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First in Human Study of TORL-1-23 in Participants With Advanced Cancer (TRIO049)

T

TORL Biotherapeutics

Status and phase

Enrolling
Phase 1

Conditions

Endometrial Cancer
Advanced Solid Tumor
Ovarian Cancer
NSCLC

Treatments

Drug: TORL-1-23

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT05103683
TORL123-001

Details and patient eligibility

About

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

Enrollment

90 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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-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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Sequential Assignment

Masking

None (Open label)

90 participants in 2 patient groups

Monotherapy Dose Finding - Part 1
Experimental group
Description:
TORL-1-23
Treatment:
Drug: TORL-1-23
Expansion as Monotherapy - Part 2
Experimental group
Description:
TORL-1-23
Treatment:
Drug: TORL-1-23

Trial contacts and locations

5

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Central trial contact

Brandon Sookdeo

Data sourced from clinicaltrials.gov

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