Trial Outcomes & Findings for Lung-MAP S1400K: c-MET Positive (NCT NCT03574753)
NCT ID: NCT03574753
Last Updated: 2021-10-18
Results Overview
The percentage of participants with confirmed and unconfirmed, partial response and complete response to treatment with ABBV-399 per Response Evaluation Criteria in Solid Tumors Criteria (RECIST 1.1).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
28 participants
Primary outcome timeframe
11 months
Results posted on
2021-10-18
Participant Flow
28 participants were enrolled, but 5 were ineligible. Thus 23 participants were eligible.
Participant milestones
| Measure |
ABBV-399
C-MET overexpression is seen in 30% of participants with lung squamous cell carcinoma (SCCA). ABBV-399 (Process II) is a first-in-class antibody-drug conjugate (ADC) comprised of ABT-700, an anti-c-Met monoclonal antibody linked to monomethyl auristatin E (MMAE), which is a potent microtubule inhibitor. This delivers a direct anti-mitotic effect without relying on MET pathway inhibition.
ABBV-399 will be administered intravenously on day 1 of each 21-day cycle. Treatment will continue in consenting patients until disease progression or intolerable toxicity.
ABBV-399: ABBV-399 (Process II), 2.7 mg/kg IV over 30 ± 10 minutes, Day 1, Every 21 days
|
|---|---|
|
Overall Study
STARTED
|
23
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
23
|
Reasons for withdrawal
| Measure |
ABBV-399
C-MET overexpression is seen in 30% of participants with lung squamous cell carcinoma (SCCA). ABBV-399 (Process II) is a first-in-class antibody-drug conjugate (ADC) comprised of ABT-700, an anti-c-Met monoclonal antibody linked to monomethyl auristatin E (MMAE), which is a potent microtubule inhibitor. This delivers a direct anti-mitotic effect without relying on MET pathway inhibition.
ABBV-399 will be administered intravenously on day 1 of each 21-day cycle. Treatment will continue in consenting patients until disease progression or intolerable toxicity.
ABBV-399: ABBV-399 (Process II), 2.7 mg/kg IV over 30 ± 10 minutes, Day 1, Every 21 days
|
|---|---|
|
Overall Study
Adverse Event
|
3
|
|
Overall Study
Progression/relapse
|
19
|
|
Overall Study
Death
|
1
|
Baseline Characteristics
Lung-MAP S1400K: c-MET Positive
Baseline characteristics by cohort
| Measure |
ABBV-399
n=23 Participants
C-MET overexpression is seen in 30% of participants with lung squamous cell carcinoma (SCCA). ABBV-399 (Process II) is a first-in-class antibody-drug conjugate (ADC) comprised of ABT-700, an anti-c-Met monoclonal antibody linked to monomethyl auristatin E (MMAE), which is a potent microtubule inhibitor. This delivers a direct anti-mitotic effect without relying on MET pathway inhibition.
ABBV-399 will be administered intravenously on day 1 of each 21-day cycle. Treatment will continue in consenting patients until disease progression or intolerable toxicity.
ABBV-399: ABBV-399 (Process II), 2.7 mg/kg IV over 30 ± 10 minutes, Day 1, Every 21 days
|
|---|---|
|
Age, Continuous
|
65.3 years
n=93 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=93 Participants
|
|
Race/Ethnicity, Customized
White
|
21 Participants
n=93 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 Participants
n=93 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
0 Participants
n=93 Participants
|
|
Number of lines of prior therapy for stage IV SCC
0
|
7 Participants
n=93 Participants
|
|
Number of lines of prior therapy for stage IV SCC
1
|
7 Participants
n=93 Participants
|
|
Number of lines of prior therapy for stage IV SCC
2
|
5 Participants
n=93 Participants
|
|
Number of lines of prior therapy for stage IV SCC
3
|
3 Participants
n=93 Participants
|
|
Number of lines of prior therapy for stage IV SCC
4
|
1 Participants
n=93 Participants
|
|
ECOG performance status
0
|
5 Participants
n=93 Participants
|
|
ECOG performance status
1
|
18 Participants
n=93 Participants
|
|
Weight loss in the last 6 months
<5%
|
17 Participants
n=93 Participants
|
|
Weight loss in the last 6 months
5%-<10%
|
3 Participants
n=93 Participants
|
|
Weight loss in the last 6 months
10%-<20%
|
3 Participants
n=93 Participants
|
|
Smoking status
Current
|
7 Participants
n=93 Participants
|
|
Smoking status
Former
|
15 Participants
n=93 Participants
|
|
Smoking status
Never
|
1 Participants
n=93 Participants
|
|
Prior anti-programmed death-ligand (PD-L1) therapy
Yes
|
12 Participants
n=93 Participants
|
|
Prior anti-programmed death-ligand (PD-L1) therapy
No
|
11 Participants
n=93 Participants
|
|
Brain metastases at baseline
Yes
|
2 Participants
n=93 Participants
|
|
Brain metastases at baseline
No
|
21 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: 11 monthsPopulation: All eligible participants
The percentage of participants with confirmed and unconfirmed, partial response and complete response to treatment with ABBV-399 per Response Evaluation Criteria in Solid Tumors Criteria (RECIST 1.1).
Outcome measures
| Measure |
ABBV-399
n=23 Participants
C-MET overexpression is seen in 30% of participants with lung squamous cell carcinoma (SCCA). ABBV-399 (Process II) is a first-in-class antibody-drug conjugate (ADC) comprised of ABT-700, an anti-c-Met monoclonal antibody linked to monomethyl auristatin E (MMAE), which is a potent microtubule inhibitor. This delivers a direct anti-mitotic effect without relying on MET pathway inhibition.
