D3S-003 / D3 Bio - LARVOL DELTA

A Phase 1 study of D3S-003 as Monotherapy in Participants with Advanced Solid Tumors with a KRAS p.G12D Mutation. (ChiCTR) - P1 | N=15 | Not yet recruiting | Sponsor: Shanghai Chest Hospital; Shanghai Chest Hospital

Monotherapy • New P1 trial • Colon Adenocarcinoma • Colon Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • BRAF • EGFR • HER-2 • HRAS • KRAS • MET • NRAS • NRG1 • NTRK • NTRK1 • NTRK2 • NTRK3 • RET • ROS1

D3S-003, an orally bioavailable potent and selective dual-state inhibitor targeting both GDP- and GTP-bound KRAS G12D (AACR 2026) - "Notably, D3S-003 showed improved potency and selectivity compared with RMC-9805, an investigational KRAS G12D (ON) inhibitor currently in clinical trials. Together, these findings highlight D3S-003 as a potent and selective KRAS G12D dual-state inhibitor with strong translational potential. A Phase 1 first-in-human (FIH) study is currently being planned."

First-in-human • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer • Solid Tumor • KRAS

First-in-human clinical pharmacokinetic prediction of D3S-003, an orally bioavailable dual-state KRAS G12D inhibitor (AACR 2026) - "A translational PK and allometric-scaling strategy successfully predicted human PK for D3S-003. Simulations under mid-range absorption conditions demonstrated linear exposure and favorable oral PK, supporting model-informed dose selection for the planned FIH study. Ongoing integration of clinical data will refine dose-exposure-response relationships and guide dose optimization in later-phase clinical development."

Clinical • First-in-human • P1 data • PK/PD data • Oncology • KRAS

A Phase 1 Study of D3S-003 as Monotherapy in Participants With Advanced Solid Tumors With a KRAS p.G12D Mutation. (clinicaltrials.gov) - P1 | N=42 | Recruiting | Sponsor: D3 Bio (Wuxi) Co., Ltd | Not yet recruiting ➔ Recruiting

Enrollment open • First-in-human • Monotherapy • Oncology • Solid Tumor • KRAS

D3 Bio to Showcase Its Innovative KRAS Pipeline at AACR 2026, Including an Oral Presentation at Clinical Plenary Session (PRNewswire) - "'These presentations will showcase our comprehensive KRAS pipeline, including Elisrasib (D3S-001), our next-generation KRAS G12C inhibitor, D3S-002, a selective ERK1/2 inhibitor designed with a unique profile for combination strategies to enhance clinical efficacy and overcome resistance to KRAS G12C inhibitors; and D3S-003, our differentiated KRAS G12D inhibitor addressing large unmet medical needs in pancreatic and colo-rectal cancers. These data highlight D3 Bio's strong scientific progress and commitment to advancing transformative therapies for patients with KRAS-driven cancers'."

Clinical data • Colorectal Cancer • Non Small Cell Lung Cancer • Pancreatic Cancer

A Phase 1 Study of D3S-003 as Monotherapy in Participants With Advanced Solid Tumors With a KRAS p.G12D Mutation. (clinicaltrials.gov) - P1 | N=42 | Not yet recruiting | Sponsor: D3 Bio (Wuxi) Co., Ltd

First-in-human • Monotherapy • New P1 trial • Oncology • Solid Tumor • KRAS

D3 Bio Receives U.S. FDA Clearance for Two IND Applications, Enabling Phase 1 Trial of D3S‑003 and Phase 2 Combination Study of Elisrasib (D3S‑001) with D3S‑002 (PRNewswire) - "With FDA clearance received, D3 Bio will advance D3S‑003 into a Phase 1 first‑in‑human study in patients with advanced solid tumors harboring KRAS G12D mutations. The newly cleared Phase 2 study will evaluate the combination of D3S‑001 and D3S‑002 in patients with KRAS G12C–mutant non‑small cell lung cancer (NSCLC) who have progressed on prior KRAS G12C‑targeted therapies. The trial, expected to begin in the first half of 2026..."

IND • New trial • Non Small Cell Lung Cancer