Ovarian NeoplasmsPhase 1NCT05229900
A Study of SGN-ALPV in Advanced Solid Tumors
A Phase 1 study testing SGN-ALPV in people with Ovarian Neoplasms and Endometrial Neoplasms, run by Seagen Inc. at 13 sites in 5 countries.
Trial summary
This study will test the safety of a drug called SGN-ALPV in participants with solid tumors. It will also study the side effects of this drug. A side effect is anything a drug does to your body besides treating your disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ovarian Neoplasms, Endometrial Neoplasms, Carcinoma, Non-Small-Cell Lung
- What is being tested?
- SGN-ALPV
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 13 sitesin 5 countries
- Study dates
- 21 Apr 2022to 13 Dec 2023
- 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
- Participants must have one of the following histologically or cytologically confirmed metastatic or unresectable solid tumor types:
- Parts A and B
- Ovarian cancer
- Endometrial cancer
- Non-small cell lung cancer (NSCLC)
- Gastric cancer, including gastroesophageal junction (GEJ) carcinoma
Show all 20Show fewer
- Cervical cancer
- Malignant testicular germ cell tumor (GCT), except for pure teratomas
- Malignant ovarian GCT, except for pure teratomas
- Malignant extragonadal GCT except for pure teratomas or tumors with primaries arising from CNS
- Part C
- High-grade serous ovarian cancer (HGSOC): Participants must have HGSOC which has progressed or relapsed within 6 months after previous platinum containing chemotherapy, received 2 to 4 prior anticancer lines of therapy, and at least 1 line of therapy in the platinum-resistant setting. If eligible at least 1 line of therapy must have contained bevacizumab or a biosimilar to bevacizumab.
- Endometrial Cancer: Participants must have unresectable locally advance or metastatic endometrial carcinoma and have had at least 1 prior line of therapy.
- NSCLC: Participants must have unresectable locally advanced or metastatic NSCLC and have received platinum-based therapy and a PD-(L)1 inhibitor.
- Gastric cancer or GEJ carcinoma: Participants must have unresectable locally advanced or metastatic gastric cancer or GEJ carcinoma and have received prior platinum and fluoropyrimidine -based chemotherapy
- Participants enrolled in the following study parts should have an appropriate tumor site and agree to a biopsy
- Part B dose and schedule optimization cohorts and Part C disease-specific expansion cohorts: pretreatment biopsy, unless clinically infeasible following consultation with the medical monitor.
- Part C biology expansion cohort: pretreatment biopsy (required), on-treatment biopsy during Cycle 1 (unless clinically infeasible following consultation with the medical monitor)
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
- Measurable disease per the RECIST v1.1 at baseline
Who cannot join
- History of another malignancy within 3 years of first dose of study treatment or any evidence of residual disease from a previously diagnosed malignancy. Exceptions are malignancies with a negligible risk of metastasis or death.
- Known active central nervous system metastases.
- Previous receipt of an MMAE-containing agent or an agent targeting ALPP or ALPPL2.
- Pre-existing neuropathy ≥ Grade 2 per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0
Trial locations and contacts
13 sites in 5 countries.
13 sites in 5 countries
United States7 sites
Virginia Cancer Specialists
Fairfax, Virginia, 22031
Women's Cancer Care
Fresno, California, 93710
START Midwest
Grand Rapids, Michigan, 49546
Yale Cancer Center
New Haven, Connecticut, 06510
Oklahoma University at Stephenson Cancer Center
Oklahoma City, Oklahoma, 73104
Florida Cancer Specialists - Lake Nona
Wellington, Florida, 33414
START Mountain Region
West Valley City, Utah, 84119
Canada2 sites
Ottawa Hospital Cancer Centre
Ottawa, Ontario, K1H 8L6
University Health Network, Princess Margaret Hospital
Toronto, Ontario, M5G 2M9
United Kingdom2 sites
The Royal Marsden NHS Foundation Trust (RM)
London, Other, SW3 6JJ
Sarah Cannon Research Institute UK
London, Other, W1G 6AD
About this study
Official title: A Phase 1 Study of SGN-ALPV in Advanced Solid Tumors
This study will test the safety of a drug called SGN-ALPV in participants with solid tumors. It will also study the side effects of this drug. A side effect is anything a drug does to your body besides treating your disease.
