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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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.

Tracking Information
First Submitted Date  ICMJE August 22, 2022
First Posted Date  ICMJE September 1, 2022
Last Update Posted Date February 8, 2023
Actual Study Start Date  ICMJE August 29, 2022
Estimated Primary Completion Date August 19, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 30, 2022)
  • Incidence of adverse events (AEs) and serious adverse events (SAEs) - (Phase 1) [ Time Frame: 1 year ]
    Escalation Period
  • Incidence and nature of dose-limiting toxicities (DLTs) - (Phase 1) [ Time Frame: up to 21 days ]
    Escalation Period
  • Maximum tolerable dose (MTD) or a recommended Phase 2 dose (RP2D) - (Phase 1) [ Time Frame: 1 year ]
    Escalation Period
  • 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).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 30, 2022)
  • 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).
  • PK (Cmax) of TT-816 - (Phase 1) [ Time Frame: 1 year ]
    Escalation Period
  • PK (AUC) of TT-816 - (Phase 1) [ Time Frame: 1 year ]
    Escalation Period
  • Incidence of adverse event of special interest (AESI) - (Phase 2) [ Time Frame: 3 years ]
    Expansion Period
  • Incidence of adverse events (AEs) and serious adverse events (SAEs) - (Phase 2) [ Time Frame: 3 years ]
    Expansion Period
  • PK (Cmax) of TT-816 - (Phase 2) [ Time Frame: 1 year ]
    Expansion Period
  • PK (AUC) of TT-816 - (Phase 2) [ Time Frame: 1 year ]
    Expansion Period
  • Progression-free survival (PFS) and overall survival (OS) - (Phase 2) [ Time Frame: 3 years ]
    Expansion Period
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE TT-816 as Monotherapy or in Combination With a PD-1 Inhibitor in Patients With Advanced Cancers (SEABEAM) (MK3475-E88)
Official Title  ICMJE 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)
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE 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
Condition  ICMJE
  • Advanced Cancer
  • Advanced Solid Tumor
  • Cancer
  • Oncology
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: Single agent TT-816
    Escalating doses followed by expansion targeting advanced cancers
    Intervention: Drug: TT-816
  • Experimental: Combination TT-816 plus a PD-1 inhibitor
    Escalating doses followed by expansion targeting advanced cancers
    Interventions:
    • Drug: TT-816
    • Drug: A PD-1 inhibitor
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 30, 2022)		 200
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 31, 2027
Estimated Primary Completion Date August 19, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Teon Therapeutics, Inc. (650) 486-1902 seabeam@teonthera.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05525455
Other Study ID Numbers  ICMJE SEABEAM
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Teon Therapeutics, Inc.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Teon Therapeutics, Inc.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Merck Sharp & Dohme LLC
Investigators  ICMJE
Study Director: Teon Clinical Development Teon Therapeutics, Inc.
PRS Account Teon Therapeutics, Inc.
Verification Date February 2023

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP