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JOURNAL ONKOLOGIE – STUDIE

A Study of SGN-B6A in Advanced Solid Tumors

Rekrutierend

NCT-Nummer:
NCT04389632

Studienbeginn:
Juni 2020

Letztes Update:
06.08.2024

Wirkstoff:
Pembrolizumab, Cisplatin, Carboplatin, sigvotatug vedotin

Indikation (Clinical Trials):
Carcinoma, Neoplasms, Carcinoma, Squamous Cell, Adenocarcinoma, Breast Neoplasms, Esophageal Squamous Cell Carcinoma, Carcinoma, Non-Small-Cell Lung, Neoplasms, Squamous Cell, Ovarian Neoplasms, Stomach Neoplasms, Squamous Cell Carcinoma of Head and Neck, Uterine Cervical Neoplasms, Urinary Bladder Neoplasms

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 1

Sponsor:
Seagen Inc.

Collaborator:
-

Studienleiter

Medical Monitor
Study Director
Seagen Inc.

Kontakt

Studienlocations
(3 von 25)

New York Cancer and Blood Specialists
11776 Port Jefferson Station
United StatesRekrutierend» Google-Maps
Ansprechpartner:
New York Cancer and Blood Specialists Research Mailbox
E-Mail: Research@nycancer.com» Ansprechpartner anzeigen
Providence Portland Medical Center
97213 Portland
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Providence Cancer Institute CT.Gov Contact
Phone: 503-215-2614
E-Mail: CanClinRsrchStudies@providence.org» Ansprechpartner anzeigen
Providence Portland Medical Center
97225 Portland
United StatesRekrutierend» Google-Maps
Institut Gustave Roussy
94805 Villejuif Cedex
FranceRekrutierend» Google-Maps
Hospital Universitari Vall d'Hebron
08035 Barcelona
SpainRekrutierend» Google-Maps
Elche General University Hospital
03203 Elche
SpainRekrutierend» Google-Maps
Hospital Universitario De Jerez
11407 Jerez de la Frontera
SpainRekrutierend» Google-Maps
Hospital Universitario Ramon y Cajal Servicio de Oncologia Medica Oficina de Ensayos Clinicos
28034 Madrid
SpainRekrutierend» Google-Maps
START Madrid-CIOCC_Hospital HM Sanchinarro
28050 Madrid
SpainRekrutierend» Google-Maps
Hospital Universitario Marques de Valdecilla
39008 Santander
SpainRekrutierend» Google-Maps
University Hospital Lausanne CHUV
1011 Lausanne
SwitzerlandRekrutierend» Google-Maps
Sarah Cannon Research Institute UK
W1G 6AD London
United KingdomRekrutierend» Google-Maps
The Royal Marsden Hospital (Surrey)
SM2 5PT Sutton
United KingdomRekrutierend» Google-Maps
Alle anzeigen

Studien-Informationen

Brief Summary:

This trial will look at a drug called sigvotatug vedotin (SGN-B6A) alone and with

pembrolizumab, with or without chemotherapy, to find out whether it is safe for people

who have solid tumors. It will study sigvotatug vedotin to find out what its side effects

are. A side effect is anything the drug does besides treating cancer. It will also study

whether sigvotatug vedotin works to treat solid tumors.

The study will have four parts.

- Part A of the study will find out how much sigvotatug vedotin should be given to

participants.

- Part B will use the dose found in Part A to find out how safe sigvotatug vedotin is

and if it works to treat solid tumors.

- Part C of the study will find out how safe sigvotatug vedotin is in combination with

these other drugs.

- Part D will include people who have not received treatment. This part of the study

will find out how safe sigvotatug vedotin is in combination with these other drugs

and if these combinations work to treat solid tumors.

- In Parts C and D, participants will receive sigvotatug vedotin with either:

- Pembrolizumab or,

- Pembrolizumab and carboplatin, or

- Pembrolizumab and cisplatin.

Ein-/Ausschlusskriterien

Inclusion Criteria:

- Disease indication

- Participants must have histologically or cytologically confirmed metastatic or

unresectable solid malignancy within one of the tumor types listed below

(dependent on study part).

- Non-small cell lung cancer (NSCLC)

- Head and neck squamous cell cancer (HNSCC)

- Advanced HER2-negative breast cancer

- Esophageal squamous cell carcinoma (ESCC)

- Esophageal/Gastro-esophageal junction adenocarcinoma (EAC/GEJ)

- Cutaneous squamous cell cancer (cSCC)

- Exocrine pancreatic adenocarcinoma

- Bladder cancer

- Cervical cancer

- Gastric cancer

- High grade serous ovarian cancer (HGSOC)

- Part A only: Participants must have disease that is relapsed or refractory or

be intolerant to standard-of-care therapies and should have no appropriate

standard-of-care therapeutic options.

- Part B only: Participants must have disease that is relapsed or refractory or

be intolerant to standard-of-care therapies. Participants must have received

platinum-based therapy and a PD-1/PD-(L)1 inhibitor, if applicable and

available.

- Part C only: For pembrolizumab combination cohorts, participants must be

eligible for pembrolizumab per local standard of care. For pembrolizumab with

cisplatin or carboplatin, participants must be eligible for both pembrolizumab

and the platinum agent per local standard of care. Participants must be

treatment naïve for locally advanced or metastatic systemic therapy (prior

definitively intended or [neo]adjuvant therapy is allowed).

- Part D only: Participants must be treatment naïve for locally advanced or

metastatic systemic therapy.

