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JOURNAL ONKOLOGIE – STUDIE

A Study of SGN-B7H4V in Advanced Solid Tumors

Rekrutierend

NCT-Nummer:
NCT05194072

Studienbeginn:
Januar 2022

Letztes Update:
16.04.2024

Wirkstoff:
SGN-B7H4V

Indikation (Clinical Trials):
Carcinoma, Neoplasms, Cholangiocarcinoma, Breast Neoplasms, Carcinoma, Non-Small-Cell Lung, Carcinoma, Adenoid Cystic, Ovarian Neoplasms, Endometrial Neoplasms, Peritoneal Neoplasms, Triple Negative Breast Neoplasms, Fallopian Tube Neoplasms

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 1

Sponsor:
Seagen Inc.

Collaborator:
-

Studienleiter

JoAl Mayor, PharmD, BCOP
Study Director
Seagen Inc.

Kontakt

Studienlocations
(3 von 18)

Charite Universitatsmedizin Berlin
10117 Berlin
(Berlin)
GermanyRekrutierend» Google-Maps
Sarah Cannon Research Institute at HealthONE - Denver
80218 Denver
United StatesRekrutierend» Google-Maps
University of Ottawa / Ottawa General Hospital
K1H 8L6 Ottawa
CanadaRekrutierend» Google-Maps
Hospital Universitari Vall d'Hebron
08035 Barcelona
SpainRekrutierend» Google-Maps
START Madrid-CIOCC_Hospital HM Sanchinarro
28050 Madrid
SpainRekrutierend» Google-Maps
Sarah Cannon Research Institute UK
W1G 6AD London
United KingdomRekrutierend» Google-Maps
Alle anzeigen

Studien-Informationen

Brief Summary:

This study will test the safety of a drug called SGN-B7H4V in participants with solid tumors.

It will also study the side effects of this drug. A side effect is anything a drug does to

the body besides treating the disease.

Participants will have cancer that has spread in the body near where it started (locally

advanced) and cannot be removed (unresectable) or has spread through the body (metastatic).

This study will have three parts. Parts A and B of the study will find out how much SGN-B7H4V

should be given to participants. Part C will use the dose found in Parts A and B to find out

how safe SGN-B7H4V is and if it works to treat solid tumor cancers.

Ein-/Ausschlusskriterien

Inclusion Criteria:

- Participants must have one of the following histologically or cytologically confirmed

locally advanced unresectable or metastatic solid tumor types:

- High-grade serous epithelial ovarian cancer, primary peritoneal cancer, or

fallopian tube cancer

- HER2-negative, HR positive breast cancer

- Triple-negative breast cancer (TNBC)

- Endometrial carcinoma

- Non-small cell lung cancer (Squamous cell carcinoma [SqCC], Adenocarcinoma [AC])

- Cholangiocarcinoma or gallbladder carcinoma

- Adenoid cystic carcinoma (ACC)

- Parts A and B: Participants must have disease that is relapsed or refractory or be

intolerant to SOC therapies, and, in the judgement of the investigator, should have no

appropriate SOC therapeutic option

- Part C: Participants must have disease that is relapsed or refractory or be intolerant

to SOC therapies, unless contraindicated

- Tumor tissue is required for enrollment.

- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1

- Measurable disease per RECIST version 1.1 at baseline

Exclusion Criteria:

- History of another malignancy within 3 years before the first dose of study drug. Any

evidence of residual disease from a previously diagnosed malignancy. Exceptions are

malignancies with a negligible risk of metastasis or death.

- Known active central nervous system metastases. Participants with previously treated

brain metastases may participate provided they:

- are clinically stable for at least 4 weeks prior to study entry after brain

metastasis treatment

- have no new or enlarging brain metastases

- and are off corticosteroids prescribed for symptoms associated with brain

metastases for at least 7 days prior to the first dose of study treatment.

- Carcinomatous meningitis

- Previous receipt of an MMAE-containing agent or an agent targeting B7-H4

- Pre-existing neuropathy ≥ Grade 2 per National Cancer Institute (NCI) Common

Terminology Criteria for Adverse Events (CTCAE) Version 5.0

- Corneal disease or injury requiring treatment or active monitoring

Studien-Rationale

Primary outcome:

1. Number of participants with adverse events (AEs) (Time Frame - Through 30 days after last study treatment, up to approximately 3 years):
Any untoward medical occurrence in a clinical investigational participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment.

2. Number of participants with laboratory abnormalities (Time Frame - Through 30-37 days after last study treatment, up to approximately 3 years)

3. Number of participants with dose limiting toxicities (DLTs) (Time Frame - Up to 28 days)

Secondary outcome:

1. Confirmed objective response rate (ORR) by investigator assessment (Time Frame - Up to approximately 3 years):
The proportion of participants with complete response (CR) or partial response (PR) which is subsequently confirmed as assessed according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 by investigator.

2. Complete response rate (CRR) (Time Frame - Up to approximately 3 years):
The proportion of participants achieving a CR as determined by the investigator per RECIST Version 1.1.

3. Duration of response (DOR) (Time Frame - Up to approximately 3 years):
The time from start of the first documentation of objective tumor response (CR or PR) to the first documentation of tumor progression or to death due to any cause.

4. Progression-free survival (PFS) (Time Frame - Up to approximately 3 years):
The time from the start of any study treatment to first documentation of disease progression or to death due to any cause.

5. Overall survival (OS) (Time Frame - Up to approximately 3 years):
The time from the start of any study treatment to the date of death due to any cause.

6. Pharmacokinetic (PK) parameter - Area under the curve (AUC) (Time Frame - Through 30-37 days after last study treatment; up to approximately 3 years):
To be summarized using descriptive statistics.

7. PK parameter - Maximum concentration (Cmax) (Time Frame - Through 30-37 days after last study treatment, up to approximately 3 years):
To be summarized using descriptive statistics.

8. PK parameter - Time to maximum concentration (Tmax) (Time Frame - Through 30-37 days after last study treatment, up to approximately 3 years):
To be summarized using descriptive statistics.

9. PK parameter - Apparent terminal half-life (t1/2) (Time Frame - Through 30-37 days after last study treatment, up to approximately 3 years):
To be summarized using descriptive statistics.

10. PK parameter - Trough concentration (Ctrough) (Time Frame - Through 30-37 days after last study treatment, up to approximately 3 years):
To be summarized using descriptive statistics.

11. Incidence of antidrug antibodies (ADAs) (Time Frame - Through 30-37 days after last study treatment, up to approximately 3 years):
To be summarized using descriptive statistics.

Geprüfte Regime

  • SGN-B7H4V:
    Given into the vein (IV; intravenously)

Quelle: ClinicalTrials.gov


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