NCT07300150

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

A Phase 1, Open-label Dose Escalation and Expansion Study OF PT0511 in Participants With KRAS Mutated OR Amplified Advanced Solid Tumors

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 195 (estimated)
• Sponsor: PAQ Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 PT0511 in adult participants with solid tumors as monotherapy and in combination with cetuximab in participants with colorectal cancer (CRC).

Conditions

• Colorectal Cancer
• Pancreatic Cancer
• Non-Small Cell Lung Cancer
• Solid Tumor

Interventions

Type	Name	Description
DRUG	PT0511	Intravenous infusion.
DRUG	Cetuximab	Intravenous infusion.

Timeline

• Start date: 2025-11-21
• Primary completion: 2028-10-18
• Completion: 2028-10-18
• First posted: 2025-12-23
• Last updated: 2025-12-23

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study