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

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ClinicalTrials.gov Identifier: NCT05525455
Recruitment Status : Recruiting
First Posted : September 1, 2022
Last Update Posted : February 8, 2023
Sponsor:
Collaborator:
Merck Sharp & Dohme LLC
Information provided by (Responsible Party):
Teon Therapeutics, Inc.

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

Condition or disease Intervention/treatment Phase
Advanced Cancer Advanced Solid Tumor Cancer Oncology Drug: TT-816 Drug: A PD-1 inhibitor Phase 1 Phase 2

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).
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention 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)
Primary Purpose: Treatment
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)
Actual Study Start Date : August 29, 2022
Estimated Primary Completion Date : August 19, 2023
Estimated Study Completion Date : August 31, 2027
Arms and Interventions
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Arm Intervention/treatment
Experimental: Single agent TT-816
Escalating doses followed by expansion targeting advanced cancers
 Drug: TT-816
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
Experimental: Combination TT-816 plus a PD-1 inhibitor
Escalating doses followed by expansion targeting advanced cancers
 Drug: TT-816
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

Drug: A PD-1 inhibitor
Programmed death receptor-1 (PD 1)-blocking antibody


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of adverse events (AEs) and serious adverse events (SAEs) - (Phase 1) [ Time Frame: 1 year ]
    Escalation Period

  2. Incidence and nature of dose-limiting toxicities (DLTs) - (Phase 1) [ Time Frame: up to 21 days ]
    Escalation Period

  3. Maximum tolerable dose (MTD) or a recommended Phase 2 dose (RP2D) - (Phase 1) [ Time Frame: 1 year ]
    Escalation Period

  4. Anti-tumor activity by objective response rate (ORR). - (Phase 2 - Expansion) [ Time Frame: 3 years ]
    Scale: Complete response (CR), Partial response (PR), Disease control rate (DCR), and Duration of response (DOR).


Secondary Outcome Measures :
  1. Anti-tumor activity by objective response rate (ORR). - (Phase 1 - Escalation) [ Time Frame: 3 years ]
    Scale: Complete response (CR), Partial response (PR), Disease control rate (DCR), Duration of response (DOR), Progression-free survival (PFS), and Overall survival (OS).

  2. PK (Cmax) of TT-816 - (Phase 1) [ Time Frame: 1 year ]
    Escalation Period

  3. PK (AUC) of TT-816 - (Phase 1) [ Time Frame: 1 year ]
    Escalation Period

  4. Incidence of adverse event of special interest (AESI) - (Phase 2) [ Time Frame: 3 years ]
    Expansion Period

  5. Incidence of adverse events (AEs) and serious adverse events (SAEs) - (Phase 2) [ Time Frame: 3 years ]
    Expansion Period

  6. PK (Cmax) of TT-816 - (Phase 2) [ Time Frame: 1 year ]
    Expansion Period

  7. PK (AUC) of TT-816 - (Phase 2) [ Time Frame: 1 year ]
    Expansion Period

  8. Progression-free survival (PFS) and overall survival (OS) - (Phase 2) [ Time Frame: 3 years ]
    Expansion Period


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients histologically or cytologically documented, locally advanced or metastatic solid tumor.
  • Disease progression confirmed by imaging or other objective evidence after having received standard treatment; or patients with refractory solid tumors who cannot tolerate standard treatment or have contraindications to standard treatment.
  • Measurable disease as determined by RECIST v.1.1 or bone-only disease.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

Exclusion Criteria:

  • History of severe hypersensitivity to any ingredient of the study drug(s), including a PD-1 inhibitor or other monoclonal antibody.
  • Impaired cardiac function or history of clinically significant cardiac disease
  • Human Immunodeficiency virus (HIV) infection, active hepatitis B infection, or hepatitis C infection.
  • Untreated central nervous system (CNS), epidural tumor or metastasis, or brain metastasis.

Other protocol defined inclusion/exclusion criteria may apply.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05525455


Contacts
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Contact: Teon Therapeutics, Inc. (650) 486-1902 seabeam@teonthera.com

Locations
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United States, Michigan
Teon Investigational Site Not yet recruiting
Detroit, Michigan, United States, 48202
Contact       seabeam@teonthera.com   
United States, Tennessee
Teon Investigational Site Not yet recruiting
Nashville, Tennessee, United States, 37203
Contact       seabeam@teonthera.com   
United States, Texas
Teon Investigational Site Recruiting
Austin, Texas, United States, 78758
Contact       seabeam@teonthera.com   
Teon Investigational Site Recruiting
San Antonio, Texas, United States, 78229
Contact       seabeam@teonthera.com   
United States, Virginia
Teon Investigational Site Recruiting
Fairfax, Virginia, United States, 22031
Contact       seabeam@teonthera.com   
Sponsors and Collaborators
Teon Therapeutics, Inc.
Merck Sharp & Dohme LLC
Investigators
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Study Director: Teon Clinical Development Teon Therapeutics, Inc.
More Information
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Responsible Party: Teon Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT05525455    
Other Study ID Numbers: SEABEAM
First Posted: September 1, 2022    Key Record Dates
Last Update Posted: February 8, 2023
Last Verified: February 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasms
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents