A Study of PT0253 in Participants With KRAS G12D Mutated Advanced Solid Tumors (NCT06797336) | Clinical Trial Compass
RecruitingPhase 1
A Study of PT0253 in Participants With KRAS G12D Mutated Advanced Solid Tumors
United States, South Korea240 participantsStarted 2024-12-19
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Histologically or cytologically confirmed advanced or metastatic solid malignancy
. Participant has a pathologically documented, locally advanced or metastatic malignancy with KRAS p.G12D mutation identified through molecular testing using a Clinical Laboratory Improvement Amendments (CLIA) certified, validated institutional or commercial test.
. Measurable disease (RECIST 1.1 Criteria).
. Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1.
. Willingness to avoid pregnancy or fathering children from screening through 90 days after the last dose of study treatment.
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Participants with Dose-limiting Toxicities (DLT)
Timeframe: Cycle 1 (Cycle length=21 days)
2
Number of Participants with Treatment-Emergent Adverse Events (TEAEs)
Timeframe: Up to 24 months
3
Number of Participants with TEAEs Leading to Treatment Interruptions, Dose Reductions and Permanent Discontinuations
. Active brain metastasis or carcinomatous meningitis. If participants have had brain metastases resected or have received radiation therapy, they may be eligible if: (1) study treatment begins at least 4 weeks from the end of brain-specific therapy, (2) residual neurological symptoms Grade less than or equal to (\<=) 2, (3) currently on stable doses of corticosteroids, and (4) pre-study brain magnetic resonance imaging (MRI) documents no new/worsening brain lesions.
. History of any other malignancy within the past 2 years, except:
. Unresolved toxicities from prior anti-cancer therapies (Common Terminology Criteria for Adverse Events \[CTCAE\] grades \>1), except for alopecia. Grade \<=2 toxicities from prior anti-tumor therapies that are considered irreversible may be allowed, provided that they are not described in the exclusion criteria AND the investigator and medical monitor are in agreement to proceed.
. Concurrent participation in another interventional clinical study.
. 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.
. Significant cardiovascular disease within 6 months of starting study therapy.
. Active infection requiring antibiotics within 1 day of study treatment.
. 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.