Primary Objectives: * Evaluate the safety and tolerability of THOR-707 as a single agent and as a combination therapy (identify Dose Limiting Toxcitiy (DLTs) in Cohorts A, B, C, D, and G, and adverse events (AEs)/serious adverse event (SAE) profile in Cohorts A, B, C, D, E, F, and G) * Define the Maximium Tolerated Dose (MTD) and/or the Recommended Phase 2 Dose (RP2D) of THOR-707 as a single agent and as a combination therapy (Cohorts A, B, C, D, and G) * Evaluate preliminary anti-tumor activity of THOR-707 as a single agent by determination of the objective response rate (ORR) defined according to the Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (Cohort H only) Secondary Objectives: * Evaluate preliminary anti-tumor activity of THOR-707 as a single agent and as a combination therapy by determination of the objective response rate (ORR) defined according to the Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (Cohorts A, B, C, D, E, F, and G) * Determine time to response (TTR), duration of response (DOR), progression-free survival (PFS), overall survival (OS), disease control rate (DCR), and clinical benefit rate (CBR) of THOR-707 as a single agent and as a combination therapy * Evaluate the safety and tolerability of THOR-707 monotherapy QW/Q2W (AE/serious adverse event \[SAE\] profile) (Cohort H only).
The study duration per participant is approximately 24 months (inclusive of follow-up). Cohorts A, B, C, and D have been completed.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
175
Pharmaceutical form: solution for intravenous (IV) administration; Route of administration: IV administration
Pharmaceutical form: solution for IV administration; Route of administration: IV administration
Pharmaceutical form: solution for IV administration; Route of administration: IV administration
Investigational Site Number-1008
Scottsdale, Arizona, United States
Investigational Site Number-1005
Denver, Colorado, United States
Investigational Site Number-1004
Sarasota, Florida, United States
Investigational Site Number-1003
Nashville, Tennessee, United States
Investigational Site Number-1007
Dallas, Texas, United States
Investigational Site Number-1002
Houston, Texas, United States
Investigational Site Number-1001
San Antonio, Texas, United States
Investigational Site Number-7002
Buenos Aires, Argentina
Investigational Site Number-2004
New South Whales, Australia
Investigational Site Number-2001
Perth, Australia
...and 14 more locations
Rate of Dose-Limiting Toxicities (DLTs)- Cohorts A, B, C, and D
Based on toxicities observed
Time frame: Study Day 1 up to Day 29
Maximum Tolerated Dose (MTD)- Cohorts A, B, C, and D
Based on toxicities observed
Time frame: Study Day 1 up to Day 29
Recommended Phase 2 Dose (RP2D)- Cohorts A, B, C, and D
Based on toxicities observed
Time frame: Study Day 1 up to Day 29
Number of participants with treatment emergent adverse events, serious adverse events, and laboratory abnormalities - Cohorts A, B, C, D, E, F, and G
Safety will be assessed by monitoring adverse events, clinical laboratory evaluations, vital signs, and ECG parameters.
Time frame: Study Day 1 up to approximately 24 months
Rate of Dose-Limiting Toxicities (DLTs) -Cohort G
Based on toxicities observed
Time frame: Study Day 1 up to Day 42 (6 week-cycle)
Recommended Phase 2 Dose (RP2D) of THOR-707- Cohort G
Based on toxicities observed
Time frame: Study Day 1 up to Day 42 (6 week-cycle)
Maximum Tolerated Dose (MTD)- Cohort G
Based on toxicities observed
Time frame: Study Day 1 up to Day 42 (6 week-cycle)
Objective Response Rate (ORR) according to RECIST version 1.1 -Cohort H
ORR, defined as the proportion of subjects with confirmed complete response (CR) or partial response (PR); a confirmed response is a response that persists on repeat-imaging ≥4 weeks after initial documentation of response.
Time frame: Study Day 1 up to approximately 24 months
Objective Response Rate (ORR) according to RECIST version 1.1 Cohort A, B, C, D, E, F, and G)
Defined as the proportion of subjects with confirmed complete response (CR) or partial response (PR); a confirmed response is a response that persists on repeat-imaging ≥4 weeks after initial documentation of response.
Time frame: Study Day 1 up to approximately 24 months
Duration of Response (DOR) according to RECIST version 1.1
Defined as time from date of first objective response (either CR or PR) to first documentation of radiographic disease progression or death due to any cause, whichever occurs first.
Time frame: Study Day 1 up to approximately 24 months
Progression-Free Survival (PFS) according to RECIST version 1.1
Defined as the time from first dose of THOR-707 to first documentation of radiographic disease progression or death due to any cause, whichever occurs first.
Time frame: Study Day 1 until the date of first documented progression or date of death from any cause, assessed up to approximately 24 months
Overall Survival according to RECIST version 1.1
Defined as the time from first dose of THOR-707 to the date of death due to any cause.
Time frame: Study Day 1 up to time of death, assessed up to approximately 24 months
Time to Response (TTR) according to RECIST version 1.1
Defined as the time from first dose of THOR-707 to first documentation of objective response (either CR or PR).
Time frame: Study Day 1 up to approximately 24 months
Disease Control Rate (DCR) according to RECIST version 1.1
Defined as the proportion of subjects who have achieved confirmed CR, PR, or stable disease (SD) determined by Investigator per RECIST 1.1.
Time frame: Study Day 1 up to approximately 24 months
Clinical Benefit Rate (CBR)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Defined as the proportion of participants with clinical benefit i.e., confirmed CR or PR as BOR (is defined as the best overall response observed from the date of first IMP until disease progression, death, cut-off date or initiation of subsequent anti-cancer therapy, whichever occurs first), or SD lasting at least 6 months.
Time frame: Study Day 1 up to approximately 24 months
Number of participants with treatment emergent adverse events, serious adverse events, laboratory abnormalities -Cohort H
Safety will be assessed by monitoring adverse events, clinical laboratory evaluations, vital signs, and ECG parameters.
Time frame: Study Day 1 up to approximately 24 months