Head and Neck Squamous Cell Carcinoma, Non Small Cell Lung Cancer, Solid Tumor, Adult, Triple Negative Breast Cancer
Conditions
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
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.
Interventions
DRUGAVID100 IV
AVID100 is administered once every 3 weeks
Sponsors
Formation Biologics
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
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 cohorts
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Phase 1 Dose Escalation: Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs) in Cycle 1 | Cycle 1 during Dose Escalation (ie the first 3 weeks of dosing) | 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 |
| Phase 2a: Number of Participants With Best Overall Response by RECIST 1.1 | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PK Profile of Total Antibody | Cycle 1 Profile (ie the first 3 weeks of dosing) | Characterization of the pharmacokinetic profile of total antibody |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| AVID100 20 mg/m^2 Phase 1 Cohort 1: Participants were administered 20 mg/m\^2 of AVID100 every 3 weeks, via intravenous catheter (IV), for a minimum of 1 cycle, with 1 month of follow-up after the last dose was administered. | 1 |
| AVID100 40 mg/m^2 Phase 1 Cohort 2: Participants were administered 40 mg/m\^2 of AVID100 every 3 weeks, via intravenous catheter (IV), for a minimum of 1 cycle, with 1 month of follow-up after the last dose was administered. | 1 |
| AVID100 80 mg/m^2 Cohort 3 Phase 1 Cohort 3: Participants were administered 80 mg/m\^2 of AVID100 every 3 weeks, via intravenous catheter (IV), for a minimum of 1 cycle, with 1 month of follow-up after the last dose was administered. | 3 |
| AVID100 120 mg/m^2 Phase 1 Cohort 4: Participants were administered 120 mg/m\^2 of AVID100 every 3 weeks, via intravenous catheter (IV), for a minimum of 1 cycle, with 1 month of follow-up after the last dose was administered. | 3 |
| AVID100 180 mg/m^2 Phase 1 Cohort 5: Participants were administered 180 mg/m\^2 of AVID100 every 3 weeks, via intravenous catheter (IV), for a minimum of 1 cycle, with 1 month of follow-up after the last dose was administered. | 3 |
| AVID100 220 mg/m^2 Phase 1 Cohort 6: Participants were administered 220 mg/m\^2 of AVID100 every 3 weeks, via intravenous catheter (IV), for a minimum of 1 cycle, with 1 month of follow-up after the last dose was administered. | 6 |
| AVID100 270 mg/m^2 Phase 1 Cohort 7: Participants were administered 270 mg/m\^2 of AVID100 every 3 weeks, via intravenous catheter (IV), for a minimum of 1 cycle, with 1 month of follow-up after the last dose was administered. | 7 |
| Phase 2a Expansion: AVID100 220 mg/m^2 Participants from expanded populations of mTNBC, SCCHN, and Sq-NSCLC with documented EGFR expression received the maximum tolerated dose (MTD) determined in Phase 1, comprising AVID100 220 mg/m\^2 administered every 3 weeks IV, for at least 1 cycle. Extended treatment was permitted for participants tolerating and benefiting from treatment. | 25 |
| Total | 49 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 |
|---|---|---|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 |
| Overall Study | Lack of Efficacy | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 21 |
| Overall Study | Trial Termination | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
| Overall Study | Withdrawal by Subject | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 |
Baseline characteristics
| Characteristic | Total | AVID100 40 mg/m^2 | AVID100 80 mg/m^2 Cohort 3 | AVID100 120 mg/m^2 | AVID100 20 mg/m^2 | AVID100 180 mg/m^2 | AVID100 220 mg/m^2 | AVID100 270 mg/m^2 | Phase 2a Expansion: AVID100 220 mg/m^2 |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 17 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants | 4 Participants | 9 Participants |
