AVID100 in Advanced Epithelial Carcinomas

Non Small Cell Lung Cancer Clinical Trial

Official title:

Phase 1a/2a Dose Escalation Trial to Determine Safety, Tolerance, MTD, and Preliminary Antineoplastic Activity of AVID100, in Patients With Advanced or Metastatic Solid Tumors of Epithelial Origin

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03094169
• Other study ID #: AVID100-01
• Status: Terminated
• Phase: Phase 1/Phase 2
• Start date: February 1, 2017
• Est. completion date: January 30, 2021

Study information

• Verified date: March 2021
• Source: Formation Biologics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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 information / eligibility

• Status: Terminated
• Enrollment: 49
• Est. completion date: January 30, 2021
• Est. primary completion date: November 28, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria (Phase 1):

1. Patients with a documented (histologically- or cytologically-proven) solid tumor epithelial carcinoma that is locally advanced or metastatic

2. Patients with a malignancy that is either refractory to standard therapy, or for which no standard therapy is available

3. Patients with a malignancy that is currently not amenable to surgical intervention due to either medical contraindications or non-resectability of the tumor

4. 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.

Inclusion Criteria (Phase 2a)

1. Patients with measurable disease according to RECIST, v1.1 criteria.

2. Patients with triple negative breast cancer who are either EGFR 2+ or EGFR 3+ by validated IHC assay.

3. Patients with squamous non-small cell lung cancer who are EGFR 3+ by validated IHC assay.

4. Patients with squamous cell carcinoma of the head and neck who are EGFR 3+ by validated IHC assay.

5. Patients whose malignancy is either refractory to standard therapy, or for which no standard therapy is available

6. 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)

1. 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.

2. 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

3. Patients with a malignancy other than that of epithelial origin

4. Patients with hematologic abnormalities at baseline

5. Patients with a significant cardiovascular disease or condition

6. Patients with a significant ocular disease or condition

7. Patients with a significant pulmonary disease or condition

8. History of pneumonia within 6 months prior to the first study drug administration

9. Patients with significant gastrointestinal (GI) abnormalities

10. Patients with non-healing wounds on any part of the body

Patients to be Excluded (patients must not meet any of the following criteria Phase 2a only)

1. 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.

2. 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

3. Patients with a malignancy other than EGFR-overexpressing triple negative breast cancer, squamous histology non-small cell lung cancer, or squamous cell carcinoma of the head and neck.

4. Patients with hematologic abnormalities at baseline

5. Patients with a significant cardiovascular disease or condition

6. Patients with a significant ocular disease or condition

7. Patients with a significant pulmonary disease or condition

8. History of pneumonia within 6 months prior to the first study drug administration

9. Patients with significant gastrointestinal (GI) abnormalities

10. Patients with non-healing wounds on any part of the body

11. Patients without measurable disease according to RECIST v1.1

12. Patients with an active second malignancy within the last 2 years prior to entry

Drugs and Other Treatments to be Excluded

1. Any antineoplastic agent for the primary malignancy (standard or investigational), without delayed toxicity, within 4 weeks, 5 plasma half-lives, or twice the duration of the biological effect, whichever is shortest, prior to first study drug administration and during study with the exception of: Nitrosoureas and nitrogen mustard within 6 weeks prior to first study drug administration and during study

2. Any other investigational treatments during study. This includes participation in any medical device or other therapeutic intervention clinical trials.

3. Radiotherapy for target lesions within 4 weeks prior to first study drug administration and during study

4. Herbal preparations or related over-the-counter (OTC) preparations/supplements containing herbal ingredients aimed at treating the underlying malignancy within 2 weeks prior to first study drug administration and during study

5. Strong inhibitors and/or inducers of cytochrome P450 (CYP) isoenzyme 3A4 within 2 weeks prior to first study drug administration and during study

6. Immunosuppressive or systemic hormonal therapy within 2 weeks prior to first study drug administration and during study.

7. Prophylactic use of hematopoietic growth factors within 1 week prior to first study drug administration and during Cycle 1 of study; thereafter prophylactic use of growth factors is allowed as clinically indicated

Related Conditions & MeSH terms

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

Intervention

Drug:
• AVID100 IV
AVID100 is administered once every 3 weeks

Locations

Country	Name	City	State
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	START Midwest	Grand Rapids	Michigan
United States	Texas Oncology McAllen	McAllen	Texas
United States	Yale	New Haven	Connecticut
United States	The Tisch Cancer Institute-Mt. Sinai	New York	New York
United States	Fox Chase	Philadelphia	Pennsylvania
United States	Texas Oncology NE San Antonio	San Antonio	Texas
United States	Texas Oncology Tyler	Tyler	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Formation Biologics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Phase 1a: Determine safety and tolerability of AVID100	Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment	6 months
Primary	Phase 2a: Evaluation of the preliminary antineoplastic effects of AVID100	Number of participants with objective response or stable disease	18 months
Secondary	PK Profile of Total Antibody	Characterization of the pharmacokinetic profile of total antibody	18 months