Carcinoma, Non-Small Cell LungPhase 1NCT04665921
A Study of SGN-STNV in Advanced Solid Tumors
A Phase 1 study testing SGN-STNV in people with Carcinoma, Non-Small Cell Lung and HER2 Negative Breast Neoplasms, run by Seagen Inc. at 18 sites in 6 countries.
Trial summary
This trial will look at a drug called SGN-STNV to find out whether it is safe for patients with solid tumors. It will study SGN-STNV to find out what its side effects are. A side effect is anything the drug does besides treating cancer. It will also study how well SGN-STNV works to treat solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Non-Small Cell Lung, HER2 Negative Breast Neoplasms, Ovarian Neoplasms
- What is being tested?
- SGN-STNV
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 111 participants
- Where
- 18 sitesin 6 countries
- Study dates
- 18 Jan 2021to 1 Mar 2024
- 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
- Disease indication
- 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)
- HER2 negative breast cancer
- Ovarian cancer
- Cervical cancer
Show all 21Show fewer
- Endometrial cancer
- Esophageal cancer
- Gastric cancer and GEJ carcinoma
- Colorectal cancer
- Exocrine pancreatic adenocarcinoma
- Appendiceal adenocarcinoma and pseudomyxoma peritonei of unknown origin
- Participants enrolled in the following study parts should have an appropriate tumor site that satisfies the following criteria:
- Site has tumor that is not a target lesion and has not been previously irradiated (unless progression has occurred since end of radiotherapy)
- Site has tumor that is accessible for a minimally invasive biopsy that does not present a significant risk, AND
- Participant must agree to a biopsy as follows
- Disease-specific expansion cohorts: pre-treatment biopsy, unless medically infeasible following consultation with the medical monitor
- Biology expansion cohort: pretreatment biopsy (required) and additional on-treatment biopsy during Cycle 1 (unless medically infeasible following consultation with the medical monitor)
- Measurable disease per the Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) at baseline
- An Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
- Adequate renal, hepatic, and hematologic function
Who cannot join
- 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.
- Known active central nervous system metastases
- Carcinomatous meningitis
- Previous receipt of monomethylauristatin E (MMAE)-containing drugs
- Pre-existing neuropathy ≥ Grade 2 per the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
- Any uncontrolled ≥ Grade 3 (per the NCI CTCAE, Version 5.0) viral, bacterial, or fungal infection within 2 weeks prior to the first dose of SGN-STNV
- There are additional inclusion and exclusion criteria. The study center will determine if criteria for participation are met.
Trial locations and contacts
18 sites in 6 countries.
18 sites in 6 countries
United States12 sites
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
Shands Cancer Center / University of Florida
Gainesville, Florida, 32610
South Texas Accelerated Research Therapeutics Midwest
Grand Rapids, Michigan, 49546
The Angeles Clinic and Research Institute
Los Angeles, California, 90025
University of Miami
Miami, Florida, 33136
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Magee Womens Hospital of UPMC
Pittsburgh, Pennsylvania, 15213
Oregon Health and Science University
Portland, Oregon, 97239-3098
South Texas Accelerated Research Therapeutics
San Antonio, Texas, 78229
University of California, San Francisco | HDFCCC - Hematopoietic Malignancies
San Francisco, California, 94158
Canada2 sites
University of Ottawa / Ottawa General Hospital
Ottawa, Ontario, K1H 8L6
University Health Network, Princess Margaret Hospital
Toronto, Other, M5G 2C1
United Kingdom1 site
The Royal Marsden Hospital (Surrey)
Sutton, Other, SM2 5PT
About this study
Official title: A Phase 1 Study of SGN-STNV in Advanced Solid Tumors
This trial will look at a drug called SGN-STNV to find out whether it is safe for patients with solid tumors. It will study SGN-STNV to find out what its side effects are. A side effect is anything the drug does besides treating cancer. It will also study how well SGN-STNV works to treat solid tumors.
The study will have two parts. Part A of the study will find out how much SGN-STNV should be given to patients. Part B will use the dose found in Part A to find out how safe SGN-STNV is and if it works to treat certain types of solid tumors.
