Description:
This trial will study SGN-CD47M to find out whether it is an effective treatment for
different types of solid tumors and what side effects (unwanted effects) may occur. The study
will have two parts. Part A of the study will find out how much SGN-CD47M should be given for
treatment and how often. Part B of the study will use the dose found in Part A and look at
how safe and effective the treatment is.
Title
- Brief Title: A Safety Study of SGN-CD47M in Patients With Solid Tumors
- Official Title: A Phase 1 Study of SGN-CD47M in Patients With Advanced Solid Tumors
Clinical Trial IDs
- ORG STUDY ID:
SGN47M-001
- NCT ID:
NCT03957096
Conditions
- Soft Tissue Sarcoma
- Colorectal Cancer
- Head and Neck Squamous Cell Carcinoma
- Non-small Cell Lung Carcinoma
- Breast Carcinoma
- Ovarian Carcinoma
- Exocrine Pancreatic Carcinoma
- Gastric Carcinoma
- Melanoma
Interventions
Drug | Synonyms | Arms |
---|
SGN-CD47M | | SGN-CD47M |
Purpose
This trial will study SGN-CD47M to find out whether it is an effective treatment for
different types of solid tumors and what side effects (unwanted effects) may occur. The study
will have two parts. Part A of the study will find out how much SGN-CD47M should be given for
treatment and how often. Part B of the study will use the dose found in Part A and look at
how safe and effective the treatment is.
Detailed Description
This is a dose-escalation study designed to evaluate the safety, tolerability,
pharmacokinetics (PK), and antitumor activity of SGN-CD47M in adults with advanced solid
tumors. The study will be conducted in 2 parts:
Part A - Dose escalation: Up to approximately 25 patients will be treated to evaluate the
safety, tolerability, and PK of SGN-CD47M, and to identify the maximum tolerated dose (MTD)
and/or optimal dose.
Part B - Dose expansion: Up to approximately 180 patients will be treated in expansion
cohorts at the MTD or optimal dose to further characterize the safety, PK, and antitumor
activity of SGN-CD47M.
In eligible patients, standard therapies must have failed, been intolerable, or been
considered medically inappropriate by the investigator. If the MTD is not reached in Part A,
safety, PK, pharmacodynamic, and biomarker analyses, as well as preliminary antitumor
activity, will be used to determine the optimal dose. Patients in Part A may continue on
treatment until confirmed progressive disease (PD) or unacceptable toxicity, whichever occurs
first. The dose(s) to be examined in Part B will be at or below the MTD and/or the optimal
dose determined in Part A.
Trial Arms
Name | Type | Description | Interventions |
---|
SGN-CD47M | Experimental | | |
Eligibility Criteria
Inclusion Criteria:
- Histologically or cytologically confirmed metastatic or unresectable solid malignancy
within one of the following indications:
1. Soft tissue sarcoma
2. Colorectal carcinoma
3. Non-small cell lung carcinoma
4. Head and neck squamous cell carcinoma
5. Breast carcinoma
6. Ovarian carcinoma
7. Exocrine pancreatic adenocarcinoma
8. Gastric carcinoma
9. Melanoma
- Relapsed, refractory, or progressive disease with no appropriate standard therapy
available at the time of enrollment
- ECOG performance status of 0 or 1
- Measureable disease per the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
at baseline
- Patients of childbearing potential may not be pregnant, must agree not to become
pregnant until at 30 days after last dose of study drug, and must use 2 effective
means of birth control.
- Patients who can father children must use 2 effective means of birth control and must
agree not to donate sperm until at least 60 days after last dose of study drug.