ABBV-399 will be administered intravenously on day 1 of each 21-day cycle. Treatment will continue in consenting patients until disease progression or intolerable toxicity.
ABBV-399: ABBV-399 (Process II), 2.7 mg/kg IV over 30 ± 10 minutes, Day 1, Every 21 days
|
|---|---|
|
Overall Response Rate in Participants With c-Met Positive Lung Squamous Cell Carcinoma (SCCA)
|
9 percentage of participants
Interval 0.0 to 20.0
|
SECONDARY outcome
Timeframe: up to 3 years post sub-study registrationPopulation: Eligible participants who had been on immunotherapy and relapsed
Duration from date of sub-study registration to date of first documentation of progression, per RECIST 1.1, assessed by local review or symptomatic deterioration or death due to any cause.
Outcome measures
| Measure |
ABBV-399
n=12 Participants
C-MET overexpression is seen in 30% of participants with lung squamous cell carcinoma (SCCA). ABBV-399 (Process II) is a first-in-class antibody-drug conjugate (ADC) comprised of ABT-700, an anti-c-Met monoclonal antibody linked to monomethyl auristatin E (MMAE), which is a potent microtubule inhibitor. This delivers a direct anti-mitotic effect without relying on MET pathway inhibition.
ABBV-399 will be administered intravenously on day 1 of each 21-day cycle. Treatment will continue in consenting patients until disease progression or intolerable toxicity.
ABBV-399: ABBV-399 (Process II), 2.7 mg/kg IV over 30 ± 10 minutes, Day 1, Every 21 days
|
|---|---|
|
Investigator-assessed Progression-free Survival) in Immunotherapy-exposed and Relapsed Participants With c-Met Positive Lung Squamous Cell Carcinoma (SCCA).
|
1.6 months
Interval 1.4 to 3.0
|
SECONDARY outcome
Timeframe: up to 3 years post sub-study registrationPopulation: Eligible participants who had been on immunotherapy and relapsed
Duration from date of sub-study registration (or date of screening/pre-screening registration if patient never enrolls in a sub-study) to date of death due to any cause
Outcome measures
| Measure |
ABBV-399
n=12 Participants
C-MET overexpression is seen in 30% of participants with lung squamous cell carcinoma (SCCA). ABBV-399 (Process II) is a first-in-class antibody-drug conjugate (ADC) comprised of ABT-700, an anti-c-Met monoclonal antibody linked to monomethyl auristatin E (MMAE), which is a potent microtubule inhibitor. This delivers a direct anti-mitotic effect without relying on MET pathway inhibition.
ABBV-399 will be administered intravenously on day 1 of each 21-day cycle. Treatment will continue in consenting patients until disease progression or intolerable toxicity.
ABBV-399: ABBV-399 (Process II), 2.7 mg/kg IV over 30 ± 10 minutes, Day 1, Every 21 days
|
|---|---|
|
Overall Survival (OS) in Immunotherapy-exposed and Relapsed Participants With c-Met Positive Lung Squamous Cell Carcinoma (SCCA).
|
4.8 months
Interval 3.9 to 9.8
|
SECONDARY outcome
Timeframe: Up to 3 yearsPopulation: Eligible participants who had been on immunotherapy and relapsed
The percentage of participants with confirmed and unconfirmed, partial response and complete response to treatment with ABBV-399 per Response Evaluation Criteria in Solid Tumors Criteria (RECIST 1.1).
Outcome measures
| Measure |
ABBV-399
n=12 Participants
C-MET overexpression is seen in 30% of participants with lung squamous cell carcinoma (SCCA). ABBV-399 (Process II) is a first-in-class antibody-drug conjugate (ADC) comprised of ABT-700, an anti-c-Met monoclonal antibody linked to monomethyl auristatin E (MMAE), which is a potent microtubule inhibitor. This delivers a direct anti-mitotic effect without relying on MET pathway inhibition.
ABBV-399 will be administered intravenously on day 1 of each 21-day cycle. Treatment will continue in consenting patients until disease progression or intolerable toxicity.
ABBV-399: ABBV-399 (Process II), 2.7 mg/kg IV over 30 ± 10 minutes, Day 1, Every 21 days
|
|---|---|
|
Overall Response Rate (ORR) in Immunotherapy-exposed and Relapsed Participants With c-Met Positive Lung Squamous Cell Carcinoma (SCCA).
|
0 percentage of participants
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: Up to 3 years post sub-study registrationPopulation: Eligible participants
Duration from date of sub-study registration to date of first documentation of progression, per RECIST 1.1, assessed by local review or symptomatic deterioration or death due to any cause
Outcome measures
| Measure |
ABBV-399
n=23 Participants
C-MET overexpression is seen in 30% of participants with lung squamous cell carcinoma (SCCA). ABBV-399 (Process II) is a first-in-class antibody-drug conjugate (ADC) comprised of ABT-700, an anti-c-Met monoclonal antibody linked to monomethyl auristatin E (MMAE), which is a potent microtubule inhibitor. This delivers a direct anti-mitotic effect without relying on MET pathway inhibition.
ABBV-399 will be administered intravenously on day 1 of each 21-day cycle. Treatment will continue in consenting patients until disease progression or intolerable toxicity.
