A Study of SGN-ALPV in Advanced Solid Tumors

  • STATUS
    Recruiting
  • End date
    Nov 30, 2027
  • participants needed
    285
  • sponsor
    Seagen Inc.
Updated on 8 July 2022
cancer
measurable disease
carcinoma
fluoropyrimidine
bevacizumab
cancer chemotherapy
ovarian cancer
metastatic gastric cancer
line of therapy
germ cell tumor
endometrial carcinoma
cancer of the ovary
lung carcinoma

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.

Details
Condition Ovarian Neoplasms, Endometrial Neoplasms, Carcinoma, Non-Small-Cell Lung, Stomach Neoplasms, Uterine Cervical Neoplasms, Testicular Neoplasms
Treatment SGN-ALPV
Clinical Study IdentifierNCT05229900
SponsorSeagen Inc.
Last Modified on8 July 2022

Eligibility

Yes No Not Sure

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
Cervical cancer
Malignant testicular germ cell tumor (GCT), except for pure teratomas
Malignant ovarian GCT, except for pure teratomas
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 and received 1 to 3 prior anticancer lines of therapy including at least 1 line of therapy containing 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: Participants must have unresectable locally advanced or metastatic gastric cancer 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
Disease-specific expansion cohorts, subjects 16 onwards: pretreatment biopsy
Biology expansion cohort: pretreatment biopsy, on-treatment biopsy during Cycle 1, and end of treatment biopsy
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
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How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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