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

ConditionSolid Tumor
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorPAQ Therapeutics, Inc.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

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.

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.

Trial design

Design model

Sequential

Treatments tested in this trial

  • PT0253

    Drug

    PT0253 injection.

  • Chemotherapy Combination 1

    Drug

    Intravenous infusion.

  • Chemotherapy Combination 2

    Drug

    Intravenous infusion.

  • Chemotherapy Combination 3

    Drug

    Intravenous infusion.

  • Cetuximab

    Drug

    Intravenous infusion.

Treatment groups

300 Participants
are divided into 5 treatment groups
Group A: Part 1a, Dose EscalationExperimental treatment 1 intervention
Group B: Part 1b, Dose Expansion: Tumor type 1Experimental treatment 2 interventions
Group C: Part 1b, Dose Expansion: Tumor type 2Experimental treatment 2 interventions
Group D: Part 1b, Dose Expansion: Tumor type 3Experimental treatment 2 interventions
Group E: Part 1b, Dose Expansion: Tumor type 4Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Number of Participants with Dose-limiting Toxicities (DLT)

Time frame
Cycle 1 (Cycle length=21 days)
2

Number of Participants with Treatment-Emergent Adverse Events (TEAEs)

Time frame
Up to 24 months
3

Number of Participants with TEAEs Leading to Treatment Interruptions, Dose Reductions and Permanent Discontinuations

Time frame
Up to 24 months

Secondary outcomes

1

Cmax/C0: Maximum Blood Concentration (Cmax) and/or Concentration at Time 0 (C0) of PT0253

Time frame
Cycle 1 Days 1 and 15: Pre-infusion and up to 24 hours post-infusion (Cycle length=21 days)
2

Tmax: Time to Reach Cmax of PT0253

Time frame
Cycle 1 Days 1 and 15: Pre-infusion and up to 24 hours post-infusion (Cycle length=21 days)
3

AUC0-t: Area Under the Curve From time 0 to the time of the Last Quantifiable Concentration of PT0253

Time frame
Cycle 1 Days 1 and 15: Pre-infusion and up to 24 hours post-infusion (Cycle length=21 days)
4

t1/2: Terminal Elimination Half-life of PT0253

Time frame
Cycle 1 Days 1 and 15: Pre-infusion and up to 24 hours post-infusion (Cycle length=21 days)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

PAQ Therapeutics, Inc.

Lead sponsor

Source ClinicalTrials.gov
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