Clinical trial NCT05229900: A Study of SGN-ALPV in Advanced Solid Tumors
Official title: A Phase 1 Study of SGN-ALPV in Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Ovarian Neoplasms
Endometrial Neoplasms
Carcinoma, Non-Small-Cell Lung
Stomach Neoplasms
Gastroesophageal Junction Carcinoma
Uterine Cervical Neoplasms
Testicular Neoplasms
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
Lead sponsor: Seagen Inc.
Sponsor class: INDUSTRY
First posted: 2022-02-08
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.


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
  * 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

Primary outcomes:
measure: Number of participants with adverse events (AEs)
timeFrame: Through 30-37 days after last study treatment, approximately 6 months
measure: Number of participants with laboratory abnormalities
timeFrame: Through 30-37 days after last study treatment, approximately 6 months
measure: Number of participants with dose-limiting toxicities (DLTs)
timeFrame: Up to 28 days
measure: Number of participants with DLTs by dose level
timeFrame: Up to 28 days
Secondary outcomes:
measure: Incidence of antidrug antibodies (ADAs)
timeFrame: Through 30-37 days after last study treatment, approximately 6 months
measure: Area under the concentration-time curve (AUC)
timeFrame: Through 14 days after last study treatment, approximately 6 months
measure: Maximum concentration (Cmax)
timeFrame: Through 14 days after last study treatment, approximately 6 months
measure: Time to Cmax (Tmax)
timeFrame: Through 14 days after last study treatment, approximately 6 months
measure: Apparent terminal half-life (t1/2)
timeFrame: Through 14 days after last study treatment, approximately 6 months
measure: Trough concentration (Ctrough)
timeFrame: Through 14 days after last study treatment, approximately 6 months
measure: Objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
timeFrame: Approximately 2 years
measure: Duration of objective response (DOR)
timeFrame: Approximately 2 years
measure: Progression-free survival (PFS)
timeFrame: Approximately 2 years
measure: Overall survival (OS)
timeFrame: Approximately 2 years
measure: CA-125 response rate according to Gynecological Cancer Intergroup (GCIG) criteria (subjects with ovarian cancer only)
timeFrame: Approximately 2 years
measure: Combined RECIST/CA-125 overall response rate according to GCIG (subjects with ovarian cancer only)
timeFrame: Approximately 2 years
Other outcomes:
Locations:
city: Fresno
country: United States
facility: Women's Cancer Care
state: California
city: New Haven
country: United States
facility: Yale Cancer Center
state: Connecticut
city: Wellington
country: United States
facility: Florida Cancer Specialists - Lake Nona
state: Florida
city: Grand Rapids
country: United States
facility: START Midwest
state: Michigan
city: Oklahoma City
country: United States
facility: Oklahoma University at Stephenson Cancer Center
state: Oklahoma
city: West Valley City
country: United States
facility: START Mountain Region
state: Utah
city: Fairfax
country: United States
facility: Virginia Cancer Specialists
state: Virginia
city: Ottawa
country: Canada
facility: Ottawa Hospital Cancer Centre
state: Ontario
city: Toronto
country: Canada
facility: University Health Network, Princess Margaret Hospital
state: Ontario
city: Madrid
country: Spain
facility: START Madrid-CIOCC_Hospital HM Sanchinarro
state: Other
city: Stockholm
country: Sweden
facility: Karolinska University Hospital
state: Other
city: London
country: United Kingdom
facility: The Royal Marsden NHS Foundation Trust (RM)
state: Other
city: London
country: United Kingdom
facility: Sarah Cannon Research Institute UK
state: Other
Study officials:
affiliation: Seagen Inc.
name: Suzanne McGoldrick, MD
role: STUDY_DIRECTOR
References: