A Study of SGN-ALPV in Advanced Solid Tumors

Sponsor

Seagen Inc. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05229900

Collaborator

(none)

285

Enrollment

Locations

Arm

67.3

Anticipated Duration (Months)

Patients Per Site

0.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Ovarian Neoplasms Endometrial Neoplasms Carcinoma, Non-Small-Cell Lung Stomach Neoplasms Uterine Cervical Neoplasms Testicular Neoplasms	Drug: SGN-ALPV	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

285 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Apr 21, 2022

Anticipated Primary Completion Date :

Dec 31, 2024

Anticipated Study Completion Date :

Nov 30, 2027

Arms and Interventions

Arm	Intervention/Treatment
Experimental: SGN-ALPV SGN-ALPV monotherapy	Drug: SGN-ALPV Given into the vein (IV; intravenously)

Arm

Intervention/Treatment

Experimental: SGN-ALPV

SGN-ALPV monotherapy

Drug: SGN-ALPV

Given into the vein (IV; intravenously)

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

Incidence of antidrug antibodies (ADAs) [Through 30-37 days after last study treatment, approximately 6 months]
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
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.
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
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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
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, 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: 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Florida Cancer Specialists - Lake Nona	Wellington	Florida	United States	33414
2	START Midwest	Grand Rapids	Michigan	United States	49546
3	START Mountain Region	West Valley City	Utah	United States	84119
4	Virginia Cancer Specialists	Fairfax	Virginia	United States	22031
5	Sarah Cannon Research Institute UK	London	Other	United Kingdom	W1G 6AD