Testing D3S-003 alone in people with advanced solid tumors that have a KRAS p.G12D mutation
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
Run by D3 Bio (Wuxi) Co., Ltd · NCT07456046 · Data updated 2026-11-12
This trial will test whether D3S-003 given by itself is safe and shows signs of benefit for people with advanced solid tumors that carry a KRAS p.G12D mutation who have already tried at least one standard therapy.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 42 (estimated) |
| Sponsor | D3 Bio (Wuxi) Co., Ltd Industry-sponsored |
| Locations | 9 sites (New Haven, Connecticut and 8 other locations) |
| Status | Recruiting |
| Started | May 29, 2026 |
| Main results expected | January 11, 2028 |
| Study ends | January 11, 2028 |
| Registry record updated | September 8, 2026 |
| Trial ID | NCT07456046 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with locally advanced, recurrent, or metastatic solid tumors confirmed to have a KRAS p.G12D mutation, measurable disease, ECOG 0–1, adequate organ and marrow function, and prior progression after at least one standard therapy are the best fit for this trial.
✕Probably not a fit
Patients who previously received a KRAS G12D or pan-RAS inhibitor/degrader, those with poor performance status (ECOG ≥2), uncontrolled serious illnesses, or without the KRAS p.G12D mutation are unlikely to benefit from this trial.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This first-in-human, open-label, dose-escalation Phase 1 trial gives D3S-003 as a single agent to adults with advanced solid tumors that harbor a KRAS p.G12D mutation. The study will escalate doses to define safety, tolerability, and the recommended dose while collecting pharmacokinetic and pharmacodynamic data. Eligible participants must have measurable disease, ECOG performance status 0–1, adequate organ function, and have progressed after prior standard therapy. Preliminary anti-tumor activity will be monitored using RECIST v1.1 alongside safety assessments.
Why it matters
Potential benefit: If successful, D3S-003 could become a targeted treatment option that specifically attacks tumors with the KRAS p.G12D mutation and may shrink tumors or slow disease progression for patients with few options.
How similar studies have gone: Direct KRAS G12D-targeted therapies are a novel approach with limited human data, although KRAS G12C inhibitors have demonstrated clinical activity and support the general strategy of mutation-specific KRAS targeting.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
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D3 Bio Investigative Site 1404
New Haven, Connecticut, United States Recruiting -
D3 Bio Investigative Site 1403
Houston, Texas, United States Recruiting -
D3 Bio Investigative Site 1402
San Antonio, Texas, United States Recruiting -
D3 Bio Investigative Site 1101
Macquarie Park, New South Wales, Australia Recruiting -
D3 Bio Investigative Site 1103
Randwick, New South Wales, Australia Recruiting -
D3 Bio Investigative Site 1102
Malvern, Victoria, Australia Recruiting
Show 3 more locations
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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
Study contacts
- Study coordinator: Medical Director
- Email: D3bio_CT@d3bio.com
- Phone: +86 21 61635900
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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D3L-002 in Advanced Solid Tumors (Phase 1)
D3L-002 is being tested in adults with advanced solid tumors to see if it is safe, tolerable, and shows any signs of benefit when given in escalating doses.
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Testing D3L-001 for HER2-Positive Advanced Solid Tumors
This study is testing a new treatment called D3L-001 to see if it is safe and effective for people with advanced HER2-positive solid tumors.
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Testing D3S-002 for advanced solid tumors with specific mutations
This study is testing a new oral medication called D3S-002 to see if it can help adults with advanced solid tumors that have specific mutations and haven't responded to other treatments.
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Treatment for advanced solid tumors with a specific KRAS mutation
This study is testing a new oral treatment called D3S-001 for people with advanced solid tumors that have a specific KRAS mutation to see if it works and is safe.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.