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A Study of CLSP 5282 in HLA-A*03:01 Positive Adult Patients With Solid Tumors (SENTINEL-101)

ConditionsAdvanced Solid TumorNon Small Cell Lung CancerPancreatic CarcinomaColorectal Cancer
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorClasp Therapeutics, Inc.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Sequential

Treatments tested in this trial

  • CLSP-5282

    Drug

    CLSP-5282 to be administered by IV infusion

Treatment groups

140 Participants
are divided into 2 treatment groups
Group A: Part A Monotherapy Dose EscalationExperimental treatment 1 intervention
Group B: Part B Monotherapy ExpansionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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\[s\]).

Time frame
28 days after infusion
2

Part B Monotherapy Expansion

To evaluate the preliminary antitumor activity of CLSP-5282

Time frame
Up to 24 months after infusion

Secondary outcomes

1

Number of patients with treatment-emergent adverse events, as assessed by CTCAE, v5.0

Incidence and severity of treatment-emergent adverse events (TEAEs)

Time frame
Up to 30 days after last infusion
2

Number of patients with treatment-related adverse events, as assessed by CTCAE, v5.0

Incidence and severity of treatment-related adverse events (TRAEs)

Time frame
Up to 30 days after last infusion
3

Determine Maximum Plasma Concentration of CLSP-5282

Determine the plasma PK parameters (Cmax) of CLSP-5282

Time frame
Pre-dose and up to 168 hours post-dose
4

Half-life (t1/2) of CLSP-5282

To determine the half-life (t1/2) of CLSP-5282

Time frame
Pre-dose and up to 168 hours post-dose

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Clasp Therapeutics, Inc.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: