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Imfinzi NSCLC
Imfinzi NSCLC
JOURNAL ONKOLOGIE – STUDIE

A Study to Determine the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of ABBV-368 Plus Tilsotolimod and Other Therapy Combinations in Participants With Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma

Rekrutierend

NCT-Nummer:
NCT04196283

Studienbeginn:
Januar 2020

Letztes Update:
14.12.2020

Wirkstoff:
ABBV-368, Tilsotolimod, Nab-Paclitaxel, ABBV-181

Indikation (Clinical Trials):
Carcinoma, Carcinoma, Squamous Cell, Squamous Cell Carcinoma of Head and Neck

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 1

Sponsor:
AbbVie

Collaborator:
Idera Pharmaceuticals, Inc.

Studienleiter

AbbVie Inc.
Study Director
AbbVie

Kontakt

Studienlocations (3 von 27)

Universitaetsklinikum Erlangen /ID# 214196
91054 Erlangen
(Bayern)
GermanyNoch nicht rekrutierend» Google-Maps
Universitaetsklinikum Leipzig /ID# 214200
04103 Leipzig
(Sachsen)
GermanyNoch nicht rekrutierend» Google-Maps
Charite-Univ. Berlin, Benjamin-Franklin /ID# 214197
12203 Berlin
(Berlin)
GermanyNoch nicht rekrutierend» Google-Maps
University of Chicago DCAM /ID# 217196
60637-1443 Chicago
United StatesNoch nicht rekrutierend» Google-Maps
Norton Cancer Institute /ID# 216179
40241-2832 Louisville
United StatesRekrutierend» Google-Maps
Karmanos Cancer Institute /ID# 214050
48201 Detroit
United StatesRekrutierend» Google-Maps
Nebraska Methodist Hospital /ID# 215786
68114 Omaha
United StatesRekrutierend» Google-Maps
Atlantic Health System /ID# 216159
07960-6136 Morristown
United StatesRekrutierend» Google-Maps
Roswell Park Comprehensive Cancer Center /ID# 215882
14263 Buffalo
United StatesNoch nicht rekrutierend» Google-Maps
Vanderbilt University Med Ctr /ID# 214040
37232-6307 Nashville
United StatesRekrutierend» Google-Maps
MD Anderson Cancer Center /ID# 214041
77030 Houston
United StatesRekrutierend» Google-Maps
Institut Curie /ID# 215653
75248 Paris CEDEX 05
FranceNoch nicht rekrutierend» Google-Maps
Gustave Roussy /ID# 215865
94805 Villejuif
FranceNoch nicht rekrutierend» Google-Maps
Hopital de la Timone /ID# 215657
13385 Marseille CEDEX 05
FranceNoch nicht rekrutierend» Google-Maps
Hopital Saint Andre /ID# 215702
33800 Bordeaux
FranceNoch nicht rekrutierend» Google-Maps
Centre Antoine Lacassagne /ID# 215706
06189 Nice
FranceNoch nicht rekrutierend» Google-Maps
Rambam Health Care Campus /ID# 215231
3109601 Haifa
IsraelRekrutierend» Google-Maps
Gastroenterology Institute, Division of Medicine /ID# 215862
91120 Jerusalem
IsraelRekrutierend» Google-Maps
Sheba Medical Center /ID# 215229
5239424 Ramat Gan
IsraelRekrutierend» Google-Maps
Antoni van Leeuwenhoek /ID# 215291
1066 CX Amsterdam
NetherlandsRekrutierend» Google-Maps
Instituto Catalan de Oncologia (ICO) L'Hospitalet /ID# 221402
08908 Hospitalet de Llobregat
SpainNoch nicht rekrutierend» Google-Maps
Hospital Universitario de Fuenlabrada /ID# 214263
28942 Fuenlabrada
SpainRekrutierend» Google-Maps
Hospital Universitario 12 de Octubre /ID# 214198
28041 Madrid
SpainRekrutierend» Google-Maps
Hospital Universitario HM Sanchinarro /ID# 214110
28050 Madrid
SpainRekrutierend» Google-Maps
Hospital Universitario Virgen de la Victoria /ID# 214109
29010 Malaga
SpainRekrutierend» Google-Maps
Hospital Clinico Universitario de Valencia /ID# 221401
46010 Valencia
SpainRekrutierend» Google-Maps
Alle anzeigen

Studien-Informationen

Brief Summary:

The main objective of this study is to assess safety, tolerability, and pharmacokinetics (PK)

of ABBV-368 plus tilsotolimod; ABBV-368 plus tilsotolimod and nab-paclitaxel; and ABBV-368

plus tilsotolimod, nab-paclitaxel, and ABBV-181 in participants with recurrent/metastatic

(R/M) head and neck squamous cell carcinoma (HNSCC).

