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.
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 Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
140
CLSP-5282 to be administered by IV infusion
Duke Cancer Institute
Durham, North Carolina, United States
Thomas Jefferson University, Sidney Kimmel Cancer Center
Philadelphia, Pennsylvania, United States
Sarah Cannon Research Institute (SCRI) Oncology Partners
Nashville, Tennessee, United States
Mary Crowley Cancer Research
Dallas, Texas, United States
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
Part B Monotherapy Expansion
To evaluate the preliminary antitumor activity of CLSP-5282
Time frame: Up to 24 months after infusion
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
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
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
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
Assess the immunogenicity of CLSP-5282
To determine the presence of anti-CLSP-5282 antibodies at baseline and on treatment
Time frame: Up to 24 months after infusion
Lauren Harshman
CONTACT
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Part A: Objective Response Rate (ORR)
Determine Objective Response Rate (ORR) per RECIST V1.1.
Time frame: 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.
Time frame: Up to 24 months after infusion
Time to Response
Determine time to response of CLSP-5282 per RECIST V1.1.
Time frame: Up to 24 months after infusion
Disease Control Rate
Determine disease control rate of CLSP-5282 per RECIST V1.1.
Time frame: 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.
Time frame: Up to 24 months after infusion
Time on Treatment
Determine Time on Treatment of CLSP-5282 from first dose to last dose.
Time frame: Up to 24 months after infusion
Overall Survival (OS)
Determine OS of CLSP-5282 until death.
Time frame: Up to 24 months after infusion