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Dexamethasone

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Rovalpituzumab tesirine

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Rovalpituzumab tesirine 0.2-0.4 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle.

Dexamethasone will be provided through a participant's local prescription by Investigator or other provider (i.e., dexamethasone will not be provided by the Sponsor).

AbbVie Inc.

The primary objective of this study is to assess the safety and tolerability of rovalpituzumab tesirine in subjects with specific delta-like protein 3-expressing advanced solid tumors.

This is a multicenter, open-label study involving multiple specific advanced solid tumor types, consisting of a dose escalation part A followed by an expansion part B. Cancer subtypes will be studied in separate disease-specific cohorts in both Parts. Eight separate cohorts will enroll malignant melanoma, medullary thyroid cancer (MTC), glioblastoma, large cell neuroendocrine carcinoma (LCNEC), neuroendocrine prostate cancer (NEPC), high-grade gastroenteropancreatic neuroendocrine carcinoma (GEP NEC), other NEC, and solid tumors other than the above.

Rovalpituzumab Tesirine in Delta-Like Protein 3-Expressing Advanced Solid Tumors

An Open-Label Study of Rovalpituzumab Tesirine in Subjects With Delta-Like Protein 3-Expressing Advanced Solid Tumors

AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.

The number of participants with TEAEs, serious TEAEs, study drug-related TEAEs, and study drug discontinuations or dose reductions due to TEAEs, summarized by dose received and neuroendocrine (NEC) or non-NEC disease groups. An adverse event (AE) is defined as any untoward medical occurrence which does not necessarily have a causal relationship with this treatment. A serious adverse event (SAE) is any untoward medical occurrence that at any dose: is fatal or life-threatening; results in death or hospitalization; is disabling/incapacitating or a congenital anomaly/birth defect; is medically significant. AE severity was graded using the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.03 terminology: grade 1=mild; grade 2=moderate; grade 3=severe; grade 4 life-threatening; grade 5=death. TEAEs were defined as AEs that were newly occurring or worsened following study treatment.

ORR is defined as percentage of participants whose best overall response was either complete response (CR) or partial response (PR), according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. CR: Disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to \<10 mm. PR: A ≥30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

CBR is defined as the percentage of participants with best overall response (confirmed or unconfirmed) of CR, PR or stable disease (SD) per RECIST v1.1. CR: Disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to \<10 mm. PR: A ≥30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressed disease (PD), taking as reference the smallest sum diameters while on study. SD criteria must have met at least once after study entry at a minimum interval of 42 days (-7 days to allow for scheduled visit window per the protocol).

DOR is defined as the time from the first assessment on therapy of a CR or PR response (per RECIST v1.1) to the date of progressive disease or death. CR: Disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to \<10 mm. PR: A ≥30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Participants who did not have progression were censored at the last non-missing response assessment on-therapy or baseline. Based on Kaplan-Meier estimates.

PFS is defined as the time from the first dose date to the date of disease progression or death. Participants who did not have progression or death are censored at the last non-missing response assessment on-therapy or baseline. Based on Kaplan-Meier estimates.

Overall survival is defined as the time from the first dose date to death for any reason. Subjects who were alive at the clinical data cut-off are censored at the last known alive date. Based on Kaplan-Meier estimates.

Number of participants treated across each dose level reported to potentially have ATAs against rovalpituzumab tesirine at any time during the study.

AbbVie

No participants with malignant melanoma (MM) or medullary thyroid cancer (MTC) received the rovalpituzumab tesirine 0.4 mg/kg dose.

Participants with large cell neuroendocrine carcinoma (LCNEC) of any origin who received rovalpituzumab tesirine 0.2 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle.

0.2_mg_kg_(LCNEC)

Participants with neuroendocrine prostate cancer (NEPC) who received rovalpituzumab tesirine 0.2 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle.

0.2_mg_kg_(NEPC)

Participants with high-grade gastroenteropancreatic neuroendocrine carcinoma (GEP NEC) who received rovalpituzumab tesirine 0.2 mg/kg administered intravenously on Day 1 of each 6-week cycle.

Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle.

0.2_mg_kg_(GEPNEC)

Participants with other neuroendocrine carcinoma (NEC), and high-grade neuroendocrine tumors who received rovalpituzumab tesirine 0.2 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle.

0.2_mg_kg_(Other_NEC)

Participants with malignant melanoma (MM) who received rovalpituzumab tesirine 0.2 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle.

0.2_mg_kg_(MM)

Participants with medullary thyroid cancer (MTC) who received rovalpituzumab tesirine 0.2 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle.

0.2_mg_kg_(MTC)

Participants with glioblastoma (GBM) who received rovalpituzumab tesirine 0.2 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle.

0.2_mg_kg_(GBM)

Participants with other solid tumors who received rovalpituzumab tesirine 0.2 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle.

0.2_mg_kg_(Other_Solid)

Participants with large cell neuroendocrine carcinoma (LCNEC) of any origin who received rovalpituzumab tesirine 0.3 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle.

0.3_mg_kg_(LCNEC)

Participants with neuroendocrine prostate cancer (NEPC) who received rovalpituzumab tesirine 0.3 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle.