Ein-/Ausschlusskriterien

Inclusion Criteria:

- Participants should weigh at least 35 kg.

- Eastern Cooperative Oncology Group performance status of 0 or 1 and a life expectancy

of >= 3 months.

- Participant have >= 1 lesion accessible for intratumoral injection.

- Histologically or cytologically confirmed R/M HNSCC (of the following 4 subsites: oral

cavity, oropharynx, larynx, and hypopharynx) who previously progressed either during

or after <= 3 prior treatment regimens administered in the recurrent or metastatic

setting.

- Must have received 1 immunotherapy regimen which included a PD-(L)1 inhibitor.

- Must have received platinum-based therapy, or be considered ineligible for

platinum-based therapy by the investigator.

Exclusion Criteria:

- Uncontrolled metastases to the central nervous system (CNS).

- Participants with brain metastases are eligible provided that evidence of

clinical and radiographic stable disease for at least 4 weeks after definitive

therapy is given and participants have not used prohibited levels of steroids for

at least 4 weeks prior to first dose of the study.

- Received prior treatment with OX40 or toll-like receptor (TLR) agonists (excluding

topical agents).

Studien-Rationale

Primary outcome:

1. Number of Participants with Adverse Events (AEs) (Time Frame - Up to approximately 2 years following the first dose):
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study.

2. Change in Vital Signs (Time Frame - Up to approximately 2 years following the first dose):
Number of participants with clinically significant change from baseline in vital signs like systolic and diastolic blood pressure will be reported.

3. Change in Clinical Laboratory Test Results (Time Frame - Up to approximately 2 years following the first dose):
Number of participants with clinically significant change from baseline in clinical laboratory test results like hematology will be reported.

4. Maximum Observed Serum Concentration (Cmax) of ABBV-368 (Time Frame - Cycle 1 through Cycle 3 (each cycle is approximately 28 days)):
Maximum Serum Concentration (Cmax) of ABBV-368

5. Time to Maximum Serum Concentration (Tmax) of ABBV-368 (Time Frame - Cycle 1 through Cycle 3 (each cycle is approximately 28 days)):
Time to Maximum Serum Concentration (Tmax) of ABBV-368

6. Area Under Serum Concentration-Time Curve of ABBV-368 From Time 0 to the Time of Last Measurable Concentration (AUCt) (Time Frame - Cycle 1 through Cycle 3 (each cycle is approximately 28 days)):
Area Under Serum Concentration-Time Curve of ABBV-368 From Time 0 to the Time of Last Measurable Concentration (AUCt)

7. Terminal-Phase Elimination Rate Constant (β) of ABBV-368 (Time Frame - Cycle 1 through Cycle 3 (each cycle is approximately 28 days)):
Terminal-Phase Elimination Rate Constant (β) of ABBV-368

8. Terminal Half-Life (t1/2) of ABBV-368 (Time Frame - Cycle 1 through Cycle 3 (each cycle is approximately 28 days)):
Terminal Half-Life (t1/2) of ABBV-368

9. Maximum Plasma Concentration (Cmax) of Tilsotolimod (Time Frame - Cycle 1 through Cycle 3 (each cycle is approximately 28 days)):
Maximum Observed Plasma Concentration (Cmax) of Tilsotolimod

10. Time to Maximum Plasma Concentration (Tmax) of Tilsotolimod (Time Frame - Cycle 1 through Cycle 3 (each cycle is approximately 28 days)):
Time to Maximum Plasma Concentration (Tmax) of Tilsotolimod

