A Study of PT0253 in Participants With KRAS G12D Mutated Advanced Solid Tumors

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
PAQ Therapeutics, Inc.
Study ID
NCT06797336
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • Solid Tumor

Eligibility Criteria

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

Interventions

  • PT0253 — DRUG
    PT0253 injection.

Study Details

The primary purpose of this study is to evaluate the safety and tolerability, determine the maximally tolerated dose (MTD) and/or recommended Phase 2 dose(s) (RP2D) of PT0253 in adult participants with Kirsten rat sarcoma viral oncogene homolog (KRAS) G12D mutated advanced solid tumors as monotherapy.

Key Dates

Start date
Dec 19, 2024
Status verified
Dec 2025
Primary completion
Dec 15, 2026
Completion
Jun 16, 2027

Study Design

Enrollment
115 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Part 1a, Dose Escalation
    Participants with any type of solid tumor will receive PT0253 injection, intravenously (IV) until disease progression or intolerance.
  • Experimental: Part 1b, Dose Expansion: Tumor type 1
    Participants with a previously treated tumor type will receive PT0253 injection until disease progression or intolerance. Recommended dose or doses for expansion for Part 1b will be determined based on the safety, tolerability, pharmacokinetic (PK) and pharmacodynamic (PD) data for PT0253 established in Part 1a.
  • Experimental: Part 1b, Dose Expansion: Tumor type 2
    Participants with a previously treated tumor type will receive PT0253 injection until disease progression or intolerance. Recommended dose or doses for expansion for Part 1b will be determined based on the safety, tolerability, PK and PD data for PT0253 established in Part 1a.
  • Experimental: Part 1b, Dose Expansion: Tumor type 3
    Participants with a previously treated tumor type will receive PT0253 injection until disease progression or intolerance. Recommended dose or doses for expansion for Part 1b will be determined based on the safety, tolerability, PK and PD data for PT0253 established in Part 1a.

Primary Outcome Measure

Number of Participants with Dose-limiting Toxicities (DLT) [ Time Frame: Cycle 1 (Cycle length=21 days) ]

Central Contacts

Locations (7)

FacilityCityStateZIPSite coordinators
Dana Farber/Massachusetts General Hospital, IncBostonMassachusetts02215
[email protected]
857-367-1486
Leon Pappas (PRINCIPAL_INVESTIGATOR)
SCRI Lake MaryNashvilleTennessee37203
Alexander Philipovskiy
SCRI Oncology PartnersNashvilleTennessee37203
Vivek Subbiah
New Experimental Therapeutics of San Antonio LLCSan AntonioTexas78229
[email protected]
(210) 580-9500
Dr. Anthony Tolcher (PRINCIPAL_INVESTIGATOR)
START - South Texas Accelerated Research Therapeutics, LLCSan AntonioTexas78229
[email protected]
(210) 593-5700
Dr. Drew Rasco (PRINCIPAL_INVESTIGATOR)
START Mountain RegionWest Valley CityUtah84119
Dr. William McKean (PRINCIPAL_INVESTIGATOR)
NEXT VirginiaFairfaxVirginia22031
[email protected]
703-783-4510
Alexander Spira (PRINCIPAL_INVESTIGATOR)

Find similar trials in Boston, MA

By research site
Dana Farber/Massachusetts General Hospital, Inc· Boston, MASCRI Lake Mary· Nashville, TNSCRI Oncology Partners· Nashville, TNNew Experimental Therapeutics of San Antonio LLC· San Antonio, TXSTART - South Texas Accelerated Research Therapeutics, LLC· San Antonio, TXSTART Mountain Region· West Valley City, UT

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