0.3_mg_kg_(NEPC)

Participants with high-grade gastroenteropancreatic neuroendocrine carcinoma (GEP NEC) who received rovalpituzumab tesirine 0.3 mg/kg administered intravenously on Day 1 of each 6-week cycle.

Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle.

0.3_mg_kg_(GEPNEC)

Participants with other neuroendocrine carcinoma (NEC), and high-grade neuroendocrine tumors who received rovalpituzumab tesirine 0.3 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle.

0.3_mg_kg_(Other_NEC)

Participants with malignant melanoma (MM) who received rovalpituzumab tesirine 0.3 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle.

0.3_mg_kg_(MM)

Participants with medullary thyroid cancer (MTC) who received rovalpituzumab tesirine 0.3 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle.

0.3_mg_kg_(MTC)

Participants with glioblastoma (GBM) who received rovalpituzumab tesirine 0.3 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle.

0.3_mg_kg_(GBM)

Participants with other solid tumors who received rovalpituzumab tesirine 0.3 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle.

0.3_mg_kg_(Other_Solid)

Participants with glioblastoma (GBM) who received rovalpituzumab tesirine 0.4 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle.

0.4_mg_kg_(GBM)

Participants with high-grade gastroenteropancreatic neuroendocrine carcinoma (GEP NEC) who received rovalpituzumab tesirine 0.4 mg/kg administered intravenously on Day 1 of each 6-week cycle.

Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle.

0.4_mg_kg_(GEPNEC)

Participants with large cell neuroendocrine carcinoma (LCNEC) of any origin who received rovalpituzumab tesirine 0.4 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle.

0.4_mg_kg_(LCNEC)

Participants with neuroendocrine prostate cancer (NEPC) who received rovalpituzumab tesirine 0.4 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle.

0.4_mg_kg_(NEPC)

Participants with other neuroendocrine carcinoma (NEC), and high-grade neuroendocrine tumors who received rovalpituzumab tesirine 0.4 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle.

0.4_mg_kg_(Other_NEC)

Participants with other solid tumors who received rovalpituzumab tesirine 0.4 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle.

0.4_mg_kg_(Other_Solid)

Participants with large cell neuroendocrine carcinoma (LCNEC) of any origin who received rovalpituzumab tesirine 0.2-0.4 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle.

Large Cell Neuroendocrine Carcinoma

Participants with neuroendocrine prostate cancer (NEPC) who received rovalpituzumab tesirine 0.2-0.4 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle.

Neuroendocrine Prostate Cancer

Participants with high-grade gastroenteropancreatic neuroendocrine carcinoma (GEP NEC) who received rovalpituzumab tesirine 0.2-0.4 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle.

Gastroenteropancreatic Neuroendocrine Carcinoma

Participants with other neuroendocrine carcinoma (NEC), and high-grade neuroendocrine tumors who received rovalpituzumab tesirine 0.2-0.4 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle.

Other Neuroendocrine Carcinoma

Participants with malignant melanoma (MM) who received rovalpituzumab tesirine 0.2-0.4 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle.

Malignant Melanoma

Participants with medullary thyroid cancer (MTC) who received rovalpituzumab tesirine 0.2-0.4 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle.

Medullary Thyroid Cancer

Participants with glioblastoma (GBM) who received rovalpituzumab tesirine 0.2-0.4 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle.

Participants with other solid tumors who received rovalpituzumab tesirine 0.2-0.4 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle.

Other Solid Tumors

Total

< 65 years old

>= 65 years old

Age, Customized

Sex: Female, Male

White

Black or African American

Asian

Other, Not Specified

Not Reported

Race/Ethnicity, Customized

Baseline characteristics are presented by disease-specific cohorts, inclusive of participants in parts A and B.

Global Medical Services

≥ 1 TEAE

≥ 1 TEAE, Grade 3-4

≥ 1 TEAE, Grade 5

≥ 1 Serious TEAE

≥ 1 Serious TEAE, Grade 3-4

≥ 1 Serious TEAE, Grade 5

≥ 1 Drug-Related (DR) Serious TEAE

≥ 1 DR Serious TEAE, Grade 3-4

≥ 1 DR Serious TEAE, Grade 5

≥ 1 DR TEAE

≥ 1 DR TEAE, Grade 3-4

≥ 1 DR TEAE, Grade 5

≥1 TEAE Leading to Study Drug Discontinuation (DC)

≥ 1 TEAE Leading to Study Drug DC, Grade 3-4

≥1 TEAE Leading to Study Drug DC, Grade 5

≥ 1 DR TEAE Leading to Study Drug DC

≥ 1 DR TEAE Leading to Study Drug DC, Grade 3-4

≥ 1 DR TEAE Leading to Study Drug DC, Grade 5

≥ 1 TEAE Leading to Dose Reduction

≥ 1 TEAE Leading to Dose Reduction, Grade 3-4

≥ 1 TEAE Leading to Dose Reduction, Grade 5

Participants with large cell neuroendocrine carcinoma (LCNEC) of any origin, neuroendocrine prostate cancer (NEPC), high-grade gastroenteropancreatic neuroendocrine carcinoma (GEP NEC), other neuroendocrine carcinoma (NEC), and high-grade neuroendocrine tumors who received rovalpituzumab tesirine 0.2 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle.

