PT0511 for Colorectal Cancer

Recruiting at 4 trial locations

Overseen By PAQ Therapeutics

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: PAQ Therapeutics, Inc.

Must not be taking: CYP3A4/5 inhibitors, P-gp inhibitors

Disqualifiers: Active brain metastasis, Significant cardiovascular disease, Active infection, HIV with low CD4, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

195 Participants Needed

What You Need to Know Before You Apply

What is the purpose of 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).

Are You a Good Fit for This Trial?

This trial is for adults with advanced solid tumors that have a KRAS mutation or amplification. They must have tried at least one, but no more than four, systemic therapies or be unable to tolerate them. Participants should be in good physical condition (ECOG 0-1) and not planning to conceive.

Inclusion Criteria

I am fully active or can carry out light work.

I agree to prevent pregnancy or fathering children during and up to 3 months after treatment.

My cancer is confirmed to be advanced or has spread to other parts.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Participants with solid tumors receive PT0511 infusion until disease progression or intolerance to determine the maximally tolerated dose

Until disease progression or intolerance

Dose Expansion

Participants receive PT0511 infusion, with or without cetuximab, until disease progression or intolerance to evaluate safety and tolerability

Until disease progression or intolerance

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Cetuximab
• PT0511

Trial Overview

The study tests the safety and tolerability of PT0511 alone and combined with cetuximab to find the highest dose patients can take without severe side effects. It's focused on those with colorectal cancer for the combination therapy part.

How Is the Trial Designed?

Group I: Part 1b: Dose Expansion: Tumor type 8 Experimental Treatment 1 Intervention

Participants with tumor type 8 will receive PT0511 infusion 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 PT0511 established in Part 1a.

Group II: Part 1b: Dose Expansion: Tumor type 7 Experimental Treatment 1 Intervention

Participants with tumor type 7 will receive PT0511 infusion 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 PT0511 established in Part 1a.

Group III: Part 1b: Dose Expansion: Tumor type 6 Experimental Treatment 1 Intervention

Participants with tumor type 6 will receive PT0511 infusion 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 PT0511 established in Part 1a.

Group IV: Part 1b: Dose Expansion: Tumor type 5 Experimental Treatment 1 Intervention

Participants with tumor type 5 will receive PT0511 infusion 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 PT0511 established in Part 1a.

Group V: Part 1b: Dose Expansion: Tumor type 4 Experimental Treatment 1 Intervention

Participants with tumor type 4 will receive PT0511 infusion 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 PT0511 established in Part 1a.

Group VI: Part 1b: Dose Expansion: Tumor type 3 Experimental Treatment 1 Intervention

Participants with tumor type 3 will receive PT0511 infusion 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 PT0511 established in Part 1a.

Group VII: Part 1b: Dose Expansion: Tumor type 2 Experimental Treatment 2 Interventions

Participants with tumor type 2 will receive PT0511 infusion in combination with cetuximab infusion, 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 PT0511 established in Part 1a.

Group VIII: Part 1b: Dose Expansion: Tumor type 1 Experimental Treatment 1 Intervention

Participants with tumor type 1 will receive PT0511 infusion 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 PT0511 established in Part 1a.

Group IX: Part 1a: Dose Escalation Experimental Treatment 1 Intervention

Participants with solid tumors with any KRAS mutation or amplified WT KRAS will receive PT0511 infusion, intravenously (IV), until disease progression or intolerance.

Who Is Running the Clinical Trial?

PAQ Therapeutics, Inc.

Lead Sponsor

Trials

1

Recruited

120+