A Phase 1, First in Human, Dose-Escalation Study of TORL-3-600 in Participants with Advanced Cancer
A Phase 1, First in Human, Dose-Escalation Study of TORL-3-600 in Participants with Advanced Cancer
NCT #
NCT05948826
Condition(s)
Colorectal
Molecular Target(s)
CDH17
Drug Classification(s)
Antibody Drug Conjugate
Agents(s)
TORL-3-600
Phase(s)
I
Mechanism of Action
TORL-3-600 is a CDH(/cadherin)17 targeting ADC
Purpose
- How much of the study can be given with an acceptable level of side effects
- The effects of the study (good and bad)
- How much of the study is absorbed into the blood and how fast it is removed
- Advanced solid tumor
- Measurable disease, per RECIST v1.1
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Adequate organ function
- Has not recovered [recovery is defined as NCI CTCAE, version 5.0, grade ≤1] from the acute toxicities of previous therapy, except treatment-related alopecia or laboratory abnormalities otherwise meeting eligibility requirements
- Received prior chemotherapeutic, investigational, or other therapies for the treatment of cancer within 14 days with small molecule and within 28 days with biologic before the first dose of TORL-3-600
- Progressive or symptomatic brain metastases
- Serious, uncontrolled medical disorder, nonmalignant systemic disease, or active, uncontrolled infection
- History of significant cardiac disease
- History of myelodysplastic syndrome (MDS) or AML
- History of another cancer within 3 years before Day 1 of study treatment, with the exception of basal or squamous cell carcinoma of the skin that has been definitively treated. A history of other malignancies with a low risk of recurrence, including appropriately treated ductal carcinoma in situ (DCIS) of the breast and prostate cancer with a Gleason score less than or equal to 6, are also not excluded
- If female, is pregnant or breastfeeding
No restrictions
Location
MCD
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