Ireland
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Recruiting Phase 1

A Phase 1 Study of D3S-003 as Monotherapy in Participants With Advanced Solid Tumors With a KRAS p.G12D Mutation.

NCT07456046 · tracked via the Priya Life Science South Korea tracker
Phase
Phase 1
Started
2026-05-29
Last updated
2026-09-08

Condition(s) studied

KRAS P.G12D

Investigational drug(s) / intervention(s)

D3S-003

D3S-003: Oral Tablet

Study summary

This is a first-in-human (FIH) multicenter, open-label, dose-escalation Phase 1 clinical trial to evaluate safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy of D3S-003 in participants with advanced KRAS p.G12D mutant solid tumors.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Subjects must have histologically confirmed locally advanced, recurrent, or metastatic malignancy that has failed to respond to adequate standard treatment(s), or for which no effective standard treatment is available. * Subjects must have documented presence of KRAS p.G12D mutation by a local test identified through tumor tissue or blood collected within the last 5 years. * Subjects must have measurable disease per RECIST v1.1. * Subject must have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. * Subject must have adequate organ and marrow function within the screening period. Exclusion Criteria: * Participant has any prior treatment with a specific KRAS G12D inhibitor/degrader or pan RAS inhibitor/degrader. * Subject has uncontrolled intercurrent illness, including but not limited to serious chronic gastrointestinal conditions associated with diarrhea, ongoing or active infections, uncontrolled or significant cardiovascular disease, autoimmune or inflammatory disorders or psychiatric illness/social situations that would limit compliance with study requirements, substantially increase risk of incurring adverse events (AEs), or compromise the ability of the subject to give written consent. * Uncontrolled or untreated brain metastases * Subject has active gastrointestinal disease or other that could interfere significantly with the absorption, distribution, metabolism, or excretion of oral therapy NOTE: Other protocol inclusion/exclusion criteria may apply.

Primary outcome measure(s)

  • Number of Participants with Dose-Limiting Toxicities (DLTs) — From Cycle 1 Day 1 through Day 21. Each cycle is 21 days.
  • Number of Participants with Adverse Events (AEs) — From screening visit until 30 days after the last dose (or specified in the protocol)
  • Maximum tolerated dose (MTD) based on dose limiting toxicities (DLTs) — First dose up to 7 months
  • Phase 2 dose (RP2D) — First dose up to 7 months

Trial sites (9)

FacilityCityRegionStatus
D3 Bio Investigative Site 1404 New Haven Connecticut Recruiting
D3 Bio Investigative Site 1403 Houston Texas Recruiting
D3 Bio Investigative Site 1402 San Antonio Texas Recruiting
D3 Bio Investigative Site 1101 Macquarie Park New South Wales Recruiting
D3 Bio Investigative Site 1103 Randwick New South Wales Recruiting
D3 Bio Investigative Site 1102 Malvern Victoria Recruiting
D3 Bio Investigative Site 1201 Seoul South Korea Recruiting
D3 Bio Investigative Site 1203 Seoul South Korea Recruiting
D3 Bio Investigative Site 1202 Seoul South Korea Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07456046 on ClinicalTrials.gov ↗ ← All trials in South Korea