Fc-Engineered Anti-CTLA-4 Monoclonal Antibody in Advanced Cancer

Conditions

• Advanced Cancer
• Angiosarcoma
• Colorectal Cancer Without Liver Metastases
• Endometrial Cancer
• Fibrolamellar Carcinoma
• Non-small-cell Lung Cancer
• Ovarian Cancer
• Prostate Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Botensilimab — DRUG
  An Fc-engineered anti-CTLA-4 monoclonal antibody
• Balstilimab — DRUG
  A fully human monoclonal anti-PD-1 antibody

Study Details

This study is an open-label, Phase 1, multicenter study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamic (PD) profiles of a novel fragment crystallizable (Fc)-engineered immunoglobulin G1 anti-cytotoxic T-lymphocyte antigen 4 (anti-CTLA-4) human monoclonal antibody (botensilimab) monotherapy and in combination with an anti-programmed cell death protein-1 (PD-1) antibody (balstilimab), and to assess the maximum tolerated dose (MTD) in participants with advanced solid tumors. This study will also determine the recommended phase 2 dose (RP2D) of botensilimab monotherapy and in combination with balstilimab.

Key Dates

Start date

Mar 20, 2019

Status verified

Mar 2026

Primary completion

Jan 13, 2025

Completion

Dec 31, 2027

Study Design

Enrollment

499 participants (actual)

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: 3-Week Monotherapy
  3+3 Dose escalation: botensilimab, every 3 weeks, starting at dose level 0.1 milligrams/kilogram (mg/kg) up to 4 mg/kg, administered intravenously (IV) for up to 2 years.
• Experimental: 6-Week Monotherapy
  3+3 Dose escalation: botensilimab, every 6 weeks, starting at dose level 1 mg/kg up to 4 mg/kg, administered IV for up to 2 years.
• Experimental: 6-Week Combination Therapy
  3+3 Dose escalation: balstilimab, every 2 weeks, at dose level 3 mg/kg in combination with botensilimab, every 6 weeks, starting at dose level 0.1 mg/kg up to 4 mg/kg, administered IV for up to 2 years. Participants enrolled at sites in the United Kingdom (UK) may have the option for extended treatment. An additional cohort will investigate balstilimab, every 3 weeks, at 450 mg in combination with botensilimab every 6 weeks, at 150 mg, administered IV for up to 2 years.

Primary Outcome Measure

Incidence Of Treatment-emergent Adverse Events (TEAEs) [ Time Frame: First dose through 90 days following last study dose (up to 2 years) ]

Locations (17)

Find similar trials in Scottsdale, AZ

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