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Advanced Solid TumorPhase 1NCT05103683

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

A Phase 1 study testing TORL-1-23 in people with Advanced Solid Tumor and Ovarian Cancer, run by TORL Biotherapeutics, LLC at 14 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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

Who is it for?
Ages 18 years and older
What is being tested?
TORL-1-23
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
14 sitesin 2 countries
Study dates
17 Nov 2021to 15 Nov 2026
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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 locations and contacts

14 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

Nora Ku, MD contact

310-348-9636

nora.ku@torlbio.com

Ibrahim Qazi contact

310-348-9636

14 sites in 2 countries

United States9 sites, 9 recruiting

  • Cleveland Clinic

    Cleveland, Ohio, 44195

    Alex Adjei, MD

    Recruiting

  • Virginia Cancer Specialists

    Fairfax, Virginia, 22031

    Alexander Spira, MD

    Recruiting

  • Providence Medical Foundation

    Fullerton, California, 92835

    Yung Lyou, MD

    Recruiting

  • University of Kentucky Medical Center

    Lexington, Kentucky, 40536

    John Villano, MD

    Recruiting

  • UCLA - JCCC Clinical Research Unit

    Los Angeles, California, 90095

    Gottfried Konecny, MD, 310-794-4955

    Gottfired Konecny, MD

    Recruiting

  • University of Minnesota

    Minneapolis, Minnesota, 55455

    Boris Winterhoff, MD, PhD, 612-624-8003

    Boris Winterhoff, MD, PhD

    Recruiting

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

    Emily Slotkin, MD

    Recruiting

  • Mayo Clinic in Rochester

    Rochester, Minnesota, 55905

    Andrea Wahner Hendrickson, MD, 855-776-0015

    Andrea Wahner Hendrickson, MD

    Recruiting

  • Sarah Cannon Research Institute Texas Oncology

    Tyler, Texas, 75702

    Heather Pulaski, MD

    Heather Pulaski, MD

    Recruiting

Other trials in United States

South Korea5 sites, 5 recruiting

  • Seoul National University Hospital

    Seoul, 03080

    Bhumsuk Keam, MD

    Bhumsuk Keam, MD

    Recruiting

  • Severance Hospital

    Seoul, 03723

    Gun Min Kim, MD

    Gun Min Kim, MD

    Recruiting

  • Asan Medical Center

    Seoul, 05505

    Shinkyo Yoon, MD

    Shinkyo Yoon, MD

    Recruiting

  • Samsung Medical Center

    Seoul, 06351

    Jinseok Ahn, MD

    Jinseok Ahn, MD

    Recruiting

  • St. Vincent's Hospital, The Catholic University of Korea

    Suwon, Gyeonggi-do, 16247

    Byoung Yong Shim, MD

    Byoung Yong Shim, MD

    Recruiting

Other trials in South Korea

About this study

Official title: A Phase 1, First in Human, Dose-Escalation Study of TORL-1-23 in Participants With Advanced Cancer

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

Being tested
TORL-1-23
Keywords
claudin6
Medical subject headings
Ovarian Neoplasms, Endometrial Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TORL-1-23Drug

    antibody drug conjugate (ADC)

Study groups in NCT05103683
Study groupRoleWhat they receive
Monotherapy Dose Finding - Part 1ExperimentalTORL-1-23
Receives: Drug: TORL-1-23
Expansion as Monotherapy - Part 2ExperimentalTORL-1-23
Receives: Drug: TORL-1-23

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: up to 2 years

  2. Maximum Tolerated Dose (MTD)

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

    Measured: 28 Days

  3. Recommended Phase 2 Dose (RP2D)

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

    Measured: up to 2 years

Secondary outcomes (20)

  1. Objective Response Rate (ORR)

    Percentage of participants with best response of complete response (CR) or partial response (PR) according to RECIST 1.1

    Measured: up to 2 years

  2. Duration of Response (DOR)

    Time from CR or PR to objective disease progression or death to any cause

    Measured: up to 2 years

  3. Progression Free Survival (PFS)

    PFS is defined as the time from the start of the treatment until objective disease progression or death from any cause

    Measured: up to 2 years

  4. Time to Response (TTR)

    Time from start of treatment to complete response or partial response

    Measured: up to 2 years

  5. 1 Year Overall Survival (1YOS)

    Proportion of participants alive at 1 year from the start of treatment to death from any cause

    Measured: 1 year

  6. 2 Year Overall Survival (2YOS)

    Proportion of participants alive at 2 years from the start of treatment to death from any cause

    Measured: 2 years

  7. Number of anti-drug antibody (ADA) Positive Participants

    Immunogenicity will be measured by the number of participants that are ADA positive.

    Measured: up to 2 years

  8. Maximum Serum Concentration of TORL-1-23 (Cmax)

    PK assessment

    Measured: 21 days

  9. Minimum Serum Concentration of TORL-1-23 (Cmin)

    PK assessment

    Measured: 21 days

  10. Maximum Serum Concentration of TORL-1-23 at Steady State (Cmax,ss)

    PK assessment

    Measured: 63 days

  11. Minimum Serum Concentration of TORL-1-23 at Steady State (Cmin,ss)

    PK assessment

    Measured: 63 days

  12. Time of Maximum Serum Concentration of TORL-1-23 (Tmax)

    PK assessment

    Measured: 21 days

  13. Time of Minimum Serum Concentration of TORL-1-23 (Tmin)

    PK Assessment

    Measured: 21 days

  14. Time of Minimum Serum Concentration of TORL-1-23 at Steady State (Tmin,ss)

    PK Assessment

    Measured: 63 days

  15. Terminal Half-life (t1/2) of Serum TORL-1-23

    PK Assessment

    Measured: 63 days

  16. Area under the Serum Concentration-Time curve from the time of dosing to the last measurable concentration (AUClast) for TORL-1-23

    PK Assessment

    Measured: 21 days

  17. Area under the Serum Concentration-Time curve from the time of dosing extrapolated to time infinity (AUCinf) for TORL-1-23

    PK Assessment

    Measured: 63 days

  18. Apparent volume of distribution during the terminal phase (Vz) of TORL-1-23

    PK Assessment

    Measured: 63 days

  19. Clearance (CL) of TORL-1-23

    PK Assessment

    Measured: 63 days

  20. Accumulation ratio (Rac) of TORL-1-23

    PK Assessment

    Measured: 63 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Nov 2021
  2. Study start17 Nov 2021
  3. Primary completion31 Aug 2026 (estimated)
  4. Study completion15 Nov 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
90 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05103683
Sponsor's protocol ID
TORL123-001
Status last verified
Jul 2025
First submitted
21 Oct 2021
Last updated
13 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing TORL-1-23 in people with Advanced Solid Tumor and Ovarian Cancer, run by TORL Biotherapeutics, LLC at 14 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 13 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in United States, South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Nora Ku, MD (310-348-9636, nora.ku@torlbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence and severity of adverse events and serious adverse events (time frame: up to 2 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05103683.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2026; AzTrials last refreshed its copy on 7 Nov 2026.

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