Participants will have solid tumor cancer that has spread through the body (metastatic) or cannot be removed with surgery (unresectable).
This study will have three parts. Parts A and B of the study will find out how much SGN-ALPV should be given to participants. Part C will use the dose and schedule found in Parts A and B to find out how safe SGN-ALPV is and if it works to treat solid tumor cancers.
- Conditions
- Ovarian Neoplasms, Endometrial Neoplasms, Carcinoma, Non-Small-Cell Lung, Stomach Neoplasms, Gastroesophageal Junction Carcinoma, Uterine Cervical Neoplasms
- Being tested
- SGN-ALPV
- Keywords
- Ovarian cancer, Endometrial cancer, Non-small cell lung cancer, NSCLC, Gastric cancer, GEJ carcinoma, Cervical cancer, Malignant Testicular Germ Cell Tumor, Malignant Ovarian Germ Cell Tumor, Malignant Extragonadal Germ Cell Tumor, High-grade serous ovarian cancer, HGSOC, Seattle Genetics
- Medical subject headings
- Ovarian Neoplasms, Endometrial Neoplasms, Carcinoma, Non-Small-Cell Lung, Stomach Neoplasms, Uterine Cervical Neoplasms, Testicular Neoplasms, Ovarian Germ Cell Cancer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SGN-ALPVDrug
Given into the vein (IV; intravenously)
| Study group | Role | What they receive |
|---|---|---|
| SGN-ALPV | Experimental | SGN-ALPV monotherapy Receives: Drug: SGN-ALPV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events (AEs)
Any untoward medical occurrence in a clinical investigational participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
Measured: Through 30-37 days after last study treatment, approximately 6 months
Number of participants with laboratory abnormalities
Measured: Through 30-37 days after last study treatment, approximately 6 months
Number of participants with dose-limiting toxicities (DLTs)
Measured: Up to 28 days
Number of participants with DLTs by dose level
Measured: Up to 28 days
Secondary outcomes (12)
Incidence of antidrug antibodies (ADAs)
Measured: Through 30-37 days after last study treatment, approximately 6 months
Area under the concentration-time curve (AUC)
PK parameter
Measured: Through 14 days after last study treatment, approximately 6 months
Maximum concentration (Cmax)
PK parameter
Measured: Through 14 days after last study treatment, approximately 6 months
Time to Cmax (Tmax)
PK parameter
Measured: Through 14 days after last study treatment, approximately 6 months
Apparent terminal half-life (t1/2)
PK parameter
Measured: Through 14 days after last study treatment, approximately 6 months
Trough concentration (Ctrough)
PK parameter
Measured: Through 14 days after last study treatment, approximately 6 months
Objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
The proportion of participants with an objective response (OR) per investigator. A participant is determined to have an OR if, based on RECIST v1.1, the subject achieves a complete response (CR) or a partial response (PR) after initiation of treatment and at or prior to the end of treatment (EOT) disease assessment.
Measured: Approximately 2 years
Duration of objective response (DOR)
The time from start of the first documentation of objective tumor response (CR or PR) to the first documentation of disease progression (based on radiographic assessments per RECIST v1.1) or death due to any cause.
Measured: Approximately 2 years
Progression-free survival (PFS)
The time from start of study treatment to first documentation of disease progression or death due to any cause
Measured: Approximately 2 years
Overall survival (OS)
The time from start of study treatment to death due to any cause
Measured: Approximately 2 years
CA-125 response rate according to Gynecological Cancer Intergroup (GCIG) criteria (subjects with ovarian cancer only)
The proportion of participants with ovarian cancer who have at least a 50% reduction in CA-125 value from baseline according to GCIG CA-125 criteria
Measured: Approximately 2 years
Combined RECIST/CA-125 overall response rate according to GCIG (subjects with ovarian cancer only)
The proportion of participants with ovarian cancer whose best response is a CR or PR according to the GCIG combined RECIST and CA-125 criteria
Measured: Approximately 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2022
- Study start21 Apr 2022
- Primary completion13 Dec 2023
- Study completion13 Dec 2023
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 Ovarian NeoplasmsStudies 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
- Sequential
- Masking
- None (open label)
- Enrolment
- 43 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
- NCT05229900
- Sponsor's protocol ID
- SGNALPV-001
- Status last verified
- Feb 2025
- First submitted
- 26 Jan 2022
- Last updated
- 10 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 10 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study of SGN-ALPV in Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT05229900
- Acronym / sponsor ID
- SGNALPV-001
- Conditions
- Ovarian Neoplasms, Endometrial Neoplasms, Carcinoma, Non-Small-Cell Lung, Stomach Neoplasms, Gastroesophageal Junction Carcinoma, Uterine Cervical Neoplasms
- Keywords
- Ovarian cancer, Endometrial cancer, Non-small cell lung cancer, NSCLC, Gastric cancer, GEJ carcinoma, Cervical cancer, Malignant Testicular Germ Cell Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study closed due to portfolio prioritization
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Seagen Inc.Industry (pharma, biotech, devices)
- Study start
- 21 Apr 2022 (actual)
- Primary completion
- 13 Dec 2023 (actual)
- Study completion
- 13 Dec 2023 (actual)
- First posted
- 8 Feb 2022 (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 study will test the safety of a drug called SGN-ALPV in participants with solid tumors. It will also study the side effects of this drug. A side effect is anything a drug does to your body besides treating your disease.
