TORL-2-307-ADC
Drugantibody drug conjugate
NCT Number: NCT05156866
This first-in-human study will evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of TORL-2-307-ADC in patients with advanced cancer
This study is active but is not currently recruiting participants.
Notify Me18 year and older
All sexes
Interventional
Phase 1
Seoul National University Bundang Hospital, Seoul, South Korea
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
antibody drug conjugate
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
TORL Biotherapeutics, LLC
Industry
A Phase 1, First in Human, Dose-Escalation Study of TORL-2-307-ADC 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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