ABBV-399: ABBV-399 (Process II), 2.7 mg/kg IV over 30 ± 10 minutes, Day 1, Every 21 days
|
|---|---|
|
Investigator-assessed Progression-free Survival (IA-PFS) in Participants With c-Met Positive Lung Squamous Cell Carcinoma (SCCA)
|
2.4 months
Interval 1.4 to 3.0
|
SECONDARY outcome
Timeframe: Up to 3 years post sub-study registrationPopulation: Eligible participants
Duration from date of sub-study registration (or date of screening/pre-screening registration if patient never enrolls in a sub-study) to date of death due to any cause.
Outcome measures
| Measure |
ABBV-399
n=23 Participants
C-MET overexpression is seen in 30% of participants with lung squamous cell carcinoma (SCCA). ABBV-399 (Process II) is a first-in-class antibody-drug conjugate (ADC) comprised of ABT-700, an anti-c-Met monoclonal antibody linked to monomethyl auristatin E (MMAE), which is a potent microtubule inhibitor. This delivers a direct anti-mitotic effect without relying on MET pathway inhibition.
ABBV-399 will be administered intravenously on day 1 of each 21-day cycle. Treatment will continue in consenting patients until disease progression or intolerable toxicity.
ABBV-399: ABBV-399 (Process II), 2.7 mg/kg IV over 30 ± 10 minutes, Day 1, Every 21 days
|
|---|---|
|
Overall Survival (OS) in Participants With c-Met Positive Lung Squamous Cell Carcinoma (SCCA)
|
5.6 months
Interval 3.9 to 9.5
|
SECONDARY outcome
Timeframe: Up to 3 years post sub-study registrationPopulation: Eligible participants who achieved complete or partial response.
Duration from date of first documentation of response (complete or partial) to date of first documentation of progression assessed by local review or symptomatic deterioration, or death due to any cause among participants who achieve a complete or partial response.
Outcome measures
| Measure |
ABBV-399
n=2 Participants
C-MET overexpression is seen in 30% of participants with lung squamous cell carcinoma (SCCA). ABBV-399 (Process II) is a first-in-class antibody-drug conjugate (ADC) comprised of ABT-700, an anti-c-Met monoclonal antibody linked to monomethyl auristatin E (MMAE), which is a potent microtubule inhibitor. This delivers a direct anti-mitotic effect without relying on MET pathway inhibition.
ABBV-399 will be administered intravenously on day 1 of each 21-day cycle. Treatment will continue in consenting patients until disease progression or intolerable toxicity.
ABBV-399: ABBV-399 (Process II), 2.7 mg/kg IV over 30 ± 10 minutes, Day 1, Every 21 days
|
|---|---|
|
Duration of Response (DoR)
|
8.9 months
Interval 2.3 to 15.5
|
SECONDARY outcome
Timeframe: Duration of treatment and follow up until death or 3 years post sub-registrationPopulation: Participants who received at least one dose of protocol treatment.
Adverse Events (AEs) are reported by CTCAE Version 5.0 for serious adverse events only and CTCAE Version 4.0 for routine toxicity reporting. Only adverse events that are possibly, probably or definitely related to study drug are reported.
Outcome measures
| Measure |
ABBV-399
n=23 Participants
C-MET overexpression is seen in 30% of participants with lung squamous cell carcinoma (SCCA). ABBV-399 (Process II) is a first-in-class antibody-drug conjugate (ADC) comprised of ABT-700, an anti-c-Met monoclonal antibody linked to monomethyl auristatin E (MMAE), which is a potent microtubule inhibitor. This delivers a direct anti-mitotic effect without relying on MET pathway inhibition.
ABBV-399 will be administered intravenously on day 1 of each 21-day cycle. Treatment will continue in consenting patients until disease progression or intolerable toxicity.
ABBV-399: ABBV-399 (Process II), 2.7 mg/kg IV over 30 ± 10 minutes, Day 1, Every 21 days
|
|---|---|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Anemia
|
1 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Anorexia
|
1 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Aspartate aminotransferase increased
|
1 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Blood bilirubin increased
|
1 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Bronchopulmonary hemorrhage
|
1 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Cardiac arrest
|
1 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Dehydration
|
1 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Fatigue
|
2 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Febrile neutropenia
|
1 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Hypocalcemia
|
1 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Hypokalemia
|
1 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Hyponatremia
|
1 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Hypophosphatemia
|
2 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Lymphocyte count decreased
|
1 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Nausea
|
1 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Neutrophil count decreased
|
1 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Peripheral sensory neuropathy
|
1 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Pneumonitis
|
2 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Respiratory failure
|
1 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Urinary tract infection
|
1 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Vomiting
|
1 Participants
|
Adverse Events
ABBV-399
Serious events: 10 serious events
Other events: 22 other events
Deaths: 17 deaths
Serious adverse events
| Measure |
ABBV-399
n=23 participants at risk
C-MET overexpression is seen in 30% of participants with lung squamous cell carcinoma (SCCA). ABBV-399 (Process II) is a first-in-class antibody-drug conjugate (ADC) comprised of ABT-700, an anti-c-Met monoclonal antibody linked to monomethyl auristatin E (MMAE), which is a potent microtubule inhibitor. This delivers a direct anti-mitotic effect without relying on MET pathway inhibition.
ABBV-399 will be administered intravenously on day 1 of each 21-day cycle. Treatment will continue in consenting patients until disease progression or intolerable toxicity.
ABBV-399: ABBV-399 (Process II), 2.7 mg/kg IV over 30 ± 10 minutes, Day 1, Every 21 days
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
4.3%
1/23 • Duration of treatment and follow up until death or 3 years post sub-study registration
23 eligible participants that received protocol therapy were assessed for AEs.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
4.3%
1/23 • Duration of treatment and follow up until death or 3 years post sub-study registration
23 eligible participants that received protocol therapy were assessed for AEs.
|
|
Cardiac disorders
Atrial fibrillation
|
4.3%
1/23 • Duration of treatment and follow up until death or 3 years post sub-study registration
23 eligible participants that received protocol therapy were assessed for AEs.
|
|
Cardiac disorders
Cardiac arrest
|
4.3%
1/23 • Duration of treatment and follow up until death or 3 years post sub-study registration
23 eligible participants that received protocol therapy were assessed for AEs.
|
|
Cardiac disorders
Myocardial infarction
|
4.3%
1/23 • Duration of treatment and follow up until death or 3 years post sub-study registration
23 eligible participants that received protocol therapy were assessed for AEs.
|
|
Cardiac disorders
Paroxysmal atrial tachycardia
|
4.3%
1/23 • Duration of treatment and follow up until death or 3 years post sub-study registration
23 eligible participants that received protocol therapy were assessed for AEs.
|
|
Cardiac disorders
Pericardial effusion
|
4.3%
1/23 • Duration of treatment and follow up until death or 3 years post sub-study registration
23 eligible participants that received protocol therapy were assessed for AEs.
|
|
Gastrointestinal disorders
Abdominal pain
|
8.7%
2/23 • Duration of treatment and follow up until death or 3 years post sub-study registration
23 eligible participants that received protocol therapy were assessed for AEs.
|
|
Gastrointestinal disorders
Constipation
|
4.3%
1/23 • Duration of treatment and follow up until death or 3 years post sub-study registration
23 eligible participants that received protocol therapy were assessed for AEs.
|
|
Gastrointestinal disorders
Nausea
|
4.3%
1/23 • Duration of treatment and follow up until death or 3 years post sub-study registration
23 eligible participants that received protocol therapy were assessed for AEs.
|
|
Gastrointestinal disorders
Stomach pain
|
4.3%
1/23 • Duration of treatment and follow up until death or 3 years post sub-study registration
23 eligible participants that received protocol therapy were assessed for AEs.
|
|
Gastrointestinal disorders
Upper gastrointestinal hemorrhage
|
4.3%
1/23 • Duration of treatment and follow up until death or 3 years post sub-study registration
23 eligible participants that received protocol therapy were assessed for AEs.
|
|
Gastrointestinal disorders
Vomiting
|
4.3%
1/23 • Duration of treatment and follow up until death or 3 years post sub-study registration
23 eligible participants that received protocol therapy were assessed for AEs.
|
|
General disorders
Fatigue
|
4.3%
1/23 • Duration of treatment and follow up until death or 3 years post sub-study registration
23 eligible participants that received protocol therapy were assessed for AEs.
|
|
General disorders
Non-cardiac chest pain
|
4.3%
1/23 • Duration of treatment and follow up until death or 3 years post sub-study registration
23 eligible participants that received protocol therapy were assessed for AEs.
|
|
General disorders
Pain
|
4.3%
1/23 • Duration of treatment and follow up until death or 3 years post sub-study registration
23 eligible participants that received protocol therapy were assessed for AEs.
|
|
Infections and infestations
Lung infection
|
8.7%
2/23 • Duration of treatment and follow up until death or 3 years post sub-study registration
23 eligible participants that received protocol therapy were assessed for AEs.
|
|
Infections and infestations
Urinary tract infection
|
4.3%
1/23 • Duration of treatment and follow up until death or 3 years post sub-study registration
23 eligible participants that received protocol therapy were assessed for AEs.
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
4.3%
1/23 • Duration of treatment and follow up until death or 3 years post sub-study registration
23 eligible participants that received protocol therapy were assessed for AEs.
|
|
Investigations
Aspartate aminotransferase increased
|
4.3%
1/23 • Duration of treatment and follow up until death or 3 years post sub-study registration
23 eligible participants that received protocol therapy were assessed for AEs.
|
|
Investigations
Blood bilirubin increased
|
4.3%
1/23 • Duration of treatment and follow up until death or 3 years post sub-study registration
23 eligible participants that received protocol therapy were assessed for AEs.
|
|
Investigations
Lymphocyte count decreased
|
4.3%
1/23 • Duration of treatment and follow up until death or 3 years post sub-study registration
23 eligible participants that received protocol therapy were assessed for AEs.
|
|
Investigations
Neutrophil count decreased
|
4.3%
1/23 • Duration of treatment and follow up until death or 3 years post sub-study registration
23 eligible participants that received protocol therapy were assessed for AEs.
|
|
Metabolism and nutrition disorders
Dehydration
|
4.3%
1/23 • Duration of treatment and follow up until death or 3 years post sub-study registration
23 eligible participants that received protocol therapy were assessed for AEs.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
8.7%
2/23 • Duration of treatment and follow up until death or 3 years post sub-study registration
23 eligible participants that received protocol therapy were assessed for AEs.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
4.3%
1/23 • Duration of treatment and follow up until death or 3 years post sub-study registration
23 eligible participants that received protocol therapy were assessed for AEs.
|
|
Nervous system disorders
Nervous system disorders-Other
|
4.3%
1/23 • Duration of treatment and follow up until death or 3 years post sub-study registration
23 eligible participants that received protocol therapy were assessed for AEs.
