A Phase 1/2 study to evaluate safety, tolerability, and anticancer activity of TORL-5-700 as a monotherapy and in combination in R/R NHL
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
155
Part 1: Monotherapy Dose Escalation - TORL-5-700 Administered once every three weeks
Part 2: Monotherapy Expansion - TORL-5-700 at Maximum tolerated Dose (MTD)/Recommended Phase 2 Dose (RP2D) Administered once every three weeks
Part 3: Combination Evaluation - TORL-5-700 at MTD/RP2D administered every three weeks in combination with another agent
UCLA
Santa Monica, California, United States
RECRUITINGStanford University
Stanford, California, United States
RECRUITINGSarah Cannon Research Institute
Nashville, Tennessee, United States
RECRUITINGEvaluate the safety of TORL-5-700 as a monotherapy
Assessment of adverse events according to NCI-CTCAE Version 5.0
Time frame: though study completion, an average of 2.5 years
Assess the antitumor activity of TORL-5-700 as monotherapy
Assess the antitumor activity of TORL-5-700 using Cheson (2014) disease grading criteria
Time frame: though study completion, an average of 2.5 years
Evaluate the safety of TORL-5-700 in combination with other agents
Assessment of adverse events according to NCI-CTCAE Version 5.0
Time frame: though study completion, an average of 2.5 years
Determine the Maximum Tolerated Dose (MTD)
Determine the MTD by assessing Protocol defined Dose Limiting Toxicities (DLT)
Time frame: 21 days from the start of treatment
Determine the Recommended Phase 2 Dose (RP2D)
Determine the RP2D by assessing Protocol defined Dose Limiting Toxicities
Time frame: 21 days from the start of treatment
Maximum Serum Concentration of TORL-5-700 (Cmax)
Pk assessment
Time frame: though end of study treatment, an average of 5 months
Maximum Serum Concentration of TORL-5-700 (Cmax) in combination with other agents
Pk assessment
Time frame: though end of study treatment, an average of 5 months
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Terminal Half-life (t1/2) of Serum TORL-5-700
Pk assessment
Time frame: though end of study treatment, an average of 5 months
Terminal Half-life (t1/2) of Serum TORL-5-700 in combination with other agents
Pk assessment
Time frame: though end of study treatment, an average of 5 months
Area under the Serum Concentration -Time curve for TORL-5-700 from the time of dosing to the last measurable concentration
Pk assessment
Time frame: though end of study treatment, an average of 5 months
Area under the Serum Concentration -Time curve for TORL-5-700 from the time of dosing to the last measurable concentration in combination with other agents
Pk assessment
Time frame: though end of study treatment, an average of 5 months
Clearance (CL) of TORL-5-700
Pk assessment
Time frame: though end of study treatment, an average of 5 months
Clearance (CL) of TORL-5-700 in combination with other agents
Pk assessment
Time frame: though end of study treatment, an average of 5 months
Volume of distribution of TORL-5-700
PK assessment
Time frame: though end of study treatment, an average of 5 months
Volume of distribution of TORL-5-700 in combination with other agents
PK assessment
Time frame: though end of study treatment, an average of 5 months
Immunogenicity of TORL-5-700
Immunogenicity will be measured by incidence of treatment emergent ADAs
Time frame: though end of study treatment, an average of 5 months
Immunogenicity of TORL-5-700 in combination with other agents
Immunogenicity will be measured by incidence of treatment emergent ADAs
Time frame: though end of study treatment, an average of 5 months
Assess the preliminary antitumor activity of TORL-5-700 in combination with other agents
Assess the antitumor activity of TORL-5-700 in combination with other agents using Cheson (2014) disease grading criteria
Time frame: though study completion, an average of 2.5 years