Description:
This trial will look at a drug called SGN-B6A to find out whether it is safe for people who
have solid tumors. It will study SGN-B6A to find out what its side effects are. A side effect
is anything the drug does besides treating cancer. It will also study whether SGN-B6A works
to treat solid tumors.
The study will have two parts. Part A of the study will find out how much SGN-B6A should be
given to participants. Part B will use the dose found in Part A to find out how safe SGN-B6A
is and if it works to treat solid tumors.
Title
- Brief Title: A Study of SGN-B6A in Advanced Solid Tumors
- Official Title: A Phase 1 Study of SGN-B6A in Advanced Solid Tumors
Clinical Trial IDs
- ORG STUDY ID:
SGNB6A-001
- NCT ID:
NCT04389632
Conditions
- Carcinoma, Non-small Cell Lung
- Squamous Cell Carcinoma of Head and Neck
- Breast Neoplasms
- Esophageal Squamous Cell Carcinoma
- Ovarian Neoplasms
- Cutaneous Squamous Cell Cancer
- Exocrine Pancreatic Adenocarcinoma
- Urinary Bladder Neoplasms
- Uterine Cervical Neoplasms
- Stomach Neoplasms
Interventions
Drug | Synonyms | Arms |
---|
SGN-B6A | | SGN-B6A |
Purpose
This trial will look at a drug called SGN-B6A to find out whether it is safe for people who
have solid tumors. It will study SGN-B6A to find out what its side effects are. A side effect
is anything the drug does besides treating cancer. It will also study whether SGN-B6A works
to treat solid tumors.
The study will have two parts. Part A of the study will find out how much SGN-B6A should be
given to participants. Part B will use the dose found in Part A to find out how safe SGN-B6A
is and if it works to treat solid tumors.
Trial Arms
Name | Type | Description | Interventions |
---|
SGN-B6A | Experimental | SGN-B6A monotherapy | |
Eligibility Criteria
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). 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 option.
- Non-small cell lung cancer (NSCLC)
- Head and neck squamous cell cancer (HNSCC)
- Advanced HER2-negative breast cancer
- Esophageal squamous cell carcinoma (ESCC)
- Cutaneous squamous cell cancer (cSCC)
- Exocrine pancreatic adenocarcinoma
- Bladder cancer
- Cervical cancer
- Gastric cancer
- High grade serous ovarian cancer (HGSOC)
- 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, participant 13 onwards: pre-treatment biopsy
- Biology expansion cohort: pre-treatment biopsy and additional on-treatment biopsy
during Cycle 1
- 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 2 or greater per the National Cancer Institute's Common
Terminology Criteria for Adverse Events, version 5.0 (NCI CTCAE v5.0)
- 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 SGN-B6A.
- Routine antimicrobial prophylaxis is permitted
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Number of participants with treatment-emergent adverse events (AEs) |
Time Frame: | Through 30-37 days following last dose of SGN-B6A; up to 3 years |
Safety Issue: | |
Description: | |
Secondary Outcome Measures
Measure: | Area under the concentration-time curve (AUC) |
Time Frame: | Through 30-37 days following last dose of SGN-B6A; up to 3 years |
Safety Issue: | |
Description: | Pharmacokinetic (PK) endpoint |
Measure: | Concentration at the end of infusion (Ceoi) |
Time Frame: | Through 30-37 days following last dose of SGN-B6A; up to 3 years |
Safety Issue: | |
Description: | PK endpoint |
Measure: | Maximum observed concentration (Cmax) |
Time Frame: | Through 30-37 days following last dose of SGN-B6A; up to 3 years |
Safety Issue: | |
Description: | PK endpoint |
Measure: | Time to maximum observed concentration (Tmax) |
Time Frame: | Through 30-37 days following last dose of SGN-B6A; up to 3 years |
Safety Issue: | |
Description: | PK endpoint |
Measure: | Trough concentration (Ctrough) |
Time Frame: | Through 30-37 days following last dose of SGN-B6A; up to 3 years |
Safety Issue: | |
Description: | PK endpoint |
Measure: | Apparent terminal elimination half-life (t1/2) |
Time Frame: | Through 30-37 days following last dose of SGN-B6A; up to 3 years |
Safety Issue: | |
Description: | PK endpoint |
Measure: | Number of participants with antidrug antibodies |
Time Frame: | Through 30-37 days following last dose of SGN-B6A; up to 3 years |
Safety Issue: | |
Description: | |
Measure: | Objective response rate (ORR) per RECIST v1.1 |
Time Frame: | Up to approximately 3 years |
Safety Issue: | |
Description: | The proportion of participants with complete response (CR) or partial response (PR) |
Measure: | Duration of objective response (DOR) |
Time Frame: | Up to approximately 3 years |
Safety Issue: | |
Description: | 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 |
Measure: | Progression-free survival (PFS) |
Time Frame: | Up to approximately 3 years |
Safety Issue: | |
Description: | The time from the start of any study treatment to the first documentation of disease progression, or death due to any cause |
Measure: | Overall survival (OS) |
Time Frame: | Up to approximately 3 years |
Safety Issue: | |
Description: | The time from the start of any study treatment to the date of death due to any cause |
Details
Phase: | Phase 1 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Seagen Inc. |
Trial Keywords
- NSCLC
- HNSCC
- cSCC
- ESCC
- HGSOC
- Advanced HER2-Negative Breast Cancer
- High Grade Serous Ovarian Cancer
- Non-small cell lung cancer
- Head and neck squamous cell cancer
- Esophageal cancer
- Bladder cancer
- Cervical cancer
- Gastric cancer
- Seattle Genetics
Last Updated
August 17, 2021