Phase 2 study

Recruiting Phase 2

Sources: ClinicalTrials.gov Checked: 11 October 2026 Not medical advice

This trial at a glance

Status Recruiting
Phase Phase 2
Sponsor D3 Bio (Wuxi) Co., Ltd
Registry number NCT05410145
Started 3 August 2022 Today 16 October 2026 Estimated completion 1 April 2027

Where this trial is running

Trial sites and the status recorded for each
SiteCityState or countryStatus at this site
D3 Bio Investigative Site 0102 Sydney NSW Recruiting
D3 Bio Investigative Site 0101 Malvern VIC Recruiting
D3 Bio Investigative Site 0105 Melbourne VIC Recruiting
D3 Bio Investigative Site 0103 Nedlands WA Recruiting
D3 Bio Investigative Site 0104 Bedford Park SA Recruiting

voxsanity.com.au · trial sites from public registries · registry record synced 11 October 2026 · not medical advice

Who can join

Age 18 Years and over
Sex Anyone, regardless of sex
Healthy volunteers Not accepted
Enrolment target 442

The official eligibility criteria

Registry text, reproduced exactly. These are the words the trial's sponsor published on ClinicalTrials.gov. They have not been edited, shortened or rewritten, and they are written for researchers rather than for patients.

Inclusion:

* Subject must have a histologically or cytologically confirmed metastatic or locally advanced solid tumor which is progressing.

* Subject must have documented KRAS p.G12C mutation identified within the last 5 years by a local test on tumor tissue or blood.

* Subject 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:

* Subject has any prior treatment with other treatments without adequate washout periods as defined in the protocol.

* Subject has uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, uncontrolled or significant cardiovascular disease, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness/social situations that would limit compliance with study requirements, substantially increase risk of incurring AEs, or compromise the ability of the subject to give written informed consent.

* Subject has unresolved treatment-related toxicities from previous anticancer therapy of NCI CTCAE Grade ≥2 (with exception of vitiligo or alopecia).

* Subject has active gastrointestinal disease or other that could interfere significantly with the absorption, distribution, metabolism, or excretion of oral therapy.

* Concurrent participation in any clinical research study involving treatment with any investigational drug, radiotherapy, or surgery, except for the nontreatment phases of these studies (e.g., follow-up phase).

Other protocol inclusion/exclusion criteria may apply

Dates on the record

Started 3 August 2022
Estimated completion 1 April 2027
Registry last updated 15 September 2026
Checked by Voxsanity 11 October 2026

Results, publications and the official record

Sources and dates

  • ClinicalTrials.gov – the record this page reformats
  • ClinicalTrials.gov processing date: 15 September 2026.
  • This page last checked by Voxsanity: 11 October 2026.

Voxsanity reformats data from public registries into this layout. It does not edit, interpret or add to what the registry published.

Not medical advice.

Individual trial records are refreshed on a rolling basis rather than all at once, so a record may be up to several weeks old. Each trial page and trial card shows the date its own record was last synced. Where a record has lagged, its status, sites and enrolment can differ from the current registry state in either direction, so check the registry link on the trial page before acting on them.

Letter for your doctor

A one-page summary of this trial to print or email to your GP. It carries the registry's own record of the trial and its eligibility criteria, and nothing Voxsanity has written about whether it suits you.