A Phase I Study of SGN-ALPV in Advanced Solid Tumors

Study Identifier:
SGNALPV-001
CT.gov Identifier:
NCT05229900
EudraCT Identifier:
N/A
EU Trial (CTIS) Number:
2022-500094-14-00
Study Contact Information:
(210) 593-5651 or [email protected]
Terminated/Withdrawn

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Study Summary

To test the safety of a drug called SGN-ALPV in participants with solid tumors

To evaluate the safety, tolerability, pharmacokinetics (PK), and antitumor activity of SGN-ALPV in patients (pts) with select advanced solid tumors.

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
  • Ovarian
  • Endometrial
  • Solid Tumor
  • Non-Small Cell Lung Cancer
  • Stomach
  • Gastroesophageal
  • Uterine
  • Testicular
    • Phase
    The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
    I
    Sex
    Female & Male
    Age
    18+ years
    Study Drug
  • Drug: Experimental: SGN-ALPV
    • Read More
  • Drug: Drug: SGN-ALPV
    • Study Status
    Indicates the current recruitment status or the expanded access status
    Terminated/Withdrawn

    Requirements information
    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
    • Adult pts (> or =18 years) with confirmed ovarian, endometrial, non-small cell lung, gastric, cervical cancer, or testicular germ-cell tumors, relapsed or refractory to approved therapies, with measurable disease per RECIST v1.1 and an ECOG PS 0–1 are eligible
    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

    Clinical Study Information for Healthcare Providers

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    Study Locations

    Location
    Investigator
    Status
    Condition(s) Treated at Site
    Location
    START Mountain Region
    West Valley City, UT, United States, 84119
    Investigator
    Justin Call
    Status
    Recruitment Complete
    Condition(s) Treated at Site
    Ovarian
    Endometrial
    Solid Tumor
    Non-Small Cell Lung Cancer
    Stomach
    Gastroesophageal
    Uterine
    Testicular