Sonntag, 28. April 2024
Navigation öffnen
Anzeige:
Wefra Programatic
 
JOURNAL ONKOLOGIE – STUDIE
iPREDICT

Study of Zirconium Zr 89 Crefmirlimab Berdoxam PET/CT in Subjects With Advanced or Metastatic Malignancies

Rekrutierend

NCT-Nummer:
NCT05013099

Studienbeginn:
Dezember 2021

Letztes Update:
11.04.2024

Wirkstoff:
zirconium Zr 89 crefmirlimab berdoxam

Indikation (Clinical Trials):
Carcinoma, Merkel Cell, Carcinoma, Carcinoma, Renal Cell

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 2

Sponsor:
ImaginAb, Inc.

Collaborator:
-

Studienleiter

Kim Margolin, MD
Principal Investigator
Providence Saint John's Cancer Institute

Kontakt

Studienlocations
(3 von 16)

Leiden University Medical Center
Leiden
NetherlandsRekrutierend» Google-Maps
Northern Centre for Cancer Care and Newcastle University
Newcastle Upon Tyne
United KingdomRekrutierend» Google-Maps
Alle anzeigen

Studien-Informationen

Brief Summary:

The purpose of this study is to evaluate whether zirconium Zr 89 crefmirlimab berdoxam (other

names 89Zr-crefmirlimab berdoxam, 89Zr-Df-crefmirlimab, 89Zr-Df-IAB22M2C) PET/CT can predict

the response of advanced or metastatic melanoma, Merkel cell carcinoma, renal cell carcinoma,

or non-small cell lung cancer tumors to immuno-oncology therapy.

Ein-/Ausschlusskriterien

Inclusion Criteria:

- Subjects will be eligible for enrollment in the study if they meet ONE criteria a, b

or c in point 1 and ALL the criteria in points 2-9.

1. Subjects must meet ONE of the criteria a, b or c below:

1. For enrollment into Cohort A: Subjects with histologically confirmed

advanced or metastatic non-uveal/non-mucosal melanoma or merkel cell

carcinoma (MCPyV positive and negative) who are not amenable to surgical

cure and are candidates to receive single- or combined IOT alone (not to

include cytotoxic chemotherapy) as first or second line treatment.

2. For enrollment into Cohort B: Subjects with histologically confirmed

advanced or metastatic clear cell Renal Cell Carcinoma or Renal Cell

Carcinoma with sarcomatoid features (regardless of subtype) as defined on

pathologic examination by a component of clear cell or sarcomatoid, who are

not amenable to surgical cure and are candidates to receive single- or

combined IOT alone or IOT in combination with VEGFR-directed or tyrosine

kinase inhibitor (not to include cytotoxic chemotherapy) as first or second

line treatment

3. For enrollment into Cohort C: Subjects with histologically confirmed

advanced or metastatic non-small cell lung cancer without non-smoker/driver

mutations who are not amenable to surgical cure, and are candidates to

receive single- or combined IOT alone (not to include cytotoxic

chemotherapy) as first or second line treatment as per the label/prescribing

information at the physicians discretion.

i. Patients with driver mutations that are expected to show significant benefit

from first line checkpoint inhibiter treatment (such as KRAS G12C mutations) are

eligible if all other I/E criteria are met

Subjects must meet All of the criteria 2-9 below:

2. At least 1 RECIST 1.1-measurable. non-irradiated, non-osseous (unless there is an

associated measurable soft-tissue component) lesion documented on intravenous

(IV) contrast-enhanced CT or MRI (per RECIST criteria 1.1) prior to first

zirconium Zr 89 crefmirlimab berdoxam administration.

3. Has an adequate amount of time between their prior treatment/procedure and the

1st administration of zirconium Zr 89 crefmirlimab berdoxam.

4. Eastern Cooperative Oncology Group (ECOG) performance status ≤2 and anticipated

survival of at least 6 months.

5. Meeting all clinical safety lab values per institution's SOC, or investigator's

discretion, for subjects receiving cancer treatment.

6. Male or female age ≥18 years.

7. Ability to understand the purposes and risks of the trial and has signed an

Institutional Review Board (IRB) approved informed consent form.

8. Willingness and ability to comply with all protocol required procedures.

9. For men and women of child-producing potential, use of effective double barrier

contraceptive methods during the study, up to 30 days after the last

administration of the investigational product.

