NCT05948826

Brief Summary

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

Trial Health

78
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P75+ for phase_1

Timeline
4mo left

Started Sep 2023

Typical duration for phase_1

Geographic Reach
2 countries

9 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress88%
Sep 2023Sep 2026

First Submitted

Initial submission to the registry

July 9, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 17, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

September 29, 2023

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 25, 2026

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2026

Last Updated

October 10, 2025

Status Verified

October 1, 2025

Enrollment Period

2.7 years

First QC Date

July 9, 2023

Last Update Submit

October 8, 2025

Conditions

Advanced Solid TumorColorectal Cancer

Outcome Measures

Primary Outcomes (3)

  • Incidence and severity of adverse events and serious adverse events

    Incidence and severity of adverse events, serious adverse events, according to NCI-CTCAE Version 5.0

    up to 2 years

  • Maximum Tolerated Dose (MTD)

    Highest administered dose with \< 33% participants experiencing dose limiting toxicity (DLT) in the first 6 DLT evaluable participants

    28 Days

  • Recommended Phase 2 Dose (RP2D)

    Based on the maximum tolerated dose, cumulative safety, and pharmacokinetic data

    up to 2 years

Secondary Outcomes (20)

  • Objective Response Rate (ORR)

    up to 2 years

  • Duration of Response (DOR)

    up to 2 years

  • Progression Free Survival (PFS)

    up to 2 years

  • Time to Response (TTR)

    up to 2 years

  • 1 Year Overall Survival (1YOS)

    1 year

  • +15 more secondary outcomes

Study Arms (2)

Monotherapy Dose Dose Finding - Part 1

EXPERIMENTAL

TORL-3-600

Drug: TORL-3-600

Expansion as Monotherapy - Part 2

EXPERIMENTAL

TORL-3-600

Drug: TORL-3-600

Interventions

TORL-3-600DRUG

antibody drug conjugate

Expansion as Monotherapy - Part 2Monotherapy Dose Dose Finding - Part 1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Providence Medical Foundation

Fullerton, California, 92835, United States

Location

UCLA - JCCC Clinical Research Unit

Los Angeles, California, 90095, United States

Location

Sarah Cannon Research Institute

Denver, Colorado, 80218, United States

Location

Fort Wayne Medical Oncology and Hematology Inc.

Fort Wayne, Indiana, 46845, United States

Location

Washington University School of Medicine-Siteman Cancer Center

St Louis, Missouri, 63110, United States

Location

Sarah Cannon Research Institute-Tennessee

Nashville, Tennessee, 37203, United States

Location

Mary Crowley Cancer Research

Dallas, Texas, 75230, United States

Location

University Health Network, Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2M9, Canada

Location

McGill University Health Centre

Montreal, Quebec, H4A 3J1, Canada

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Caroline Labib, PharmD

    TORL Biotherapeutics, LLC

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 9, 2023

First Posted

July 17, 2023

Study Start

September 29, 2023

Primary Completion (Estimated)

June 25, 2026

Study Completion (Estimated)

September 15, 2026

Last Updated

October 10, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share

Locations

US(7)CA(2)