Advanced or Metastatic Solid TumorsPhase 1/2INCLINE-101NCT05399654
A Dose Escalation and Expansion Study of TAC-001 in Patients With Select Advanced or Metastatic Solid Tumors
A Phase 1/2 study testing TAC-001 in people with Advanced or Metastatic Solid Tumors, run by Tallac Therapeutics at 12 sites in 2 countries.
Trial summary
INCLINE-101 is an open label, multicenter Phase 1/2 study designed to evaluate safety, pharmacokinetics (PK), and preliminary anti-tumor activity of TAC-001 administered intravenously. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced or Metastatic Solid Tumors
- What is being tested?
- TAC-001
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 12 sitesin 2 countries
- Study dates
- 28 Jun 2022to 19 May 2026
- Phase
- Phase 1/2
- 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
- Histologically or cytologically-documented solid tumors.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1.
- Demonstrate adequate organ function.
Who cannot join
- Prior history of or active malignant disease other than that being treated in this study.
- Known brain metastases or cranial epidural disease.
- A known hypersensitivity to the components of the study therapy or its' analogs.
Trial locations and contacts
12 sites in 2 countries.
12 sites in 2 countries
United States11 sites
University of Colorado
Aurora, Colorado, 80045
Sarah Cannon Research Institute (SCRI)- Denver
Denver, Colorado, 80218
NEXT Oncology- Virginia
Fairfax, Virginia, 22031
West Cancer Center & Research Institute
Germantown, Tennessee, 38138
John Theurer Cancer Center
Hackensack, New Jersey, 07601
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
NEXT Oncology
Irving, Texas, 75039
University of Southern California (USC)
Los Angeles, California, 90033
Weill Cornell Medicine- NYU Clinical Cancer Center
New York, New York, 10065
AdventHealth Cancer Institute
Orlando, Florida, 32804
Sarah Cannon Research Institute (SCRI)- Florida Cancer Specialists and Research Institute, LLC
Orlando, Florida, 32827
About this study
Official title: A Phase 1/2, Open Label, Dose Escalation and Expansion Study of TAC-001 in Patients With Select Advanced or Metastatic Solid Tumors
INCLINE-101 is an open label, multicenter Phase 1/2 study designed to evaluate safety, pharmacokinetics (PK), and preliminary anti-tumor activity of TAC-001 administered intravenously.
- Conditions
- Advanced or Metastatic Solid Tumors
- Being tested
- TAC-001
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAC-001Drug
TAC-001 is a Toll-like Receptor Agonist Antibody Conjugate (TRAAC)
| Study group | Role | What they receive |
|---|---|---|
| TAC-001 Single-Agent Dose-Escalation Cohorts | Experimental | Not described Receives: Drug: TAC-001 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-Escalation Stage: RP2D for TAC-001
To identify the recommended dose phase 2 dose (RP2D) for further evaluation of TAC-001 when administered as monotherapy in subjects with advanced or metastatic solid tumors
Measured: 2-years
Dose Expansion: Characterization of ORR for TAC-001
To evaluate preliminary efficacy of TAC-001 by estimating the overall response rate (ORR; combined complete response [CR] and partial response [PR]) as assessed by the Investigator per RECIST 1.1 and iRECIST
Measured: 2 years
Dose Expansion: Characterization of duration of response for TAC-001
To evaluate preliminary efficacy of TAC-001 by estimating the duration of response as assessed by the Investigator per RECIST 1.1 and iRECIST
Measured: 2 years
Dose Expansion: Characterization of clinical benefit rate for TAC-001
To evaluate preliminary efficacy of TAC-001 by estimating the clinical benefit rate as assessed by the Investigator per RECIST 1.1 and iRECIST
Measured: 2 years
Secondary outcomes (7)
Incidence and Severity of Nonserious Adverse Events (AEs) and Serious Adverse Events (SAEs)
To evaluate the safety of TAC-001 monotherapy through the evaluation of incidence and severity of nonserious AEs and SAEs, including immune-related adverse events (irAEs), as graded by investigators according to CTCAE version 5.0
Measured: 2 years
Maximum Plasma Concentration (Cmax)
To evaluate the Cmax of TAC-001 monotherapy
Measured: 2 years
Maximum Plasma Concentration (Tmax)
To evaluate the Tmax of TAC-001 monotherapy
Measured: 2 years
Area Under the Plasma Concentration-Time Curve (AUC)
To evaluate the AUC of TAC-001 monotherapy
Measured: 2 years
