TORL-1-23
Drugantibody drug conjugate (ADC)
NCT Number: NCT05103683
This first-in-human study will evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of TORL-1-23 in patients with advanced cancer
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 1
St. Vincent's Hospital, The Catholic University of Korea, Suwon, Gyeonggi-do, South Korea
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
antibody drug conjugate (ADC)
Time frame: up to 2 years
Incidence and severity of adverse events, serious adverse events, according to NCI-CTCAE Version 5.0
Time frame: 28 Days
Highest administered dose with < 33% participants experiencing dose limiting toxicity (DLT) in the first 6 DLT evaluable participants
Time frame: up to 2 years
Based on the maximum tolerated dose, cumulative safety, and pharmacokinetic data
Time frame: up to 2 years
Percentage of participants with best response of complete response (CR) or partial response (PR) according to RECIST 1.1
Time frame: up to 2 years
Time from CR or PR to objective disease progression or death to any cause
Time frame: up to 2 years
PFS is defined as the time from the start of the treatment until objective disease progression or death from any cause
Time frame: up to 2 years
Time from start of treatment to complete response or partial response
Time frame: 1 year
Proportion of participants alive at 1 year from the start of treatment to death from any cause
Time frame: 2 years
Proportion of participants alive at 2 years from the start of treatment to death from any cause
Time frame: up to 2 years
Immunogenicity will be measured by the number of participants that are ADA positive.
Time frame: 21 days
PK assessment
Time frame: 21 days
PK assessment
Time frame: 63 days
PK assessment
Time frame: 63 days
PK assessment
Time frame: 21 days
PK assessment
Time frame: 21 days
PK Assessment
Time frame: 63 days
PK Assessment
Time frame: 63 days
PK Assessment
Time frame: 21 days
PK Assessment
Time frame: 63 days
PK Assessment
Time frame: 63 days
PK Assessment
Time frame: 63 days
PK Assessment
Time frame: 63 days
PK Assessment
Contact information is provided by the study sponsor or research team.
TORL Biotherapeutics, LLC
Industry
A Phase 1, First in Human, Dose-Escalation Study of TORL-1-23 in Participants With Advanced Cancer
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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