NEC: 0.2 mg/kg

Participants with large cell neuroendocrine carcinoma (LCNEC) of any origin, neuroendocrine prostate cancer (NEPC), high-grade gastroenteropancreatic neuroendocrine carcinoma (GEP NEC), other neuroendocrine carcinoma (NEC), and high-grade neuroendocrine tumors who received rovalpituzumab tesirine 0.3 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle.

NEC: 0.3 mg/kg

Participants with large cell neuroendocrine carcinoma (LCNEC) of any origin, neuroendocrine prostate cancer (NEPC), high-grade gastroenteropancreatic neuroendocrine carcinoma (GEP NEC), other neuroendocrine carcinoma (NEC), and high-grade neuroendocrine tumors who received rovalpituzumab tesirine 0.4 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle.

NEC: 0.4 mg/kg

Participants with large cell neuroendocrine carcinoma (LCNEC) of any origin, neuroendocrine prostate cancer (NEPC), high-grade gastroenteropancreatic neuroendocrine carcinoma (GEP NEC), other neuroendocrine carcinoma (NEC), and high-grade neuroendocrine tumors who received tesirine 0.2-0.4 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle.

NEC: Any Dose

Participants with malignant melanoma (MM), medullary thyroid cancer (MTC), glioblastoma (GBM), or other solid tumors who received rovalpituzumab tesirine 0.2 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle.

Non-NEC: 0.2 mg/kg

Participants with malignant melanoma (MM), medullary thyroid cancer (MTC), glioblastoma (GBM), or other solid tumors who received rovalpituzumab tesirine 0.3 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle.

Non-NEC: 0.3 mg/kg

Participants with malignant melanoma (MM), medullary thyroid cancer (MTC), glioblastoma (GBM), or other solid tumors who received rovalpituzumab tesirine 0.4 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle.

Non-NEC: 0.4 mg/kg

Participants with malignant melanoma (MM), medullary thyroid cancer (MTC), glioblastoma (GBM), or other solid tumors who received rovalpituzumab tesirine 0.2-0.4 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle.

Non-NEC: Any Dose

Safety Analysis Set: participants who received any amount of study drug. Presented by NEC/Non-NEC groups, inclusive of participants in parts A and B.

Summary of Treatment-Emergent Adverse Events (TEAEs), by Dose and Neuroendocrine (NEC) or Non-NEC Disease Groups

Full Analysis Set: All enrolled participants who received any amount of study drug. Presented by disease-specific groups, inclusive of participants in parts A and B.

Objective Response Rate (ORR)

Participants with other neuroendocrine carcinoma (NEC), and high-grade neuroendocrine tumors who received tesirine 0.2-0.4 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle.

Clinical Benefit Rate (CBR)

Participants with glioblastoma (GBM) who received rovalpituzumab rovalpituzumab tesirine 0.2-0.4 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle.

Full Analysis Set: All enrolled participants who received any amount of study drug. Responders (CR or PR response). Presented by disease-specific groups, inclusive of participants in parts A and B.

Duration of Response (DOR)

Progression Free Survival (PFS)

Overall Survival (OS)

Cycle 1: 0 hour

Cycle 1: 0.5 hour postdose

Cycle 1: 6 hours postdose

Cycle 1: 48 hours postdose

Cycle 1: 168 hours postdose

Cycle 1: 336 hours postdose

Cycle 1: 672 hours postdose

Participants who received rovalpituzumab tesirine 0.2 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle.

0.2 mg/kg

Participants who received rovalpituzumab tesirine 0.3 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle.

0.3 mg/kg

Participants who received rovalpituzumab tesirine 0.4 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle.

0.4 mg/kg

Participants who received at least 1 dose of study drug and had an assessment at given time point. Presented by dose-specific groups, inclusive of participants in parts A and B.

Serum Concentrations of Rovalpituzumab Tesirine Over Time

Participants who received at least 1 dose of study drug with available ATA data. Presented by dose-specific groups, inclusive of participants in parts A and B.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Rovalpituzumab Tesirine in Delta-Like Protein 3-Expressing Advanced Solid Tumors	NCT02709889	Malignant Melan... Medullary Thyro... Glioblastoma Large-Cell Neur... Neuroendocrine ... High Grade Gast... Other Neuroendo... Other Solid Tum...	Rovalpituzumab ... Dexamethasone	18 Years - 99 Years	AbbVie
Rovalpituzumab Tesirine in Delta-Like Protein 3-Expressing Advanced Solid Tumors	NCT02709889	Malignant Melan... Medullary Thyro... Glioblastoma Large-Cell Neur... Neuroendocrine ... High Grade Gast... Other Neuroendo... Other Solid Tum...	Rovalpituzumab ... Dexamethasone	18 Years - 99 Years	AbbVie

Spots Global Cancer Trial Database for other neuroendocrine carcinoma