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Advanced CancerPhase 1/2NCT05525455

TT-816 As Monotherapy or in Combination with a PD-1 Inhibitor in Patients with Advanced Cancers (SEABEAM) (MK3475-E88)

A Phase 1/2 study testing TT-816 and A PD-1 inhibitor in people with Advanced Cancer and Advanced Solid Tumor, run by Teon Therapeutics, Inc. at 5 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

A first-in-human study using TT-816 as a single agent and in combination with a PD-1 inhibitor in advanced cancers. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Cancer, Advanced Solid Tumor, Cancer
What is being tested?
TT-816 and A PD-1 inhibitor
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
9 participants
Where
5 sitesUnited States
Study dates
29 Aug 2022to 7 Sep 2023
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

None listed.

Who cannot join

  • All patients, regardless of phase or cohort, who meet any of the following criteria will not be eligible for participation in the study:
  • Received another systemic anticancer therapy including investigational agents within 4 weeks or 5 half-lives (whichever is shorter) prior to the first dose of study drug. Note: Patients must have recovered from all AEs due to previous therapies to ≤ Grade 1 or baseline. Patients with ≤ Grade 2 neuropathy may be eligible. Patients with endocrine-related AEs ≤ Grade 2 requiring treatment or hormone replacement may be eligible.
  • Received radiotherapy within 2 weeks prior to the first dose of study drug or palliative radiation therapy within 1 week prior to the first dose of study drug.
  • Have another primary malignancy that is progressing, has required active treatment within the last 3 years, or has not been treated with curative intent within the last 3 years (discuss with Medical Monitor). Patients with carcinoma-in-situ that has been treated successfully more than 3 years prior to screening, non-metastatic cutaneous basal cell or squamous cell carcinoma, or non-muscle invasive bladder cancer are not excluded.
  • Have untreated central nervous system (CNS), epidural tumor or metastasis, or brain metastasis. Patients with previously treated brain metastases may participate provided they are radiologically stable, i.e., without evidence of progression for at least 4 weeks by repeat imaging (repeat MRI or CT with contrast should be performed during study screening), clinically stable, and without requirement of steroid treatment for at least 14 days prior to first dose of study treatment.
  • Major surgical procedures within 4 weeks (28 days) of the first dose of study drug. If the patient had major surgery, the patient must have recovered adequately from the procedure and/or any complications from the surgery prior to starting study drug.
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  • Patients previously enrolled on this study and received at least one dose of study drug.
  • Is currently participating in or has participated in a study of an investigational agent or therapy, or has used an implantable investigational device within 4 weeks prior to the first dose of study treatment. Note: Patients who have entered the follow-up phase of an investigational study may participate as long as it has been 4 weeks after the last dose of the previous investigational agent.
  • Have a QT interval corrected (QTc) prolongation to > 470 milliseconds (ms) at screening based on a 12-lead electrocardiogram (ECG) in triplicate using the Fridericia formula (QTcF): QTc = QT / RR 1/3.
  • Patients on concomitant medications that increase or possibly increase the risk of QTc prolongation and/or induce Torsades de Pointes, including antifungals, antibiotics, antipsychotics, antiemetics, antiarrhythmics, and antineoplastic medications.
  • Patients on proton pump inhibitors (PPIs) who cannot switch to H2 inhibitors (or cannot stop PPI therapy entirely) at least 3 days before their first dose of TT-816 study drug for the duration of the study. See protocol Section 5.2 for permissible usage of H2 inhibitors during the study.
  • Have received a live or live-attenuated vaccine within 30 days prior to the first dose of study intervention. Administration of killed vaccines are allowed.
  • Have a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study drug.
  • Have a history of (non-infectious) pneumonitis / interstitial lung disease that required steroids or has current pneumonitis / interstitial lung disease
  • Have significant, uncontrolled, or active cardiovascular disease, including, but not restricted to:
  • Myocardial infarction (MI) or unstable angina within 6 months before the first dose of study drug.
  • History of an arterial thrombotic event, stroke, or transient ischemia attack within 12 months prior to first dose of study drug
  • Symptomatic congestive heart failure (New York Heart Association classes II-IV) within 6 months before the first dose of study drug
  • A cardiac arrhythmia that requires treatment within 6 months before the first dose of study drug
  • Patients with evidence of an active infection requiring intravenous (IV) antibiotics within 7 days prior to the first dose of study drug.
  • Patients with active uncontrolled bleeding, or a bleeding diathesis within 7 days prior to the first dose of study drug.
  • Patients with serious or non-healing wound, fistula, skin ulcer, or non-healing bone fracture within 7 days prior to the first dose of study drug.
  • Patients with known history of human immunodeficiency virus (HIV) infection. Note: No HIV testing is required unless patient history of HIV is unknown or if mandated by local health authority.
  • Patients with a known history of Hepatitis B (defined as HBsAg reactive) or known active Hepatitis C virus infection (defined as HCV RNA [qualitative] is detected). Note: No testing for Hepatitis B and Hepatitis C is required unless patient history of Hepatitis B or Hepatitis C is unknown or if mandated by local health authority.
  • Pregnant or breastfeeding or plans to become pregnant during the study.
  • Patients unwilling or unable to follow protocol requirements, including any known psychiatric or substance use disorder that would interfere with the patient's ability to comply with the requirements of the study.
  • Have a history or current evidence of any condition, therapy, or laboratory abnormality, or other circumstance that might confound the results of the study or interfere with the patient's participation for the full duration of the study, such that it is not in the best interest of the patient to participate, in the opinion of the Investigator.
  • There are no additional exclusionary criteria specific to participation in Phases 1m and 2m.
  • For Phases 1p and 2p, patients who meet any of the following criteria will not be eligible for participation in the study:
  • Have severe hypersensitivity (≥ Grade 3) to pembrolizumab and/or any of its excipients.
  • Have any history of radiation pneumonitis. Note: Patients must have recovered from all radiation-related toxicities and not require corticosteroids.
  • Have received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX 40, CD137), and was discontinued from that treatment due to an irAE.
  • Have had an allogeneic tissue/solid organ transplant.
  • For patients with NSCLC, have received radiation therapy to the lung that is >30Gy within 6 months of the first dose of trial treatment.
  • Have an active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs).
  • Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed.

