Phase I Dose-Escalation, Safety, Pharmacokinetic and Pharmacodynamic Study of BVD-523 in Patients With Advanced Malignancies

• Status: Completed
• Trial end date: 2018-09-01
• Target enrollment: 0
• Participant gender: All

Summary

This open-label, multi-center Phase 1/2 study will assess the safety, pharmacokinetics, and pharmacodynamics of escalating doses of BVD-523 in patients with advanced malignancies. The study also seeks to demonstrate target modulation and early signs of clinical response in select patient populations.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: BioMed Valley Discoveries, Inc

Criteria

Inclusion Criteria:

• Patients with metastatic or advanced-stage malignant tumor. Patients may have received up to 2 prior lines of chemotherapy for their metastatic disease

• ECOG score of 0 or 1

• Predicted life expectancy of ≥ 3 months

• Adequate bone marrow, liver and renal function renal function

• Adequate cardiac function

• For women: Negative pregnancy test for females of child-bearing potential; must be surgically sterile, postmenopausal, or compliant with a contraceptive regimen during and for 3 months after the treatment period

• For men: Must be surgically sterile, or compliant with a contraceptive regimen during and for 3 months after the treatment period

• For Part 2 of the Study only, patients must have measurable disease by RECIST 1.1 and be in one of the the groups below. Patients in groups 1, 2, 4, 5 and 6 may not have been previously treated with BRAF and/or MEK inhibitors

• Group 1: Patients with BRAF mutated cancer, except those with colorectal or non-small cell lung cancers

• Group 2: Patients with BRAF mutated colorectal cancer

• Group 3: Patients with BRAF mutated melanoma who have progressed on, or are refractory to BRAF and/or MEK inhibitors

• Group 4: Patients with NRAS mutated melanoma

• Group 5: Patients with MEK mutated cancer

• Group 6: Patients with BRAF mutated non-small cell lung cancer

• Group 7: Patients with ERK mutated cancer

Exclusion Criteria:

• Gastrointestinal condition which could impair absorption of study medication

• Uncontrolled or severe intercurrent medical condition

• Known uncontrolled brain metastases. Stable brain metastases either treated or being treated with a stable dose of steroids/anticonvulsants

• Any cancer-directed therapy (chemotherapy, radiotherapy, hormonal therapy, biologic or immunotherapy, etc.) within 28 days or 5 half-lives, whichever is shorter

• Major surgery within 4 weeks prior to first dose

• Any use of an investigational drug within 28 days or 5 half-lives (whichever is shorter) prior to the first dose of BVD-523.

• Pregnant or breast-feeding women

• Any evidence of serious active infections

• Any important medical illness or abnormal laboratory finding that would increase the risk of participating in this study

• A history or current evidence/risk of retinal vein occlusion or central serous retinopathy

• Concurrent therapy with any other investigational agent

• Concomitant malignancies or previous malignancies with less than 2 years disease-free interval at the time of enrollment