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
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
Drug | Synonyms | Arms |
---|
AVID100 IV | | Dose 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
Name | Type | Description | Interventions |
---|
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. | |
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. | |
Phase 2a Head and Neck Carcinoma | Experimental | Addition of 15 patients with squamous head and neck carcinoma. Patients will have 3+ EGFR over-expression. | |
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 | |
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: | Terminated |
Lead Sponsor: | Formation Biologics |
Last Updated
March 24, 2021