|
|
Nervous system disorders
Syncope
|
4.3%
1/23 • Duration of treatment and follow up until death or 3 years post sub-study registration
23 eligible participants that received protocol therapy were assessed for AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial obstruction
|
4.3%
1/23 • Duration of treatment and follow up until death or 3 years post sub-study registration
23 eligible participants that received protocol therapy were assessed for AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopulmonary hemorrhage
|
4.3%
1/23 • Duration of treatment and follow up until death or 3 years post sub-study registration
23 eligible participants that received protocol therapy were assessed for AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
8.7%
2/23 • Duration of treatment and follow up until death or 3 years post sub-study registration
23 eligible participants that received protocol therapy were assessed for AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
8.7%
2/23 • Duration of treatment and follow up until death or 3 years post sub-study registration
23 eligible participants that received protocol therapy were assessed for AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
4.3%
1/23 • Duration of treatment and follow up until death or 3 years post sub-study registration
23 eligible participants that received protocol therapy were assessed for AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
8.7%
2/23 • Duration of treatment and follow up until death or 3 years post sub-study registration
23 eligible participants that received protocol therapy were assessed for AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
4.3%
1/23 • Duration of treatment and follow up until death or 3 years post sub-study registration
23 eligible participants that received protocol therapy were assessed for AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Resp, thoracic and mediastinal disorders - Other
|
4.3%
1/23 • Duration of treatment and follow up until death or 3 years post sub-study registration
23 eligible participants that received protocol therapy were assessed for AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
4.3%
1/23 • Duration of treatment and follow up until death or 3 years post sub-study registration
23 eligible participants that received protocol therapy were assessed for AEs.
|
|
Vascular disorders
Hypertension
|
4.3%
1/23 • Duration of treatment and follow up until death or 3 years post sub-study registration
23 eligible participants that received protocol therapy were assessed for AEs.
|
|
Vascular disorders
Thromboembolic event
|
4.3%
1/23 • Duration of treatment and follow up until death or 3 years post sub-study registration
23 eligible participants that received protocol therapy were assessed for AEs.
|
Other adverse events
| Measure |
ABBV-399
n=23 participants at risk
C-MET overexpression is seen in 30% of participants with lung squamous cell carcinoma (SCCA). ABBV-399 (Process II) is a first-in-class antibody-drug conjugate (ADC) comprised of ABT-700, an anti-c-Met monoclonal antibody linked to monomethyl auristatin E (MMAE), which is a potent microtubule inhibitor. This delivers a direct anti-mitotic effect without relying on MET pathway inhibition.
ABBV-399 will be administered intravenously on day 1 of each 21-day cycle. Treatment will continue in consenting patients until disease progression or intolerable toxicity.
ABBV-399: ABBV-399 (Process II), 2.7 mg/kg IV over 30 ± 10 minutes, Day 1, Every 21 days
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
4.3%
1/23 • Duration of treatment and follow up until death or 3 years post sub-study registration
23 eligible participants that received protocol therapy were assessed for AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
4.3%
1/23 • Duration of treatment and follow up until death or 3 years post sub-study registration
23 eligible participants that received protocol therapy were assessed for AEs.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
4.3%
1/23 • Duration of treatment and follow up until death or 3 years post sub-study registration
23 eligible participants that received protocol therapy were assessed for AEs.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other
|
4.3%
1/23 • Duration of treatment and follow up until death or 3 years post sub-study registration
23 eligible participants that received protocol therapy were assessed for AEs.
|
|
Vascular disorders
Hypertension
|
17.4%
4/23 • Duration of treatment and follow up until death or 3 years post sub-study registration
23 eligible participants that received protocol therapy were assessed for AEs.
|
|
Vascular disorders
Hypotension
|
8.7%
2/23 • Duration of treatment and follow up until death or 3 years post sub-study registration
23 eligible participants that received protocol therapy were assessed for AEs.
|
|
Blood and lymphatic system disorders
Anemia
|
52.2%
12/23 • Duration of treatment and follow up until death or 3 years post sub-study registration
23 eligible participants that received protocol therapy were assessed for AEs.
|
|
Cardiac disorders
Palpitations
|
4.3%
1/23 • Duration of treatment and follow up until death or 3 years post sub-study registration
23 eligible participants that received protocol therapy were assessed for AEs.
|
|
Cardiac disorders
Sinus bradycardia
|
4.3%
1/23 • Duration of treatment and follow up until death or 3 years post sub-study registration
23 eligible participants that received protocol therapy were assessed for AEs.
|
|
Cardiac disorders
Sinus tachycardia
|
8.7%
2/23 • Duration of treatment and follow up until death or 3 years post sub-study registration
23 eligible participants that received protocol therapy were assessed for AEs.
|
|
Ear and labyrinth disorders
Vertigo
|
8.7%
2/23 • Duration of treatment and follow up until death or 3 years post sub-study registration
23 eligible participants that received protocol therapy were assessed for AEs.
|
|
Endocrine disorders
Endocrine disorders-Other
|
8.7%
2/23 • Duration of treatment and follow up until death or 3 years post sub-study registration
23 eligible participants that received protocol therapy were assessed for AEs.
|
|
Endocrine disorders
Hyperthyroidism
|
4.3%
1/23 • Duration of treatment and follow up until death or 3 years post sub-study registration
23 eligible participants that received protocol therapy were assessed for AEs.
