AVID100 in Advanced Epithelial Carcinomas

• Sponsor: Formation Biologics (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT03094169
• Collaborator: (none)
• Enrollment: 49
• Locations: 10
• Arms: 4
• Actual Duration (Months): 47.9
• Patients Per Site: 4.9
• Patients Per Site Per Month: 0.1

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Solid Tumor, Adult; Triple Negative Breast Cancer; Head and Neck Squamous Cell Carcinoma; Non Small Cell Lung Cancer	Drug: AVID100 IV	Phase 1/Phase 2

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 49 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: 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 cohortsUncontrolled, 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
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Feb 1, 2017
• Actual Primary Completion Date: Nov 28, 2020
• Actual Study Completion Date: Jan 30, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Dose escalation 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; AVID100 is administered once every 3 weeks
Experimental: Phase 2a Triple Negative Breast Cancer 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; AVID100 is administered once every 3 weeks
Experimental: Phase 2a Head and Neck Carcinoma Addition of 15 patients with squamous head and neck carcinoma. Patients will have 3+ EGFR over-expression.	Drug: AVID100 IV; AVID100 is administered once every 3 weeks
Experimental: Phase 2a Non-Small Cell Lung Carcinoma Addition of 15 patients with squamous histology non-small cell lung carcinoma. Patients will have 3+ EGFR over-expression	Drug: AVID100 IV; AVID100 is administered once every 3 weeks

Outcome Measures

Primary Outcome Measures

1. Phase 1a: Determine safety and tolerability of AVID100 [6 months]

   Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment

2. Phase 2a: Evaluation of the preliminary antineoplastic effects of AVID100 [18 months]

   Number of participants with objective response or stable disease

Secondary Outcome Measures

1. PK Profile of Total Antibody [18 months]

   Characterization of the pharmacokinetic profile of total antibody

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Yale	New Haven	Connecticut	United States	06511
2	START Midwest	Grand Rapids	Michigan	United States	49503
3	The Tisch Cancer Institute-Mt. Sinai	New York	New York	United States	10029
4	Fox Chase	Philadelphia	Pennsylvania	United States	19111
5	Texas Oncology Midtown	Austin	Texas	United States	78705
6	Texas Oncology-Baylor -Charles A. Sammons Cancer Center	Dallas	Texas	United States	75246
7	University of Texas Southwestern Medical Center	Dallas	Texas	United States	75390
8	Texas Oncology McAllen	McAllen	Texas	United States	78503
9	Texas Oncology NE San Antonio	San Antonio	Texas	United States	78217
10	Texas Oncology Tyler	Tyler	Texas	United States	75702

Sponsors and Collaborators

• Formation Biologics

Investigators

• Principal Investigator: Nehal Lakhani, MD, START Midwest

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Formation Biologics
• ClinicalTrials.gov Identifier: NCT03094169
• Other Study ID Numbers: AVID100-01
• First Posted: Mar 29, 2017
• Last Update Posted: Mar 24, 2021
• Last Verified: Mar 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Carcinoma; Triple Negative Breast Neoplasms; Squamous Cell Carcinoma of Head and Neck

Study Results

No Results Posted as of Mar 24, 2021