AVID100 in Advanced Epithelial Carcinomas

Phase 1

Terminated

Conditions: Non Small Cell Lung Cancer
Solid Tumor, Adult
Triple Negative Breast Cancer
Head and Neck Squamous Cell Carcinoma

Interventions: Drug: AVID100 IV

Registration Number: NCT03094169

Lead Sponsor: Formation Biologics

Brief Summary: Approximately 90 male and female patients with documented solid tumor malignancies of epithelial origin that are locally advanced or metastatic, and either refractory to standard therapy or for whom no standard therapy is available, will be entered into this Phase 1a/2a, multicenter, open-label, dose-escalation, cohort study of AVID100. Phase 2a will include evaluation of patient with EGFR-overexpressing squamous histology non-small cell lung cancer, squamous cell carcinoma of the head and neck, and triple negative breast cancer

Detailed Description: On Day 1 of study, patients will receive study drug administered by 2-hour IV infusion. AVID100 will be administered once every 3 weeks (Q3W) with administration on Day 1 of the first week, followed by a 3-week recovery period. In Phase 2a AVID100 will be administered at a dose of 220 mg/m2.

Evidence of progressive disease at any point in the study will necessitate withdrawal of the patient from further participation so that alternative management of their malignancy may be considered. All patients will be followed to further evaluate safety as well as evidence of the anti-tumor effects of AVID100 in these selected patient populations. If anti-tumor activity is observed additional patients may be added to the planned Phase 2a patient populations to further characterize these effects.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 49

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dose escalation	AVID100 IV	Minimum of 1 to 3 patients per dose cohort; approximately 4 dose cohorts to be evaluated to establish the Maximum tolerated dose.
Phase 2a Triple Negative Breast Cancer	AVID100 IV	Addition of up to 15 patients in each of 2 subpopulations of patients with triple negative breast cancer (30 total). One group of 15 patients will have 3+ EGFR over-expression. The second group will have 2+ EGFR over-expression.
Phase 2a Head and Neck Carcinoma	AVID100 IV	Addition of 15 patients with squamous head and neck carcinoma. Patients will have 3+ EGFR over-expression.
Phase 2a Non-Small Cell Lung Carcinoma	AVID100 IV	Addition of 15 patients with squamous histology non-small cell lung carcinoma. Patients will have 3+ EGFR over-expression

Primary Outcome Measures

Name	Time	Method
Phase 2a: Number of Participants With Best Overall Response by RECIST 1.1	Imaging for Disease status (tumour measurements) occurred after every even cycle for the full duration of treatment and at EOT visit up to approximately 24 weeks total	Tumor responses were evaluated using appropriate imaging and categorized according to RECIST 1.1 at Screening and every 2 cycles during study treatment. Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non- target) must have reduction in short axis to \< 10 mm.
Phase 1 Dose Escalation: Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs) in Cycle 1	Cycle 1 during Dose Escalation (ie the first 3 weeks of dosing)	Any of the following toxicities, if judged to be associated with study, were considered a DLT: 1. Evidence of pulmonary fibrosis 2. G3 non-hematologic toxicity regardless of duration with the exceptions of: * G3 nausea, vomiting, diarrhea, or fatigue lasting \< 2 days * G3 asymptomatic electrolyte abnormalities lasting \< 3 days not considered clinically relevant 3. AST and/or ALT elevation \> 3 x ULN with total bilirubin \> 2 x ULN without initial findings of cholestasis, that cannot be explained by other factors 4. Any G4 non-hematologic toxicity with the exception of: • G4 asymptomatic electrolyte abnormalities lasting \< 7 days not considered clinically significant 5. Neutropenia that is: * \> G3 and associated with fever * G4 and sustained (ANC \< 500 per mm3, duration \> 5 days) 6. Thrombocytopenia that is: * G3 with clinically significant hemorrhage or requirement for transfusion * G4 (platelets \< 25,000 per mm3) 7. Inability to complete Cycle 1 at the assigned dose

Secondary Outcome Measures

Name	Time	Method
PK Profile of Total Antibody	Cycle 1 Profile (ie the first 3 weeks of dosing)	Characterization of the pharmacokinetic profile of total antibody

Trial Locations

Locations (10): Yale
🇺🇸
New Haven, Connecticut, United States
START Midwest
🇺🇸
Grand Rapids, Michigan, United States
The Tisch Cancer Institute-Mt. Sinai
🇺🇸
New York, New York, United States
Fox Chase
🇺🇸
Philadelphia, Pennsylvania, United States
Texas Oncology Midtown
🇺🇸
Austin, Texas, United States
Texas Oncology-Baylor -Charles A. Sammons Cancer Center
🇺🇸
Dallas, Texas, United States
University of Texas Southwestern Medical Center
🇺🇸
Dallas, Texas, United States
Texas Oncology McAllen
🇺🇸
McAllen, Texas, United States
Texas Oncology NE San Antonio
🇺🇸
San Antonio, Texas, United States
Texas Oncology Tyler
🇺🇸
Tyler, Texas, United States
Yale
🇺🇸New Haven, Connecticut, United States