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A Single-Arm, Open-Label, Multicenter Phase 2 Study to Evaluate the Efficacy and Safety of Taletrectinib in Patients with Advanced or Metastatic ROS1 Positive NSCLC and Other Solid Tumors

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-516604-41-00
Acronym
AB-106-G208
Enrollment
98
Registered
2024-10-10
Start date
2022-08-08
Completion date
Unknown
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

Non-small Cell Lung Cancer

Brief summary

Confirmed ORR according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 assessed by an independent radiology review committee (IRC) (Cohorts 1-2)

Detailed description

Efficacy DOR according to RECIST 1.1 assessed by IRC (Cohorts 1-2), Efficacy PFS according to RECIST 1.1 assessed by IRC (Cohorts 1-2), Efficacy TTF according to RECIST 1.1 assessed by IRC (Cohorts 1-2), Efficacy TTR according to RECIST 1.1 assessed by IRC (Cohorts 1-2), Efficacy ORR, DOR, and PFS according to RECIST 1.1 assessed by investigators (Cohorts 1-2), Efficacy Confirmed intracranial (IC)-ORR, IC-DOR, IC-PFS, and time to intracranial progression (TTiP) according to mRECIST 1.1 assessed by IRC (Cohorts 1-2), Efficacy OS (Cohorts 1-2)

Interventions

DRUGTaletrectinib

Sponsors

Anheart Therapeutics Inc.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Confirmed ORR according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 assessed by an independent radiology review committee (IRC) (Cohorts 1-2)—

Secondary

MeasureTime frame
Efficacy DOR according to RECIST 1.1 assessed by IRC (Cohorts 1-2), Efficacy PFS according to RECIST 1.1 assessed by IRC (Cohorts 1-2), Efficacy TTF according to RECIST 1.1 assessed by IRC (Cohorts 1-2), Efficacy TTR according to RECIST 1.1 assessed by IRC (Cohorts 1-2), Efficacy ORR, DOR, and PFS according to RECIST 1.1 assessed by investigators (Cohorts 1-2), Efficacy Confirmed intracranial (IC)-ORR, IC-DOR, IC-PFS, and time to intracranial progression (TTiP) according to mRECIST 1.1 assessed by IRC (Cohorts 1-2), Efficacy OS (Cohorts 1-2)—

Countries

France, Italy, Poland, Spain

Outcome results

None listed

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