| Age, Categorical Between 18 and 65 years | 32 Participants | 0 Participants | 2 Participants | 3 Participants | 1 Participants | 3 Participants | 4 Participants | 3 Participants | 16 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 43 Participants | 1 Participants | 3 Participants | 3 Participants | 1 Participants | 2 Participants | 6 Participants | 5 Participants | 22 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 5 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 7 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 6 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) White | 38 Participants | 1 Participants | 3 Participants | 2 Participants | 1 Participants | 2 Participants | 6 Participants | 7 Participants | 16 Participants |
| Region of Enrollment Canada | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants |
| Region of Enrollment United States | 47 Participants | 1 Participants | 3 Participants | 3 Participants | 1 Participants | 3 Participants | 6 Participants | 7 Participants | 23 Participants |
| Sex: Female, Male Female | 24 Participants | 0 Participants | 1 Participants | 2 Participants | 0 Participants | 2 Participants | 4 Participants | 5 Participants | 10 Participants |
| Sex: Female, Male Male | 25 Participants | 1 Participants | 2 Participants | 1 Participants | 1 Participants | 1 Participants | 2 Participants | 2 Participants | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk |
|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 1 | 0 / 1 | 0 / 3 | 0 / 3 | 0 / 3 | 0 / 6 | 1 / 7 | 3 / 25 |
| other Total, other adverse events | 1 / 1 | 1 / 1 | 3 / 3 | 3 / 3 | 3 / 3 | 6 / 6 | 7 / 7 | 25 / 25 |
| serious Total, serious adverse events | 0 / 1 | 0 / 1 | 1 / 3 | 2 / 3 | 1 / 3 | 3 / 6 | 2 / 7 | 13 / 25 |
Outcome results
Primary
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)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Dose Escalation Phase 1-Cohort 1 | Phase 1 Dose Escalation: Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs) in Cycle 1 | 0 Participants |
| Dose Escalation Phase 1-Cohort 2 | Phase 1 Dose Escalation: Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs) in Cycle 1 | 0 Participants |
| Dose Escalation Phase 1-Cohort 3 | Phase 1 Dose Escalation: Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs) in Cycle 1 | 0 Participants |
| Dose Escalation Phase 1-Cohort 4 | Phase 1 Dose Escalation: Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs) in Cycle 1 | 0 Participants |
| Dose Escalation Phase 1-Cohort 5 | Phase 1 Dose Escalation: Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs) in Cycle 1 | 0 Participants |
| Dose Escalation Phase 1-Cohort 6 | Phase 1 Dose Escalation: Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs) in Cycle 1 | 0 Participants |
| Dose Escalation Phase 1-Cohort 7 | Phase 1 Dose Escalation: Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs) in Cycle 1 | 2 Participants |
Primary
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
Population: Patients who completed Cycle 2 (6 weeks) of treatment, received at least 2 planned doses during that period, and had a follow-up assessment of disease status were considered evaluable for assessment of antineoplastic activity. Patients who were withdrawn from the study before completion of Cycle 2 because of progressive disease also were included in assessments of antineoplastic activity.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Dose Escalation Phase 1-Cohort 1 | Phase 2a: Number of Participants With Best Overall Response by RECIST 1.1 | Complete Response | 1 Participants |
| Dose Escalation Phase 1-Cohort 1 | Phase 2a: Number of Participants With Best Overall Response by RECIST 1.1 | Progressive Disease | 23 Participants |
| Dose Escalation Phase 1-Cohort 1 | Phase 2a: Number of Participants With Best Overall Response by RECIST 1.1 | Stable Disease | 0 Participants |
