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TerminatedNCT03094169Updated Jun 11, 2025Results posted

AVID100 in Advanced Epithelial Carcinomas

A Phase 1/2 interventional study of AVID100 IV in Solid Tumor, Adult, Triple Negative Breast Cancer and Head and Neck Squamous Cell Carcinoma, sponsored by Formation Biologics. Terminated at 10 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-06-11.

Sponsored by Formation Biologics · Phase 1/2, Interventional, and Treatment

Why this study was terminated
lack of efficacy
Phase
Phase 1/2
Study type
Interventional
Enrollment
49
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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

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.

02

Conditions studied

  • Solid Tumor, Adult
  • Triple Negative Breast Cancer
  • Head and Neck Squamous Cell Carcinoma
  • Non Small Cell Lung Cancer
03

In context

Carcinoma

6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.

This study's enrollment of 49 is close to the median of 45 across 5,170 interventional studies indexed under Carcinoma.

Browse Carcinoma studies →

Lead sponsor

This is the only study on the registry with Formation Biologics as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
49 participants (actual)

Study arms

  • 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

  • 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

  • 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

  • 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

Interventions

  • DrugAVID100 IV

    AVID100 is administered once every 3 weeks

06

What researchers measure

Primary outcomes

  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 3. 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 4. Any G4 non-hematologic toxicity with the exception of: • G4 asymptomatic electrolyte abnormalities lasting \< 7 days not considered clinically significant 5. Neutropenia that is: * \> G3 and associated with fever * G4 and sustained (ANC \< 500 per mm3, duration \> 5 days) 6. Thrombocytopenia that is: * G3 with clinically significant hemorrhage or requirement for transfusion * G4 (platelets \< 25,000 per mm3) 7. Inability to complete Cycle 1 at the assigned dose

    Time frame: 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.

    Time frame: 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. PK Profile of Total Antibody

    Characterization of the pharmacokinetic profile of total antibody

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

07

Results

Posted Jun 11, 2025

Participant flow

Participant flow — Overall Study
MilestoneAVID100 20 mg/m^2AVID100 40 mg/m^2AVID100 80 mg/m^2AVID100 120 mg/m^2AVID100 180 mg/m^2AVID100 220 mg/m^2AVID100 270 mg/m^2Phase 2a Expansion: AVID100 220 mg/m^2
Started113336725
Completed11333660
Not completed000000125
Withdrew: Lack of efficacy000000021
Withdrew: Adverse event00000002
Withdrew: Withdrawal by subject00000011
Withdrew: Trial termination00000001

Outcome measures

PrimaryPhase 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 3. 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 4. Any G4 non-hematologic toxicity with the exception of: • G4 asymptomatic electrolyte abnormalities lasting \< 7 days not considered clinically significant 5. Neutropenia that is: * \> G3 and associated with fever * G4 and sustained (ANC \< 500 per mm3, duration \> 5 days) 6. Thrombocytopenia that is: * G3 with clinically significant hemorrhage or requirement for transfusion * G4 (platelets \< 25,000 per mm3) 7. Inability to complete Cycle 1 at the assigned dose

Time frame:
Cycle 1 during Dose Escalation (ie the first 3 weeks of dosing)
Reported as:
Count of participants · Participants
Phase 1 Dose Escalation: Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs) in Cycle 1
ParticipantsDose Escalation Phase 1-Cohort 1Dose Escalation Phase 1-Cohort 2Dose Escalation Phase 1-Cohort 3Dose Escalation Phase 1-Cohort 4Dose Escalation Phase 1-Cohort 5Dose Escalation Phase 1-Cohort 6Dose Escalation Phase 1-Cohort 7
Phase 1 Dose Escalation: Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs) in Cycle 10000002
PrimaryPhase 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.

