A Study of PT0511 in Participants With KRAS Mutated or Amplified Advanced Solid Tumors

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
PAQ Therapeutics, Inc.
Study ID
NCT07300150
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

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

Interventions

  • PT0511 — DRUG
    Intravenous infusion.
  • Cetuximab — DRUG
    Intravenous infusion.

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 PT0511 in adult participants with solid tumors as monotherapy and in combination with cetuximab in participants with colorectal cancer (CRC).

Key Dates

Start date
Nov 21, 2025
Status verified
Dec 2025
Primary completion
Oct 18, 2028
Completion
Oct 18, 2028

Study Design

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

Arms

  • Experimental: Part 1a: Dose Escalation
    Participants with solid tumors with any KRAS mutation or amplified WT KRAS will receive PT0511 infusion, intravenously (IV), until disease progression or intolerance.
  • Experimental: Part 1b: Dose Expansion: Tumor type 1
    Participants with tumor type 1 will receive PT0511 infusion 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 PT0511 established in Part 1a.
  • Experimental: Part 1b: Dose Expansion: Tumor type 2
    Participants with tumor type 2 will receive PT0511 infusion in combination with cetuximab infusion, 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 PT0511 established in Part 1a.
  • Experimental: Part 1b: Dose Expansion: Tumor type 3
    Participants with tumor type 3 will receive PT0511 infusion 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 PT0511 established in Part 1a.
  • Experimental: Part 1b: Dose Expansion: Tumor type 4
    Participants with tumor type 4 will receive PT0511 infusion 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 PT0511 established in Part 1a.
  • Experimental: Part 1b: Dose Expansion: Tumor type 5
    Participants with tumor type 5 will receive PT0511 infusion 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 PT0511 established in Part 1a.
  • Experimental: Part 1b: Dose Expansion: Tumor type 6
    Participants with tumor type 6 will receive PT0511 infusion 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 PT0511 established in Part 1a.
  • Experimental: Part 1b: Dose Expansion: Tumor type 7
    Participants with tumor type 7 will receive PT0511 infusion 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 PT0511 established in Part 1a.
  • Experimental: Part 1b: Dose Expansion: Tumor type 8
    Participants with tumor type 8 will receive PT0511 infusion 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 PT0511 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 (5)

FacilityCityStateZIPSite coordinators
Dana-Farber/Massachusetts General Hospital, IncBostonMassachusetts02215
New Experimental Therapeutics of San Antonio LLCSan AntonioTexas78229
Ildefonso Ismael Rodriguez Rivera
[email protected]
START - South Texas Accelerated Research Therapeutics, LLCSan AntonioTexas78229
START Mountain RegionWest Valley CityUtah84119
William McKean
[email protected]
NEXT VirginiaFairfaxVirginia22031
Alexander Spira
[email protected]

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