A Dose Escalation and Expansion Study of MVC-101 in Patients With Advanced Cancer

• Status: Recruiting
• Trial end date: 2024-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics and preliminary antitumor activity of MVC-101

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

Details

• Lead Sponsor: Maverick Therapeutics, Inc; Takeda

Criteria

Inclusion Criteria:

• Tumor histologies:

• Dose Escalation: Patients with histologically proven, unresectable, locally advanced or metastatic solid cancers that are considered to express EGFR

• Cohort Expansion:

• NSCLC that has progressed during or following treatment with platinum-based chemotherapy and an anti-PDx therapy NSCLC with EGFR mutation or ALK rearrangement must have progressed following available EGFR or ALK targeted therapy in addition to treatment with platinum-based chemotherapy

• HNSCC that has progressed during or following treatment with an anti-PDx (unless ineligible, e.g. patients failing chemotherapy and PD-L1 CPS < 1) and platinum-based chemotherapy (unless ineligible/intolerant of platinum-based chemotherapy) for metastatic or recurrent disease

• CRC

• K-Ras WT: Patients who have progressed during or after, or are ineligible for, both irinotecan and oxaliplatin based chemotherapy and who are relapsed or refractory to at least 1 prior systemic therapy that included an anti-EGFR antibody

• K-Ras mutant: Patients who have progressed during or after, or are ineligible for, both irinotecan and oxaliplatin based chemotherapy

• ECOG performance status of ≤ 1

• Measurable disease as per RECIST v1.1 criteria and documented by CT and/or MRI

• Patients must allow acquisition of existing archival tumor sample, either a block or unstained slides.

• Patients are required to consent for paired tumor biopsies: one in the screening period and on during the first cycle of treatment

• Acceptable laboratory parameters and adequate organ reserve

• Patients who have previously received an immune checkpoint prior to enrollment must have checkpoint inhibitor immune-related toxicity resolved to either Grade ≤ 1 or baseline

• Patients with symptomatic central nervous system metastases must have been treated, be asymptomatic for ≥ 14 days, and must not have concurrent treatment or concurrent leptomeningeal disease / cord compression

Exclusion Criteria:

• Patients with a history of known autoimmune disease with certain exceptions

• Patients with clinically significant cardiovascular / vascular disease

• Patients with clinically significant inflammatory gastrointestinal disorders

• Patients with clinically significant pulmonary compromise

• Major surgery or traumatic injury within 8 weeks from the date of first study dose

• Unhealed wounds from surgery or injury

• Treatment with radiation therapy < 2 weeks from the date of first study dose

• Inflammatory process that has not resolved for ≥ 4 weeks from the date of first study dose