Advanced Solid TumorPhase 1NCT07650357
A Study of CLSP 5282 in HLA-A*03:01 Positive Adult Patients With Solid Tumors (SENTINEL-101)
A Phase 1 study testing CLSP-5282 in people with Advanced Solid Tumor and Non Small Cell Lung Cancer, run by Clasp Therapeutics, Inc. at 4 sites in United States.
Trial summary
Phase 1, open-label, multicenter study to evaluate the safety, tolerability, PK, PD, and preliminary clinical activity of CLSP 5282 when administered to HLA A*03:01-positive adult patients with advanced solid tumors that harbor the KRas G12V mutation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumor, Non Small Cell Lung Cancer, Pancreatic Carcinoma
- What is being tested?
- CLSP-5282
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 4 sitesUnited States
- Study dates
- Jul 2026to Jul 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
- Adults at least 18 years of age on the day of signing informed consent.
- Willing and able to provide written informed consent for the study.
- Histologically or cytologically diagnosed, locally advanced or metastatic solid tumors that have progressed after standard of care therapy or for which no standard therapy exists.
- Tumors must harbor the KRas G12V mutation confirmed by the site's local or preferred tissue or ctDNA testing platform in an accredited laboratory.
- Patients must be HLA-A*03:01 positive by central assay.
- Eastern Cooperative Oncology Group performance status of 0 or 1.
- Adequate hematological, renal and hepatic function.
- Per Investigator judgement, patient is willing and able to complete study visits and/or procedures per the protocol and comply with study requirements for study participation.
Who cannot join
- Patients who have received other KRas G12V directed cellular therapies or TCEs.
- Patients may not be on other anticancer therapies at the time of the first dose of CLSP-5282. Exceptions upon agreement with Sponsor.
- Any other primary malignancy within the 2 years prior to first dose of study treatment except for non-melanoma skin cancer, carcinoma in situ (e.g., cervix, bladder, breast), or prostate cancer in remission.
- Patients who have not fully recovered from adverse events due to previous anticancer therapies
- Patients with active infection requiring systemic antimicrobial therapy
- Known primary malignant brain tumors, active central nervous system metastases and/or carcinomatous meningitis
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Lauren Harshman contact
United States4 sites
Mary Crowley Cancer Research
Dallas, Texas, 75230
972-566-3000
Duke Cancer Institute
Durham, North Carolina, 27701
Sarah Cannon Research Institute (SCRI) Oncology Partners
Nashville, Tennessee, 37203
615-329-7640
Thomas Jefferson University, Sidney Kimmel Cancer Center
Philadelphia, Pennsylvania, 19107
Aliya Rogers, axr028@jefferson.edu
About this study
Official title: SENTINEL-101: A Phase 1 Dose Escalation and Expansion Study of CLSP-5282 in HLA-A*03:01 Positive Adult Patients With Solid Tumors That Harbor the KRas G12V Mutation
Phase 1, open-label, multicenter study to evaluate the safety, tolerability, PK, PD, and preliminary clinical activity of CLSP 5282 when administered to HLA A*03:01-positive adult patients with advanced solid tumors that harbor the KRas G12V mutation.
Read the detailed description
CLSP-5282-101 is a Phase 1, open-label, multicenter study designed to evaluate the safety, tolerability, PK, PD, and preliminary clinical activity of CLSP-5282 when administered to HLA A*03:01-positive adult patients with advanced solid tumors that harbor the KRas G12V mutation.
The study will be conducted in 2 parts:
Part A Monotherapy Dose Escalation to determine the MTD and/or RDE(s) to characterize safety and clinical activity of CLSP-5282.
Part B Monotherapy Expansion to explore the preliminary antitumor activity and further characterize the safety, tolerability, PK, and PD of CLSP-5282 at the RDE(s). Part B will include three indication-specific cohorts in pancreatic adenocarcinoma (PDAC), colorectal cancer (CRC), and non-small cell lung carcinoma (NSCLC) as well as an all-other solid tumor cohort.