Time frame:
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
Reported as:
Count of participants · Participants
Phase 2a: Number of Participants With Best Overall Response by RECIST 1.1
ParticipantsPhase 2a Expansion: AVID100 220 mg/m^2
Progressive Disease23
Stable Disease0
Complete Response1
SecondaryPK Profile of Total Antibody

Characterization of the pharmacokinetic profile of total antibody

Time frame:
Cycle 1 Profile (ie the first 3 weeks of dosing)
Reported as:
Mean · ng/mL
PK Profile of Total Antibody
ng/mLAVID100 20 mg/m^2AVID100 40 mg/m^2AVID100 80 mg/m^2AVID100 120 mg/m^2AVID100 180 mg/m^2AVID100 220 mg/m^2AVID100 270 mg/m^2Phase 2a Expansion: AVID100 220 mg/m^2
Cycle 1 D1 prior SOINANANA ± NANA ± NANA ± NANA ± NANA ± NANA ± NA
Cycle D1 EOI9213.313686.741140.7 ± 7472.071440.9 ± 9107.385982.9 ± 8517.2113401.6 ± 18740.3136306.3 ± 16938.5122464.3 ± 20790.1
Cycle 1 D1 2h post SOI8066.314003.536935.8 ± 7089.366587.4 ± 6199.489676.6 ± 6216.5112663.3 ± 21616.7131267.2 ± 10585.7NA ± NA
Cycle 1 D1 4h post SOI8351.914555.134399.7 ± 5940.661468.6 ± 4879.179581.1 ± 9542.3101809.1 ± 17330.1132671.4 ± 13243.3NA ± NA
Cycle 1 D23217.69390.725236.4 ± 2159.343504.6 ± 5940.363001.5 ± 5837.368284.5 ± 6605.499382.8 ± 13832.9NA ± NA
Cycle 1 D4876.34578.314638.5 ± 1776.924985.3 ± 6859.735500.0 ± 5004.538068.0 ± 7890.369578.4 ± 10616.0NA ± NA
Cycle 1 D8NANA2450.7 ± 1422.78768.0 ± 5393.112590.0 ± 1531.918581.5 ± 3128.727982.5 ± 13531.7NA ± NA
Cycle 2 D1 prior to SOINANANA ± NANA ± NANA ± NANA ± NA866.5 ± 855.8131.1 ± 40.6

Adverse events

Collected over Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
AVID100 20 mg/m^20/1 (0%)0/1 (0%)1/1 (100%)
AVID100 40 mg/m^20/1 (0%)0/1 (0%)1/1 (100%)
AVID100 80 mg/m^20/3 (0%)1/3 (33.3%)3/3 (100%)
AVID100 120 mg/m^20/3 (0%)2/3 (66.7%)3/3 (100%)
AVID100 180 mg/m^20/3 (0%)1/3 (33.3%)3/3 (100%)
AVID100 220 mg/m^20/6 (0%)3/6 (50%)6/6 (100%)
AVID100 270 mg/m^21/7 (14.3%)2/7 (28.6%)7/7 (100%)
Phase 2a Expansion: AVID100 220 mg/m^23/25 (12%)13/25 (52%)25/25 (100%)
Most frequent serious events
Showing 10 of 30
Most frequent serious events
EventAVID100 20 mg/m^2AVID100 40 mg/m^2AVID100 80 mg/m^2AVID100 120 mg/m^2AVID100 180 mg/m^2AVID100 220 mg/m^2AVID100 270 mg/m^2Phase 2a Expansion: AVID100 220 mg/m^2
Hypertension CrisisVascular disorders0/10/10/31/30/30/60/70/25
Upper GI HemorrhageGastrointestinal disorders0/10/10/31/30/30/60/70/25
Infusion related reactionImmune system disorders0/10/11/30/30/30/60/71/25
DysphasiaGeneral disorders0/10/10/30/31/30/60/70/25
Urinary tract obstructionRenal and urinary disorders0/10/10/31/30/30/60/70/25
Abdominal PainGastrointestinal disorders0/10/10/30/30/31/60/70/25
Influenza AInfections and infestations0/10/10/30/30/31/60/70/25
Urinary tract ObstructionRenal and urinary disorders0/10/10/30/30/31/60/70/25
Super Ventricular TachycardiaCardiac disorders0/10/10/30/30/31/60/70/25
Progression of DiseaseGeneral disorders0/10/10/30/30/30/61/72/25
Most frequent other events
Showing 10 of 50
Most frequent other events
EventAVID100 20 mg/m^2AVID100 40 mg/m^2AVID100 80 mg/m^2AVID100 120 mg/m^2AVID100 180 mg/m^2AVID100 220 mg/m^2AVID100 270 mg/m^2Phase 2a Expansion: AVID100 220 mg/m^2
NauseaGastrointestinal disorders1/10/10/31/32/32/64/78/25
DiarrhoeaGastrointestinal disorders0/11/11/30/30/31/61/73/25
VomitingGastrointestinal disorders0/11/11/31/32/30/62/72/25
Dermatitis AcneformSkin and subcutaneous tissue disorders1/10/10/30/32/34/63/73/25
InsomniaPsychiatric disorders1/10/10/30/30/30/60/72/25
Nasal CongestionRespiratory, thoracic and mediastinal disorders0/10/10/31/32/30/61/70/25
Aspartate Aminotransferase IncreasedInvestigations0/10/10/30/32/31/61/75/25
Infusion Related ReactionInjury, poisoning and procedural complications0/10/12/32/31/30/60/71/25
FatigueGeneral disorders0/10/11/31/31/30/64/712/25
Rash MaculopapularSkin and subcutaneous tissue disorders0/10/11/30/31/30/63/70/25

