SPYK04 / Roche - LARVOL DELTA

A Dose-Escalation Study of SPYK04 in Patients With Locally Advanced or Metastatic Solid Tumors (With Expansion). (clinicaltrials.gov) - P1 | N=113 | Active, not recruiting | Sponsor: Chugai Pharmaceutical | Trial completion date: Sep 2025 ➔ Sep 2026 | Trial primary completion date: Sep 2025 ➔ Sep 2026

Monotherapy • Trial completion date • Trial primary completion date • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor • BRAF • KRAS

SPYK04, a novel RAF-MEK molecular glue: Dose escalation (DE) in first-in-human study for MAPK pathway-altered solid tumors. (ASCO 2025) - P1 | "SPYK04 was tolerated at doses up to 1.3 mg/day in patients with advanced solid tumors. PRs were observed in two patients with ovarian cancer. Further evaluation of safety and efficacy will occur in the expansion part of this study."

P1 data • Dental Disorders • Dermatitis • Dermatology • Immunology • Oncology • Ovarian Cancer • Solid Tumor • Stomatitis • Targeted Protein Degradation

A Dose-Escalation Study of SPYK04 in Patients With Locally Advanced or Metastatic Solid Tumors (With Expansion). (clinicaltrials.gov) - P1 | N=113 | Active, not recruiting | Sponsor: Chugai Pharmaceutical | Recruiting ➔ Active, not recruiting | Trial completion date: Sep 2024 ➔ Sep 2025 | Trial primary completion date: Jun 2024 ➔ Sep 2025

Enrollment closed • Metastases • Monotherapy • Trial completion date • Trial primary completion date • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor • BRAF • KRAS

A Dose-Escalation Study of SPYK04 in Patients With Locally Advanced or Metastatic Solid Tumors (With Expansion). (clinicaltrials.gov) - P1 | N=113 | Recruiting | Sponsor: Chugai Pharmaceutical | Trial completion date: Mar 2024 ➔ Sep 2024 | Trial primary completion date: Dec 2023 ➔ Jun 2024

Metastases • Monotherapy • Trial completion date • Trial primary completion date • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor • BRAF • KRAS

"Any idea what SPYK04 is? Chugai just says small molecule, MoA undisclosed https://t.co/d3mYEKv7Xs $RHHBY" (@JacobPlieth)

A Dose-Escalation Study of SPYK04 in Patients With Locally Advanced or Metastatic Solid Tumors (With Expansion). (clinicaltrials.gov) - P1; N=90; Recruiting; Sponsor: Chugai Pharmaceutical; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Monotherapy • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • BRAF • KRAS

A Dose-Escalation Study of SPYK04 in Patients With Locally Advanced or Metastatic Solid Tumors (With Expansion). (clinicaltrials.gov) - P1; N=90; Not yet recruiting; Sponsor: Chugai Pharmaceutical

Clinical • Monotherapy • New P1 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor