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Soft Tissue SarcomaPhase 1NCT03957096

A Safety Study of SGN-CD47M in Patients With Solid Tumors

A Phase 1 study testing SGN-CD47M in people with Soft Tissue Sarcoma and Colorectal Cancer, run by Seagen Inc. at 5 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
SGN-CD47M
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
16 participants
Where
5 sitesUnited States
Study dates
17 Jul 2019to 14 Sep 2020
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically or cytologically confirmed metastatic or unresectable solid malignancy within one of the following indications:
  • Soft tissue sarcoma
  • Colorectal carcinoma
  • Non-small cell lung carcinoma
  • Head and neck squamous cell carcinoma
  • Breast carcinoma
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  • Ovarian carcinoma
  • Exocrine pancreatic adenocarcinoma
  • Gastric carcinoma
  • 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.

Who cannot join

  • 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
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  • 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

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

United States5 sites

  • Case Western Reserve University / University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106

  • MD Anderson Cancer Center / University of Texas

    Houston, Texas, 77030-4095

  • Tennessee Oncology-Nashvilee/Sarah Cannon Research Institute

    Nashville, Tennessee, 37203

  • Providence Portland Medical Center

    Portland, Oregon, 97213

  • NEXT Oncology

    San Antonio, Texas, 78229

Other trials in United States

About this study

Official title: A Phase 1 Study of SGN-CD47M in Patients With Advanced Solid Tumors

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.

Read the 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.

Being tested
SGN-CD47M
Keywords
HNSCC, NSCLC
Medical subject headings
Sarcoma, Colorectal Neoplasms, Squamous Cell Carcinoma of Head and Neck, Carcinoma, Non-Small-Cell Lung, Breast Neoplasms, Ovarian Neoplasms, Stomach Neoplasms, Melanoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SGN-CD47MDrug

    SGN-CD47M administered intravenously

Study groups in NCT03957096
Study groupRoleWhat they receive
SGN-CD47MExperimentalNot described
Receives: Drug: SGN-CD47M

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of patients with adverse events

    Measured: Up to approximately 24 months

  2. Number of patients with laboratory abnormalities

    Measured: Up to approximately 24 months

  3. Number of patients with dose-limiting toxicities (DLTs)

    Measured: 28 days

Secondary outcomes (14)

  1. Objective response rate (ORR) per RECIST v1.1

    Defined as the proportion of patients with CR or PR

    Measured: Up to approximately 2.5 years

  2. ORR per iRECIST

    Defined as the proportion of patients with iCR or iPR

    Measured: Up to approximately 2.5 years

  3. Duration of objective response (DOR) per RECIST v1.1

    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

    Measured: Up to approximately 2.5 years

  4. DOR per iRECIST

    Measured: Up to approximately 2.5 years

  5. Duration of complete response (CR) per RECIST v1.1

    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

    Measured: Up to approximately 2.5 years

  6. Duration of CR per iRECIST

    Measured: Up to approximately 2.5 years

  7. Progression-free survival (PFS) per RECIST v1.1

    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

    Measured: Up to approximately 2.5 years

  8. PFS per iRECIST

    Measured: Up to approximately 2.5 years

  9. Overall survival (OS)

    Defined as the time from the start of any study treatment to the date of death due to any cause

    Measured: Up to approximately 4 years

  10. Area under the concentration-time curve (AUC)

    Measured: Up to approximately 24 months

  11. Maximum concentration (Cmax)

    Measured: Up to approximately 24 months

  12. Time to Cmax (Tmax)

    Measured: Up to approximately 24 months

  13. Trough concentration (Ctrough)

    Measured: Up to approximately 24 months

  14. Incidence of antidrug antibodies (ADA)

    Measured: Up to approximately 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 May 2019
  2. Study start17 Jul 2019
  3. Primary completion14 Sep 2020
  4. Study completion14 Sep 2020

Why it stopped: Sponsor decision based on portfolio prioritization

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03957096
Sponsor's protocol ID
SGN47M-001
Status last verified
Sep 2020
First submitted
17 May 2019
Last updated
17 Sep 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing SGN-CD47M in people with Soft Tissue Sarcoma and Colorectal Cancer, run by Seagen Inc. at 5 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 17 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Sponsor decision based on portfolio prioritization). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of patients with adverse events (time frame: Up to approximately 24 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03957096.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2020.

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