Baseline characteristics

Participants treated with at least 1 dose

Age, Categorical
Age, Categorical(Participants)AVID100 20 mg/m^2AVID100 40 mg/m^2AVID100 80 mg/m^2 Cohort 3AVID100 120 mg/m^2AVID100 180 mg/m^2AVID100 220 mg/m^2AVID100 270 mg/m^2Phase 2a Expansion: AVID100 220 mg/m^2Total
<=18 years000000000
Between 18 and 65 years10233431632
>=65 years0110024917
Sex: Female, Male
Sex: Female, Male(Participants)AVID100 20 mg/m^2AVID100 40 mg/m^2AVID100 80 mg/m^2 Cohort 3AVID100 120 mg/m^2AVID100 180 mg/m^2AVID100 220 mg/m^2AVID100 270 mg/m^2Phase 2a Expansion: AVID100 220 mg/m^2Total
Female00122451024
Male11211221525
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)AVID100 20 mg/m^2AVID100 40 mg/m^2AVID100 80 mg/m^2 Cohort 3AVID100 120 mg/m^2AVID100 180 mg/m^2AVID100 220 mg/m^2AVID100 270 mg/m^2Phase 2a Expansion: AVID100 220 mg/m^2Total
Hispanic or Latino000000011
Not Hispanic or Latino11332652243
Unknown or Not Reported000010225
Race (NIH/OMB)
Race (NIH/OMB)(Participants)AVID100 20 mg/m^2AVID100 40 mg/m^2AVID100 80 mg/m^2 Cohort 3AVID100 120 mg/m^2AVID100 180 mg/m^2AVID100 220 mg/m^2AVID100 270 mg/m^2Phase 2a Expansion: AVID100 220 mg/m^2Total
American Indian or Alaska Native000000000
Asian000000011
Native Hawaiian or Other Pacific Islander000000000
Black or African American000100067
White11322671638
More than one race000000000
Unknown or Not Reported000010023
Region of Enrollment
Region of Enrollment(Participants)AVID100 20 mg/m^2AVID100 40 mg/m^2AVID100 80 mg/m^2 Cohort 3AVID100 120 mg/m^2AVID100 180 mg/m^2AVID100 220 mg/m^2AVID100 270 mg/m^2Phase 2a Expansion: AVID100 220 mg/m^2Total
United States11333672347
Canada000000022
08

Study locations

10 sites
  • Yale
    New Haven, Connecticut 06511, United States
  • START Midwest
    Grand Rapids, Michigan 49503, United States
  • The Tisch Cancer Institute-Mt. Sinai
    New York, New York 10029, United States
  • Fox Chase
    Philadelphia, Pennsylvania 19111, United States
  • Texas Oncology Midtown
    Austin, Texas 78705, United States
  • Texas Oncology-Baylor -Charles A. Sammons Cancer Center
    Dallas, Texas 75246, United States
  • University of Texas Southwestern Medical Center
    Dallas, Texas 75390, United States
  • Texas Oncology McAllen
    McAllen, Texas 78503, United States
  • Texas Oncology NE San Antonio
    San Antonio, Texas 78217, United States
  • Texas Oncology Tyler
    Tyler, Texas 75702, United States
09

References and documents

Study documents

  • Protocol and statistical analysis plan · May 30, 2020
  • Informed consent form · May 30, 2020

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 11, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03094169
Lead sponsor
Formation Biologics
Responsible party
Sponsor
First posted
Mar 29, 2017
Start date
Feb 1, 2017
Primary completion
Nov 28, 2020
Completion
Jan 30, 2021
Results posted
Jun 11, 2025
Last update
Jun 11, 2025

Study contacts

Nehal Lakhani, MD
principal investigator · START Midwest

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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