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Solid Tumor, AdultPhase 1/2NCT03094169

AVID100 in Advanced Epithelial Carcinomas

A Phase 1/2 study testing AVID100 IV in people with Solid Tumor, Adult and Triple Negative Breast Cancer, run by Formation Biologics at 10 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
AVID100 IV
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
49 participants
Where
10 sitesUnited States
Study dates
1 Feb 2017to 30 Jan 2021
Phase
Phase 1/2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 42Show fewer
  • 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
  • Patients with a significant cardiovascular disease or condition
  • Patients with a significant ocular disease or condition
  • Patients with a significant pulmonary disease or condition
  • History of pneumonia within 6 months prior to the first study drug administration
  • Patients with significant gastrointestinal (GI) abnormalities
  • 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)
  • 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 EGFR-overexpressing triple negative breast cancer, squamous histology non-small cell lung cancer, or squamous cell carcinoma of the head and neck.
  • Patients with hematologic abnormalities at baseline
  • Patients with a significant cardiovascular disease or condition
  • Patients with a significant ocular disease or condition
  • Patients with a significant pulmonary disease or condition
  • History of pneumonia within 6 months prior to the first study drug administration
  • Patients with significant gastrointestinal (GI) abnormalities
  • Patients with non-healing wounds on any part of the body
  • Patients without measurable disease according to RECIST v1.1
  • Patients with an active second malignancy within the last 2 years prior to entry
  • Drugs and Other Treatments to be Excluded
  • 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
  • Any other investigational treatments during study. This includes participation in any medical device or other therapeutic intervention clinical trials.
  • Radiotherapy for target lesions within 4 weeks prior to first study drug administration and during study
  • 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
  • Strong inhibitors and/or inducers of cytochrome P450 (CYP) isoenzyme 3A4 within 2 weeks prior to first study drug administration and during study
  • Immunosuppressive or systemic hormonal therapy within 2 weeks prior to first study drug administration and during study.
  • 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

Who cannot join

None listed.

Trial locations and contacts

10 sites in 1 country.

10 sites in 1 country

United States10 sites

  • Texas Oncology Midtown

    Austin, Texas, 78705

  • Texas Oncology-Baylor -Charles A. Sammons Cancer Center

    Dallas, Texas, 75246

  • University of Texas Southwestern Medical Center

    Dallas, Texas, 75390

  • START Midwest

    Grand Rapids, Michigan, 49503

  • Texas Oncology McAllen

    McAllen, Texas, 78503

  • Yale

    New Haven, Connecticut, 06511

  • The Tisch Cancer Institute-Mt. Sinai

    New York, New York, 10029

  • Fox Chase

    Philadelphia, Pennsylvania, 19111

  • Texas Oncology NE San Antonio

    San Antonio, Texas, 78217

  • Texas Oncology Tyler

    Tyler, Texas, 75702

Other trials in United States

About this study

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

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

Read the 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.

Being tested
AVID100 IV
Medical subject headings
Triple Negative Breast Neoplasms, Squamous Cell Carcinoma of Head and Neck, Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AVID100 IVDrug

    AVID100 is administered once every 3 weeks

Study groups in NCT03094169
Study groupRoleWhat they receive
Dose escalationExperimentalMinimum of 1 to 3 patients per dose cohort; approximately 4 dose cohorts to be evaluated to establish the Maximum tolerated dose.
Receives: Drug: 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.
Receives: Drug: AVID100 IV
Phase 2a Head and Neck CarcinomaExperimentalAddition of 15 patients with squamous head and neck carcinoma. Patients will have 3+ EGFR over-expression.
Receives: Drug: 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
Receives: Drug: AVID100 IV

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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
    1. 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
    2. Any G4 non-hematologic toxicity with the exception of:
    • G4 asymptomatic electrolyte abnormalities lasting < 7 days not considered clinically significant
    1. Neutropenia that is:
    • > G3 and associated with fever
    • G4 and sustained (ANC < 500 per mm3, duration > 5 days)
    1. Thrombocytopenia that is:
    • G3 with clinically significant hemorrhage or requirement for transfusion
    • G4 (platelets < 25,000 per mm3)
    1. Inability to complete Cycle 1 at the assigned dose

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

  2. 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.

    Measured: 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)

  1. PK Profile of Total Antibody

    Characterization of the pharmacokinetic profile of total antibody

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Mar 2017
  2. Study start1 Feb 2017
  3. Primary completion28 Nov 2020
  4. Study completion30 Jan 2021

Why it stopped: lack of efficacy

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
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 cohorts
Masking
None (open label)
Enrolment
49 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03094169
Sponsor's protocol ID
AVID100-01
Status last verified
Mar 2022
First submitted
6 Feb 2017
Last updated
11 Jun 2025
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing AVID100 IV in people with Solid Tumor, Adult and Triple Negative Breast Cancer, run by Formation Biologics at 10 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 42 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 11 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Phase 1 Dose Escalation: Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs) in Cycle 1 (time frame: Cycle 1 during Dose Escalation (ie the first 3 weeks of dosing)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03094169.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2025.

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AVID100 in Advanced Epithelial Carcinomas | AzTrials