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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| D3S-003 | Drug | Oral Tablet |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| D3S-003 concentration of drug immediately before the administration of next dose (Ctrough) | First dose up to 7 months | |
| D3S-003 maximum observed plasma concentration (Cmax) | First dose up to 7 months |
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Inclusion Criteria:
Exclusion Criteria:
NOTE: Other protocol inclusion/exclusion criteria may apply.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Medical Director | Contact | +86 21 61635900 | D3bio_CT@d3bio.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| D3 Bio Investigative Site 1402 | Recruiting | San Antonio | Texas | 78229 | United States | |
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| D3S-003 time to maximum plasma concentration (tmax) | First dose up to 7 months |
| D3S-003 half-life (t1/2) | First dose up to 7 months |
| D3S-003 area under the concentration-time curve (AUC) | 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) | 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) | 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) | 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) | Until disease progression or end of treatment (up to approximately 7 months) |
| D3 Bio Investigative Site 1103 |
| Recruiting |
| Randwick |
| New South Wales |
| 2031 |
| Australia |
| D3 Bio Investigative Site 1201 | Recruiting | Seoul | 03080 | South Korea |
| D3 Bio Investigative Site 1203 | Recruiting | Seoul | 03722 | South Korea |
| D3 Bio Investigative Site 1202 | Recruiting | Seoul | 06591 | South Korea |