- Participants enrolled in the following study parts should have a tumor site

accessible for biopsy and agree to biopsy as follows:

- Disease-specific expansion cohorts (Part B and Part D): A baseline fresh tumor

biopsy is required. An archival biopsy collected within 90 days prior to first

dose of study drug may be used.

- Biology expansion cohort: pretreatment biopsy and on-treatment (Cycle 1) biopsy

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

- Measurable disease per the RECIST v1.1 at baseline

Exclusion Criteria

- History of another malignancy within 3 years before first dose of study drug, or 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 of corticosteroids prescribed for symptoms associated with brain

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

- Carcinomatous meningitis

- Previous receipt of an MMAE-containing agent or an agent targeting integrin beta-6

- Pre-existing neuropathy Grade 1 or greater per the National Cancer Institute's

Common Terminology Criteria for Adverse Events, version 5.0 (NCI CTCAE v5.0) for

Parts C and D cohorts with cisplatin or carboplatin; Grade 2 or greater per the NCI

CTCAE v5.0 for all other cohorts

- Any uncontrolled Grade 3 or higher (per NCI CTCAE v5.0) viral, bacterial, or fungal

infection within 2 weeks prior to the first dose of sigvotatug vedotin.

- Routine antimicrobial prophylaxis is permitted

- Grade ≥3 pulmonary disease unrelated to underlying malignancy. This includes

clinically severe pulmonary function compromise resulting from clinically

significant pulmonary illnesses

- Part C and D: Prior therapy with a PD-1 inhibitor, anti-PD-(L)1, or anti PD-L2 agent

or with an agent directed to another stimulatory or co-inhibitory T-cell receptor

and was discontinued from that treatment due to a Grade 3 or higher immune-mediated

adverse event (IMAE).

- History of noninfectious interstitial lung disease (ILD) or pneumonitis that

required steroids, current ILD or pneumonitis, or suspected ILD or pneumonitis that

cannot be ruled out by imaging at screening

- Known diffusing capacity of the lung for carbon monoxide (DLCO; adjusted for

hemoglobin) <50% predicted

Studien-Rationale

Primary outcome:

1. Number of participants with adverse events (AEs) (Time Frame - Through 30-37 days following last dose of sigvotatug vedotin. For participants receiving pembrolizumab up to 90 days after last dose of pembrolizumab; up to 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 patients with laboratory abnormalities (Time Frame - Through 30-37 days following last dose of sigvotatug vedotin; up to 3 years)

3. Number of participants with dose-limiting toxicities (DLTs) (Time Frame - Through 30-37 days following last dose of sigvotatug vedotin; up to 3 years)

Secondary outcome:

1. Confirmed objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 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 RECIST v1.1.

2. Duration of objective response (DOR) per RECIST v1.1 by investigator assessment (Time Frame - Up to approximately 3 years):
The time from the first documentation of objective response (CR or PR that is subsequently confirmed) to the first documentation of progressive disease (PD) or to death due to any cause

3. Progression-free survival (PFS) per RECIST v1.1 by investigator assessment (Time Frame - Up to approximately 3 years):
The time from the start of any study treatment to the first documentation of PD, or death due to any cause

4. 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

5. Area under the concentration-time curve (AUC) (Time Frame - Through 30-37 days following last dose of sigvotatug vedotin; up to 3 years):
Pharmacokinetic (PK) endpoint

6. Concentration at the end of infusion (Ceoi) (Time Frame - Through 30-37 days following last dose of sigvotatug vedotin; up to 3 years):
PK endpoint

7. Maximum observed concentration (Cmax) (Time Frame - Through 30-37 days following last dose of sigvotatug vedotin; up to 3 years):
PK endpoint

8. Time to maximum observed concentration (Tmax) (Time Frame - Through 30-37 days following last dose of sigvotatug vedotin; up to 3 years):
PK endpoint

9. Trough concentration (Ctrough) (Time Frame - Through 30-37 days following last dose of sigvotatug vedotin; up to 3 years):
PK endpoint

10. Apparent terminal elimination half-life (t1/2) (Time Frame - Through 30-37 days following last dose of sigvotatug vedotin; up to 3 years):
PK endpoint

11. Number of participants with antidrug antibodies (ADAs) (Time Frame - Through 30-37 days following last dose of sigvotatug vedotin; up to 3 years)

Studien-Arme

  • Experimental: Part A: Dose escalation
    sigvotatug vedotin monotherapy
  • Experimental: Part B: Dose expansion
    sigvotatug vedotin monotherapy
  • Experimental: Part C: sigvotatug vedotin combination therapy in NSCLC, HNSCC, ESCC
    sigvotatug vedotin + pembrolizumab +/- (carboplatin or cisplatin)
  • Experimental: Part D: sigvotatug vedotin combination therapy in 1L NSCLC
    sigvotatug vedotin + pembrolizumab +/- (carboplatin)
  • Experimental: Part D: sigvotatug vedotin combination therapy in 1L HNSCC
    sigvotatug vedotin + pembrolizumab +/- (carboplatin or cisplatin)

Geprüfte Regime

  • sigvotatug vedotin (SGN-B6A):
    Administered into the vein (IV; intravenously)
  • pembrolizumab (Keytruda):
    200mg every 3 weeks or 400mg every 6 weeks, given by IV
  • cisplatin:
    75 mg/m2 every 3 weeks, given by IV
  • carboplatin:
    AUC 5 mg/mL per min every 3 weeks, given by IV

Quelle: ClinicalTrials.gov


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