Clinical Trials /

AVID100 in Advanced Epithelial Carcinomas

NCT03094169

Description:

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

Related Conditions:
  • Breast Carcinoma
  • Carcinoma
  • Head and Neck Squamous Cell Carcinoma
  • Squamous Cell Lung Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Title

  • Brief Title: AVID100 in Advanced Epithelial Carcinomas
  • 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 IDs

  • ORG STUDY ID: AVID100-01
  • NCT ID: NCT03094169

Conditions

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

Interventions

DrugSynonymsArms
AVID100 IVDose escalation

Purpose

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.
    

Trial Arms

NameTypeDescriptionInterventions
Dose escalationExperimentalMinimum of 1 to 3 patients per dose cohort; approximately 4 dose cohorts to be evaluated to establish the Maximum tolerated dose.
  • AVID100 IV
Phase 2a Triple Negative Breast CancerExperimentalAddition 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.
  • AVID100 IV
Phase 2a Head and Neck CarcinomaExperimentalAddition of 15 patients with squamous head and neck carcinoma. Patients will have 3+ EGFR over-expression.
  • AVID100 IV
Phase 2a Non-Small Cell Lung CarcinomaExperimentalAddition of 15 patients with squamous histology non-small cell lung carcinoma. Patients will have 3+ EGFR over-expression
  • AVID100 IV

Eligibility Criteria

        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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Phase 1a: Determine safety and tolerability of AVID100
Time Frame:6 months
Safety Issue:
Description:Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment

Secondary Outcome Measures

Measure:PK Profile of Total Antibody
Time Frame:18 months
Safety Issue:
Description:Characterization of the pharmacokinetic profile of total antibody

Details

Phase:Phase 1/Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Formation Biologics

Last Updated

August 28, 2019