Study of the Safety and Pharmacokinetics of BGB-283 (Lifirafenib) and PD-0325901 (Mirdametinib) in Participants With Advanced or Refractory Solid Tumors
NCT03905148 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 91
Last updated 2026-01-07
Summary
This is a 2-part Phase 1b study of BGB-283 (lifirafenib) and PD-0325901 (mirdametinib) combination in participants with tumors.
Conditions
- Solid Tumor, Adult
Interventions
- DRUG
-
Lifirafenib
RAF Dimer Inhibitor
- DRUG
-
mirdametinib
MEK Inhibitor
Sponsors & Collaborators
-
SpringWorks Therapeutics, Inc.
collaborator INDUSTRY -
BeiGene
lead INDUSTRY
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-05-01
- Primary Completion
- 2024-10-09
- Completion
- 2025-10-23
- FDA Drug
- Yes
Countries
- United States
- Australia
Study Locations
More Related Trials
-
An Investigational Study of BGB-58067 As a Single Agent and in Combination With Anticancer Agents in Participants With Advanced Solid Tumors
NCT06589596 ·Status: RECRUITING ·Phase: PHASE1
-
Study of the Efficacy, Safety and Pharmacokinetics of Pamiparib (BGB-290) in Participants With Advanced Solid Tumors
NCT03333915 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Study of PF-07224826, as a Single Agent or in Combination With Endocrine Therapy in Participants With Breast Cancer and Other Advanced Solid Tumors.
NCT05905341 ·Status: WITHDRAWN ·Phase: PHASE1
-
BGB-21447 (Bcl-2 Inhibitor) Combinations for Adults With Hormone-Receptor Positive (HR+)/Human Epidermal Growth Factor Receptor 2 Negative (HER2-) Metastatic Breast Cancer
NCT06756932 ·Status: RECRUITING ·Phase: PHASE1
-
Pharmacokinetic Study of Lurbinectedin in Combination With Irinotecan in Patients With Selected Solid Tumors
NCT02611024 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Treatment Extension Study for Patients Who Have Previously Participated and Have Benefited From Iniparib in a Clinical Trial
NCT01593228 ·Status: COMPLETED ·Phase: PHASE3
-
Study of Safety and Efficacy of Dapagliflozin + Metformin XR Versus Metformin XR in Participants With HR+, HER2-, Advanced Breast Cancer While on Treatment With Alpelisib and Fulvestrant
NCT04899349 ·Status: TERMINATED ·Phase: PHASE2
-
A Study of Mirdametinib on Its Own or in Combination With Fulvestrant in People With Solid Tumor Cancer
NCT05054374 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
A Study of GDC-9545 Alone or in Combination With Palbociclib and/or Luteinizing Hormone-Releasing Hormone (LHRH) Agonist in Locally Advanced or Metastatic Estrogen Receptor-Positive Breast Cancer
NCT03332797 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE1
-
A Study of Debio 1347 Plus Fulvestrant in Patients With Metastatic Breast Cancer
NCT03344536 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
A First-in-human Study of BGB-53038, a Pan-KRAS Inhibitor, Alone or in Combinations in Participants With Advanced or Metastatic Solid Tumors With KRAS Mutations or Amplification
NCT06585488 ·Status: RECRUITING ·Phase: PHASE1
-
Safety, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of MT-304 in Adults With Advanced HER2-Expressing Solid Tumors
NCT07334119 ·Status: RECRUITING ·Phase: PHASE1
-
This Study in Patients With Different Types of Cancer (Solid Tumours) Aims to Find a Safe Dose of Xentuzumab in Combination With Abemaciclib With or Without Hormonal Therapies. The Study Also Tests How Effective These Medicines Are in Patients With Lung and Breast Cancer
NCT03099174 ·Status: COMPLETED ·Phase: PHASE1
-
A Phase Ib Dose De-escalation Study With BYL719 in Premenopausal Patients With Locally Advanced or Metastatic Breast Cancer
NCT02058381 ·Status: COMPLETED ·Phase: PHASE1
-
A First-in-human Dose Escalation and Expansion Study to Evaluate the Safety, and Tolerability of AZD8421 Alone or in Combination in Participants With Selected Advanced or Metastatic Solid Tumors
NCT06188520 ·Status: RECRUITING ·Phase: PHASE1/PHASE2
-
A Study of Zilovertamab Vedotin (MK-2140/VLS-101) in Participants With Solid Tumors (MK-2140-002)
NCT04504916 ·Status: TERMINATED ·Phase: PHASE2
-
A Study of Neoadjuvant Treatment With TQB2102 for Injection for Human Epidermal Growth Factor Receptor 2 (HER2) Positive Breast Cancer
NCT06198751 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
Study of CX-5461 in Patients With Solid Tumours and BRCA1/2, PALB2 or Homologous Recombination Deficiency (HRD) Mutation
NCT04890613 ·Status: RECRUITING ·Phase: PHASE1
-
Study of LY3537982 in Cancer Patients With a Specific Genetic Mutation (KRAS G12C)
NCT04956640 ·Status: RECRUITING ·Phase: PHASE1/PHASE2
-
A Study of Multiple Immunotherapy-Based Treatment Combinations in Hormone Receptor (HR)-Positive Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Breast Cancer
NCT03280563 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Study of Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy for HR+/HER2- Locally Recurrent Inoperable or Metastatic Breast Cancer (MK-3475-B49/KEYNOTE-B49)
NCT04895358 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
A Phase Ib/II Study of the Combination of BYL719 Plus AMG 479 in Adult Patients With Selected Solid Tumors
NCT01708161 ·Status: TERMINATED ·Phase: PHASE1/PHASE2
-
A Study to Test How Well Different Doses of BI 3820768 Are Tolerated by People With Advanced Cancer (Solid Tumours)
NCT07306559 ·Status: RECRUITING ·Phase: PHASE1
-
Study to Assess Effectiveness of Giving Combination of Standard Chemotherapy Drugs Versus Combination of Standard Chemotherapy and New Drug Ixabepilone When Given Before Surgical Removal of Early Stage Breast Cancer
NCT00455533 ·Status: COMPLETED ·Phase: PHASE2
-
A Phase Ib/II Study to Evaluate Multiple Combination Therapies of FWD1802 in Patients With ER+/HER2- BC
NCT07002177 ·Status: RECRUITING ·Phase: PHASE1/PHASE2