|
|
Eye disorders
Blurred vision
|
4.3%
1/23 • Duration of treatment and follow up until death or 3 years post sub-study registration
23 eligible participants that received protocol therapy were assessed for AEs.
|
|
Eye disorders
Cataract
|
4.3%
1/23 • Duration of treatment and follow up until death or 3 years post sub-study registration
23 eligible participants that received protocol therapy were assessed for AEs.
|
|
Eye disorders
Eye disorders-Other
|
4.3%
1/23 • Duration of treatment and follow up until death or 3 years post sub-study registration
23 eligible participants that received protocol therapy were assessed for AEs.
|
|
Eye disorders
Watering eyes
|
4.3%
1/23 • Duration of treatment and follow up until death or 3 years post sub-study registration
23 eligible participants that received protocol therapy were assessed for AEs.
|
|
Gastrointestinal disorders
Abdominal pain
|
13.0%
3/23 • Duration of treatment and follow up until death or 3 years post sub-study registration
23 eligible participants that received protocol therapy were assessed for AEs.
|
|
Gastrointestinal disorders
Constipation
|
34.8%
8/23 • Duration of treatment and follow up until death or 3 years post sub-study registration
23 eligible participants that received protocol therapy were assessed for AEs.
|
|
Gastrointestinal disorders
Diarrhea
|
39.1%
9/23 • Duration of treatment and follow up until death or 3 years post sub-study registration
23 eligible participants that received protocol therapy were assessed for AEs.
|
|
Gastrointestinal disorders
Dyspepsia
|
4.3%
1/23 • Duration of treatment and follow up until death or 3 years post sub-study registration
23 eligible participants that received protocol therapy were assessed for AEs.
|
|
Gastrointestinal disorders
Dysphagia
|
4.3%
1/23 • Duration of treatment and follow up until death or 3 years post sub-study registration
23 eligible participants that received protocol therapy were assessed for AEs.
|
|
Gastrointestinal disorders
Esophageal pain
|
4.3%
1/23 • Duration of treatment and follow up until death or 3 years post sub-study registration
23 eligible participants that received protocol therapy were assessed for AEs.
|
|
Gastrointestinal disorders
Esophageal stenosis
|
4.3%
1/23 • Duration of treatment and follow up until death or 3 years post sub-study registration
23 eligible participants that received protocol therapy were assessed for AEs.
|
|
Gastrointestinal disorders
Esophagitis
|
4.3%
1/23 • Duration of treatment and follow up until death or 3 years post sub-study registration
23 eligible participants that received protocol therapy were assessed for AEs.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
8.7%
2/23 • Duration of treatment and follow up until death or 3 years post sub-study registration
23 eligible participants that received protocol therapy were assessed for AEs.
|
|
Gastrointestinal disorders
Mucositis oral
|
8.7%
2/23 • Duration of treatment and follow up until death or 3 years post sub-study registration
23 eligible participants that received protocol therapy were assessed for AEs.
|
|
Gastrointestinal disorders
Nausea
|
34.8%
8/23 • Duration of treatment and follow up until death or 3 years post sub-study registration
23 eligible participants that received protocol therapy were assessed for AEs.
|
|
Gastrointestinal disorders
Oral dysesthesia
|
4.3%
1/23 • Duration of treatment and follow up until death or 3 years post sub-study registration
23 eligible participants that received protocol therapy were assessed for AEs.
|
|
Gastrointestinal disorders
Oral pain
|
4.3%
1/23 • Duration of treatment and follow up until death or 3 years post sub-study registration
23 eligible participants that received protocol therapy were assessed for AEs.
|
|
Gastrointestinal disorders
Stomach pain
|
4.3%
1/23 • Duration of treatment and follow up until death or 3 years post sub-study registration
23 eligible participants that received protocol therapy were assessed for AEs.
|
|
Gastrointestinal disorders
Toothache
|
4.3%
1/23 • Duration of treatment and follow up until death or 3 years post sub-study registration
23 eligible participants that received protocol therapy were assessed for AEs.
|
|
Gastrointestinal disorders
Vomiting
|
21.7%
5/23 • Duration of treatment and follow up until death or 3 years post sub-study registration
23 eligible participants that received protocol therapy were assessed for AEs.
|
|
General disorders
Chills
|
17.4%
4/23 • Duration of treatment and follow up until death or 3 years post sub-study registration
23 eligible participants that received protocol therapy were assessed for AEs.
|
|
General disorders
Edema limbs
|
13.0%
3/23 • Duration of treatment and follow up until death or 3 years post sub-study registration
23 eligible participants that received protocol therapy were assessed for AEs.
|
|
General disorders
Fatigue
|
47.8%
11/23 • Duration of treatment and follow up until death or 3 years post sub-study registration
23 eligible participants that received protocol therapy were assessed for AEs.
|
|
General disorders
Flu like symptoms
|
4.3%
1/23 • Duration of treatment and follow up until death or 3 years post sub-study registration
23 eligible participants that received protocol therapy were assessed for AEs.
|
|
General disorders
General disorders and admin site conditions - Other
|
4.3%
1/23 • Duration of treatment and follow up until death or 3 years post sub-study registration
23 eligible participants that received protocol therapy were assessed for AEs.
|
|
General disorders
Non-cardiac chest pain
|
17.4%
4/23 • Duration of treatment and follow up until death or 3 years post sub-study registration
23 eligible participants that received protocol therapy were assessed for AEs.
|
|
General disorders
Pain
|
13.0%
3/23 • Duration of treatment and follow up until death or 3 years post sub-study registration
23 eligible participants that received protocol therapy were assessed for AEs.
