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First in Human Study of TORL-3-600 in Participants With Advanced Cancer

Colorectal Cancer | Advanced Solid Tumor

This first-in-human study will evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of TORL-3-600 in patients with advanced cancer

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Conditions de participation

  • Sexe:

    ALL
  • Âges admissibles:

    18 and up

Critères de participation

Inclusion Criteria:

* Advanced solid tumor
* Measurable disease, per RECIST v1.1
* Eastern Cooperative Oncology Group (ECOG) performance status 0-1
* Adequate organ function

Exclusion Criteria:

* 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

Lieu de l'étude

McGill University Health Centre
McGill University Health Centre
Montréal, Quebec
Canada

Contactez l'équipe d'étude

Primary Contact

Ramy Saleh, MD

University Health Network, Princess Margaret Cancer Centre
University Health Network, Princess Margaret Cancer Centre
Toronto, Ontario
Canada

Contactez l'équipe d'étude

Primary Contact

Abdulazeez Salawu

Étude parrainée par
TORL Biotherapeutics, LLC
Participants recherchés
Plus d'informations
ID de l'étude: NCT05948826