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A Phase 1 Study of SGN-ALPV in Advanced Solid Tumors
EU CTIS ID: 2022-500094-14-00
What this study is testing
To evaluate the safety and tolerability of SGN-ALPV To identify the maximum tolerated dose (MTD) of SGN-ALPV (Part A) To identify a recommended dose and schedule for SGN-ALPV (Parts A and B)
- Human Pharmacology (Phase I)- First administration to humans
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Participants must have one of the following histologically or cytologically confirmed metastatic or unresectable tumor types: Part A and Part 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 advanced 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
- Aged 18 years or older.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
- Measurable disease per the RECIST v1.1 at baseline
You likely can't join if
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Canada
- United Kingdom
- United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Canada; United Kingdom; United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.