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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03000257
Other study ID # M15-891
Secondary ID 2016-002520-89
Status Completed
Phase Phase 1
First received
Last updated
Start date December 14, 2016
Est. completion date March 29, 2022

Study information

Verified date April 2022
Source AbbVie
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is an open-label, Phase I, dose-escalation study to determine the recommended Phase 2 dose (RPTD), maximum tolerated dose (MTD), and evaluate the safety and pharmacokinetic (PK) profile of budigalimab. This study will also evaluate the safety and tolerability of budigalimab in combination with Rovalpituzumab Tesirine and budigalimab in combination with venetoclax. The study will consist of 3 parts: budigalimab monotherapy dose escalation and expansion, budigalimab in combination with Rovalpituzumab Tesirine and budigalimab in combination with venetoclax.


Recruitment information / eligibility

Status Completed
Enrollment 182
Est. completion date March 29, 2022
Est. primary completion date March 29, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Participant must have an advanced solid tumor and must not be a candidate for surgical resection or other approved therapeutic regimen known to provide clinical benefit. For dose escalation, the participant may have been previously treated with a programmed cell death 1 (PD-I) targeting agent. For dose expansion, the participant must be PD-I/PD-L1 targeting agent naïve. For Part 2 budigalimab in combination with rovalpituzumab tesirine, the participant must have SCLC with progressive disease and have failed platinum containing therapy and be PD-1/PD-L1 targeting agent naïve. For Part 3 budigalimab in combination with venetoclax, the participant must have locally advanced or metastatic NSCLC and received 1 to 4 prior lines of therapy in the advanced or metastatic setting including 1 regimen that included a PD-1 or PD-L1 targeting agent which was discontinued following disease progression. Participants who are naïve to treatment with a PD-1/PD-L1 targeting agent OR who have received more than 1 regimen containing a PD-1/PD-L1 targeting agent are NOT eligible for Part 3. - Participant has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2 for the monotherapy cohort and an ECOG 0 to 1 for budigalimab in combination with rovalpituzumab tesirine cohort (Part 2) and budigalimab in combination with venetoclax (Part 3). - Participants have adequate bone marrow, renal, hepatic and coagulation function. - Participants must have measurable or evaluable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 in the dose escalation portion of the trial. Participants in the expansion cohort must have measurable disease per RECIST version 1.1 or disease evaluable by assessment of tumor antigens. Participants enrolled in budigalimab in combination with venetoclax cohort (Part 3) must have measurable disease per RECIST version 1.1. Exclusion Criteria: - Participant has received anticancer therapy including chemotherapy, immunotherapy, radiation therapy, biologic, small molecule, herbal therapy, or any investigational therapy within a period of 5 half-lives, prior to the first dose of budigalimab or Rovalpituzumab Tesirine or venetoclax. - For budigalimab in combination with rovalpituzumab tesirine cohort (Part 2), participant must not have had prior exposure to Rovalpituzumab Tesirine or a pyrrolobenzodiazepine (PBD) based drug. - Participant has unresolved adverse events greater than grade 1 from prior anticancer therapy except for alopecia. - Current or prior use of immunosuppressive medication within 14 days prior to the first dose (with certain exceptions). - History of primary immunodeficiency, bone marrow transplantation, chronic lymphocytic leukemia, solid organ transplantation, or previous clinical diagnosis of tuberculosis. - Confirmed positive test results for human immunodeficiency virus (HIV), or participants with chronic or active hepatitis A, B or C. Participants who have a history of hepatitis B or C who have undetectable hepatitis B (HBV) DNA or hepatitis C (HCV) RNA after anti-viral therapy may be enrolled. - Participant has known history or inflammatory bowel disease, pneumonitis, or known uncontrolled metastases to the central nervous system (CNS) (with certain exceptions). - Participants with a history of or ongoing pneumonitis or interstitial lung disease are also excluded. - For budigalimab plus venetoclax therapy (Part 3), participant must not receive a strong or moderate inducer or inhibitor of cytochrome P450 (CYP)3A within 7 days before first venetoclax dose. - For budigalimab plus venetoclax therapy (Part 3), participants with a known gastrointestinal disorder (i.e.: malabsorption syndrome), complication (i.e.: dysphagia) or surgery that could make consumption or absorption of oral medication problematic are also excluded. - All Cohorts: Participants with a history of Stevens-Johnson syndrome (SJS), Toxic epidermal necrolysis (TEN), or drug reaction with eosinophilia and systemic symptoms (DRESS)

