Advanced Solid TumorPhase 1NCT05948826
First in Human Study of TORL-3-600 in Participants With Advanced Cancer
A Phase 1 study testing TORL-3-600 in people with Advanced Solid Tumor and Colorectal Cancer, run by TORL Biotherapeutics, LLC at 9 sites in 2 countries.
Trial summary
This first-in-human study will evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of TORL-3-600 in patients with advanced cancer Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumor, Colorectal Cancer
- What is being tested?
- TORL-3-600
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 9 sitesin 2 countries
- Study dates
- 29 Sep 2023to 15 Sep 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-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
Trial locations and contacts
9 sites in 2 countries.
9 sites in 2 countries
United States7 sites
Mary Crowley Cancer Research
Dallas, Texas, 75230
Sarah Cannon Research Institute
Denver, Colorado, 80218
Fort Wayne Medical Oncology and Hematology Inc.
Fort Wayne, Indiana, 46845
Providence Medical Foundation
Fullerton, California, 92835
UCLA - JCCC Clinical Research Unit
Los Angeles, California, 90095
Sarah Cannon Research Institute-Tennessee
Nashville, Tennessee, 37203
Washington University School of Medicine-Siteman Cancer Center
St Louis, Missouri, 63110
Canada2 sites
McGill University Health Centre
Montreal, Quebec, H4A 3J1
University Health Network, Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2M9
About this study
Official title: A Phase 1, First in Human, Dose-Escalation Study of TORL-3-600 in Participants With Advanced Cancer
This first-in-human study will evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of TORL-3-600 in patients with advanced cancer
- Conditions
- Advanced Solid Tumor, Colorectal Cancer
- Being tested
- TORL-3-600
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TORL-3-600Drug
antibody drug conjugate
| Study group | Role | What they receive |
|---|---|---|
| Monotherapy Dose Dose Finding - Part 1 | Experimental | TORL-3-600 Receives: Drug: TORL-3-600 |
| Expansion as Monotherapy - Part 2 | Experimental | TORL-3-600 Receives: Drug: TORL-3-600 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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
Recommended Phase 2 Dose (RP2D)
Based on the maximum tolerated dose, cumulative safety, and pharmacokinetic data
Measured: up to 2 years
Secondary outcomes (20)
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
Duration of Response (DOR)
Time from CR or PR to objective disease progression or death to any cause
Measured: up to 2 years
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
Time to Response (TTR)
Time from start of treatment to complete response or partial response
Measured: up to 2 years
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
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
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
Maximum Serum Concentration of TORL-3-600 (Cmax)
PK assessment
Measured: 21 days
Minimum Serum Concentration of TORL-3-600 (Cmin)
PK assessment
Measured: 21 days
Maximum Serum Concentration of TORL-3-600 at Steady State (Cmax,ss)
PK assessment
Measured: 63 days
Minimum Serum Concentration of TORL-3-600 at Steady State (Cmin,ss)
PK assessment
Measured: 63 days
Time of Maximum Serum Concentration of TORL-3-600 (Tmax)
PK assessment
Measured: 21 days
Time of Minimum Serum Concentration of TORL-3-600 (Tmin)
PK Assessment
Measured: 21 days
Time of Minimum Serum Concentration of TORL-3-600 at Steady State (Tmin,ss)
PK Assessment
Measured: 63 days
Terminal Half-life (t1/2) of Serum TORL-3-600-ADC
PK Assessment
Measured: 63 days
Area under the Serum Concentration-Time curve from the time of dosing to the last measurable concentration (AUClast) for TORL-3-600
PK Assessment
Measured: 21 days
Area under the Serum Concentration-Time curve from the time of dosing extrapolated to time infinity (AUCinf) for TORL-3-600
PK Assessment
Measured: 63 days
Apparent volume of distribution during the terminal phase (Vz) of TORL-3-600
PK Assessment
Measured: 63 days
Clearance (CL) of TORL-3-600
PK Assessment
Measured: 63 days
Accumulation ratio (Rac) of TORL-3-600
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.
