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An open-label, multicenter Phase 1/2 dose escalation and expansion study of THOR-707 as a single agent and as a combination therapy in adult subjects with advanced or metastatic solid tumors

Status
Completed
Phases
Phase 1Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-508422-95-00
Acronym
TCD16843
Enrollment
31
Registered
2024-02-07
Start date
2023-05-25
Completion date
2025-12-02
Last updated
2025-11-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer

Brief summary

Rate of Dose-Limiting Toxicities (DLTs) - Cohorts A, B, C, and D, Rate of Dose-Limiting Toxicities (DLTs) -Cohort G, Maximum Tolerated Dose (MTD)- Cohorts A, B, C, and D, Recommended Phase 2 Dose (RP2D) or THOR-707- Cohorts A, B, C, and D, Recommended Phase 2 Dose (RP2D) of THOR-707- Cohort G, Maximum Tolerated Dose (MTD)- Cohort G, Number of participants with treatment emergent adverse events, serious adverse events, and laboratory abnormalities – Cohorts A, B, C, D, E, F, and G, Objective Response Rate (ORR) according to RECIST version 1.1 -Cohort H

Detailed description

ORR according to RECIST version 1.1 Cohort A, B, C, D, E, F, and G), Duration of Response (DOR) according to RECIST version 1.1, Progression-Free Survival (PFS) according to RECIST version 1.1, Overall Survival according to RECIST version 1.1, Time to Response (TTR) according to RECIST version 1.1, Disease Control Rate (DCR) according to RECIST version 1.1, Percentage of subjects with no disease progression at 6 months post-treatment, Number of participants with treatment emergent adverse events, serious adverse events, laboratory abnormalities -Cohort H

Interventions

DRUGDIPHENHYDRAMINE
DRUGFAMOTIDINE
DRUGPEGENZILEUKIN
DRUGTOCILIZUMAB
DRUGONDANSETRON
DRUGDEXAMETHASONE
DRUGPARACETAMOL

Sponsors

Synthorx Inc.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Rate of Dose-Limiting Toxicities (DLTs) - Cohorts A, B, C, and D, Rate of Dose-Limiting Toxicities (DLTs) -Cohort G, Maximum Tolerated Dose (MTD)- Cohorts A, B, C, and D, Recommended Phase 2 Dose (RP2D) or THOR-707- Cohorts A, B, C, and D, Recommended Phase 2 Dose (RP2D) of THOR-707- Cohort G, Maximum Tolerated Dose (MTD)- Cohort G, Number of participants with treatment emergent adverse events, serious adverse events, and laboratory abnormalities – Cohorts A, B, C, D, E, F, and G, Objective Response Rate (ORR) according to RECIST version 1.1 -Cohort H—

Secondary

MeasureTime frame
ORR according to RECIST version 1.1 Cohort A, B, C, D, E, F, and G), Duration of Response (DOR) according to RECIST version 1.1, Progression-Free Survival (PFS) according to RECIST version 1.1, Overall Survival according to RECIST version 1.1, Time to Response (TTR) according to RECIST version 1.1, Disease Control Rate (DCR) according to RECIST version 1.1, Percentage of subjects with no disease progression at 6 months post-treatment, Number of participants with treatment emergent adverse events, serious adverse events, laboratory abnormalities -Cohort H—

Countries

Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026