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D3S-001

DRUG4 trials

Sponsors

D3 Bio (Wuxi) Co. Ltd., D3 Bio (Wuxi) Co., Ltd

Conditions

Advanced Solid Tumors With MAPK Pathway MutationsAdvanced Solid Tumors with a KRAS p.G12C MutationHealthy Adult VolunteersKRAS P.G12C

Phase 1

A Study of D3S-001 Monotherapy or Combination Therapy in Subjects With Advanced Solid Tumors With a KRAS p.G12C Mutation
RecruitingNCT05410145
D3 Bio (Wuxi) Co., LtdKRAS P.G12C
Start: 2022-08-03End: 2027-04-01Target: 442Updated: 2026-09-15
A Phase 1/2 Study of D3S-002 as Monotherapy or Combination Therapy in Adult Subjects With Advanced Solid Tumors With MAPK Pathway Mutations
RecruitingNCT05886920
D3 Bio (Wuxi) Co., LtdAdvanced Solid Tumors With MAPK Pathway Mutations
Start: 2023-07-10End: 2028-08-01Target: 67Updated: 2026-09-04
A Phase 1/2, Open-label, Dose-escalation, and Dose-expansion Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of D3S-001 Monotherapy or Combination Therapy in Subjects with Advanced Solid Tumors with a KRAS p.G12C Mutation"
RecruitingCTIS2023-508517-16-00
D3 Bio (Wuxi) Co. Ltd.Advanced Solid Tumors with a KRAS p.G12C Mutation
Start: 2024-11-10Target: 95Updated: 2025-09-24
A Phase 1 Study to Assess Food Effect on the Pharmacokinetics of D3S-001 in Healthy Adult Participants
CompletedNCT07093398
D3 Bio (Wuxi) Co., LtdHealthy Adult Volunteers
Start: 2025-07-11End: 2025-11-17Updated: 2026-03-25

Related Papers

Elisrasib (D3S-001), a next-generation GDP-bound KRAS G12C inhibitor, as first-line therapy for <i>KRAS</i> G12C mutation–positive non–small cell lung cancer (NSCLC).
Journal of Clinical Oncology2026-05-28
Abstract CT020: Safety and efficacy of Elisrasib (D3S-001), a next generation GDP-bound KRAS G12C inhibitor, as monotherapy in advanced non-small cell lung cancer (NSCLC) previously treated with or without a KRAS G12C inhibitor: Results from a phase 1/2 study
Cancer Research2026-05-15
Abstract CT303: Safety and efficacy of Elisrasib (D3S-001), a next generation GDP-bound KRAS G12C inhibitor, as monotherapy or combination therapy with cetuximab in previously treated metastatic CRC and PDAC: Results from a phase 1/2 study
Cancer Research2026-04-17
Abstract CT060: First in human phase 1 study of D3S-002, a purposely designed ERK1/2 inhibitor, in advanced solid tumors with MAPK pathway mutations
Cancer Research2026-04-17
Abstract A005: D3S-002: A Purposefully Designed ERK1/2 Inhibitor Achieving Low-Dose, Pulsatile Target Inhibition for Combination with D3S-001, a New-Generation KRAS G12C Inhibitor
Cancer Research2026-03-05
D3S-001 in advanced solid tumors with KRAS&lt;sup&gt;G12C&lt;/sup&gt; mutations: a phase 1 trial.
2025-04-296 citations
Abstract CT266: D3S-001, a next generation GDP-bound KRAS G12C inhibitor, as monotherapy in KRAS G12C inhibitor resistant non-small cell lung cancer
Cancer Research2025-04-251 citations
D3S-001, a KRAS G12C Inhibitor with Rapid Target Engagement Kinetics, Overcomes Nucleotide Cycling, and Demonstrates Robust Preclinical and Clinical Activities
Cancer Discovery2024-05-0723 citations
Abstract CT117: A phase 1 study of D3S-001, a second-generation GDP-bound KRAS G12C inhibitor, as monotherapy in patients with KRAS G12C-mutated solid tumors
Cancer Research2024-04-052 citations
Abstract 6503: D3S-001, a second-generation GDP-bound KRAS G12C inhibitor, overcomes nucleotide cycling and demonstrates robust preclinical and clinical activities
Cancer Research2024-03-221 citations