Carcinoma, Non-Small-Cell Lung, Endometrial Neoplasms, Gastroesophageal Junction Carcinoma, Ovarian Neoplasms, Stomach Neoplasms, Testicular Neoplasms, Uterine Cervical Neoplasms
Conditions
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
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.
Interventions
DRUGSGN-ALPV
Given into the vein (IV; intravenously)
Sponsors
Seagen Inc.
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 * 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 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 ALPPL2. * Pre-existing neuropathy ≥ Grade 2 per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with adverse events (AEs) | 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 | Through 30-37 days after last study treatment, approximately 6 months | — |
| Number of participants with dose-limiting toxicities (DLTs) | Up to 28 days | — |
| Number of participants with DLTs by dose level | Up to 28 days | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Apparent terminal half-life (t1/2) | Through 14 days after last study treatment, approximately 6 months | PK parameter |
| Trough concentration (Ctrough) | Through 14 days after last study treatment, approximately 6 months | PK parameter |
| Objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) | Approximately 2 years | 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. |
| Duration of objective response (DOR) | Approximately 2 years | 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. |
| Incidence of antidrug antibodies (ADAs) | Through 30-37 days after last study treatment, approximately 6 months | — |
| Overall survival (OS) | Approximately 2 years | The time from start of study treatment to death due to any cause |
| CA-125 response rate according to Gynecological Cancer Intergroup (GCIG) criteria (subjects with ovarian cancer only) | Approximately 2 years | 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 |
| Combined RECIST/CA-125 overall response rate according to GCIG (subjects with ovarian cancer only) | Approximately 2 years | 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 |
| Progression-free survival (PFS) | Approximately 2 years | The time from start of study treatment to first documentation of disease progression or death due to any cause |
| Area under the concentration-time curve (AUC) | Through 14 days after last study treatment, approximately 6 months | PK parameter |
| Maximum concentration (Cmax) | Through 14 days after last study treatment, approximately 6 months | PK parameter |
| Time to Cmax (Tmax) | Through 14 days after last study treatment, approximately 6 months | PK parameter |
Countries
Canada, Spain, Sweden, United Kingdom, United States
Outcome results
None listed