- First posted17 Jul 2023
- Study start29 Sep 2023
- Primary completion25 Jun 2026 (estimated)
- Study completion15 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- TORL Biotherapeutics, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Translational Research in Oncology
- Responsible party
- Sponsor
- Investigators
- Caroline Labib, PharmD, Study chair, TORL Biotherapeutics, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05948826
- Sponsor's protocol ID
- TORL3600-001
- Status last verified
- Oct 2025
- First submitted
- 9 Jul 2023
- Last updated
- 10 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, First in Human, Dose-Escalation Study of TORL-3-600 in Participants With Advanced Cancer
- ClinicalTrials.gov ID
- NCT05948826
- Acronym / sponsor ID
- TORL3600-001
- Conditions
- Advanced Solid Tumor, Colorectal Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- TORL Biotherapeutics, LLCIndustry (pharma, biotech, devices)
- Collaborators
- Translational Research in Oncology
- Study start
- 29 Sep 2023 (actual)
- Primary completion
- 25 Jun 2026 (estimated)
- Study completion
- 15 Sep 2026 (estimated)
- First posted
- 17 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This first-in-human study will evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of TORL-3-600 in patients with advanced cancer
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Monotherapy Dose Dose Finding - Part 1 | Experimental | Drug: TORL-3-600TORL-3-600 |
| Expansion as Monotherapy - Part 2 | Experimental | Drug: TORL-3-600TORL-3-600 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Advanced solid tumor
- Measurable disease, per RECIST v1.1
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Adequate organ function
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TORL-3-600antibody drug conjugate | Drug | Expansion as Monotherapy - Part 2, Monotherapy Dose Dose Finding - Part 1 |
Primary outcome
Incidence and severity of adverse events and serious adverse events
Time frame: up to 2 years
Incidence and severity of adverse events, serious adverse events, according to NCI-CTCAE Version 5.0
Maximum Tolerated Dose (MTD)
Time frame: 28 Days
Highest administered dose with < 33% participants experiencing dose limiting toxicity (DLT) in the first 6 DLT evaluable participants
Recommended Phase 2 Dose (RP2D)
Time frame: up to 2 years
Based on the maximum tolerated dose, cumulative safety, and pharmacokinetic data
20 secondary outcomes
Objective Response Rate (ORR)
Time frame: up to 2 years
Duration of Response (DOR)
Time frame: up to 2 years
Progression Free Survival (PFS)
Time frame: up to 2 years
Time to Response (TTR)
Time frame: up to 2 years
1 Year Overall Survival (1YOS)
Time frame: 1 year
2 Year Overall Survival (2YOS)
Time frame: 2 years
Number of anti-drug antibody (ADA) Positive Participants
Time frame: up to 2 years
Maximum Serum Concentration of TORL-3-600 (Cmax)
Time frame: 21 days
Minimum Serum Concentration of TORL-3-600 (Cmin)
Time frame: 21 days
Maximum Serum Concentration of TORL-3-600 at Steady State (Cmax,ss)
Time frame: 63 days
Minimum Serum Concentration of TORL-3-600 at Steady State (Cmin,ss)
Time frame: 63 days
Time of Maximum Serum Concentration of TORL-3-600 (Tmax)
Time frame: 21 days
Time of Minimum Serum Concentration of TORL-3-600 (Tmin)
Time frame: 21 days
Time of Minimum Serum Concentration of TORL-3-600 at Steady State (Tmin,ss)
Time frame: 63 days
Terminal Half-life (t1/2) of Serum TORL-3-600-ADC
Time frame: 63 days
Area under the Serum Concentration-Time curve from the time of dosing to the last measurable concentration (AUClast) for TORL-3-600
Time frame: 21 days
Area under the Serum Concentration-Time curve from the time of dosing extrapolated to time infinity (AUCinf) for TORL-3-600
Time frame: 63 days
Apparent volume of distribution during the terminal phase (Vz) of TORL-3-600
Time frame: 63 days
Clearance (CL) of TORL-3-600
Time frame: 63 days
Accumulation ratio (Rac) of TORL-3-600
Time frame: 63 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Caroline Labib, PharmD study chair
TORL Biotherapeutics, LLC
9 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TORL-3-600 in people with Advanced Solid Tumor and Colorectal Cancer, run by TORL Biotherapeutics, LLC at 9 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: under way, not looking for participants, as of the sponsor's last update on 10 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States, Canada. 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?
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?
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 10 Oct 2025.