AVID100 in Advanced Epithelial Carcinomas

NCT03094169 | Terminated Phase 1 Results FDA Drug

• 1 other identifier: AVID100-01
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 10

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

Conditions

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

Outcome Measures

Primary Outcomes (2)

• Phase 1 Dose Escalation: Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs) in Cycle 1

  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

  Cycle 1 during Dose Escalation (ie the first 3 weeks of dosing)

• Phase 2a: Number of Participants With Best Overall Response by RECIST 1.1

  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.

  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

Secondary Outcomes (1)

• PK Profile of Total Antibody

  Cycle 1 Profile (ie the first 3 weeks of dosing)

Study Arms (4)

Dose escalation

EXPERIMENTAL

Minimum of 1 to 3 patients per dose cohort; approximately 4 dose cohorts to be evaluated to establish the Maximum tolerated dose.

Drug: AVID100 IV

Phase 2a Triple Negative Breast Cancer

EXPERIMENTAL

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.

Drug: AVID100 IV

Phase 2a Head and Neck Carcinoma

EXPERIMENTAL

Addition of 15 patients with squamous head and neck carcinoma. Patients will have 3+ EGFR over-expression.

Drug: AVID100 IV

Phase 2a Non-Small Cell Lung Carcinoma

EXPERIMENTAL

Addition of 15 patients with squamous histology non-small cell lung carcinoma. Patients will have 3+ EGFR over-expression

Drug: AVID100 IV

Interventions

AVID100 IV DRUG

AVID100 is administered once every 3 weeks

Dose escalation; Phase 2a Head and Neck Carcinoma; Phase 2a Non-Small Cell Lung Carcinoma; Phase 2a Triple Negative Breast Cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with a documented (histologically- or cytologically-proven) solid tumor epithelial carcinoma that is locally advanced or metastatic
• Patients with a malignancy that is either refractory to standard therapy, or for which no standard therapy is available
• Patients with a malignancy that is currently not amenable to surgical intervention due to either medical contraindications or non-resectability of the tumor
• Phase 1a Dose-Escalation Cohorts: Patients with measurable or non-measurable disease according to RECIST, v1.1 criteria. To include patients reasonably likely to express EGFR.
• Patients with measurable disease according to RECIST, v1.1 criteria.
• Patients with triple negative breast cancer who are either EGFR 2+ or EGFR 3+ by validated IHC assay.
• Patients with squamous non-small cell lung cancer who are EGFR 3+ by validated IHC assay.
• Patients with squamous cell carcinoma of the head and neck who are EGFR 3+ by validated IHC assay.
• Patients whose malignancy is either refractory to standard therapy, or for which no standard therapy is available
• Patients whose malignancy is currently not amenable to surgical intervention due to either medical contraindications or non-resectability of the tumor
• Patients to be Excluded (patients must not meet any of the following criteria Phase 1 only)
• Women who are pregnant or lactating. Women of child-bearing potential (WOCBP) and fertile men with WOCBP partner(s), not using and not willing to use a medically effective method of contraception.
• Patients with known central nervous system (CNS) or leptomeningeal metastases, or spinal cord compression not controlled by prior surgery or radiotherapy, or patients with symptoms suggesting CNS involvement for which treatment is required
• Patients with a malignancy other than that of epithelial origin
• Patients with hematologic abnormalities at baseline

Sponsors & Collaborators

• Formation Biologics: lead

Study Sites (10)

Yale

New Haven, Connecticut, 06511, United States

Location

START Midwest

Grand Rapids, Michigan, 49503, United States

Location

The Tisch Cancer Institute-Mt. Sinai

New York, New York, 10029, United States

Location

Fox Chase

Philadelphia, Pennsylvania, 19111, United States

Location

Texas Oncology Midtown

Austin, Texas, 78705, United States

Location

Texas Oncology-Baylor -Charles A. Sammons Cancer Center

Dallas, Texas, 75246, United States

Location

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

Texas Oncology McAllen

McAllen, Texas, 78503, United States

Location

Texas Oncology NE San Antonio

San Antonio, Texas, 78217, United States

Location

Texas Oncology Tyler

Tyler, Texas, 75702, United States

Location

MeSH Terms

Conditions

Triple Negative Breast Neoplasms; Squamous Cell Carcinoma of Head and Neck; Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Head and Neck Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Sandra Sinclair
• Organization: Formation Biologics

sandra@forbius.com

8326221699

Study Officials

• Nehal Lakhani, MD

  START Midwest

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Uncontrolled, open label, non-randomized, Enrollment in the order of confirmation of eligibility, Escalating doses of study drug in sequential patient cohorts (Phase 1a). Uncontrolled, open label, non-randomised. Enrollment into three individual Phase 2a study cohorts

Study Record Dates

• First Submitted: February 6, 2017
• First Posted: March 29, 2017
• Study Start: February 1, 2017
• Primary Completion: November 28, 2020
• Study Completion: January 30, 2021
• Last Updated: June 11, 2025
• Results First Posted: June 11, 2025

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (10)