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Venetoclax
Tablet taken orally
Rovalpituzumab Tesirine
Intravenous infusion
ABBV-181
Intravenous infusion

Locations

Country Name City State
Australia Blacktown Hospital /ID# 167386 Blacktown New South Wales
Australia St Vincent's Hospital Melbourne /ID# 167552 Fitzroy Melbourne Victoria
Australia Linear Clinical Research /ID# 170797 Nedlands Western Australia
Austria Medizinische Universitaet Graz /ID# 168752 Graz Steiermark
Belgium Universitair Ziekenhuis Antwerpen /ID# 170702 Edegem Antwerpen
Belgium UZ Gent /ID# 170881 Gent Oost-Vlaanderen
Canada Cross Cancer Institute /ID# 167603 Edmonton Alberta
Finland Docrates Cancer Center /ID# 166838 Helsinki
Finland Tampere University Hospital /ID# 166839 Tampere Pirkanmaa
France Institut Bergonie /ID# 162662 Bordeaux Gironde
France Centre Leon Berard /ID# 162660 Lyon CEDEX 08 Rhone
France Institut du Cancer de Montpellier - Val d'Aurelle /ID# 163999 Montpellier CEDEX 5 Herault
France Institut Gustave Roussy /ID# 162753 Villejuif Cedex Val-de-Marne
Japan National Cancer Center Hospital /ID# 166279 Chuo-ku Tokyo
Japan National Hospital Organization Kyushu Cancer Center /ID# 206229 Fukuoka-shi Fukuoka
Japan National Cancer Center Hospital East /ID# 166433 Kashiwa-shi Chiba
Spain Hospital Universitario Fundacion Jimenez Diaz /ID# 163862 Madrid
Spain Hospital Universitario HM Sanchinarro /ID# 163861 Madrid
Spain Hospital Clinico Universitario de Valencia /ID# 163925 Valencia
Taiwan National Taiwan University Hospital /ID# 163997 Taipei City
Taiwan Taipei Medical University Hospital /ID# 163998 Taipei City
United States The University of Chicago Medical Center /ID# 157375 Chicago Illinois
United States Virginia Cancer Specialists - Fairfax /ID# 157377 Fairfax Virginia
United States Carolina BioOncology Institute /ID# 157376 Huntersville North Carolina
United States Moores Cancer Center at UC San Diego /ID# 157374 La Jolla California
United States South Texas Accelerated Research Therapeutics /ID# 157378 San Antonio Texas

Sponsors (1)

