JOURNAL ONKOLOGIE – STUDIE

Study to Evaluate Adverse Events, Change in Disease Activity, and How ABBV-706 Moves Through the Body When Intravenously (IV) Infused Alone or in Combination With IV Infused Budigalimab, Cisplatin, or Carboplatin in Adult Participants With Advanced Solid Tumors

Studien-Informationen Einschlusskriterien Studien-Rationale Studien-Arme Geprüfte Regime

Rekrutierend

NCT-Nummer:
NCT05599984

Studienbeginn:
Dezember 2022

Letztes Update:
21.06.2024

Wirkstoff:
ABBV-706, Cisplatin, Budigalimab, Carboplatin

Indikation (Clinical Trials):
Neoplasms

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 1

Sponsor:
AbbVie

Collaborator:
-

Studienleiter

ABBVIE INC.
Study Director
AbbVie

Kontakt

ABBVIE CALL CENTER
Kontakt:
Phone: 844-663-3742
E-Mail: abbvieclinicaltrials@abbvie.com» Kontaktdaten anzeigen

Studienlocations
(3 von 47)

Technische Universitat Dresden /ID# 259414
01307 Dresden
(Sachsen)
GermanyRekrutierend» Google-Maps

Banner MD Anderson Cancer Ctr /ID# 260129
85234 Gilbert
United StatesRekrutierend» Google-Maps

City of Hope /ID# 259884
91010 Duarte
United StatesRekrutierend» Google-Maps

Yale School of Medicine /ID# 246647
06519 New Haven
United StatesRekrutierend» Google-Maps

Georgetown University Hospital /ID# 255352
20007 Washington
United StatesRekrutierend» Google-Maps

Fort Wayne Medical Oncology and Hematology, Inc /ID# 260130
46804 Fort Wayne
United StatesRekrutierend» Google-Maps

University of Iowa Hospitals and Clinics /ID# 246638
52242 Iowa City
United StatesRekrutierend» Google-Maps

Barbara Ann Karmanos Cancer In /ID# 261799
48201 Detroit
United StatesRekrutierend» Google-Maps

Henry Ford Hospital /ID# 246648
48202 Detroit
United StatesRekrutierend» Google-Maps

START Midwest /ID# 251257
49546-7062 Grand Rapids
United StatesRekrutierend» Google-Maps

St. Luke's Hosp. of Kansas City /ID# 259958
64111 Kansas City
United StatesRekrutierend» Google-Maps

Washington University-School of Medicine /ID# 246286
63110 Saint Louis
United StatesRekrutierend» Google-Maps

Memorial Sloan Kettering Cancer Center-Koch Center /ID# 246303
10065-6007 New York
United StatesRekrutierend» Google-Maps

Duke Cancer Center /ID# 246285
27710 Durham
United StatesRekrutierend» Google-Maps

UH Cleveland Medical Center /ID# 246641
44106 Cleveland
United StatesRekrutierend» Google-Maps

Univ Oklahoma HSC /ID# 250884
73117 Oklahoma City
United StatesRekrutierend» Google-Maps

Tennessee Oncology, PLLC /ID# 246283
37203 Nashville
United StatesRekrutierend» Google-Maps

University of Texas MD Anderson Cancer Center /ID# 246287
77030 Houston
United StatesRekrutierend» Google-Maps

South Texas Accelerated Research Therapeutics /ID# 248946
78229 San Antonio
United StatesRekrutierend» Google-Maps

University of Utah /ID# 246640
84112-5500 Salt Lake City
United StatesRekrutierend» Google-Maps

Northwest Medical Specialties - Tacoma /ID# 262801
98405 Tacoma
United StatesRekrutierend» Google-Maps

Chris O'Brien Lifehouse /ID# 259087
2050 Camperdown
AustraliaRekrutierend» Google-Maps

The Kinghorn Cancer Centre /ID# 260874
2010 Darlinghurst
AustraliaRekrutierend» Google-Maps

Austin Health and Ludwig Institute for Cancer Research /ID# 255174
3084 Heidelberg
AustraliaRekrutierend» Google-Maps

Peter MacCallum Cancer Ctr /ID# 259197
3000 Melbourne
AustraliaRekrutierend» Google-Maps

Rambam Health Care Campus /ID# 255059
3109601 Haifa
IsraelRekrutierend» Google-Maps

The Chaim Sheba Medical Center /ID# 254915
5265601 Ramat Gan
IsraelRekrutierend» Google-Maps

Hadassah Medical Center-Hebrew University /ID# 255147
91120 Jerusalem
IsraelRekrutierend» Google-Maps

National Cancer Center Hospital East /ID# 259417
277-8577 Kashiwa-shi
JapanRekrutierend» Google-Maps

National Hospital Organization Shikoku Cancer Center /ID# 261279
791-0280 Matsuyama-shi
JapanRekrutierend» Google-Maps

Hokkaido Cancer Center /ID# 261278
003-0804 Sapporo-shi
JapanRekrutierend» Google-Maps

Kyoto University Hospital /ID# 259419
606-8507 Kyoto-shi
JapanRekrutierend» Google-Maps

Shizuoka Cancer Center /ID# 261277
411-8777 Sunto-gun
JapanRekrutierend» Google-Maps

National Cancer Center Hospital /ID# 259418
104-0045 Chuo-ku
JapanRekrutierend» Google-Maps

The Cancer Institute Hospital Of JFCR /ID# 260132
135-8550 Koto
JapanRekrutierend» Google-Maps

Wakayama Medical University Hospital /ID# 260131
641-8510 Wakayama-shi
JapanRekrutierend» Google-Maps

National Cancer Center /ID# 248938
10408 Goyang-si
Korea, Republic ofRekrutierend» Google-Maps

CHA Bundang Medical Center /ID# 248939
13496 Seongnam
Korea, Republic ofRekrutierend» Google-Maps

Chonnam National University Hwasun Hospital /ID# 248943
58128 Hwasun-gun
Korea, Republic ofRekrutierend» Google-Maps

Yonsei University Health System Severance Hospital /ID# 248937
03722 Seoul
Korea, Republic ofRekrutierend» Google-Maps

Seoul National University Hospital /ID# 248940
03080 Seoul
Korea, Republic ofRekrutierend» Google-Maps

Samsung Medical Center /ID# 248936
06351 Seoul
Korea, Republic ofRekrutierend» Google-Maps

Hospital Universitario Vall d'Hebron /ID# 258659
08035 Barcelona
SpainRekrutierend» Google-Maps

Hospital Universitario Ramon y Cajal /ID# 257291
28034 Madrid
SpainRekrutierend» Google-Maps

Hospital Universitario 12 de Octubre /ID# 258658
28041 Madrid
SpainRekrutierend» Google-Maps

Hospital Universitario HM Sanchinarro /ID# 258657
28050 Madrid
SpainRekrutierend» Google-Maps

Hospital Clinico Universitario de Valencia /ID# 257290
46010 Valencia
SpainRekrutierend» Google-Maps

Alle anzeigen

Studien-Informationen

Brief Summary:

Cancer is a condition where cells in a specific part of body grow and reproduce

uncontrollably. The purpose of this study is to assess safety, tolerability, pharmacokinetics

and preliminary efficacy of ABBV-706 as a monotherapy and in combination with budigalimab,

carboplatin, or cisplatin.

ABBV-706 is an investigational drug being developed for the treatment of small cell lung

cancer (SCLC), high-grade central nervous system (CNS) tumors and high-grade neuroendocrine

carcinomas (NECs). There are multiple treatment arms in this study. Participants will either

receive ABBV-706 as a single agent or in combination with budigalimab (another

investigational drug), carboplatin or cisplatin at different doses. Approximately 350 adult

participants will be enrolled in the study across sites worldwide.

In part 1 (dose escalation), ABBV-706 will be intravenously infused in escalating doses as a

monotherapy until the maximum tolerated dose (MTD) is determined in participants with SCLC,

high-grade CNS tumors, and high-grade NECs. In part 2, multiple doses will be selected from

Part 1 and SCLC participants will be assigned to one of these doses in a randomized fashion

to determine the recommended Phase 2 dose. In Part 3a, participants with SCLC or NECs will

receive ABBV-706 in combination with budigalimab intravenously every 3 weeks. In Part 3b

participants with SCLC or NECs will receive ABBV-706 in combination with either carboplatin

or cisplatin intravenously. In Part 4a, participants with CNS tumors will receive ABBV-706

intravenously at a dose determined from Part 1. In Part 4b, participants with NECs will

receive ABBV-706 intravenously at a dose selected from Part 1. The estimated duration of the

study is up to 3 years.

There may be higher treatment burden for participants in this trial compared to their

standard of care. Participants will attend regular visits during the study at a hospital or

clinic and may require frequent medical assessments, blood tests, and scans.

