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Advanced Solid TumorPhase 1NCT05159440

First in Human Study of TORL-2-307-MAB in Participants With Advanced Cancer

A Phase 1 study testing TORL-2-307-MAB in people with Advanced Solid Tumor and Gastric Cancer, run by TORL Biotherapeutics, LLC at 8 sites in 2 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This first-in-human study will evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of TORL-2-307-MAB in patients with advanced cancer Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
TORL-2-307-MAB
Could I receive a placebo?
No, everyone receives an active treatment
How many people
70 participants
Where
8 sitesin 2 countries
Study dates
20 Jan 2022to 15 Dec 2025
Phase
Phase 1
Are there results?
None posted in the registry

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-2-307-MAB
  • 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

8 sites in 2 countries.

8 sites in 2 countries

United States5 sites

  • Fort Wayne Medical Oncology and Hematology

    Fort Wayne, Indiana, 46804

  • Providence St. Jude Medical Center

    Fullerton, California, 92835

  • UCLA - JCCC Clinical Research Unit

    Los Angeles, California, 90095

  • Washington University School of Medicine-Siteman Cancer Center

    St Louis, Missouri, 63110

  • Torrance Memorial Medical

    Torrance, California, 90505

Other trials in United States

South Korea3 sites

  • Seoul National University Hospital

    Seoul, 03080

  • Severance Hospital, Yonsei University Health System

    Seoul, 03722

  • Seoul National University Bundang Hospital

    Seoul, 13620

Other trials in South Korea

About this study

Official title: A Phase 1, First in Human, Dose-Escalation Study of TORL-2-307-MAB in Participants With Advanced Cancer

This first-in-human study will evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of TORL-2-307-MAB in patients with advanced cancer

Being tested
TORL-2-307-MAB
Keywords
claudin18.2
Medical subject headings
Stomach Neoplasms, Pancreatic Neoplasms

What participants receive

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

  • TORL-2-307-MABDrug

    monoclonal antibody

Study groups in NCT05159440
Study groupRoleWhat they receive
Monotherapy Dose Dose Finding - Part 1ExperimentalTORL-2-307-MAB
Receives: Drug: TORL-2-307-MAB
Expansion as Monotherapy - Part 2ExperimentalTORL-2-307-MAB
Receives: Drug: TORL-2-307-MAB

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-2-307-MAB (Cmax)

    PK assessment

    Measured: 21 days

  9. Minimum Serum Concentration of TORL-2-307-MAB (Cmin)

    PK assessment

    Measured: 21 days

  10. Maximum Serum Concentration of TORL-2-307-MAB at Steady State (Cmax,ss)

    PK assessment

    Measured: 63 days

  11. Minimum Serum Concentration of TORL-2-307-MAB at Steady State (Cmin,ss)

    PK assessment

    Measured: 63 days

  12. Time of Maximum Serum Concentration of TORL-2-307-MAB (Tmax)

    PK assessment

    Measured: 21 days

  13. Time of Minimum Serum Concentration of TORL-2-307-MAB (Tmin)

    PK Assessment

    Measured: 21 days

  14. Time of Minimum Serum Concentration of TORL-2-307-MAB at Steady State (Tmin,ss)

    PK Assessment

    Measured: 63 days

  15. Terminal Half-life (t1/2) of Serum TORL-2-307-MAB

    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-2-307-MAB

    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-2-307-MAB

    PK Assessment

    Measured: 63 days

  18. Apparent volume of distribution during the terminal phase (Vz) of TORL-2-307-MAB

    PK Assessment

    Measured: 63 days

  19. Clearance (CL) of TORL-2-307-MAB

    PK Assessment

    Measured: 63 days

  20. Accumulation ratio (Rac) of TORL-2-307-MAB

    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 posted16 Dec 2021
  2. Study start20 Jan 2022
  3. Primary completion15 Dec 2024 (estimated)
  4. Study completion15 Dec 2025 (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
70 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05159440
Sponsor's protocol ID
TORL2307MAB-001
Status last verified
Oct 2024
First submitted
1 Dec 2021
Last updated
22 Oct 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • O'Brien NA, McDermott MSJ, Zhang J, Gong KW, Lu M, Hoffstrom B, Luo T, Ayala R, Chau K, Liang M, Madrid AM, Donahue TR, Glaspy JA, Presta L, Slamon DJ. Development of a Novel CLDN18.2-directed Monoclonal Antibody and Antibody-Drug Conjugate for Treatment of CLDN18.2-Positive Cancers. Mol Cancer Ther. 2023 Dec 1;22(12):1365-1375. doi: 10.1158/1535-7163.MCT-23-0353.

    PubMed 37788341

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing TORL-2-307-MAB in people with Advanced Solid Tumor and Gastric Cancer, run by TORL Biotherapeutics, LLC at 8 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: status not confirmed, as of the sponsor's last update on 22 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 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?

Results are not available in the source record.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. 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 NCT05159440, which also lists 1 linked publication.

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 22 Oct 2024.

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