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First in Human Study of TORL-1-23 in Participants With Advanced Cancer

Sponsored by TORL Biotherapeutics, LLC

About this trial

Last updated 2 years ago

Study ID

TORL123-001

Status

Recruiting

Type

Interventional

Phase

Phase 1

Placebo

No

Accepting

18-75 Years
18+ Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Started 4 years ago

What is this trial about?

This first-in-human study will evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of TORL-1-23 in patients with advanced cancer

What are the participation requirements?

Yes

Inclusion Criteria

- Advanced solid tumor

- Measurable disease, per RECIST v1.1

- Eastern Cooperative Oncology Group (ECOG) performance status 0-1

- Adequate organ function

No

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-1-23

- 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

Locations

Location

Status

Recruiting
Recruiting
Recruiting