Clinical trial
A Phase 1 Study of SGN-BB228 in Advanced Melanoma and Other Solid Tumors
Aliases
SGNBB228-001
Name
SGNBB228-001
Description
This study will test the safety of a drug called SGN-BB228 in participants with melanoma and other solid tumors that are hard to treat or have spread through the body. 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.
This study will have 3 parts. Parts A and B of the study will find out how much SGN-BB228 should be given to participants. Part C will use the information from Parts A and B to see if SGN-BB228 is safe and if it works to treat solid tumor cancers.
Trial arms
Arm 1
arm_1
Sample size
0
Intervention
Dosage information
Dosage schedule
Population
Adults ≥18 years, Metastatic or unresectable cutaneous melanoma, Disease relapsed, refractory, or intolerant to standard of care therapies, ECOG PS 0-1, Adequate organ function, Prior anti PD(L)-1 therapy for cutaneous melanoma, Prior BRAF/MEK therapy if BRAF mutation positive
Trial start
2023-01-03
Estimated PCD
2025-10-31
Trial end
2028-09-30
Status
Recruiting
Phase
Early phase I
Treatment
SGN-BB228
Given into the vein (IV; intravenous)
Arms:
SGN-BB228
Size
275
Primary endpoint
Number of participants with adverse events (AEs)
Through 30 days after the last study treatment; approximately 7 months
Number of participants with laboratory abnormalities
Through 30 days after the last study treatment; approximately 7 months
Number of participants with dose limiting toxicities
Up to 28 days
Eligibility criteria
Inclusion Criteria:
* All Parts: Participants must have disease that is relapsed, refractory, or intolerant to standard of care. Participants must have histologically or cytologically confirmed metastatic malignancy.
* Participants must have one of the following tumor types:
* Parts A and B: Participants must have metastatic or unresectable cutaneous melanoma.
* Part C: Participants must have one of the following tumor types:
* Cutaneous Melanoma
* Non-small Cell Lung Cancer (NSCLC)
* Colorectal Cancer (CRC)
* Pancreatic Cancer
* Mesothelioma
* A pre-treatment biopsy or submission of archival tissue is required
* For participants with cutaneous melanoma
* Must have been previously treated with an anti-programmed death-1 (anti-PD-1) or anti-programmed death ligand-1 (anti-PD-L1) agent given alone or with other therapies.
* Participants with a targetable BRAF mutation must have been treated with, been intolerant of, or been deemed ineligible to receive treatment with BRAF/MEK targeted therapy prior to study entry.
* Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1
* Measurable disease per RECIST v1.1 at baseline
Exclusion Criteria:
* History of another malignancy within 3 years before the 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.
* Active central nervous system metastases or leptomeningeal disease. 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,
* they 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 the first dose of study drug.
* Prior therapies cannot include any drugs targeting CD228 or 4-1BB
* Immunotherapy, biologics, and/or other approved or investigational antitumor treatment that is not completed 4 weeks prior to first dose of study drug, or within 2 weeks prior to the first dose of study drug if the underlying disease has progressed on treatment
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 275, 'type': 'ESTIMATED'}}
Updated at
2024-05-07
1 organization
1 product
5 indications
Organization
SeagenProduct
SGN-BB228Indication
MelanomaIndication
Lung CancerIndication
Colorectal CancerIndication
Pancreatic CancerIndication
Mesothelioma