Ein-/Ausschlusskriterien

Inclusion Criteria:

- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

- The laboratory values criteria must be met within 7 days prior to the first dose of

study drug as per the protocol.

- QT interval corrected for heart rate (QTc) <= 450 msec (males) or <= 470 msec

(females) using Fridericia's correction, and an ejection fraction of >= 50% as

measured by echocardiogram or multigated acquisition (MUGA) scan at Screening.

- Part 1 only: Advanced recurrent or refractory solid tumors with potential SEZ6

expression including small cell lung cancer (SCLC), high-grade central nervous system

(CNS) tumors (glioblastoma [GBM], IDH-wildtype Grade 4; oligodendroglioma, IDH-mutant,

and 1p/19q-codeleted Grade 3; astrocytoma, IDH-mutant Grade 3 or Grade 4),

neuroendocrine prostate cancer (NEPC), high-grade poorly differentiated

gastroenteropancreatic neuroendocrine carcinoma (GEP-NEC)s, large cell neuroendocrine

carcinoma (LCNEC)s, SCLC transformed from epidermal growth factor receptor (EGFR)

mutant non-small cell lung cancer (NSCLC), atypical lung carcinoids, and other

high-grade poorly differentiated NECs, who have progressed on or after standard of

care (SoC) therapy and with no curative therapy available. For SCLC, participants must

have histologically or cytologically confirmed SCLC that is relapsed or refractory

following at least 1 prior platinum-containing chemotherapy.

- Part 2 only: Histologically or cytologically confirmed SCLC that is relapsed or

refractory (R/R) following at least 1 prior platinum-containing chemotherapy and with

no curative therapy available. For the purposes of this study, a line of therapy is

defined as >= 1 complete cycle of either a single agent or combination of drugs,

including any planned sequential therapy of various regimens.

- Part 3a only: Participants with R/R SCLC following at least 1 prior

platinum-containing chemotherapy or R/R poorly differentiated NECs, e.g., NEPC,

GEP-NECs, LCNECs, SCLC transformed from EGFR mutant Non-small cell lung cancer

(NSCLC), atypical lung carcinoids, other high-grade poorly differentiated NECs.

- Part 3b only: Participants with R/R SCLC who have only progressed following a

frontline regimen containing a platinum-based chemotherapy or R/R NECs, e.g., NEPC,

GEP-NECs, LCNECs, SCLC transformed from EGFR mutant NSCLC, atypical lung carcinoids,

other NECs.

- Part 4a only: Participants with R/R high-grade CNS tumors (GBM, IDH-wildtype Grade 4;

oligodendroglioma, IDH-mutant, and 1p/19q-codeleted Grade 3; astrocytoma, IDH-mutant

Grade 3 or Grade 4) who have progressed on SoC therapy and with no curative therapy

options available.

- Part 4b only: Participants with R/R neuroendocrine tumors, including NEPC, GEP-NECs,

LCNECs, SCLC transformed from EGFR mutant NSCLC, atypical lung carcinoids, and other

high-grade poorly differentiated NECs, who have progressed on SoC therapy and with no

curative therapy options available.

- Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version

1.1 for participants with extracranial solid tumors or Response Assessment for

Neuro-Oncology (RANO)for participants with primary high-grade CNS tumors (GBM,

IDH-wildtype Grade 4; oligodendroglioma, IDH-mutant, and 1p/19q-codeleted Grade 3;

astrocytoma, IDH-mutant Grade 3 or Grade 4).

- Primary CNS tumors within 12 weeks from radiation therapy should have unequivocal

progression as documented by either tumor recurrence predominantly outside of

radiation field on magnetic resonance imaging (MRI) or confirmed on tumor biopsy.

- Participants with brain metastases from an extracranial solid tumor are eligible if

the brain metastases as outlined in the protocol.

- Fresh or archival tumor tissue available for submission, for retrospective SEZ6

expression analysis as outlined in the protocol.

Exclusion Criteria:

- History of interstitial lung disease (ILD) or pneumonitis that required treatment with

systemic steroids, nor any evidence of active ILD or pneumonitis.

- History of idiopathic pulmonary fibrosis or organizing pneumonia.

- Prior treatment with an antibody drug conjugate that consists of a Top1 inhibitor

payload.

- Part 2 only: Prior treatment with a SEZ6-targeted antibody drug conjugate.

Studien-Rationale

Primary outcome:

1. Percentage of Participants With Adverse Events (AE) (Time Frame - Up to Approximately 2 Years):
An AE is 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.