Terminal Half-Life
To evaluate the terminal half-life of TAC-001 monotherapy
Measured: 2 years
Clearance of TAC-001
To evaluate the drug clearance of TAC-001 monotherapy
Measured: 2 years
Evaluation of immunogenicity of TAC-001
Incidence of antidrug antibodies (ADA) against TAC-001
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2022
- Study start28 Jun 2022
- Primary completion27 Jan 2026 (estimated)
- Study completion19 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced or Metastatic Solid TumorsStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tallac Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05399654
- Sponsor's protocol ID
- INCLINE-101
- Acronym
- INCLINE-101
- Status last verified
- Aug 2024
- First submitted
- 19 May 2022
- Last updated
- 16 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2, Open Label, Dose Escalation and Expansion Study of TAC-001 in Patients With Select Advanced or Metastatic Solid Tumors
- ClinicalTrials.gov ID
- NCT05399654
- Acronym / sponsor ID
- INCLINE-101 / INCLINE-101
- Conditions
- Advanced or Metastatic Solid Tumors
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Tallac TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 28 Jun 2022 (actual)
- Primary completion
- 27 Jan 2026 (estimated)
- Study completion
- 19 May 2026 (estimated)
- First posted
- 1 Jun 2022 (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.
INCLINE-101 is an open label, multicenter Phase 1/2 study designed to evaluate safety, pharmacokinetics (PK), and preliminary anti-tumor activity of TAC-001 administered intravenously.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TAC-001 Single-Agent Dose-Escalation Cohorts | Experimental | Drug: TAC-001 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Histologically or cytologically-documented solid tumors.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1.
- Demonstrate adequate organ function.
Key exclusion criteria (3 listed)
- Prior history of or active malignant disease other than that being treated in this study.
- Known brain metastases or cranial epidural disease.
- A known hypersensitivity to the components of the study therapy or its' analogs.
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 |
|---|---|---|
| TAC-001TAC-001 is a Toll-like Receptor Agonist Antibody Conjugate (TRAAC) | Drug | TAC-001 Single-Agent Dose-Escalation Cohorts |
Primary outcome
Dose-Escalation Stage: RP2D for TAC-001
Time frame: 2-years
To identify the recommended dose phase 2 dose (RP2D) for further evaluation of TAC-001 when administered as monotherapy in subjects with advanced or metastatic solid tumors
Dose Expansion: Characterization of ORR for TAC-001
Time frame: 2 years
To evaluate preliminary efficacy of TAC-001 by estimating the overall response rate (ORR; combined complete response [CR] and partial response [PR]) as assessed by the Investigator per RECIST 1.1 and iRECIST
Dose Expansion: Characterization of duration of response for TAC-001
Time frame: 2 years
To evaluate preliminary efficacy of TAC-001 by estimating the duration of response as assessed by the Investigator per RECIST 1.1 and iRECIST
Dose Expansion: Characterization of clinical benefit rate for TAC-001
Time frame: 2 years
To evaluate preliminary efficacy of TAC-001 by estimating the clinical benefit rate as assessed by the Investigator per RECIST 1.1 and iRECIST
7 secondary outcomes
Incidence and Severity of Nonserious Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: 2 years
Maximum Plasma Concentration (Cmax)
Time frame: 2 years
Maximum Plasma Concentration (Tmax)
Time frame: 2 years
Area Under the Plasma Concentration-Time Curve (AUC)
Time frame: 2 years
Terminal Half-Life
Time frame: 2 years
Clearance of TAC-001
Time frame: 2 years
Evaluation of immunogenicity of TAC-001
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
12 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing TAC-001 in people with Advanced or Metastatic Solid Tumors, run by Tallac Therapeutics at 12 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 3 inclusion and 3 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 16 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States, Australia. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Dose-Escalation Stage: RP2D for TAC-001 (time frame: 2-years). The study lists 4 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 16 Aug 2024.