|
|
Infections and infestations
Infections and infestations-Other
|
8.7%
2/23 • Duration of treatment and follow up until death or 3 years post sub-study registration
23 eligible participants that received protocol therapy were assessed for AEs.
|
|
Infections and infestations
Lung infection
|
8.7%
2/23 • Duration of treatment and follow up until death or 3 years post sub-study registration
23 eligible participants that received protocol therapy were assessed for AEs.
|
|
Infections and infestations
Upper respiratory infection
|
4.3%
1/23 • Duration of treatment and follow up until death or 3 years post sub-study registration
23 eligible participants that received protocol therapy were assessed for AEs.
|
|
Injury, poisoning and procedural complications
Fall
|
13.0%
3/23 • Duration of treatment and follow up until death or 3 years post sub-study registration
23 eligible participants that received protocol therapy were assessed for AEs.
|
|
Investigations
Alanine aminotransferase increased
|
13.0%
3/23 • Duration of treatment and follow up until death or 3 years post sub-study registration
23 eligible participants that received protocol therapy were assessed for AEs.
|
|
Investigations
Alkaline phosphatase increased
|
4.3%
1/23 • Duration of treatment and follow up until death or 3 years post sub-study registration
23 eligible participants that received protocol therapy were assessed for AEs.
|
|
Investigations
Aspartate aminotransferase increased
|
8.7%
2/23 • Duration of treatment and follow up until death or 3 years post sub-study registration
23 eligible participants that received protocol therapy were assessed for AEs.
|
|
Investigations
Blood bilirubin increased
|
4.3%
1/23 • Duration of treatment and follow up until death or 3 years post sub-study registration
23 eligible participants that received protocol therapy were assessed for AEs.
|
|
Investigations
Creatinine increased
|
4.3%
1/23 • Duration of treatment and follow up until death or 3 years post sub-study registration
23 eligible participants that received protocol therapy were assessed for AEs.
|
|
Investigations
Ejection fraction decreased
|
4.3%
1/23 • Duration of treatment and follow up until death or 3 years post sub-study registration
23 eligible participants that received protocol therapy were assessed for AEs.
|
|
Investigations
GGT increased
|
34.8%
8/23 • Duration of treatment and follow up until death or 3 years post sub-study registration
23 eligible participants that received protocol therapy were assessed for AEs.
|
|
Investigations
Investigations-Other
|
17.4%
4/23 • Duration of treatment and follow up until death or 3 years post sub-study registration
23 eligible participants that received protocol therapy were assessed for AEs.
|
|
Investigations
Lymphocyte count decreased
|
34.8%
8/23 • Duration of treatment and follow up until death or 3 years post sub-study registration
23 eligible participants that received protocol therapy were assessed for AEs.
|
|
Investigations
Neutrophil count decreased
|
4.3%
1/23 • Duration of treatment and follow up until death or 3 years post sub-study registration
23 eligible participants that received protocol therapy were assessed for AEs.
|
|
Investigations
Platelet count decreased
|
13.0%
3/23 • Duration of treatment and follow up until death or 3 years post sub-study registration
23 eligible participants that received protocol therapy were assessed for AEs.
|
|
Investigations
Weight loss
|
30.4%
7/23 • Duration of treatment and follow up until death or 3 years post sub-study registration
23 eligible participants that received protocol therapy were assessed for AEs.
|
|
Metabolism and nutrition disorders
Anorexia
|
30.4%
7/23 • Duration of treatment and follow up until death or 3 years post sub-study registration
23 eligible participants that received protocol therapy were assessed for AEs.
|
|
Metabolism and nutrition disorders
Dehydration
|
13.0%
3/23 • Duration of treatment and follow up until death or 3 years post sub-study registration
23 eligible participants that received protocol therapy were assessed for AEs.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
4.3%
1/23 • Duration of treatment and follow up until death or 3 years post sub-study registration
23 eligible participants that received protocol therapy were assessed for AEs.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
17.4%
4/23 • Duration of treatment and follow up until death or 3 years post sub-study registration
23 eligible participants that received protocol therapy were assessed for AEs.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
4.3%
1/23 • Duration of treatment and follow up until death or 3 years post sub-study registration
23 eligible participants that received protocol therapy were assessed for AEs.
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
8.7%
2/23 • Duration of treatment and follow up until death or 3 years post sub-study registration
23 eligible participants that received protocol therapy were assessed for AEs.
|
|
Metabolism and nutrition disorders
Hypernatremia
|
4.3%
1/23 • Duration of treatment and follow up until death or 3 years post sub-study registration
23 eligible participants that received protocol therapy were assessed for AEs.
