A Phase 1, First in Human Study of TORL-4-500 in Patients With Advanced Cancer

Summary

This first-in-human study will evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of TORL-4-500 in patients with advanced cancer. For Part 1, any advanced or metastatic solid tumor malignancy will be evaluated including, for example, adrenocortical carcinoma (ACC).

Eligibility

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-4-500
* 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

Conditions5

Locations8 sites

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