PTT-936 Alone or in Combination in Patients With Locally Advanced or Metastatic Solid Tumors

Part of paid clinical trials in Beverly Hills, California.

Sponsor
Pyrotech Therapeutics, Inc.
Study ID
NCT06244992
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Locally Advanced or Metastatic Solid Tumors

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • PTT-936 — DRUG
    Eligible patients will receive single-agent PTT-936 administered per orally (PO).
  • Combination of PTT-936 and anti-PD-1/L1 therapy — DRUG
    Eligible patients will receive combination treatment consisting of PTT-936 administered PO in combination with a Standard of Care (SOC) regimen of an anti-PD-1/L1 agent administered intravenously (IV).

Study Details

This Phase 1/2a study will explore the safety and efficacy of PTT-936, an Alpha Kinase 1 (ALPK1) activator, used alone or in combination with anti-PD-1/L1 therapy in patients with locally advanced or metastatic solid tumors. The study is divided into two parts: Phase 1 (Part A) focuses on determining the pharmaceutically active dosage range and evaluating the safety profile of PTT-936 when administered as a monotherapy. Phase 2a (Part B) will assess the safety and efficacy of PTT-936 combined with anti-PD-1/L1 therapy in patients suitable for anti- PD-1/L1 monotherapy. The study aims to understand how PTT-936, alone or in combination, impacts tumor progression and patients' overall response.

Key Dates

Start date
Jan 26, 2024
Status verified
Mar 2025
Primary completion
Dec 31, 2025
Completion
Feb 28, 2026

Study Design

Enrollment
68 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: PTT-936 Dose Level 1
    PTT-936 will be administered once a week (QW)
  • Experimental: PTT-936 Dose Level 2
    PTT-936 will be administered once a week (QW)
  • Experimental: PTT-936 Dose Level 3
    PTT-936 will be administered once a week (QW)
  • Experimental: PTT-936 Dose Level 4
    PTT-936 will be administered once a week (QW)
  • Experimental: PTT-936 Dose Level 5
    PTT-936 will be administered once a week (QW)
  • Experimental: PTT-936 and anti-PD-1/L1 combination therapy
    PTT-936 will be administered once a week (QW) in combination with a standard-of-care (SOC) regimen of an anti-PD-1/L1 agent every three weeks (Q3W)

Primary Outcome Measure

Incidence of TEAEs and TRAEs (with severity determined using NCI CTCAE v5.0), Grade >3 TEAEs, Grade >3 TRAEs, SAEs, and AESIs [ Time Frame: 7 months ]

Locations (3)

FacilityCityStateZIPSite coordinators
Precision NextGen Oncology and Research CenterBeverly HillsCalifornia90212
Rebecca Godin, RN, BSN
[email protected]
424-777-0708
D&H Cancer Research CenterMargateFlorida33063
Alexandar M Finol
[email protected]
954-323-2422
The START CenterSan AntonioTexas78229
Isabel Jimenez
[email protected]
210-593-5265

Find similar trials in Beverly Hills, CA

By research site
Precision NextGen Oncology and Research Center· Beverly Hills, CAD&H Cancer Research Center· Margate, FLThe START Center· San Antonio, TX

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