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JOURNAL ONKOLOGIE – STUDIE

CAB-ROR2-ADC Safety and Efficacy Study in Patients With TNBC or Head & Neck Cancer (Ph1) and NSCLC or Melanoma (Ph2)

Rekrutierend

NCT-Nummer:
NCT03504488

Studienbeginn:
Juni 2018

Letztes Update:
31.01.2024

Wirkstoff:
CAB-ROR2-ADC, PD-1 Inhibitor

Indikation (Clinical Trials):
Melanoma, Head and Neck Neoplasms, Triple Negative Breast Neoplasms

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
BioAtla, Inc.

Collaborator:
-

Kontakt

BioAtla Medical Affairs
Kontakt:
Phone: 8585580708
Phone (ext.): 3333
E-Mail: medicalaffairs@bioatla.com» Kontaktdaten anzeigen

Studienlocations
(3 von 66)

Thea Resch
45136 Essen
(Nordrhein-Westfalen)
GermanyZurückgezogen» Google-Maps
Asklepios Clinical Center Harburg
21075 Hamburg
(Hamburg)
GermanyZurückgezogen» Google-Maps
University of Arizona Cancer Center
85724 Tucson
United StatesAbgeschlossen» Google-Maps
City of Hope - Duarte
91010 Duarte
United StatesAktiv, nicht rekrutierend» Google-Maps
University of California, San Diego (UCSD) - Moores Cancer Center
92093 La Jolla
United StatesAktiv, nicht rekrutierend» Google-Maps
California Research Institute
90027 Los Angeles
United StatesAktiv, nicht rekrutierend» Google-Maps
UC Irvine Medical Center - Chao Family Comprehensive Cancer Center
92868 Orange
United StatesAktiv, nicht rekrutierend» Google-Maps
University of California San Francisco
94158 San Francisco
United StatesAktiv, nicht rekrutierend» Google-Maps
American Institute of Research
90603 Whittier
United StatesAbgeschlossen» Google-Maps
University of Colorado
80045 Aurora
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Teresa Medina, MD
Phone: 303-266-3764
E-Mail: theresa.medina@ucdenver.edu

Rebeca Elizondo
Phone: 720-848-4288
E-Mail: rebeca.elizondo@cuanschutz.edu» Ansprechpartner anzeigen
Sarah Cannon Research Institute at Health One
80218 Denver
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Gerald Falchook, MD
Phone: 720-754-2610
E-Mail: gerald.falchook@scresaerch.net

Susan Hall
Phone: 720-754-2610
E-Mail: Susan.Hall3@sarahcannon.com» Ansprechpartner anzeigen
Florida Cancer Specialists & Research Institute
32003 Fleming Island
United StatesAktiv, nicht rekrutierend» Google-Maps
Florida Cancer Specialists & Research Institute
33916 Fort Myers
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Donna-May Bernard
Phone: 239-274-9930
E-Mail: Donna.Bernard@flcancer.com» Ansprechpartner anzeigen
Memorial Cancer Institute (MCI)
33028 Hollywood
United StatesAktiv, nicht rekrutierend» Google-Maps
Florida Cancer Specialist - North
34474 Saint Petersburg
United StatesAktiv, nicht rekrutierend» Google-Maps
Memorial Sloan-Kettering Cancer Center
33612 Tampa
United StatesAktiv, nicht rekrutierend» Google-Maps
Moffitt Cancer Center
33612 Tampa
United StatesAktiv, nicht rekrutierend» Google-Maps
Florida Cancer Specialists
33401 West Palm Beach
United StatesAktiv, nicht rekrutierend» Google-Maps
Augusta University - Georgia Cancer Center
30912 Augusta
United StatesAktiv, nicht rekrutierend» Google-Maps
Baptist Health Systems
40503 Lexington
United StatesAbgeschlossen» Google-Maps
University of Kentucky
40536 Lexington
United StatesAktiv, nicht rekrutierend» Google-Maps
Dana-Farber Cancer Institute
02215 Boston
United StatesAbgeschlossen» Google-Maps
Comprehensive Cancer Care of Nevada
89169 Las Vegas
United StatesAbgeschlossen» Google-Maps
OptumCare Cancer Care
89169 Las Vegas
United StatesAbgeschlossen» Google-Maps
Columbia University Medical Center
10032 New York
United StatesAktiv, nicht rekrutierend» Google-Maps
FirstHealth Outpatient Cancer Center
28374 Pinehurst
United StatesAktiv, nicht rekrutierend» Google-Maps
Wake Forest Baptist Health
27157 Winston-Salem
United StatesAbgeschlossen» Google-Maps
The Christ Hospital
45219 Cincinnati
United StatesAktiv, nicht rekrutierend» Google-Maps
Oregon Health & Science University
97239 Portland
United StatesAbgeschlossen» Google-Maps
Sarah Cannon Research Institute
37203 Nashville
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Howard Burris, MD
E-Mail: Howard.Burris@SarahCannon.com