- Being tested
- CLSP-5282
- Keywords
- T-Cell Engager, TCE, Clasp-5282, KRas G12V mutation, HLA A*03:01
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Pancreatic Neoplasms, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CLSP-5282Drug
CLSP-5282 to be administered by IV infusion
| Study group | Role | What they receive |
|---|---|---|
| Part A Monotherapy Dose Escalation | Experimental | Dose Escalation of CLSP-5282 in HLA A*03:01-positive adult patients with advanced solid tumors that harbor the KRas G12V mutation. Receives: Drug: CLSP-5282 |
| Part B Monotherapy Expansion | Experimental | Dose expansion of CLSP-5282 in indication-specific cohorts in pancreatic adenocarcinoma (PDAC), colorectal cancer (CRC), and non-small cell lung carcinoma (NSCLC) as well as an all-other solid tumor cohort conducted at the RDE. Receives: Drug: CLSP-5282 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part A Monotherapy Dose Escalation
To characterize the safety and tolerability of CLSP-5282 and to determine the maximum tolerated dose (MTD) and/or recommended dose(s) for expansion (RDE[s]).
Measured: 28 days after infusion
Part B Monotherapy Expansion
To evaluate the preliminary antitumor activity of CLSP-5282
Measured: Up to 24 months after infusion
Secondary outcomes (12)
Number of patients with treatment-emergent adverse events, as assessed by CTCAE, v5.0
Incidence and severity of treatment-emergent adverse events (TEAEs)
Measured: Up to 30 days after last infusion
Number of patients with treatment-related adverse events, as assessed by CTCAE, v5.0
Incidence and severity of treatment-related adverse events (TRAEs)
Measured: Up to 30 days after last infusion
Determine Maximum Plasma Concentration of CLSP-5282
Determine the plasma PK parameters (Cmax) of CLSP-5282
Measured: Pre-dose and up to 168 hours post-dose
Half-life (t1/2) of CLSP-5282
To determine the half-life (t1/2) of CLSP-5282
Measured: Pre-dose and up to 168 hours post-dose
Assess the immunogenicity of CLSP-5282
To determine the presence of anti-CLSP-5282 antibodies at baseline and on treatment
Measured: Up to 24 months after infusion
Part A: Objective Response Rate (ORR)
Determine Objective Response Rate (ORR) per RECIST V1.1.
Measured: Up to 24 months after infusion
Duration of response (DOR)
Determine DOR of CLSP-5282 until radiographic disease progression per RECIST V1.1 or death.
Measured: Up to 24 months after infusion
Time to Response
Determine time to response of CLSP-5282 per RECIST V1.1.
Measured: Up to 24 months after infusion
Disease Control Rate
Determine disease control rate of CLSP-5282 per RECIST V1.1.
Measured: Up to 24 months after infusion
Progression-free survival (PFS)
Determine PFS of CLSP-5282 until radiographic disease progression per RECIST V1.1 or death.
Measured: Up to 24 months after infusion
Time on Treatment
Determine Time on Treatment of CLSP-5282 from first dose to last dose.
Measured: Up to 24 months after infusion
Overall Survival (OS)
Determine OS of CLSP-5282 until death.
Measured: Up to 24 months after infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2026
- Study startJul 2026 (estimated)
- Primary completionMay 2029 (estimated)
- Study completionJul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorStudies 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
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clasp Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lauren Harshman, MD, Study director, Clasp Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07650357
- Sponsor's protocol ID
- CLSP-5282-101
- Status last verified
- Jun 2026
- First submitted
- 8 Jun 2026
- Last updated
- 16 Jun 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 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SENTINEL-101: A Phase 1 Dose Escalation and Expansion Study of CLSP-5282 in HLA-A*03:01 Positive Adult Patients With Solid Tumors That Harbor the KRas G12V Mutation
- ClinicalTrials.gov ID
- NCT07650357
- Acronym / sponsor ID
- CLSP-5282-101
- Keywords
- T-Cell Engager, TCE, Clasp-5282, KRas G12V mutation, HLA A*03:01
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Clasp Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2026 (estimated)
- Primary completion
- May 2029 (estimated)
- Study completion
- Jul 2029 (estimated)
- First posted
- 16 Jun 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.
Phase 1, open-label, multicenter study to evaluate the safety, tolerability, PK, PD, and preliminary clinical activity of CLSP 5282 when administered to HLA A*03:01-positive adult patients with advanced solid tumors that harbor the KRas G12V mutation.
Detailed description
CLSP-5282-101 is a Phase 1, open-label, multicenter study designed to evaluate the safety, tolerability, PK, PD, and preliminary clinical activity of CLSP-5282 when administered to HLA A*03:01-positive adult patients with advanced solid tumors that harbor the KRas G12V mutation.
