Health TrialsbyHealthPanel

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

ConditionsColorectal CancerPancreatic CancerNon-Small Cell Lung CancerSolid 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 PT0511 in adult participants with solid tumors as monotherapy and in combination with cetuximab in participants with colorectal cancer (CRC).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Men or women less than or equal to (>=) 18 years of age

Histologically or cytologically confirmed advanced or metastatic solid malignancy

Participant has a pathologically documented, locally advanced or metastatic malignancy with any KRAS mutation or wild-type (WT) KRAS amplification identified through molecular testing using a Clinical Laboratory Improvement Amendments (CLIA) certified, validated institutional or commercial test

Participant must have received at least 1 and no more than 4 prior systemic therapies or be intolerant or ineligible for available therapies known to provide clinical benefit

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 <=2, (3) currently on stable doses of corticosteroids, and (4) pre-study brain 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. Participants with prior endocrine replacement therapies are eligible for entry even if administered to treat endocrine deficiency due to the prior anti-cancer therapy

Trial design

Design model

Sequential

Treatments tested in this trial

  • PT0511

    Drug

    Intravenous infusion.

  • Cetuximab

    Drug

    Intravenous infusion.

Treatment groups

210 Participants
are divided into 9 treatment groups

9

Treatment groups

See each treatment group below.

Group A: Part 1a: Dose EscalationExperimental treatment 1 intervention
Group B: Part 1b: Dose Expansion: Tumor type 1Experimental treatment 1 intervention
Group C: Part 1b: Dose Expansion: Tumor type 2Experimental treatment 2 interventions
Group D: Part 1b: Dose Expansion: Tumor type 3Experimental treatment 1 intervention
Group E: Part 1b: Dose Expansion: Tumor type 4Experimental treatment 1 intervention
Group F: Part 1b: Dose Expansion: Tumor type 5Experimental treatment 1 intervention
Group G: Part 1b: Dose Expansion: Tumor type 6Experimental treatment 1 intervention
Group H: Part 1b: Dose Expansion: Tumor type 7Experimental treatment 1 intervention
Group I: Part 1b: Dose Expansion: Tumor type 8Experimental treatment 1 intervention

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 PT0511

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 PT0511

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 PT0511

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 PT0511

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
Apply now