Leigh Bumpous
Phone: 615-748-0767
E-Mail: Leigh.Bumpous@SarahCannon.com» Ansprechpartner anzeigen
Mary Crowley Cancer Research
75230 Dallas
United StatesAktiv, nicht rekrutierend» Google-Maps
University of Utah - Huntsman Cancer Institute
84112 Salt Lake City
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Mia Klonsky
Phone: 801-581-5260
E-Mail: Mia.Klonsky@hci.utah.edu

Ashley Lewary
E-Mail: Ashley.Leary@hci.utah.edu» Ansprechpartner anzeigen
HENRY DUNANT Hospital Center, 4th Department of Medical Oncology and Clinical Trials Unit
11526 Athens
GreeceAbgeschlossen» Google-Maps
"Sotiria" Chest Diseases Hospital of Athens, 3rd Department of Internal Medicine of University of Athens, Oncology Unit
11527 Athens
GreeceZurückgezogen» Google-Maps
Metropolitan Hospital "Perseus Healthcare Group SA" 4th Oncology Department
18547 Piraeus
GreeceAktiv, nicht rekrutierend» Google-Maps
European Interbalkan Medical Center, Οncology Department
57001 Thessaloniki
GreeceAktiv, nicht rekrutierend» Google-Maps
Queen Mary Hospital
Hong Kong
Hong KongAktiv, nicht rekrutierend» Google-Maps
Santa Maria delle Croci Hospital of Ravenna
48121 Ravenna
ItalyZurückgezogen» Google-Maps
"IRCCS Osp. Policlinico San Martino Pad Ex microbiologia, stanza 9, 1 piano."
16132 Genoa
ItalyZurückgezogen» Google-Maps
Polish Mother's Memorial Hospital-Research Institute
93-338 Lodz
PolandAktiv, nicht rekrutierend» Google-Maps
Beata Głogowska
97-200 Tomaszów Mazowiecki
PolandAbgeschlossen» Google-Maps
Institute of Genetics and Immunology GENIM LCC in Lublin
20-609 Lublin
PolandAktiv, nicht rekrutierend» Google-Maps
MED-Polonia, Sp. z o.o. (LLC)
60-693 Poznan
PolandAktiv, nicht rekrutierend» Google-Maps
University Hospital Nuestra Senora de Valme
41014 Sevilla
SpainAktiv, nicht rekrutierend» Google-Maps
University Clinic of Navarra - Madrid
28027 Madrid
SpainAktiv, nicht rekrutierend» Google-Maps
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City
TaiwanAktiv, nicht rekrutierend» Google-Maps
National Cheng Kung University Hospital
Tainan
TaiwanAktiv, nicht rekrutierend» Google-Maps
Alle anzeigen

Studien-Informationen

Detailed Description:

This is a multi-center, open-label, Phase 1/2 study designed to evaluate the safety,

tolerability, PK, immunogenicity, and antitumor activity of BA3021, a conditionally active

biologic (CAB) ROR2-targeted antibody drug conjugate (CAB-ROR2-ADC) BA3021 in patients with

advanced solid tumors.

This study will consist of a dose escalation phase and a dose expansion phase with BA3021 in

Phase 1. Phase 2 will study BA3021 alone or in combination with a PD-1 inhibitor.

Ein-/Ausschlusskriterien

Inclusion Criteria:

- Patients must have histologically or cytologically confirmed locally advanced

unresectable or metastatic solid tumor and have failed all available standard of care

(SoC) therapy and for whom no curative therapy is available or who are not eligible,

intolerant to or refuse standard therapy.

