A Study of SGN-ALPV in Advanced Solid Tumors
Research type
Research Study
Full title
A Phase 1 Study of SGN‑ALPV in Advanced Solid Tumors
IRAS ID
1005170
Contact name
Suzanne McGoldrick
Contact email
Sponsor organisation
Seagen Inc.
Eudract number
2021-005266-18
Clinicaltrials.gov Identifier
Research summary
Research Summary
Study of SGN-ALPV is a phase 1, open-label, multicentre study designed to evaluate the safety, tolerability, pharmacokinetics (how the study medication moves through the body) (PK), pharmacodynamic (effects of the study medication on the body) activity, and antitumor activity of SGN-ALPV. This is a phase 1 study in adults with selected advanced solid tumours.
The study is conducted in three parts:
Part A includes dose escalation, an optional Part B dose and schedule optimisation and Part C includes disease-specific expansion cohorts and 1 optional biology cohort.
For Part A, participants may have ovarian cancer, endometrial cancer, non-small cell lung cancer (NSCLC), gastric cancer, cervical cancer, malignant testicular or ovarian germ cell tumour (GCT) (with the exception of pure teratomas). Approximately 45 participants will be enrolled to receive increasing doses of SGN-ALPV to determine the Maximum Tolerated Dose (MTD).
At the completion of dose escalation, dose and schedule optimization (Part B) may be activated to additionally optimise the dose and schedule of SGN-ALPV before determining dose and schedule for subsequent phases of clinical investigation.
10 participants each in up to 4 cohorts (up to 40 total participants) evaluating different doses and schedules may be enrolled. The dose for each schedule evaluated in Part B will be selected by the sponsor in consultation with the Safety Monitoring Committee (SMC) and may be at or below the MTD identified in Part A. Different dosing schedules may be evaluated in parallel cohorts.
At the end of dose and schedule optimisation, the SMC will make a recommendation to the sponsor to bring forward a dose and schedule to be evaluated in Part C.
To further characterize the safety, tolerability, PK, and antitumor activity of SGN-ALPV, approximately 200 additional participants may be enrolled in expansion cohorts (Part C). Expansion cohorts will enrol participants with selected tumour types for dose escalation.Summary of Results
This study provided participants with a potential treatment option after trying all standard of care options. While no objective responses (best overall response of disappearance of disease after treatment) were observed, some participants did experience prolonged stable disease (cancer had neither increased nor decreased in extent or severity). As with any first in human study, the benefit to participants may be limited, given the nature of these studies that evaluate an investigational medicine for the first time in humans.
REC name
East of Scotland Research Ethics Service REC 2
REC reference
22/ES/0025
Date of REC Opinion
5 Jul 2022
REC opinion
Further Information Favourable Opinion