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

United States5 sites

  • Teon Investigational Site

    Austin, Texas, 78758

  • Teon Investigational Site

    Fairfax, Virginia, 22031

  • Teon Investigational Site

    Nashville, Tennessee, 37203

  • Teon Investigational Site

    San Antonio, Texas, 78229

  • Teon Investigational Site

    West Valley City, Utah, 84119

Other trials in United States

About this study

Official title: A Phase 1/2, First-in-human Study of the Safety, Pharmacokinetics, and Preliminary Anti-tumor Activity of TT-816 As Monotherapy or in Combination with a PD-1 Inhibitor in Patients with Advanced Cancers (SEABEAM) (MK3475-E88)

A first-in-human study using TT-816 as a single agent and in combination with a PD-1 inhibitor in advanced cancers.

Read the detailed description

This is an open-label, Phase 1/2, first-in-human (FIH), multiple ascending dose and dose-expansion study of TT-816 administered as monotherapy and in combination with a PD-1 inhibitor. Phase 1 will define the maximum tolerated dose (MTD) or recommended Phase 2 dose (RP2D) of TT-816 and of combination therapy that can be advanced to Phase 2. Phase 2 will define the preliminary efficacy of these regimens in the setting of advanced solid tumors with high unmet medical needs including Non-Small Cell Lung Cancer (NSCLC), Ovarian Cancer and Renal Cell Carcinoma (RCC).

Being tested
TT-816, A PD-1 inhibitor
Medical subject headings
Neoplasms

What participants receive

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

  • TT-816Drug

    TT-816 is a novel, oral cannabinoid CB2 receptor antagonist acting as an immune checkpoint inhibitor for the treatment of a broad range of solid tumors

  • A PD-1 inhibitorDrug

    Programmed death receptor-1 (PD 1)-blocking antibody

Study groups in NCT05525455
Study groupRoleWhat they receive
Single agent TT-816ExperimentalEscalating doses followed by expansion targeting advanced cancers
Receives: Drug: TT-816
Combination TT-816 plus a PD-1 inhibitorExperimentalEscalating doses followed by expansion targeting advanced cancers
Receives: Drug: TT-816; Drug: A PD-1 inhibitor

What is being measured

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

  1. Incidence of adverse events (AEs) and serious adverse events (SAEs) - (Phase 1)

    Incidence of adverse events (AEs) and serious adverse events (SAEs) graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0