- Patients must have measurable disease.

- For the dose expansion phase: Patients with locally advanced unresectable or

metastatic, non-small cell lung cancer (NSCLC), triple negative breast cancer (TNBC)

and soft tissue sarcoma (STS)

- Age ≥ 18 years.

- Adequate renal function

- Adequate liver function

- Adequate hematological function

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

- Life expectancy of at least three months.

Exclusion Criteria:

- Patients must not have clinically significant cardiac disease.

- Patients must not have known non-controlled CNS metastasis.

- Patients must not have a history of ≥ Grade 3 allergic reactions to mAb therapy as

wellas known or suspected allergy or intolerance to any agent given during this study.

- Patients must not have had major surgery within 4 weeks before first BA3021

administration.

- Patients must not have had prior therapy with a conjugated or unconjugated auristatin

derivative/vinca-binding site targeting payload.

- Patients must not have known human immunodeficiency virus (HIV) infection, active

hepatitis B and/or hepatitis C.

- Patients must not be women who are pregnant or breast feeding.

Studien-Rationale

Primary outcome:

1. Phase 1: Safety Profile (Time Frame - Up to 24 months):
Assess dose limiting toxicity as defined in the protocol

2. Phase 1: Safety Profile (Time Frame - Up to 24 months):
Assess maximum tolerated dose as defined in the protocol

3. Phase 1 and 2: Safety Profile (Time Frame - Up to 24 months):
Frequency and severity of AEs and/or SAEs

4. Phase 2: Confirmed Objective Response Rate (ORR) (Time Frame - Up to 24 months):
Proportion of patients who achieve a confirmed CR or PR

Secondary outcome:

1. Phase 1: Pharmacokinetics (Time Frame - Up to 24 months):
Plasma concentrations of ADC, total antibody and MMAE

2. Phase 1: Pharmacokinetics (Time Frame - Up to 24 months):
Peak Plasma Concentration (Cmax)

3. Phase 1: Pharmacokinetics (Time Frame - Up to 24 months):
Area under the plasma concentration versus time curve

4. Phase 1: Confirmed Objective Response Rate (ORR) (Time Frame - Up to 24 months):
Proportion of patients who achieve a confirmed CR or PR

5. Phase 1: Immunogenicity (Time Frame - Up to 24 months):
The number and percentage of patients who develop detectable anti-drug antibodies (ADAs)

6. Phase 1 and 2: Duration of response (DOR) (Time Frame - Up to 24 months):
Time from the first documented OR until the first documented disease progression or death (due to any cause), whichever occurs first

7. Phase 1 and 2: Progression-free survival (PFS) (Time Frame - Up to 24 months):
Time from the first dose of IP until the first documentation of disease progression or death due to any cause, whichever occurs first

8. Phase 1 and 2: Best overall response (OR) (Time Frame - Up to 24 months):
All post-baseline disease assessments that occur prior to the initiation of subsequent anticancer therapy

9. Phase 1 and 2: Disease control rate (DCR) (Time Frame - Up to 24 months):
Proportion of patients with a best overall response of confirmed CR, confirmed PR, or stable disease (SD) ≥ 12 weeks

10. Phase 1 and 2: Time to response (TTR) (Time Frame - Up to 24 months):
Time from the first dose of investigational product until the first documentation of OR

11. Phase 1 and 2: Overall survival (OS) (Time Frame - Up to 24 months):
Time from the first dose of BA3021 treatment until death due to any cause

12. Phase 1 and 2: Tumor size (Time Frame - Up to 24 months):
Percent change from baseline in tumor size

Studien-Arme

  • Experimental: Monotherapy - CAB-ROR2-ADC (BA3021) alone
    BA3021 alone Q2W dosing regimen
  • Experimental: Combination Therapy
    CAB-ROR2-ADC (BA3021) with PD-1 inhibitor

Geprüfte Regime

  • CAB-ROR2-ADC (BA3021):
    Conditionally active biologic anti-ROR2 antibody drug conjugate
  • PD-1 inhibitor:
    PD-1 inhibitor

Quelle: ClinicalTrials.gov


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