NCT04785365

Brief Summary

This is an Open-Label, Multi-Centre Phase II study to evaluate the long-term safety and clinical activity of ATL001, previously administered intravenously to patients in Study ATX-NS-001 (NCT04032847) or Study ATX-ME-001 (NCT03997474).

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jun 2022

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 1, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 5, 2021

Completed
1.2 years until next milestone

Study Start

First participant enrolled

June 1, 2022

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 18, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 18, 2023

Completed
Last Updated

November 21, 2023

Status Verified

November 1, 2023

Enrollment Period

1.4 years

First QC Date

March 1, 2021

Last Update Submit

November 17, 2023

Conditions

MelanomaAdvanced Non Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (4)

  • Assessment of adverse events to evaluate long-term Safety and Tolerability of ATL001

    Evaluate the frequency and severity of adverse events related or possibly related to ATL001

    Every 4 months to 60 months; then every 6 months until death or until the end of the study, whichever came first, assessed up to 84 months.

  • Assessment of autoimmune adverse events

    Evaluate the frequency and severity of autoimmune adverse events

    Every 4 months to 60 months; then every 6 months until death or until the end of the study, whichever came first, assessed up to 84 months.

  • Assessment of new malignancies

    Evaluate the frequency and severity of new malignancies

    Every 4 months to 60 months; then every 6 months until death or until the end of the study, whichever came first, assessed up to 84 months.

  • Assessment of the use of medications to manage ATL001-related toxicities

    Evaluate the use of medications to manage ATL001-related toxicities

    Every 4 months to 60 months; then every 6 months until death or until the end of the study, whichever came first, assessed up to 84 months.

Secondary Outcomes (5)

  • Disease Assessment for Duration of Response ( DoR)

    Maximum 60 months.

  • Disease Assessment for Progression Free Survival (PFS)

    Maximum 60 months.

  • Disease Assessment for Time to First Subsequent anti-cancer Therapy (TFST)

    Maximum 60 months.

  • Assessment for Overall Survival (OS)

    6 months until death or until the end of the study, whichever came first, assessed up to 84 months

  • Assessment for cancer-related medical resources

    Maximum 60 months.

Study Arms (2)

Experimental: ATL001

OTHER

Patients who have previously received ATL001 in a clinical trial will be evaluated in this trial for long-term safety and clinical activity.

Other: Biological: ATL001

Patients who have previously received ATL001 in study ATX-NS-001 or study ATX-ME-001

OTHER

Patients who have previously received ATL001 in study ATX-NS-001 or study ATX-ME-001

Other: Biological: ATL001

Interventions

Biological: ATL001OTHER

No investigational product will be administered

Experimental: ATL001Patients who have previously received ATL001 in study ATX-NS-001 or study ATX-ME-001

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients must have given written informed consent to participate in the study.
  • Patients must have received ATL001 in a previous Clinical Trial.
  • Patients must be considered, in the opinion of the Investigator, capable of complying with the protocol requirements.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University College London Hospital (UCLH) NHS Foundation Trust, University College Hospital

London, NW12PG, United Kingdom

Location

Related Links

MeSH Terms

Conditions

Melanoma

Condition Hierarchy (Ancestors)

Neuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Medical Monitor, MD

    Achilles Therapeutics UK Limited

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 1, 2021

First Posted

March 5, 2021

Study Start

June 1, 2022

Primary Completion

October 18, 2023

Study Completion

October 18, 2023

Last Updated

November 21, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)