11. Area Under Plasma Concentration-Time Curve of Tilsotolimod From Time 0 to the Time of Last Measurable Concentration (AUCt) (Time Frame - Cycle 1 through Cycle 3 (each cycle is approximately 28 days)):
Area Under Plasma Concentration-Time Curve of Tilsotolimod From Time 0 to the Time of Last Measurable Concentration (AUCt)

12. Terminal-Phase Elimination Rate Constant (β) of Tilsotolimod (Time Frame - Cycle 1 through Cycle 3 (each cycle is approximately 28 days)):
Terminal-Phase Elimination Rate Constant (β) of Tilsotolimod

13. Terminal Half-Life (t1/2) of Tilsotolimod (Time Frame - Cycle 1 through Cycle 3 (each cycle is approximately 28 days)):
Terminal Half-Life (t1/2) of Tilsotolimod

14. Maximum Observed Serum Concentration (Cmax) of ABBV-181 (Arm 3 Only) (Time Frame - Cycle 1 through Cycle 3 (each cycle is approximately 28 days)):
Maximum Observed Serum Concentration (Cmax) of ABBV-181

15. Time to Maximum Serum Concentration (Tmax) of ABBV-181 (Arm 3 Only) (Time Frame - Cycle 1 through Cycle 3 (each cycle is approximately 28 days)):
Time to Maximum Serum Concentration (Tmax) of ABBV-181

16. Area Under Serum Concentration-Time Curve of ABBV-181 From Time 0 to the Time of Last Measurable Concentration (AUCt) (Arm 3 Only) (Time Frame - Cycle 1 through Cycle 3 (each cycle is approximately 28 days)):
Area Under Serum Concentration-Time Curve of ABBV-181 From Time 0 to the Time of Last Measurable Concentration (AUCt)

17. Terminal-Phase Elimination Rate Constant (β) of ABBV-181 (Arm 3 Only) (Time Frame - Cycle 1 through Cycle 3 (each cycle is approximately 28 days)):
Terminal-Phase Elimination Rate Constant (β) of ABBV-181

18. Terminal Half-Life (t1/2) of ABBV-181 (Arm 3 Only) (Time Frame - Cycle 1 through Cycle 3 (each cycle is approximately 28 days)):
Terminal Half-Life (t1/2) of ABBV-181

Secondary outcome:

1. Objective Response Rate (ORR) (Time Frame - Up to approximately 2 years following the first dose):
ORR is measured as the percentage of participants with a complete response (CR) or partial response (PR) as a confirmed response.

2. Clinical Benefit Rate (CBR) (Time Frame - Up to approximately 2 years following the first dose):
CBR is measured as the percentage of participants with a confirmed complete response (CR), confirmed partial response (PR), or stable disease (SD)

3. Time to Response (TTR) (Time Frame - Up to approximately 2 years following the first dose):
TTR is the time from date of first study drug exposure to the first instance of a complete response (CR) or partial response (PR) as a confirmed response, whichever occurs first.

4. Progression Free Survival (PFS) (Time Frame - Up to approximately 2 years following the first dose):
PFS is the time from date of first study drug exposure to disease progression or death, whichever occurs first.

5. Duration of Response (DOR) (Time Frame - Up to approximately 2 years following the first dose):
DOR is the time from the participant's initial response (CR or PR as a confirmed response) to disease progression or death, whichever occurs first.

Studien-Arme

  • Experimental: Arm 3: ABBV-368 + Tilsotolimod + Nab-paclitaxel + ABBV-181
    Participants will be administered ABBV-368, Tilsotolimod, Nab-paclitaxel and ABBV-181 at various timepoints as described in the protocol.
  • Experimental: Arm 2: ABBV-368 + Tilsotolimod + Nab-paclitaxel
    Participants will be administered ABBV-368, Tilsotolimod and Nab-paclitaxel at various timepoints as described in the protocol.
  • Experimental: Arm 1: ABBV-368 + Tilsotolimod
    Participants will be administered ABBV-368 and Tilsotolimod at various timepoints as described in the protocol.

Geprüfte Regime

  • ABBV-368:
    Intravenous (IV) infusion
  • Tilsotolimod:
    Intratumoral (IT) injection
  • Nab-paclitaxel:
    Intravenous (IV) infusion
  • ABBV-181 (Budigalimab):
    Intravenous (IV) infusion

Quelle: ClinicalTrials.gov


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