KRAS P.G12DPhase 1NCT07456046
A Phase 1 Study of D3S-003 as Monotherapy in Participants With Advanced Solid Tumors With a KRAS p.G12D Mutation.
A Phase 1 study testing D3S-003 in people with KRAS P.G12D, run by D3 Bio (Wuxi) Co., Ltd at 9 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- KRAS P.G12D
- What is being tested?
- D3S-003
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 9 sitesin 3 countries
- Study dates
- 29 May 2026to 11 Jan 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
9 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
9 sites in 3 countries
United States3 sites, 3 recruiting
- Recruiting
D3 Bio Investigative Site 1403
Houston, Texas, 77030
- Recruiting
D3 Bio Investigative Site 1404
New Haven, Connecticut, 06511
- Recruiting
D3 Bio Investigative Site 1402
San Antonio, Texas, 78229
Australia3 sites, 3 recruiting
- Recruiting
D3 Bio Investigative Site 1101
Macquarie Park, New South Wales, 2109
- Recruiting
D3 Bio Investigative Site 1102
Malvern, Victoria, 3144
- Recruiting
D3 Bio Investigative Site 1103
Randwick, New South Wales, 2031
South Korea3 sites, 3 recruiting
- Recruiting
D3 Bio Investigative Site 1201
Seoul, 03080
- Recruiting
D3 Bio Investigative Site 1203
Seoul, 03722
- Recruiting
D3 Bio Investigative Site 1202
Seoul, 06591
About this study
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
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.
- Conditions
- KRAS P.G12D
- Being tested
- D3S-003
- Keywords
- KRAS P.G12D Mutation, Advanced solid tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
D3S-003Drug
Oral Tablet
| Study group | Role | What they receive |
|---|---|---|
| D3S-003 | Experimental | Part 1a Dose Escalation in subjects with KRAS p.G12D-mutated solid tumors (Once Daily Dosing)
Part 1b Dose Escalation in subjects with KRAS p.G12D-mutated solid tumors (Twice Daily Dosing) Receives: Drug: D3S-003 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Dose-Limiting Toxicities (DLTs)
Measured: From Cycle 1 Day 1 through Day 21. Each cycle is 21 days.
Number of Participants with Adverse Events (AEs)
Measured: 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)
Measured: First dose up to 7 months
Phase 2 dose (RP2D)
Measured: First dose up to 7 months
Secondary outcomes (9)
D3S-003 concentration of drug immediately before the administration of next dose (Ctrough)
Measured: First dose up to 7 months
D3S-003 maximum observed plasma concentration (Cmax)
Measured: First dose up to 7 months
D3S-003 time to maximum plasma concentration (tmax)
Measured: First dose up to 7 months
D3S-003 half-life (t1/2)
Measured: First dose up to 7 months
D3S-003 area under the concentration-time curve (AUC)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: Until disease progression or end of treatment (up to approximately 7 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2026
- Study start29 May 2026
- Primary completion11 Jan 2028 (estimated)
- Study completion11 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for KRAS P.G12DStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- D3 Bio (Wuxi) Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07456046
- Sponsor's protocol ID
- D3S-003-100
- Status last verified
- Sep 2026
- First submitted
- 3 Mar 2026
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07456046
- Acronym / sponsor ID
- D3S-003-100
- Conditions
- KRAS P.G12D
- Keywords
- KRAS P.G12D Mutation, Advanced solid tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- D3 Bio (Wuxi) Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 29 May 2026 (actual)
- Primary completion
- 11 Jan 2028 (estimated)
- Study completion
- 11 Jan 2028 (estimated)
- First posted
- 6 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| D3S-003 | Experimental | Drug: D3S-003Part 1a Dose Escalation in subjects with KRAS p.G12D-mutated solid tumors (Once Daily Dosing) Part 1b Dose Escalation in subjects with KRAS p.G12D-mutated solid tumors (Twice Daily Dosing) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| D3S-003Oral Tablet | Drug | D3S-003 |
Primary outcome
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
9 secondary outcomes
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
9 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing D3S-003 in people with KRAS P.G12D, run by D3 Bio (Wuxi) Co., Ltd at 9 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States, Australia, South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Medical Director (+86 21 61635900, D3bio_CT@d3bio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Dose-Limiting Toxicities (DLTs) (time frame: From Cycle 1 Day 1 through Day 21. Each cycle is 21 days.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2026; AzTrials last refreshed its copy on 6 Nov 2026.