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

Conditions

• Solid Tumor

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• 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.

Study Details

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.

Key Dates

First listed

Jan 28, 2025

Start date

Dec 19, 2024

Status verified

Aug 2026

Primary completion

Dec 15, 2026

Completion

Jun 16, 2027

Study Design

Enrollment

240 participants (estimated)

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: Part 1a, Dose Escalation
  Participants with any type of solid tumor will receive PT0253 injection, intravenously (IV) until disease progression or intolerance.
• Experimental: Part 1b, Dose Expansion: Tumor type 1
  Participants with a previously treated tumor type will receive PT0253 injection in combination with intravenous infusion of Chemotherapy Combination 1 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 PT0253 established in Part 1a.
• Experimental: Part 1b, Dose Expansion: Tumor type 2
  Participants with a previously treated tumor type will receive PT0253 injection in combination with intravenous infusion of Chemotherapy Combination 2 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 PT0253 established in Part 1a.
• Experimental: Part 1b, Dose Expansion: Tumor type 3
  Participants with a previously treated tumor type will receive PT0253 injection in combination with intravenous infusion of Cetuximab 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 PT0253 established in Part 1a.
• Experimental: Part 1b, Dose Expansion: Tumor type 4
  Participants with a previously treated tumor type will receive PT0253 injection in combination with intravenous infusion of Chemotherapy Combination 3 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 PT0253 established in Part 1a.

Primary Outcome Measure

Number of Participants with Dose-limiting Toxicities (DLT) [ Time Frame: Cycle 1 (Cycle length=21 days) ]

Central Contacts

• PAQ Therapeutics
  781-819-2949
  [email protected]

Locations (9)

Find similar trials in Los Angeles, CA

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