Exclusion Criteria:
- History of another malignancy within 3 years prior to first dose of study drug
(exceptions for malignancies with negligible risk of metastasis)
- Previous exposure to CD47 or SIRPα targeted therapy
- Chemotherapy, systemic radiotherapy, biologics, other anti-neoplastic or
investigational agents, and/or other antitumor treatment with immunotherapy that is
not completed 4 weeks prior to first dose of SGN-CD47M. Focal radiotherapy that is not
completed 2 weeks prior to the first dose of SGN-CD47M
- Known active central nervous system metastases
- Positive for hepatitis B, active hepatitis C infections, positive for human
immunodeficiency virus (HIV), or known active or latent tuberculosis
- History of sickle cell anemia, auto-immune hemolytic anemia, or idiopathic
thrombocytopenic purpura
- Carcinomatous meningitis
- Red blood cell transfusion within 4 weeks prior to enrollment or platelet transfusion
within 2 weeks prior to enrollment
- Any active Grade 3 or higher viral, bacterial, or fungal infection within 2 weeks
prior to first dose
- History of a cerebral vascular event, unstable angina, myocardial infarction, or
cardiac symptoms consistent with New York Heart Association Class III-IV within 6
months prior to first dose
- Condition requiring systemic treatment with corticosteroids or other immunosuppressive
medications within 2 week prior to first dose
- Active autoimmune disease, autoimmune-related toxicity from prior
immuno-oncology-based therapy
- Estimated life expectancy of less than 12 weeks
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Number of patients with adverse events |
Time Frame: | Up to approximately 24 months |
Safety Issue: | |
Description: | |
Secondary Outcome Measures
Measure: | Objective response rate (ORR) per RECIST v1.1 |
Time Frame: | Up to approximately 2.5 years |
Safety Issue: | |
Description: | Defined as the proportion of patients with CR or PR |
Measure: | ORR per iRECIST |
Time Frame: | Up to approximately 2.5 years |
Safety Issue: | |
Description: | Defined as the proportion of patients with iCR or iPR |
Measure: | Duration of objective response (DOR) per RECIST v1.1 |
Time Frame: | Up to approximately 2.5 years |
Safety Issue: | |
Description: | Defined as the time from start of the first documentation of objective tumor response (CR or PR) to the first documentation of disease progression or to death due to any cause, whichever comes first |
Measure: | DOR per iRECIST |
Time Frame: | Up to approximately 2.5 years |
Safety Issue: | |
Description: | |
Measure: | Duration of complete response (CR) per RECIST v1.1 |
Time Frame: | Up to approximately 2.5 years |
Safety Issue: | |
Description: | Defined as the time from start of the first documentation of objective tumor response to the first documentation of confirmed tumor progression or to death due to any cause, whichever comes first for the subgroup of patients achieving a CR |
Measure: | Duration of CR per iRECIST |
Time Frame: | Up to approximately 2.5 years |
Safety Issue: | |
Description: | |
Measure: | Progression-free survival (PFS) per RECIST v1.1 |
Time Frame: | Up to approximately 2.5 years |
Safety Issue: | |
Description: | Defined as the time from start of study treatment to first documentation of disease progression or to death due to any cause, whichever comes first |
Measure: | PFS per iRECIST |
Time Frame: | Up to approximately 2.5 years |
Safety Issue: | |
Description: | |
Measure: | Overall survival (OS) |
Time Frame: | Up to approximately 4 years |
Safety Issue: | |
Description: | Defined as the time from the start of any study treatment to the date of death due to any cause |
Measure: | Area under the concentration-time curve (AUC) |
Time Frame: | Up to approximately 24 months |
Safety Issue: | |
Description: | |
Measure: | Maximum concentration (Cmax) |
Time Frame: | Up to approximately 24 months |
Safety Issue: | |
Description: | |
Measure: | Time to Cmax (Tmax) |
Time Frame: | Up to approximately 24 months |
Safety Issue: | |
Description: | |
Measure: | Trough concentration (Ctrough) |
Time Frame: | Up to approximately 24 months |
Safety Issue: | |
Description: | |
Measure: | Incidence of antidrug antibodies (ADA) |
Time Frame: | Up to approximately 24 months |
Safety Issue: | |
Description: | |
Details
Phase: | Phase 1 |
Primary Purpose: | Interventional |
Overall Status: | Terminated |
Lead Sponsor: | Seagen Inc. |
Trial Keywords
Last Updated
September 17, 2020