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
8.7%
2/23 • Duration of treatment and follow up until death or 3 years post sub-study registration
23 eligible participants that received protocol therapy were assessed for AEs.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
82.6%
19/23 • Duration of treatment and follow up until death or 3 years post sub-study registration
23 eligible participants that received protocol therapy were assessed for AEs.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
26.1%
6/23 • Duration of treatment and follow up until death or 3 years post sub-study registration
23 eligible participants that received protocol therapy were assessed for AEs.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
21.7%
5/23 • Duration of treatment and follow up until death or 3 years post sub-study registration
23 eligible participants that received protocol therapy were assessed for AEs.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
26.1%
6/23 • Duration of treatment and follow up until death or 3 years post sub-study registration
23 eligible participants that received protocol therapy were assessed for AEs.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
43.5%
10/23 • Duration of treatment and follow up until death or 3 years post sub-study registration
23 eligible participants that received protocol therapy were assessed for AEs.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
21.7%
5/23 • Duration of treatment and follow up until death or 3 years post sub-study registration
23 eligible participants that received protocol therapy were assessed for AEs.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
17.4%
4/23 • Duration of treatment and follow up until death or 3 years post sub-study registration
23 eligible participants that received protocol therapy were assessed for AEs.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
17.4%
4/23 • Duration of treatment and follow up until death or 3 years post sub-study registration
23 eligible participants that received protocol therapy were assessed for AEs.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
8.7%
2/23 • Duration of treatment and follow up until death or 3 years post sub-study registration
23 eligible participants that received protocol therapy were assessed for AEs.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
13.0%
3/23 • Duration of treatment and follow up until death or 3 years post sub-study registration
23 eligible participants that received protocol therapy were assessed for AEs.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness upper limb
|
4.3%
1/23 • Duration of treatment and follow up until death or 3 years post sub-study registration
23 eligible participants that received protocol therapy were assessed for AEs.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
8.7%
2/23 • Duration of treatment and follow up until death or 3 years post sub-study registration
23 eligible participants that received protocol therapy were assessed for AEs.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
4.3%
1/23 • Duration of treatment and follow up until death or 3 years post sub-study registration
23 eligible participants that received protocol therapy were assessed for AEs.
|
|
Nervous system disorders
Dizziness
|
21.7%
5/23 • Duration of treatment and follow up until death or 3 years post sub-study registration
23 eligible participants that received protocol therapy were assessed for AEs.
|
|
Nervous system disorders
Dysgeusia
|
8.7%
2/23 • Duration of treatment and follow up until death or 3 years post sub-study registration
23 eligible participants that received protocol therapy were assessed for AEs.
|
|
Nervous system disorders
Dysphasia
|
4.3%
1/23 • Duration of treatment and follow up until death or 3 years post sub-study registration
23 eligible participants that received protocol therapy were assessed for AEs.
|
|
Nervous system disorders
Headache
|
8.7%
2/23 • Duration of treatment and follow up until death or 3 years post sub-study registration
23 eligible participants that received protocol therapy were assessed for AEs.
|
|
Nervous system disorders
Nervous system disorders-Other
|
4.3%
1/23 • Duration of treatment and follow up until death or 3 years post sub-study registration
23 eligible participants that received protocol therapy were assessed for AEs.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
4.3%
1/23 • Duration of treatment and follow up until death or 3 years post sub-study registration
23 eligible participants that received protocol therapy were assessed for AEs.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
17.4%
4/23 • Duration of treatment and follow up until death or 3 years post sub-study registration
23 eligible participants that received protocol therapy were assessed for AEs.
|
|
Nervous system disorders
Syncope
|
8.7%
2/23 • Duration of treatment and follow up until death or 3 years post sub-study registration
23 eligible participants that received protocol therapy were assessed for AEs.
|
|
Nervous system disorders
Tremor
|
4.3%
1/23 • Duration of treatment and follow up until death or 3 years post sub-study registration
23 eligible participants that received protocol therapy were assessed for AEs.
|
|
Psychiatric disorders
Anxiety
|
8.7%
2/23 • Duration of treatment and follow up until death or 3 years post sub-study registration
23 eligible participants that received protocol therapy were assessed for AEs.
|
|
Psychiatric disorders
Depression
|
4.3%
1/23 • Duration of treatment and follow up until death or 3 years post sub-study registration
23 eligible participants that received protocol therapy were assessed for AEs.
|
|
Psychiatric disorders
Insomnia
|
4.3%
1/23 • Duration of treatment and follow up until death or 3 years post sub-study registration
23 eligible participants that received protocol therapy were assessed for AEs.
|
|
Renal and urinary disorders
Renal and urinary disorders-Other
|
4.3%
1/23 • Duration of treatment and follow up until death or 3 years post sub-study registration
23 eligible participants that received protocol therapy were assessed for AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
4.3%
1/23 • Duration of treatment and follow up until death or 3 years post sub-study registration
23 eligible participants that received protocol therapy were assessed for AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
34.8%
8/23 • Duration of treatment and follow up until death or 3 years post sub-study registration
23 eligible participants that received protocol therapy were assessed for AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
30.4%
7/23 • Duration of treatment and follow up until death or 3 years post sub-study registration
23 eligible participants that received protocol therapy were assessed for AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
4.3%
1/23 • Duration of treatment and follow up until death or 3 years post sub-study registration
23 eligible participants that received protocol therapy were assessed for AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal inflammation
|
4.3%
1/23 • Duration of treatment and follow up until death or 3 years post sub-study registration
23 eligible participants that received protocol therapy were assessed for AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
4.3%
1/23 • Duration of treatment and follow up until death or 3 years post sub-study registration
23 eligible participants that received protocol therapy were assessed for AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
4.3%
1/23 • Duration of treatment and follow up until death or 3 years post sub-study registration
23 eligible participants that received protocol therapy were assessed for AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
8.7%
2/23 • Duration of treatment and follow up until death or 3 years post sub-study registration
23 eligible participants that received protocol therapy were assessed for AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
4.3%
1/23 • Duration of treatment and follow up until death or 3 years post sub-study registration
23 eligible participants that received protocol therapy were assessed for AEs.
|
Additional Information
Lung Committee Statistician
SWOG Statistics and Data Management Center
Phone: 2066674623
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place