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Recruiting NCT07456046

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

Phase I Interventional KRAS P.G12D

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: D3S-003.
Who it may be relevant to
Registry conditions: KRAS P.G12D. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Australia, South Korea
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Phase 1, Open-label, Dose-Escalation Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of D3S-003 Monotherapy in Participants With Advanced Solid Tumors With a KRAS p.G12D Mutation

Overview

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.

Interventions

  • Drug D3S-003
    Oral Tablet

Primary outcome measures

  • Number of Participants with Dose-Limiting Toxicities (DLTs) [Time frame: From Cycle 1 Day 1 through Day 21. Each cycle is 21 days.]
  • Number of Participants with Adverse Events (AEs) [Time frame: 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) [Time frame: First dose up to 7 months]
  • Phase 2 dose (RP2D) [Time frame: First dose up to 7 months]
Secondary outcome measures (9)
  • D3S-003 concentration of drug immediately before the administration of next dose (Ctrough) [Time frame: First dose up to 7 months]
  • D3S-003 maximum observed plasma concentration (Cmax) [Time frame: First dose up to 7 months]
  • D3S-003 time to maximum plasma concentration (tmax) [Time frame: First dose up to 7 months]
  • D3S-003 half-life (t1/2) [Time frame: First dose up to 7 months]
  • D3S-003 area under the concentration-time curve (AUC) [Time frame: First dose up to 7 months]
  • Objective response rate (ORR) as Determined by the Investigator According to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1) [Time frame: Until disease progression or end of treatment (up to approximately 7 months)]
  • Duration of Response (DOR) as Determined by the Investigator According to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1) [Time frame: Until disease progression or end of treatment (up to approximately 7 months)]
  • Disease Control Rate (DCR) as Determined by the Investigator According to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1) [Time frame: Until disease progression or end of treatment (up to approximately 7 months)]
  • Progression-free survival (PFS) as Determined by the Investigator According to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1) [Time frame: Until disease progression or end of treatment (up to approximately 7 months)]

Eligibility criteria

Inclusion criteria

  • Subjects must have histologically confirmed locally advanced, recurrent, or metastatic malignancy that has progressed following at least one line of standard therapy or where standard therapy has proven to be ineffective or intolerable or is considered inappropriate or when participation in a clinical trial of an investigational agent is considered a standard therapeutic option.
  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Sequential
Masking
Open label
Primary purpose
Treatment

Study locations

Australia · 3 centers
  • D3 Bio Investigative Site 1101 — Macquarie Park
  • D3 Bio Investigative Site 1103 — Randwick
  • D3 Bio Investigative Site 1102 — Malvern
South Korea · 3 centers
  • D3 Bio Investigative Site 1201 — Seoul
  • D3 Bio Investigative Site 1203 — Seoul
  • D3 Bio Investigative Site 1202 — Seoul
United States · 2 centers
  • D3 Bio Investigative Site 1404 — New Haven
  • D3 Bio Investigative Site 1402 — San Antonio

Identifiers

NCT: NCT07456046 · D3S-003-100

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