: Number of Participants With TEAEs
Time frame: Up to approximately 2 years
Dose Expansion Cohorts: Number of Participants with Dose Interruptions, Dose Reductions, and Discontinuations
Time frame: Up to approximately 2 years
Dose Expansion Cohorts: Relative Dose Intensity and Treatment Exposure
Time frame: Up to approximately 2 years
Dose Expansion Cohorts: Concentration of KST-6051 in the Whole Blood After Multiple Dose Administration
Time frame: Up to Week 6
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing KST-6051, Gemcitabine/nab-paclitaxel and Cetuximab in people with KRAS-mutant Non-small Cell Lung Cancer (NSCLC) and KRAS-mutant Pancreatic Ductal Adenocarcinoma (PDAC), run by Kestrel Therapeutics, Inc. at 9 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kestrel Therapeutics, Inc. (617-612-6810, clinicaltrials@kestreltherapeutics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose Escalation Cohorts: Number of Participants With Dose-limiting Toxicities (DLTs) at the end of Cycle 1 (Each Cycle is 21 Days) (time frame: Up to Day 21 of Treatment Cycle 1). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026.