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TCC1727 in Advanced Solid Tumors
NCT05970016Phase 2
Key facts
- Status
- Recruiting
- Start
- Aug 2023
- Primary completion
- Jul 2025
- Countries
- 1
- Modality
- Small Molecules
- Drugs
- TCC1727
- Conditions
- solid tumor (advanced stage)
01
Overview
Phase 2, open-label trial of TCC1727 in solid tumor (advanced stage) (11 arms), sponsored by Beijing Tide Pharmaceutical Co., Ltd. Primary endpoints: Dose-Limiting Toxicity at 21 days, Maximum Tolerated Dose at 21 days and 2 more. Started Aug 2023; status: recruiting.
02
Design
11 arms- Study design
- Non-randomizedOpen-label
5mg QD
TCC1727 5mg QD (3 days on/4 days off)
10mg QD
TCC1727 10mg QD (3 days on/4 days off)
20mg QD
TCC1727 20mg QD (3 days on/4 days off)
40mg QD
TCC1727 40mg QD (3 days on/4 days off)
60mg QD
TCC1727 60mg QD (3 days on/4 days off)
80mg QD
TCC1727 80mg QD (3 days on/4 days off)
5 more in the full profile.
03
Who it enrols
Patients with advanced solid tumors who have progressed on standard therapy. Phase II focuses on patients with DDR defects. Patients must have adequate organ function and no history of prior ATR inhibitor treatment.
04
Endpoints
Primary
Dose-Limiting Toxicity
Maximum Tolerated Dose
Recommended Phase 2 Dose
Overall Response Rate
Secondary
Overall Response Rate (Phase I)
Pharmacokinetics
Safety and Tolerability
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