Participants will have solid tumor cancer that has spread through the body (metastatic) or cannot be removed with surgery (unresectable).
This study will have three parts. Parts A and B of the study will find out how much SGN-ALPV should be given to participants. Part C will use the dose and schedule found in Parts A and B to find out how safe SGN-ALPV is and if it works to treat solid tumor cancers.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SGN-ALPV | Experimental | Drug: SGN-ALPVSGN-ALPV monotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Participants must have one of the following histologically or cytologically confirmed metastatic or unresectable solid tumor types:
- Participants enrolled in the following study parts should have an appropriate tumor site and agree to a biopsy
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
- Measurable disease per the RECIST v1.1 at baseline
Key exclusion criteria (4 listed)
- History of another malignancy within 3 years of first dose of study treatment or any evidence of residual disease from a previously diagnosed malignancy. Exceptions are malignancies with a negligible risk of metastasis or death.
- Known active central nervous system metastases.
- Previous receipt of an MMAE-containing agent or an agent targeting ALPP or ALPPL2.
- Pre-existing neuropathy ≥ Grade 2 per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0
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-ALPVGiven into the vein (IV; intravenously) | Drug | SGN-ALPV |
Primary outcome
Number of participants with adverse events (AEs)
Time frame: Through 30-37 days after last study treatment, approximately 6 months
Any untoward medical occurrence in a clinical investigational participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
Number of participants with laboratory abnormalities
Time frame: Through 30-37 days after last study treatment, approximately 6 months
Number of participants with dose-limiting toxicities (DLTs)
Time frame: Up to 28 days
Number of participants with DLTs by dose level
Time frame: Up to 28 days
12 secondary outcomes
Incidence of antidrug antibodies (ADAs)
Time frame: Through 30-37 days after last study treatment, approximately 6 months
Area under the concentration-time curve (AUC)
Time frame: Through 14 days after last study treatment, approximately 6 months
Maximum concentration (Cmax)
Time frame: Through 14 days after last study treatment, approximately 6 months
Time to Cmax (Tmax)
Time frame: Through 14 days after last study treatment, approximately 6 months
Apparent terminal half-life (t1/2)
Time frame: Through 14 days after last study treatment, approximately 6 months
Trough concentration (Ctrough)
Time frame: Through 14 days after last study treatment, approximately 6 months
Objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
Time frame: Approximately 2 years
Duration of objective response (DOR)
Time frame: Approximately 2 years
Progression-free survival (PFS)
Time frame: Approximately 2 years
Overall survival (OS)
Time frame: Approximately 2 years
CA-125 response rate according to Gynecological Cancer Intergroup (GCIG) criteria (subjects with ovarian cancer only)
Time frame: Approximately 2 years
Combined RECIST/CA-125 overall response rate according to GCIG (subjects with ovarian cancer only)
Time frame: Approximately 2 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 10 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.
13 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SGN-ALPV in people with Ovarian Neoplasms and Endometrial Neoplasms, run by Seagen Inc. at 13 sites in 5 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 20 inclusion and 4 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 10 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 13 sites in United States, Canada, United Kingdom, Spain, Sweden. 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?
Number of participants with adverse events (AEs) (time frame: Through 30-37 days after last study treatment, approximately 6 months). The study lists 4 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 10 Feb 2025.