A Study of PT0253 in Participants With KRAS G12D Mutated Advanced Solid Tumors
NCT ID: NCT06797336
Last Updated: 2025-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
115 participants
INTERVENTIONAL
2024-12-19
2027-06-16
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Part 1a, Dose Escalation
Participants with any type of solid tumor will receive PT0253 injection, intravenously (IV) until disease progression or intolerance.
PT0253
PT0253 injection.
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.
PT0253
PT0253 injection.
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.
PT0253
PT0253 injection.
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.
PT0253
PT0253 injection.
Interventions
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PT0253
PT0253 injection.
Eligibility Criteria
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Inclusion Criteria
2. Participant has a pathologically documented, locally advanced or metastatic malignancy with KRAS p.G12D mutation identified through molecular testing using a validated institutional or commercial test.
3. Measurable disease (RECIST 1.1 Criteria).
4. Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1.
5. Willingness to avoid pregnancy or fathering children from screening through 90 days after the last dose of study treatment.
Exclusion Criteria
2. History of any other malignancy within the past 2 years, except:
* 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.
4. Concurrent participation in another interventional clinical study.
5. Treatment with anticancer medications or investigational drugs within 14-28 days or 5 half-lives (whichever is longer) before the first administration of study drug. Concurrent hormonal therapy for prostate or breast cancer is allowed.
6. Significant cardiovascular disease within 6 months of starting study therapy.
7. Active infection requiring antibiotics within 1 day of study treatment.
8. Known HIV infection with a cluster of differentiation 4+ (CD4+) T-cell count less than (\<) 200 cells per microliter \[/mcL\] and/or a detectable viral load per parameters of assay and/or on an anti-retroviral regimen containing a strong or moderate cytochrome (CY)P3A4/5 inhibitor or inducer and/or on a new anti-retroviral regimen for less than 28 days prior to the initiation of study treatment.
9. Known history of drug-induced liver injury; primary biliary cirrhosis; or ongoing extrahepatic obstruction caused by stones, cirrhosis of the liver, or portal hypertension.
10. Major surgery within 4 weeks of the start of study therapy or postoperative complications preventing the participant from adhering to protocol assessments and procedures.
11. Known hypersensitivity to any of the products to be administered during dosing.
12. Any disease or disorder that, in the opinion of the investigator, may compromise the ability of the participant to provide written informed consent and/or to comply with all required study procedures.
13. Part 1a (Dose escalation): Use of a strong or moderate CYP3A4/5 inhibitor or inducer, strong P-glycoprotein (P-gp) inhibitor or inducer or P-gp substrate.
14. Use of multidrug and toxin extrusion protein 1 (MATE) or MATE2-K substrates that cannot be discontinued prior to the start of study treatment.
15. Participants with laboratory values indicating inadequate hematology, hepatic, or renal function.
16. Clinically significant abnormalities in rhythm, conduction, or morphology of resting electrocardiogram (ECG) or baseline QT interval corrected for heart rate using Fridericia's formula (QTcF) \>=450 milliseconds (msec).
17. Female participants who are pregnant or lactating/breast feeding or who plan to breastfeed while on study through 28 days after receiving the last dose of study drug.
18. Active hepatitis B virus (HBV) infection. Participants with resolved infection or who are on stable antiviral therapy are eligible.
19. Active hepatitis C virus (HCV) infection. Participants who have completed definitive antiviral therapy with post treatment confirmation of eradication are eligible.
18 Years
ALL
No
Sponsors
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PAQ Therapeutics, Inc.
INDUSTRY
Responsible Party
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Locations
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Dana Farber/Massachusetts General Hospital, Inc
Boston, Massachusetts, United States
SCRI Lake Mary
Nashville, Tennessee, United States
SCRI Oncology Partners
Nashville, Tennessee, United States
New Experimental Therapeutics of San Antonio LLC
San Antonio, Texas, United States
START - South Texas Accelerated Research Therapeutics, LLC
San Antonio, Texas, United States
START Mountain Region
West Valley City, Utah, United States
NEXT Virginia
Fairfax, Virginia, United States
Countries
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Central Contacts
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Facility Contacts
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Role: primary
Alexander Philipovskiy
Role: primary
Vivek Subbiah
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Other Identifiers
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PT0253-101
Identifier Type: -
Identifier Source: org_study_id