Trials / Terminated
TerminatedNCT03957096
A Safety Study of SGN-CD47M in Patients With Solid Tumors
A Phase 1 Study of SGN-CD47M in Patients With Advanced Solid Tumors
- Status
- Terminated
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 16 (actual)
- Sponsor
- Seagen Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
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
| Type | Name | Description |
|---|---|---|
| DRUG | SGN-CD47M | SGN-CD47M administered intravenously |
Timeline
- Start date
- 2019-07-17
- Primary completion
- 2020-09-14
- Completion
- 2020-09-14
- First posted
- 2019-05-21
- Last updated
- 2020-09-17
Locations
5 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03957096. Inclusion in this directory is not an endorsement.