Read the detailed description
The study will include dose escalation (Part A) and dose expansion (Part B), with multiple disease-specific cohorts and a biology cohort in dose expansion. The biology cohort will require additional biopsies. At the completion of dose escalation, up to 5 disease specific expansion cohorts and 1 biology expansion cohort may be activated by the sponsor in consultation with the Safety Monitoring Committee (SMC). Expansion cohorts in Part B will enroll subjects with selected tumors that are eligible for enrollment in Part A. The dose(s) to be examined in Part B will be at or below the maximum tolerated dose and/or the recommended dose determined in Part A. The recommended dose and/or schedule may differ between cohorts.
- Conditions
- Carcinoma, Non-Small Cell Lung, HER2 Negative Breast Neoplasms, Ovarian Neoplasms, Uterine Cervical Neoplasms, Endometrial Neoplasms, Esophageal Neoplasms
- Being tested
- SGN-STNV
- Keywords
- NSCLC, Non-Small Cell Lung Cancer, HER2-Negative Breast Cancer, High-Grade Serous Ovarian Cancer, HGSOC, Ovarian Cancer, Cervical Cancer, Endometrial Cancer, Esophageal Cancer, Gastric Cancer, GEJ Carcinoma, Colorectal Cancer, Seattle Genetics
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Ovarian Neoplasms, Uterine Cervical Neoplasms, Endometrial Neoplasms, Esophageal Neoplasms, Stomach Neoplasms, Colorectal Neoplasms, Adenocarcinoma, Mucinous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SGN-STNVDrug
Given into the vein (IV; intravenously)
| Study group | Role | What they receive |
|---|---|---|
| SGN-STNV | Experimental | SGN-STNV monotherapy Receives: Drug: SGN-STNV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events (AEs)
To be summarized using descriptive statistics
Measured: Through 30-37 days following last dose of SGN-STNV; up to approximately 3 years
Incidence of laboratory abnormalities
To be summarized using descriptive statistics
Measured: Through 30-37 days following last dose of SGN-STNV; up to approximately 3 years
Incidence of dose limiting toxicities
To be summarized using descriptive statistics
Measured: Up to 28 days
Secondary outcomes (9)
Objective response rate (ORR) as assessed by the investigator per RECIST v1.1
ORR is defined as the proportion of subjects achieving a partial response (PR) or complete response (CR).
Measured: Up to approximately 3 years
Progression-free survival (PFS)
PFS is defined as the time from the start of any study treatment to first documentation of disease progression or to death due to any cause, whichever comes first.
Measured: Up to approximately 3 years
Overall survival (OS)
OS is defined as the time from the start of any study treatment to the date of death due to any cause.
Measured: Up to approximately 3 years
Duration of objective response (DOR)
DOR is defined as 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, whichever comes first.
Measured: Up to approximately 3 years
Area under the concentration-time curve (AUC)
Pharmacokinetic (PK) endpoint
Measured: Through 30-37 days following last dose of SGN-STNV; up to approximately 3 years
Time to maximum concentration (Tmax)
PK endpoint
Measured: Through 30-37 days following last dose of SGN-STNV; up to approximately 3 years
Maximum concentration (Cmax)
PK endpoint
Measured: Through 30-37 days following last dose of SGN-STNV; up to approximately 3 years
Trough concentration (Ctrough)
PK endpoint
Measured: Through 30-37 days following last dose of SGN-STNV; up to approximately 3 years
Incidence of antidrug antibodies (ADA)
Immunogenicity endpoint
Measured: Through 30-37 days following last dose of SGN-STNV; up to approximately 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2020
- Study start18 Jan 2021
- Primary completion1 Mar 2024
- Study completion1 Mar 2024
Why it stopped: Study closed due to portfolio prioritization
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, Non-Small Cell LungStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seagen Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Suzanne McGoldrick, MD, Study director, Seagen Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04665921
- Sponsor's protocol ID
- SGNSTNV-001
- Status last verified
- Feb 2025
- First submitted
- 7 Dec 2020
- Last updated
- 7 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study of SGN-STNV in Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT04665921
- Acronym / sponsor ID
- SGNSTNV-001
- Conditions
- Carcinoma, Non-Small Cell Lung, HER2 Negative Breast Neoplasms, Ovarian Neoplasms, Uterine Cervical Neoplasms, Endometrial Neoplasms, Esophageal Neoplasms
- Keywords
- NSCLC, Non-Small Cell Lung Cancer, HER2-Negative Breast Cancer, High-Grade Serous Ovarian Cancer, HGSOC, Ovarian Cancer, Cervical Cancer, Endometrial Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study closed due to portfolio prioritization
- Enrolment
- 111 participants (actual)
- Lead sponsor
- Seagen Inc.Industry (pharma, biotech, devices)
- Study start
- 18 Jan 2021 (actual)
- Primary completion
- 1 Mar 2024 (actual)
- Study completion
- 1 Mar 2024 (actual)
- First posted
- 14 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial will look at a drug called SGN-STNV to find out whether it is safe for patients with solid tumors. It will study SGN-STNV to find out what its side effects are. A side effect is anything the drug does besides treating cancer. It will also study how well SGN-STNV works to treat solid tumors.
