Study BT5528-100 in Patients With Advanced Solid Tumors Associated With EphA2 Expression

Conditions

• Advanced Solid Tumor Historically Known for High EphA2 Expression
• Gastric/Upper Gastrointestinal Cancer
• Head and Neck Cancer
• Non-small Cell Lung Cancer
• Ovarian Cancer
• Triple Negative Breast Cancer
• Urothelial Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• BT5528 — DRUG
  Participants will receive a 60-minute intravenous infusion of BT5528 once a week (Days 1, 8, 15, and 22) or every other week (Days 1 and 15) on a 4-week cycle at the selected dose.
• Nivolumab — DRUG
  Participants will receive nivolumab at 480mg intravenous infusion every 4 weeks.

Study Details

This clinical trial is evaluating a drug called BT5528 alone and in combination with nivolumab in participants with advanced solid tumors historically known for expression of EphA2. The main goals of this study are to: * Find the recommended dose(s) of BT5528 that can be given safely to participants alone and in combination with nivolumab * Learn more about the side effects of BT5528 * Learn about how effective BT5528 is for the treatment of ovarian cancer, urothelial/bladder cancer, lung cancer (NSCLC), triple-negative breast cancer, head and neck cancer (HNSCC), and gastric/upper gastrointestinal cancer. * Learn more about BT5528 therapy alone and in combination with nivolumab.

Key Dates

Start date

Nov 7, 2019

Status verified

Nov 2025

Primary completion

Jul 31, 2026

Completion

Jul 31, 2027

Study Design

Enrollment

288 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: Phase I - Dose escalation (BT5528)
  Cohorts of participants will receive increasing doses of BT5528. It is expected that up to 72 participants will participate in this dose escalation arm.
• Experimental: Phase I - Dose escalation combination (BT5528 & nivolumab)
  Cohorts of participants will receive increasing doses of BT5528 and a standard dose of nivolumab. It is expected that up to 24 participants will participate in this dose-escalation combination arm.
• Experimental: Phase II - Dose expansion 1 (BT5528)
  A cohort of participants will receive the selected dose of BT5528 as a monotherapy. It is expected that up to 164 patients have solid tumors (Cohort 1: urothelial cancers, Cohort 2: ovarian cancer, Cohort 3: non-small cell lung cancer, Cohort 4: head and neck cancer, Cohort 5: triple-negative breast cancer, and Cohort 6: gastric/upper gastrointestinal cancer) historically known for high expression of EphA2 will participate in this dose-expansion arm, Cohort 7: urothelial MMAE exposed, Cohort 8: head and neck squamous cell carcinoma

Primary Outcome Measure

Part A-1 and A-2(escalations): Number of participants receiving BT5528 alone and in combination with nivolumab with treatment-emergent adverse events [ Time Frame: From Cycle 1 Day 1 (each cycle is 28 days) until 30 days post last dose ]

Locations (12)

Find similar trials in Encinitas, CA

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