The study will be conducted in 2 parts:
Part A Monotherapy Dose Escalation to determine the MTD and/or RDE(s) to characterize safety and clinical activity of CLSP-5282.
Part B Monotherapy Expansion to explore the preliminary antitumor activity and further characterize the safety, tolerability, PK, and PD of CLSP-5282 at the RDE(s). Part B will include three indication-specific cohorts in pancreatic adenocarcinoma (PDAC), colorectal cancer (CRC), and non-small cell lung carcinoma (NSCLC) as well as an all-other solid tumor cohort.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part A Monotherapy Dose Escalation | Experimental | Drug: CLSP-5282Dose Escalation of CLSP-5282 in HLA A*03:01-positive adult patients with advanced solid tumors that harbor the KRas G12V mutation. |
| Part B Monotherapy Expansion | Experimental | Drug: CLSP-5282Dose expansion of CLSP-5282 in indication-specific cohorts in pancreatic adenocarcinoma (PDAC), colorectal cancer (CRC), and non-small cell lung carcinoma (NSCLC) as well as an all-other solid tumor cohort conducted at the RDE. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Adults at least 18 years of age on the day of signing informed consent.
- Willing and able to provide written informed consent for the study.
- Histologically or cytologically diagnosed, locally advanced or metastatic solid tumors that have progressed after standard of care therapy or for which no standard therapy exists.
- Tumors must harbor the KRas G12V mutation confirmed by the site's local or preferred tissue or ctDNA testing platform in an accredited laboratory.
- Patients must be HLA-A*03:01 positive by central assay.
Key exclusion criteria (6 listed)
- Patients who have received other KRas G12V directed cellular therapies or TCEs.
- Patients may not be on other anticancer therapies at the time of the first dose of CLSP-5282. Exceptions upon agreement with Sponsor.
- Any other primary malignancy within the 2 years prior to first dose of study treatment except for non-melanoma skin cancer, carcinoma in situ (e.g., cervix, bladder, breast), or prostate cancer in remission.
- Patients who have not fully recovered from adverse events due to previous anticancer therapies
- Patients with active infection requiring systemic antimicrobial therapy
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 |
|---|---|---|
| CLSP-5282CLSP-5282 to be administered by IV infusion | Drug | Part A Monotherapy Dose Escalation, Part B Monotherapy Expansion |
Primary outcome
Part A Monotherapy Dose Escalation
Time frame: 28 days after infusion
To characterize the safety and tolerability of CLSP-5282 and to determine the maximum tolerated dose (MTD) and/or recommended dose(s) for expansion (RDE[s]).
Part B Monotherapy Expansion
Time frame: Up to 24 months after infusion
To evaluate the preliminary antitumor activity of CLSP-5282
12 secondary outcomes
Number of patients with treatment-emergent adverse events, as assessed by CTCAE, v5.0
Time frame: Up to 30 days after last infusion
Number of patients with treatment-related adverse events, as assessed by CTCAE, v5.0
Time frame: Up to 30 days after last infusion
Determine Maximum Plasma Concentration of CLSP-5282
Time frame: Pre-dose and up to 168 hours post-dose
Half-life (t1/2) of CLSP-5282
Time frame: Pre-dose and up to 168 hours post-dose
Assess the immunogenicity of CLSP-5282
Time frame: Up to 24 months after infusion
Part A: Objective Response Rate (ORR)
Time frame: Up to 24 months after infusion
Duration of response (DOR)
Time frame: Up to 24 months after infusion
Time to Response
Time frame: Up to 24 months after infusion
Disease Control Rate
Time frame: Up to 24 months after infusion
Progression-free survival (PFS)
Time frame: Up to 24 months after infusion
Time on Treatment
Time frame: Up to 24 months after infusion
Overall Survival (OS)
Time frame: Up to 24 months after infusion
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 16 Jun 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.
Lauren Harshman contact
Lauren Harshman, MD study director
Clasp Therapeutics
4 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 CLSP-5282 in people with Advanced Solid Tumor and Non Small Cell Lung Cancer, run by Clasp Therapeutics, Inc. at 4 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 8 inclusion and 6 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: opening soon, as of the sponsor's last update on 16 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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 Lauren Harshman, MD (+1-617-812-1431, LHarshman@clasptx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Part A Monotherapy Dose Escalation (time frame: 28 days after infusion). The study lists 2 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 16 Jun 2026.