A Study of SGN-ALPV in Advanced Solid Tumors

Carcinoma, Non-Small-Cell Lung Clinical Trial

Official title:

A Phase 1 Study of SGN-ALPV in Advanced Solid Tumors

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05229900
• Other study ID #: SGNALPV-001
• Status: Terminated
• Phase: Phase 1
• Start date: April 21, 2022
• Est. completion date: December 13, 2023

Study information

• Verified date: December 2023
• Source: Seagen Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 43
• Est. completion date: December 13, 2023
• Est. primary completion date: December 13, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Non-Small-Cell Lung
• Endometrial Neoplasms
• Gastroesophageal Junction Carcinoma
• Neoplasms
• Ovarian Neoplasms
• Stomach Neoplasms
• Testicular Neoplasms
• Uterine Cervical Neoplasms

Intervention

Drug:
• SGN-ALPV
Given into the vein (IV; intravenously)

Locations

Country	Name	City	State
Canada	Ottawa Hospital Cancer Centre	Ottawa	Ontario
Canada	University Health Network, Princess Margaret Hospital	Toronto	Ontario
Spain	START Madrid-CIOCC_Hospital HM Sanchinarro	Madrid	Other
Sweden	Karolinska University Hospital	Stockholm	Other
United Kingdom	Sarah Cannon Research Institute UK	London	Other
United Kingdom	The Royal Marsden NHS Foundation Trust (RM)	London	Other
United States	Virginia Cancer Specialists	Fairfax	Virginia
United States	Women's Cancer Care	Fresno	California
United States	START Midwest	Grand Rapids	Michigan
United States	Yale Cancer Center	New Haven	Connecticut
United States	Oklahoma University at Stephenson Cancer Center	Oklahoma City	Oklahoma
United States	Florida Cancer Specialists - Lake Nona	Wellington	Florida
United States	START Mountain Region	West Valley City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
Seagen Inc.

Countries where clinical trial is conducted

United States,  Canada,  Spain,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with adverse events (AEs)	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.	Through 30-37 days after last study treatment, approximately 6 months
Primary	Number of participants with laboratory abnormalities		Through 30-37 days after last study treatment, approximately 6 months
Primary	Number of participants with dose-limiting toxicities (DLTs)		Up to 28 days
Primary	Number of participants with DLTs by dose level		Up to 28 days
Secondary	Incidence of antidrug antibodies (ADAs)		Through 30-37 days after last study treatment, approximately 6 months
Secondary	Area under the concentration-time curve (AUC)	PK parameter	Through 14 days after last study treatment, approximately 6 months
Secondary	Maximum concentration (Cmax)	PK parameter	Through 14 days after last study treatment, approximately 6 months
Secondary	Time to Cmax (Tmax)	PK parameter	Through 14 days after last study treatment, approximately 6 months
Secondary	Apparent terminal half-life (t1/2)	PK parameter	Through 14 days after last study treatment, approximately 6 months
Secondary	Trough concentration (Ctrough)	PK parameter	Through 14 days after last study treatment, approximately 6 months
Secondary	Objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)	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.	Approximately 2 years
Secondary	Duration of objective response (DOR)	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.	Approximately 2 years
Secondary	Progression-free survival (PFS)	The time from start of study treatment to first documentation of disease progression or death due to any cause	Approximately 2 years
Secondary	Overall survival (OS)	The time from start of study treatment to death due to any cause	Approximately 2 years
Secondary	CA-125 response rate according to Gynecological Cancer Intergroup (GCIG) criteria (subjects with ovarian cancer only)	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	Approximately 2 years
Secondary	Combined RECIST/CA-125 overall response rate according to GCIG (subjects with ovarian cancer only)	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	Approximately 2 years