Exclusion Criteria:

- Subjects will NOT be eligible for enrollment in the study if they meet ANY of the

following criteria:

1. Bone-only disease without a measurable soft tissue component on conventional

imaging (MRI, PET, CT).

2. Subjects with skin-only (cutaneous) lesions will be excluded from the tumor

biopsy assessment.

3. Serious nonmalignant disease, additional active malignant disease or conditions

that in the opinion of the investigator and/or ImaginAb could compromise protocol

objectives.

4. Subjects with splenic dysfunction or who are status post splenectomy.

Post-splenectomy subjects who develop an accessory spleen with clinical and

radiographic evidence of splenic function will be allowed with prior approval

from the Sponsor.

5. Corticosteroid therapy is prohibited if used for the treatment of inflammatory or

autoimmune conditions. Patients with adrenal insufficiency from prior surgery or

immunotherapy toxicity may be on standard chronic replacement doses of

hydrocortisone that also require sporadic use of stress doses of steroid .

6. Pregnant women or nursing mothers.

Studien-Rationale

Primary outcome:

1. Best overall response (BOR) assessed by conventional imaging CT and/or MRI using RECIST 1.1 tomography/computed tomography (PET/CT) (Time Frame - Baseline to at least 24 or 27 weeks after the start of IOT, depending on treatment schedule.):
Best overall response (BOR) assessed by conventional imaging CT and/or MRI using RECIST 1.1 from 3 (or up to 3) consecutive imaging assessments (CT and/or MRI) following onset of immuno-oncology treatment.



Secondary outcome:

1. Largest measured difference from baseline in the lesion major axis from three (or up to three) consecutive standard of care imaging assessments (CT and/or MRI) (Time Frame - Baseline to at least 24 or 27 weeks after the start IOT, depending on treatment schedule.):
Largest measured difference from baseline in the lesion major axis from three (or up to three) consecutive standard of care imaging assessments (CT and/or MRI) following onset of immuno-oncology treatment.

2. Incidence and severity of AEs (Time Frame - Up to 48 weeks or end of treatment.):
Incidence and severity of AEs

3. Incidence and severity of infusion or injection reactions (Time Frame - 33 days post infusion):
Incidence and severity of infusion or injection reactions reported during or shortly after administration of the investigational product.

4. Incidence of withdrawal from scanning protocol due to zirconium Zr 89 crefmirlimab berdoxam related AEs (Time Frame - Up to 48 weeks or end of treatment):
Incidence of withdrawal from scanning protocol due to zirconium Zr 89 crefmirlimab berdoxam related AEs

5. 12-lead ECG ventricular rate (bpm) (Time Frame - baseline to 48 weeks or end of study):
Ventricular rate (bpm) will be recorded from the 12-lead ECG

6. 12-lead ECG PR interval (msec) (Time Frame - baseline to 48 weeks or end of study):
PR interval (msec) will be recorded from the 12-lead ECG

7. 12-lead ECG QRS interval (msec) (Time Frame - baseline to 48 weeks or end of study):
QRS interval (msec) will be recorded from the 12-lead ECG

8. 12-lead ECG QT interval (msec) (Time Frame - baseline to 48 weeks or end of study):
QT interval (msec) will be recorded from the 12-lead ECG

9. 12-lead ECG QTc interval (msec) (Time Frame - baseline to 48 weeks or end of study):
QTc interval (msec) will be recorded from the 12-lead ECG

10. 12-lead ECG Overall Result (Time Frame - baseline to 48 weeks or end of study):
Investigator's overall assessment of the ECG reading will be recorded as normal or abnormal. If abnormal, as either "not clinically significant" or "clinically significant"

11. Anti-drug antibody (Time Frame - baseline to 48 weeks or end of study):
Detection of anti-drug antibodies

12. Change in blood AST levels (U/L) from baseline. (Time Frame - Baseline through 48 weeks or end of treatment.):
Blood AST levels (U/L) will be obtained at baseline and collected prior to each administration and 60 minutes post administration.

13. Change in blood ALT levels (U/L) from baseline. (Time Frame - Baseline through 48 weeks or end of treatment.):
Blood ALT levels (U/L) will be obtained at baseline and collected prior to each administration and 60 minutes post administration.

