Status:
TERMINATED
A Study of SGN-ALPV in Advanced Solid Tumors
Lead Sponsor:
Seagen Inc.
Conditions:
Ovarian Neoplasms
Endometrial Neoplasms
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 beside...
Eligibility Criteria
Inclusion
- 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
- 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
Exclusion
- 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
Key Trial Info
Start Date :
April 21 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 13 2023
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT05229900
Start Date
April 21 2022
End Date
December 13 2023
Last Update
February 10 2025
Active Locations (13)
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1
Women's Cancer Care
Fresno, California, United States, 93710
2
Yale Cancer Center
New Haven, Connecticut, United States, 06510
3
Florida Cancer Specialists - Lake Nona
Wellington, Florida, United States, 33414
4
START Midwest
Grand Rapids, Michigan, United States, 49546