Secondary
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)
Population: Patients who have completed Cycle 1 for which PK analysis was performed
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dose Escalation Phase 1-Cohort 1 | PK Profile of Total Antibody | Cycle 1 D4 | 876.3 ng/mL | — |
| Dose Escalation Phase 1-Cohort 1 | PK Profile of Total Antibody | Cycle D1 EOI | 9213.3 ng/mL | — |
| Dose Escalation Phase 1-Cohort 1 | PK Profile of Total Antibody | Cycle 1 D1 4h post SOI | 8351.9 ng/mL | — |
| Dose Escalation Phase 1-Cohort 1 | PK Profile of Total Antibody | Cycle 1 D1 2h post SOI | 8066.3 ng/mL | — |
| Dose Escalation Phase 1-Cohort 1 | PK Profile of Total Antibody | Cycle 1 D1 prior SOI | NA ng/mL | — |
| Dose Escalation Phase 1-Cohort 1 | PK Profile of Total Antibody | Cycle 1 D2 | 3217.6 ng/mL | — |
| Dose Escalation Phase 1-Cohort 1 | PK Profile of Total Antibody | Cycle 1 D8 | NA ng/mL | — |
| Dose Escalation Phase 1-Cohort 1 | PK Profile of Total Antibody | Cycle 2 D1 prior to SOI | NA ng/mL | — |
| Dose Escalation Phase 1-Cohort 2 | PK Profile of Total Antibody | Cycle 1 D1 prior SOI | NA ng/mL | — |
| Dose Escalation Phase 1-Cohort 2 | PK Profile of Total Antibody | Cycle 1 D1 4h post SOI | 14555.1 ng/mL | — |
| Dose Escalation Phase 1-Cohort 2 | PK Profile of Total Antibody | Cycle 2 D1 prior to SOI | NA ng/mL | — |
| Dose Escalation Phase 1-Cohort 2 | PK Profile of Total Antibody | Cycle 1 D4 | 4578.3 ng/mL | — |
| Dose Escalation Phase 1-Cohort 2 | PK Profile of Total Antibody | Cycle D1 EOI | 13686.7 ng/mL | — |
| Dose Escalation Phase 1-Cohort 2 | PK Profile of Total Antibody | Cycle 1 D2 | 9390.7 ng/mL | — |
| Dose Escalation Phase 1-Cohort 2 | PK Profile of Total Antibody | Cycle 1 D1 2h post SOI | 14003.5 ng/mL | — |
| Dose Escalation Phase 1-Cohort 2 | PK Profile of Total Antibody | Cycle 1 D8 | NA ng/mL | — |
| Dose Escalation Phase 1-Cohort 3 | PK Profile of Total Antibody | Cycle 1 D4 | 14638.5 ng/mL | Standard Deviation 1776.9 |
| Dose Escalation Phase 1-Cohort 3 | PK Profile of Total Antibody | Cycle D1 EOI | 41140.7 ng/mL | Standard Deviation 7472 |
| Dose Escalation Phase 1-Cohort 3 | PK Profile of Total Antibody | Cycle 1 D1 4h post SOI | 34399.7 ng/mL | Standard Deviation 5940.6 |
| Dose Escalation Phase 1-Cohort 3 | PK Profile of Total Antibody | Cycle 1 D1 2h post SOI | 36935.8 ng/mL | Standard Deviation 7089.3 |
| Dose Escalation Phase 1-Cohort 3 | PK Profile of Total Antibody | Cycle 1 D2 | 25236.4 ng/mL | Standard Deviation 2159.3 |
| Dose Escalation Phase 1-Cohort 3 | PK Profile of Total Antibody | Cycle 1 D1 prior SOI | NA ng/mL | — |
| Dose Escalation Phase 1-Cohort 3 | PK Profile of Total Antibody | Cycle 2 D1 prior to SOI | NA ng/mL | — |
| Dose Escalation Phase 1-Cohort 3 | PK Profile of Total Antibody | Cycle 1 D8 | 2450.7 ng/mL | Standard Deviation 1422.7 |
| Dose Escalation Phase 1-Cohort 4 | PK Profile of Total Antibody | Cycle 1 D1 2h post SOI | 66587.4 ng/mL | Standard Deviation 6199.4 |
| Dose Escalation Phase 1-Cohort 4 | PK Profile of Total Antibody | Cycle 1 D4 | 24985.3 ng/mL | Standard Deviation 6859.7 |
| Dose Escalation Phase 1-Cohort 4 | PK Profile of Total Antibody | Cycle 1 D8 | 8768.0 ng/mL | Standard Deviation 5393.1 |
| Dose Escalation Phase 1-Cohort 4 | PK Profile of Total Antibody | Cycle D1 EOI | 71440.9 ng/mL | Standard Deviation 9107.3 |
| Dose Escalation Phase 1-Cohort 4 | PK Profile of Total Antibody | Cycle 1 D1 prior SOI | NA ng/mL | — |
| Dose Escalation Phase 1-Cohort 4 | PK Profile of Total Antibody | Cycle 2 D1 prior to SOI | NA ng/mL | — |
| Dose Escalation Phase 1-Cohort 4 | PK Profile of Total Antibody | Cycle 1 D1 4h post SOI | 61468.6 ng/mL | Standard Deviation 4879.1 |
| Dose Escalation Phase 1-Cohort 4 | PK Profile of Total Antibody | Cycle 1 D2 | 43504.6 ng/mL | Standard Deviation 5940.3 |