2. Maximum Observed Serum/Plasma Concentration (Cmax) of ABBV-706 (Time Frame - Up to Approximately 2 Years):
Maximum observed serum/plasma concentration of ABBV-706.

3. Time to Cmax (Tmax) of ABBV-706 (Time Frame - Up to Approximately 2 Years):
Time to Cmax of ABBV-706.

4. Terminal Phase Elimination Half-Life (t1/2) of ABBV-706 (Time Frame - Up to Approximately 2 Years):
Terminal phase elimination half-life (t1/2) of ABBV-706.

5. Area Under the Serum/Plasma Concentration-Time Curve (AUC) of ABBV-706 (Time Frame - Up to Approximately 2 Years):
Area under the serum/plasma concentration-time curve of ABBV-706.

6. Antidrug Antibodies (ADAs) (Time Frame - Up to Approximately 2 Years):
Incidence and concentration of anti-drug antibodies.

7. Neutralizing Antibodies (nAbs) (Time Frame - Up to Approximately 2 Years):
Incidence and concentration of neutralizing antibodies.

8. Percentage of Participants with Objective Response, for Participants with Extracranial Solid Tumors (Time Frame - Up to Approximately 2 Years):
Objective response is defined as participants achieving a confirmed best overall response of complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1 for for extracranial solid tumors per investigator assessment.

9. Recommended Phase 2 Dose (RP2D) of ABBV-706 (Time Frame - Up to Approximately 2 Years):
The RP2D will be determined using all available information, including, but not limited to, AEs, dose-limiting toxicities, pharmacokinetic parameters, clinical laboratory tests, and efficacy measures.

10. Percentage of Participants with Objective Response for Participants with Central Nervous System (CNS) Tumors (Time Frame - Up to Approximately 2 Years):
Objective response is as participants achieving a confirmed best overall response of CR and PR according to Response Assessment for Neuro-Oncology (RANO), version 1.1 for CNS tumors per investigator assessment.

11. Duration of response (DOR) for Participants with Confirmed CR/PR (Time Frame - Up to Approximately 2 Years):
For participants achieving a confirmed CR/PR, DOR is defined as the time from the initial response of CR/PR to disease progression or death of any cause, whichever occurs earlier.

12. Percentage of Participants with Clinical Benefit (Time Frame - Up to Approximately 2 Years):
Clinical benefit is defined as a participant achieving CR/PR, or Stable Disease (SD).

13. Progression-Free Survival (PFS) (Time Frame - Up to Approximately 2 Years):
PFS is defined as time from first study treatment to a documented disease progression, as determined by the investigator, or death due to any cause, whichever occurs earlier.

14. Overall survival (OS) (Time Frame - Up to Approximately 2 Years):
OS is defined as time from first study treatment to death due to any cause.

Studien-Arme

Experimental: Part 1: ABBV-706 Monotherapy Dose Escalation
Participants will receive escalating doses of ABBV-706 until doses for optimization are determined, as part of an approximately 1 year treatment period.
Experimental: Part 2: ABBV-706 Monotherapy Dose Optimization and Expansion
Participants with small cell lung cancer will receive varying doses of ABBV-706 in a randomized manner until the recommended phase 2 dose (RP2D) is achieved, as part of an approximately 1 year treatment period..
Experimental: Part 3a: ABBV-706 + Budigalimab
Participants will receive ABBV-706 in combination with budigalimab, as part of an approximately 1 year treatment period.
Experimental: Part 3b: ABBV-706 + Platinum Chemotherapy
Participants will receive ABBV-706 in combination with carboplatin or cisplatin, as part of an approximately 1 year treatment period.
Experimental: Part 4a: ABBV-706 Monotherapy Dose Expansion CNS Tumors
Participants with relapsed/refractory (R/R) central nervous system (CNS) tumors will receive ABBV-706 as a monotherapy at or below the maximum tolerated dose (MTD) maximum administered dose (MAD), as part of an approximately 1 year treatment period.
Experimental: Part 4b: ABBV-706 Monotherapy Dose Expansion NECs
Participants with R/R neuroendocrine carcinomas (NECs) will receive IV Infused ABBV-706 as a monotherapy at or below the MTD/MAD, as part of an approximately 1 year treatment period.

Geprüfte Regime

ABBV-706:
Intravenous (IV) Infusion
Cisplatin:
Intravenous infusion
Budigalimab (ABBV-181):
IV Infusion
Carboplatin:
Intravenous infusion

Quelle: ClinicalTrials.gov

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