    Measured: 3 years

  2. Incidence and nature of dose-limiting toxicities (DLTs) - (Phase 1)

    Incidence and nature of DLTs within a 3+3 trial design

    Measured: up to 21 days

  3. Changes from baseline in clinical safety laboratory values and vital signs

    Changes from baseline in clinical safety laboratory values and vital signs

    Measured: 2 years

  4. MTD or RP2D of oral TT816 - (Phase 1m)

    The Maximum Tolerated Dose (MTD) or Recommended Phase 2 Dose (RP2D) of oral TT-816 as monotherapy (Phase 1m)

    Measured: 1 year

  5. MTD or RP2D of oral TT816 - (Phase 1p)

    The Maximum Tolerated Dose (MTD) or Recommended Phase 2 Dose (RP2D) of oral TT-816 in combination with a PD-1 inhibitor (Phase 1p)

    Measured: 1 year

  6. Efficacy assessments according to RECIST 1.1 (Phase 2)

    Overall Response Rate. Scale: confirmed Complete response (CR) or Partial response (PR), Duration of Response (DOR), and Disease Control Rate (DCR).

    Measured: 3 years

Secondary outcomes (12)

  1. Objective response rate (ORR). - (Phase 1)

    Efficacy assessments according to RECIST 1.1. Objective Response Rate (ORR) Scale: Complete response (CR), Partial response (PR)

    Measured: 3 years

  2. Disease control rate (DCR) (Phase 1)

    Disease control rate (DCR)

    Measured: 3 years

  3. Duration of response (DOR) (Phase 1)

    Duration of Response (DOR)

    Measured: 3 years

  4. Progression-free survival (PFS) (Phase 1)

    Progression-free survival (PFS)

    Measured: 3 years

  5. Overall survival (OS) (Phase 1)

    Overall survival (OS).

    Measured: 3 years

  6. PK (Cmax) of TT-816 - (Phase 1)

    Noncompartmental Pharmacokinetic (PK) parameters of TT-816 including the maximum plasma concentration (Cmax )

    Measured: 2 years

  7. PK (AUC) of TT-816 - (Phase 1)

    Noncompartmental PK parameters of TT-816 including area under the plasma concentration-time curve (AUC)

    Measured: 2 years

  8. Incidence of AESIs - (Phase 2)

    Incidence of AEs of special interest

    Measured: 3 years

  9. Incidence of AEs and SAEs - (Phase 2)

    Incidence of AEs and SAEs graded according to the NCI CTCAE v5.0

    Measured: 3 years

  10. PK (Cmax) of TT-816 - (Phase 2)

    Noncompartmental PK parameters of TT-816 including the maximum plasma concentration (Cmax )

    Measured: 2 years

  11. PK (AUC) of TT-816 - (Phase 2)

    Noncompartmental PK parameters of TT-816 including area under the plasma concentration-time curve (AUC)

    Measured: 2 years

  12. PFS and OS - (Phase 2)

    Progression Free Survival (PFS) and Overall Survival (OS)

    Measured: 3 years

Timeline

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

  1. First posted1 Sep 2022
  2. Study start29 Aug 2022
  3. Primary completion7 Sep 2023
  4. Study completion7 Sep 2023

Why it stopped: Company operational decision. Decision to stop study is not due to safety or efficacy concerns.

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 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Model description
Multiple ascending dose and dose-expansion of TT-816 administered as a single agent or in combination with a PD-1 inhibitor.
Masking
None (open label)
Enrolment
9 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05525455
Sponsor's protocol ID
SEABEAM
Status last verified
Oct 2023
First submitted
22 Aug 2022
Last updated
21 Nov 2024
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 1/2 study testing TT-816 and A PD-1 inhibitor in people with Advanced Cancer and Advanced Solid Tumor, run by Teon Therapeutics, Inc. at 5 sites in United States.

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 0 inclusion and 36 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: stopped early, as of the sponsor's last update on 21 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. 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?

The study was stopped early (reason given: Company operational decision. Decision to stop study is not due to safety or efficacy concerns.). 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 of adverse events (AEs) and serious adverse events (SAEs) - (Phase 1) (time frame: 3 years). The study lists 6 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 NCT05525455.

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 21 Nov 2024.

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