14. Change in blood ALP levels (U/L) from baseline. (Time Frame - Baseline through 48 weeks or end of treatment.):
Blood ALP levels (U/L) will be obtained at baseline and collected prior to each administration and 60 minutes post administration.

15. Change in blood bilirubin levels (mg/dL) from baseline. (Time Frame - Baseline through 48 weeks or end of treatment.):
Blood bilirubin levels (mg/dL) will be obtained at baseline and collected prior to each administration and 60 minutes post administration.

16. Change in blood LDH levels (U/L) from baseline. (Time Frame - Baseline through 48 weeks or end of treatment.):
Blood LDH levels (U/L) will be obtained at baseline and collected prior to each administration and 60 minutes post administration.

17. Change in blood BUN levels (mg/dL) from baseline. (Time Frame - Baseline through 48 weeks or end of treatment.):
Blood BUN levels (mg/dL) will be obtained at baseline and collected prior to each administration and 60 minutes post administration.

18. Change in blood GGT levels (U/L) from baseline. (Time Frame - Baseline through 48 weeks or end of treatment.):
Blood GGT levels (U/L) will be obtained at baseline and collected prior to each administration and 60 minutes post administration.

19. Change in serum creatinine levels (mg/dL) from baseline. (Time Frame - Baseline through 48 weeks or end of treatment.):
Serum creatinine levels (mg/dL) will be obtained at baseline and collected prior to each administration and 60 minutes post administration.

20. Change in blood uric acid levels (mg/dL) from baseline. (Time Frame - Baseline through 48 weeks or end of treatment.):
Blood uric acid levels (mg/dL) will be obtained at baseline and collected prior to each administration and 60 minutes post administration.

21. Change in blood sodium levels (mmol/L) from baseline. (Time Frame - Baseline through 48 weeks or end of treatment.):
Blood sodium (mmol/L) will be obtained at baseline and collected prior to each administration and 60 minutes post administration.

22. Change in blood potassium levels (mmol/L) from baseline. (Time Frame - Baseline through 48 weeks or end of treatment.):
Blood potassium (mmol/L) will be obtained at baseline and collected prior to each administration and 60 minutes post administration.

23. Change in blood chloride levels (mmol/L) from baseline. (Time Frame - Baseline through 48 weeks or end of treatment.):
Blood chloride (mmol/L) will be obtained at baseline and collected prior to each administration and 60 minutes post administration.

24. Change in blood glucose levels (mg/dL) from baseline. (Time Frame - Baseline through 48 weeks or end of treatment.):
Blood glucose (mg/dL) will be obtained at baseline and collected prior to each administration and 60 minutes post administration.

Geprüfte Regime

  • zirconium Zr 89 crefmirlimab berdoxam (89Zr-Df-crefmirlimab / 89Zr-Df-IAB22M2C / ):
    Up to three zirconium Zr 89 crefmirlimab berdoxam PET scans (up to 1.0 mCi ± 20% at 1.5 mg API per scan, for a total of up to 3.0 mCi ± 20% and 4.5 mg API) as an IV infusion or slow bolus injection as follows: First (PETbaseline) within 14 days prior to the onset of IOT, and a second (PETEOC1) 4 to 6 weeks after start of immunotherapy. The second zirconium Zr 89 crefmirlimab berdoxam administration and scan (PETEOC1) should be completed prior to the start of the third cycle of IOT. Subjects who are determined by the treating physician to have PD on immunotherapy can receive the optional third zirconium Zr 89 crefmirlimab berdoxam PET scan at the principal investigator's (PI's) discretion.

Quelle: ClinicalTrials.gov


Sie können folgenden Inhalt einem Kollegen empfehlen:

"Study of Zirconium Zr 89 Crefmirlimab Berdoxam PET/CT in Subjects With Advanced or Metastatic Malignancies"

Bitte tragen Sie auch die Absenderdaten vollständig ein, damit Sie der Empfänger erkennen kann.

Die mit (*) gekennzeichneten Angaben müssen eingetragen werden!

Die Verwendung Ihrer Daten für den Newsletter können Sie jederzeit mit Wirkung für die Zukunft gegenüber der MedtriX GmbH - Geschäftsbereich rs media widersprechen ohne dass Kosten entstehen. Nutzen Sie hierfür etwaige Abmeldelinks im Newsletter oder schreiben Sie eine E-Mail an: rgb-info[at]medtrix.group.