| Dose Escalation Phase 1-Cohort 5 | PK Profile of Total Antibody | Cycle 1 D1 4h post SOI | 79581.1 ng/mL | Standard Deviation 9542.3 |
| Dose Escalation Phase 1-Cohort 5 | PK Profile of Total Antibody | Cycle 1 D1 2h post SOI | 89676.6 ng/mL | Standard Deviation 6216.5 |
| Dose Escalation Phase 1-Cohort 5 | PK Profile of Total Antibody | Cycle D1 EOI | 85982.9 ng/mL | Standard Deviation 8517.2 |
| Dose Escalation Phase 1-Cohort 5 | PK Profile of Total Antibody | Cycle 1 D1 prior SOI | NA ng/mL | — |
| Dose Escalation Phase 1-Cohort 5 | PK Profile of Total Antibody | Cycle 1 D4 | 35500.0 ng/mL | Standard Deviation 5004.5 |
| Dose Escalation Phase 1-Cohort 5 | PK Profile of Total Antibody | Cycle 1 D2 | 63001.5 ng/mL | Standard Deviation 5837.3 |
| Dose Escalation Phase 1-Cohort 5 | PK Profile of Total Antibody | Cycle 1 D8 | 12590.0 ng/mL | Standard Deviation 1531.9 |
| Dose Escalation Phase 1-Cohort 5 | PK Profile of Total Antibody | Cycle 2 D1 prior to SOI | NA ng/mL | — |
| Dose Escalation Phase 1-Cohort 6 | PK Profile of Total Antibody | Cycle 1 D1 prior SOI | NA ng/mL | — |
| Dose Escalation Phase 1-Cohort 6 | PK Profile of Total Antibody | Cycle 2 D1 prior to SOI | NA ng/mL | — |
| Dose Escalation Phase 1-Cohort 6 | PK Profile of Total Antibody | Cycle D1 EOI | 113401.6 ng/mL | Standard Deviation 18740.3 |
| Dose Escalation Phase 1-Cohort 6 | PK Profile of Total Antibody | Cycle 1 D1 2h post SOI | 112663.3 ng/mL | Standard Deviation 21616.7 |
| Dose Escalation Phase 1-Cohort 6 | PK Profile of Total Antibody | Cycle 1 D1 4h post SOI | 101809.1 ng/mL | Standard Deviation 17330.1 |
| Dose Escalation Phase 1-Cohort 6 | PK Profile of Total Antibody | Cycle 1 D2 | 68284.5 ng/mL | Standard Deviation 6605.4 |
| Dose Escalation Phase 1-Cohort 6 | PK Profile of Total Antibody | Cycle 1 D4 | 38068.0 ng/mL | Standard Deviation 7890.3 |
| Dose Escalation Phase 1-Cohort 6 | PK Profile of Total Antibody | Cycle 1 D8 | 18581.5 ng/mL | Standard Deviation 3128.7 |
| Dose Escalation Phase 1-Cohort 7 | PK Profile of Total Antibody | Cycle 1 D2 | 99382.8 ng/mL | Standard Deviation 13832.9 |
| Dose Escalation Phase 1-Cohort 7 | PK Profile of Total Antibody | Cycle 1 D1 4h post SOI | 132671.4 ng/mL | Standard Deviation 13243.3 |
| Dose Escalation Phase 1-Cohort 7 | PK Profile of Total Antibody | Cycle 1 D1 2h post SOI | 131267.2 ng/mL | Standard Deviation 10585.7 |
| Dose Escalation Phase 1-Cohort 7 | PK Profile of Total Antibody | Cycle D1 EOI | 136306.3 ng/mL | Standard Deviation 16938.5 |
| Dose Escalation Phase 1-Cohort 7 | PK Profile of Total Antibody | Cycle 1 D1 prior SOI | NA ng/mL | — |
| Dose Escalation Phase 1-Cohort 7 | PK Profile of Total Antibody | Cycle 2 D1 prior to SOI | 866.5 ng/mL | Standard Deviation 855.8 |
| Dose Escalation Phase 1-Cohort 7 | PK Profile of Total Antibody | Cycle 1 D8 | 27982.5 ng/mL | Standard Deviation 13531.7 |
| Dose Escalation Phase 1-Cohort 7 | PK Profile of Total Antibody | Cycle 1 D4 | 69578.4 ng/mL | Standard Deviation 10616 |
| Phase 2a Expansion: AVID100 220 mg/m^2 | PK Profile of Total Antibody | Cycle 1 D2 | NA ng/mL | — |
| Phase 2a Expansion: AVID100 220 mg/m^2 | PK Profile of Total Antibody | Cycle 1 D1 prior SOI | NA ng/mL | — |
| Phase 2a Expansion: AVID100 220 mg/m^2 | PK Profile of Total Antibody | Cycle D1 EOI | 122464.3 ng/mL | Standard Deviation 20790.1 |
| Phase 2a Expansion: AVID100 220 mg/m^2 | PK Profile of Total Antibody | Cycle 1 D1 2h post SOI | NA ng/mL | — |
| Phase 2a Expansion: AVID100 220 mg/m^2 | PK Profile of Total Antibody | Cycle 1 D1 4h post SOI | NA ng/mL | — |
| Phase 2a Expansion: AVID100 220 mg/m^2 | PK Profile of Total Antibody | Cycle 1 D8 | NA ng/mL | — |
| Phase 2a Expansion: AVID100 220 mg/m^2 | PK Profile of Total Antibody | Cycle 1 D4 | NA ng/mL | — |
| Phase 2a Expansion: AVID100 220 mg/m^2 | PK Profile of Total Antibody | Cycle 2 D1 prior to SOI | 131.1 ng/mL | Standard Deviation 40.6 |