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A Study of PT0253 for KRAS G12D Mutated Advanced Solid Tumors

This study is testing a drug called PT0253 in adults with advanced solid tumors that have a specific genetic change called KRAS G12D. The main goals are to understand the safety of PT0253, find the highest dose that can be given safely, and determine the recommended dose for future studies. To join, you must have a confirmed advanced or metastatic solid tumor with the KRAS G12D mutation and measurable disease. The study plans to enroll 115 participants, but its current status is unclear.

Study design
This is an interventional study, meaning participants will receive the study drug PT0253. It aims to enroll 115 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be monitored for treatment-emergent adverse events (side effects) for up to 24 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06797336

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
PAQ Therapeutics, Inc.
~240 participants
Updated 2026-08-12 on ClinicalTrials.gov
What's tested:PT0253Chemotherapy Combination 1Chemotherapy Combination 2Chemotherapy Combination 3Cetuximab

At a glance

Recruiting sites
13 of 15 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of Participants with Dose-limiting Toxicities (DLT)
Measured over Cycle 1 (Cycle length=21 days)
+2 more outcomes measured

Conditions

Solid Tumor

Explore related trials

Solid NeoplasmGTPase KRas

Where it's being run

15 sites across 8 states
South Korea6
Tennessee2
Texas2
California1
Massachusetts1
Michigan1
Utah1
Virginia1

Who to contact

PAQ Therapeutics
[email protected]
781-819-2949
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Exclusion

Malignancy treated with curative intent and with no known active disease present \>=2 years before enrolment and felt to be at low risk for recurrence by the investigator
Basal or squamous cell carcinoma of the skin, in situ cervical cancer, early -stage endometrial cancer that has been definitively treated, superficial bladder cancer, Gleason 6/7 treated prostate cancer, and ductal carcinoma in situ or lobular carcinoma in situ of the breast.

What this trial measures

  • Number of Participants with Dose-limiting Toxicities (DLT)Cycle 1 (Cycle length=21 days)
  • Number of Participants with Treatment-Emergent Adverse Events (TEAEs)Up to 24 months
  • Number of Participants with TEAEs Leading to Treatment Interruptions, Dose Reductions and Permanent DiscontinuationsUp to 24 months