Lead Sponsor Collaborator
AbbVie

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Belgium,  Canada,  Finland,  France,  Japan,  Spain,  Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Part 1: Recommended Phase 2 Dose (RPTD) for Budigalimab If a maximum tolerated dose (MTD) is reached, the RPTD of budigalimab will not be a dose higher than the defined MTD, and will be selected based on the type(s) and occurrence(s) of dose limiting toxicities which occur in addition to the MTD. If a MTD is not reached, then the RPTD will be defined based on the safety and other available data. Up to 6 months
Primary Part 1: Maximum tolerated dose (MTD) of Budigalimab MTD will be defined at the highest dose level at which less than 2 of 6 subjects or less than 33% of (if cohort is expanded beyond 6) participants experience a dose limiting toxicity. Up to 6 months
Primary Part 1 and Part 3: Terminal Half-life (t1/2) of Budigalimab Terminal phase elimination half-life (t1/2) of Budigalimab Up to 4 Weeks
Primary Part 1 and Part 3: Maximum Observed Serum Concentration (Cmax) of Budigalimab Maximum Serum Concentration (Cmax) of Budigalimab Up to 12 Weeks
Primary Part 1 and Part 3: Time to Cmax (Tmax) of Budigalimab Time to maximum plasma concentration of Budigalimab Up to 12 Weeks
Primary Part 1 and Part 3: Area Under the Serum Concentration Time Curve from Time 0 to Last Measurable Concentration (AUCt) of Budigalimab Area Under the Plasma Concentration-time Curve from time 0 to last measurable concentration (AUCt) of Budigalimab Up to 12 Weeks
Primary Part 2: Recommended Phase 2 Dose (RPTD) and Schedule for Budigalimab and Rovalpituzumab Tesirine Combination The safety and tolerability of a single dose of Budigalimab in combination with Rovalpituzumab Tesirine will be assessed in patients with advanced small cell lung cancer (SCLC) to determine the RPTD and schedule for the combination. Up to 6 Months
Primary Part 3: Recommended Phase 2 Dose (RPTD) and Schedule for Budigalimab and Venetoclax Combination. The safety and tolerability of Budigalimab in combination with venetoclax will be assessed in patients with metastatic Non-Small Cell Lung Cancer (NSCLC) to determine the RPTD for the combination. Up to 6 Months
Primary Part 3: Maximum Observed Serum Concentration (Cmax) for Venetoclax Maximum Serum Concentration (Cmax) for Venetoclax Up to 12 Weeks
Primary Part 3: Area Under the Serum Concentration Time Curve from Time 0 to 24 Hours Post-dose (AUC(0-24)) of Venetoclax Area Under the Plasma Concentration-time Curve from time 0 to time 0 to 24 hours post-dose (AUC(0-24)) of Venetoclax Up to 12 Weeks
Primary Part 3: Time to Cmax (Tmax) of Venetoclax Time to maximum plasma concentration of of Venetoclax Up to 12 Weeks
Primary Part 1, Part 2, Part 3: Number of Participants with Adverse Events An adverse event is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. From first dose of study drug until 90 days following last dose of study drug (up to 24 months)
Secondary Part 2: Terminal Half-life (t1/2) of Budigalimab Terminal phase elimination half-life (t1/2) of Budigalimab Up to 4 Weeks
Secondary Part 2: Terminal Half-life (t1/2) of Rovalpituzumab Tesirine Terminal phase elimination half-life (t1/2) of Rovalpituzumab Tesirine Up to 4 Weeks
Secondary Part 2: Maximum Observed Serum Concentration (Cmax) of Rovalpituzumab Tesirine Maximum Serum Concentration (Cmax) of Rovalpituzumab Tesirine Up to 12 Weeks
Secondary Part 2: Area Under the Serum Concentration Time Curve from Time 0 to Last Measurable Concentration (AUCt) of Rovalpituzumab Tesirine Area Under the Plasma Concentration-time Curve from time 0 to last measurable concentration (AUCt) of Rovalpituzumab Tesirine Up to 12 Weeks
Secondary Part 2: Area Under the Serum Concentration Time Curve from Time 0 to Last Measurable Concentration (AUCt) of Budigalimab Area Under the Plasma Concentration-time Curve from time 0 to last measurable concentration (AUCt) of Budigalimab Up to 12 Weeks
Secondary Part 2: Time to Cmax (Tmax) of Budigalimab Time to maximum plasma concentration of Budigalimab Up to 12 Weeks
Secondary Part 2: Time to Cmax (Tmax) of Rovalpituzumab Tesirine Time to maximum plasma concentration of Rovalpituzumab Tesirine Up to 12 Weeks
Secondary Part 1 and Part 3: Objective response rate (ORR) ORR is defined as the proportion of subjects with a confirmed partial or complete response to the treatment. First dose of study drug through at least 30 days after last dose of study drug.
Secondary Part 1 and Part 3: Clinical benefit rate (CBR, defined as CR, PR or SD) CBR defined as the proportion of subjects with a confirmed partial response (PR), complete response (CR), or stable disease. First dose of study drug through at least 30 days after last dose of study drug.
Secondary Part 1 and Part 3: Progression-free survival (PFS) PFS time is defined as the time from the participant's first dose of study drug (Day 1) to either the participant's disease progression or death, whichever occurs first. First dose of study drug through at least 30 days after last dose of study drug.
Secondary Part 1, Part 2 and Part 3: Duration of objective response (DOR) DOR for a participant is defined as the time from the participant's initial objective response to study drug therapy to disease progression or death, whichever occurs first. First dose of study drug through at least 30 days after last dose of study drug.
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