The study will have two parts. Part A of the study will find out how much SGN-STNV should be given to patients. Part B will use the dose found in Part A to find out how safe SGN-STNV is and if it works to treat certain types of solid tumors.
Detailed description
The study will include dose escalation (Part A) and dose expansion (Part B), with multiple disease-specific cohorts and a biology cohort in dose expansion. The biology cohort will require additional biopsies. At the completion of dose escalation, up to 5 disease specific expansion cohorts and 1 biology expansion cohort may be activated by the sponsor in consultation with the Safety Monitoring Committee (SMC). Expansion cohorts in Part B will enroll subjects with selected tumors that are eligible for enrollment in Part A. The dose(s) to be examined in Part B will be at or below the maximum tolerated dose and/or the recommended dose determined in Part A. The recommended dose and/or schedule may differ between cohorts.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SGN-STNV | Experimental | Drug: SGN-STNVSGN-STNV monotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Disease indication
- Participants enrolled in the following study parts should have an appropriate tumor site that satisfies the following criteria:
- Measurable disease per the Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) at baseline
- An Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
- Adequate renal, hepatic, and hematologic function
Key exclusion criteria (7 listed)
- 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.
- Known active central nervous system metastases
- Carcinomatous meningitis
- Previous receipt of monomethylauristatin E (MMAE)-containing drugs
- Pre-existing neuropathy ≥ Grade 2 per the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SGN-STNVGiven into the vein (IV; intravenously) | Drug | SGN-STNV |
Primary outcome
Incidence of adverse events (AEs)
Time frame: Through 30-37 days following last dose of SGN-STNV; up to approximately 3 years
To be summarized using descriptive statistics
Incidence of laboratory abnormalities
Time frame: Through 30-37 days following last dose of SGN-STNV; up to approximately 3 years
To be summarized using descriptive statistics
Incidence of dose limiting toxicities
Time frame: Up to 28 days
To be summarized using descriptive statistics
9 secondary outcomes
Objective response rate (ORR) as assessed by the investigator per RECIST v1.1
Time frame: Up to approximately 3 years
Progression-free survival (PFS)
Time frame: Up to approximately 3 years
Overall survival (OS)
Time frame: Up to approximately 3 years
Duration of objective response (DOR)
Time frame: Up to approximately 3 years
Area under the concentration-time curve (AUC)
Time frame: Through 30-37 days following last dose of SGN-STNV; up to approximately 3 years
Time to maximum concentration (Tmax)
Time frame: Through 30-37 days following last dose of SGN-STNV; up to approximately 3 years
Maximum concentration (Cmax)
Time frame: Through 30-37 days following last dose of SGN-STNV; up to approximately 3 years
Trough concentration (Ctrough)
Time frame: Through 30-37 days following last dose of SGN-STNV; up to approximately 3 years
Incidence of antidrug antibodies (ADA)
Time frame: Through 30-37 days following last dose of SGN-STNV; up to approximately 3 years
Results and safety
The study was stopped early (reason given: Study closed due to portfolio prioritization). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Suzanne McGoldrick, MD study director
Seagen Inc.
18 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SGN-STNV in people with Carcinoma, Non-Small Cell Lung and HER2 Negative Breast Neoplasms, run by Seagen Inc. at 18 sites in 6 countries.
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 21 inclusion and 7 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 7 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in United States, Canada, France, Italy, Spain and 1 more country. 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: Study closed due to 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?
Incidence of adverse events (AEs) (time frame: Through 30-37 days following last dose of SGN-STNV; up to approximately 3 years). 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?
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 7 Feb 2025.