A Phase 1 Study of SGN-ALPV in Advanced Solid Tumors
Overview
- Phase
- Phase 1
- Intervention
- SGN-ALPV
- Conditions
- Ovarian Neoplasms
- Sponsor
- Seagen Inc.
- Enrollment
- 43
- Locations
- 13
- Primary Endpoint
- Number of participants with adverse events (AEs)
- Status
- Terminated
- Last Updated
- last year
Overview
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 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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 ALPPL
- •Pre-existing neuropathy ≥ Grade 2 per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0
Arms & Interventions
SGN-ALPV
SGN-ALPV monotherapy
Intervention: SGN-ALPV
Outcomes
Primary Outcomes
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
Secondary Outcomes
- Area under the concentration-time curve (AUC)(Through 14 days after last study treatment, approximately 6 months)
- Incidence of antidrug antibodies (ADAs)(Through 30-37 days after last study treatment, approximately 6 months)
- Maximum concentration (Cmax)(Through 14 days after last study treatment, approximately 6 months)
- Time to Cmax (Tmax)(Through 14 days after last study treatment, approximately 6 months)
- Apparent terminal half-life (t1/2)(Through 14 days after last study treatment, approximately 6 months)
- Trough concentration (Ctrough)(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)(Approximately 2 years)
- Duration of objective response (DOR)(Approximately 2 years)
- Progression-free survival (PFS)(Approximately 2 years)
- Overall survival (OS)(Approximately 2 years)
- CA-125 response rate according to Gynecological Cancer Intergroup (GCIG) criteria (subjects with ovarian cancer only)(Approximately 2 years)
- Combined RECIST/CA-125 overall response rate according to GCIG (subjects with ovarian cancer only)(Approximately 2 years)