A Phase 1 Dose Escalation and Expansion Study of GIGA-564, a Minimally Blocking Anti-CTLA-4 Monoclonal Antibody, in Participants With Locally Advanced or Metastatic Solid Tumor Malignancies
Summary
The purpose of this study is to assess the safety and tolerability of GIGA-564 and identify the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) level(s) of GIGA-564 in participants with metastatic or locally advanced solid tumor malignancies.
Arms & interventions
- DrugGIGA-564
Administered by intravenous infusion
- DrugGIGA-564
Administered by intravenous infusion
Outcome measures
Primary
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Time frame: Up to 154 days
Number of Participants With Grade 3 or 4 TEAEs
Time frame: Up to 154 days
Number of Participants With Treatment-related TEAEs
Time frame: Up to 154 days
Number of Participants With Grade 3 or 4 Treatment-related TEAEs
Time frame: Up to 154 days
Number of Participants With Serious Adverse Events (SAE's)
Time frame: Up to 154 days
Number of Participants Who Discontinued Treatment due to Adverse Events (AEs)
Time frame: Up to 154 days
Number of Participants With Dose-limiting Toxicities (DLTs) during Cycle 1
Time frame: Up to 21 days
Secondary
Objective Response Rate (ORR) Based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
Time frame: Up to Week 24
Percentage of Participants with Minor RECIST 1.1 Response
Time frame: Up to Week 24
Disease Control Rate (DCR) per RECIST 1.1
Time frame: Up to Week 24
Progression Free Survival (PFS)
Time frame: Up to 2 years
Duration of Response (DOR)
Time frame: Up to 2 years
Area Under the Serum Concentration-time Curve during a Dosage Interval (AUC0-tau) of GIGA-564 during Cycle 1 and Cycle 4
Time frame: Up to 84 days
Area Under the Serum Concentration-time Curve From Time Zero to Infinity (AUC[0-inf)] of GIGA-564 during Cycle 1
Time frame: Up to 21 days
Maximum Observed Serum concentration (Cmax) of GIGA-564 during Cycle 1 and Cycle 4
Time frame: Up to 154 days
Time to Reach Maximum Observed Serum Concentration (Tmax) of GIGA-564 during Cycle 1 and Cycle 4
Time frame: Up to 154 days
Trough Observed Serum Concentration (C trough) of GIGA-564 during Cycle 1 and Cycle 4
Time frame: Up to 154 days
Elimination Half-life (t1/2) of GIGA-564 during Cycle 1 and Cycle 4
Time frame: Up to 154 days
Apparent Total Body Clearance (CL) of GIGA-564 during Cycle 1
Time frame: Up to 21 days
Volume of Distribution at Steady State (Vss) of GIGA-564 during Cycle 1
Time frame: Up to 21 days
Accumulation Ratio for Maximum Observed Serum Concentration (Cmax) of GIGA-564
Time frame: Up to 154 days
Accumulation Ratio for Trough Observed Serum Concentration (Ctrough) of GIGA-564
Time frame: Up to 154 days
Accumulation Ratio for Area Under the Serum Concentration-time Curve (AUC) of GIGA-564
Time frame: Up to 154 days
Eligibility criteria
Study locations (1)
National Cancer Institute
Bethesda, Maryland, 20892