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

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Seagen Inc.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

8 Nov 2022 → 13 Dec 2023

Decision date (initial)

2023-01-23

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Seagen Inc.

External identifiers

EU CT number

2022-500094-14-00

ClinicalTrials.gov

NCT05229900

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Pharmacodynamic, Pharmacokinetic

To evaluate the safety and tolerability of SGN-ALPV
To identify the maximum tolerated dose (MTD) of SGN-ALPV (Part A)
To identify a recommended dose and schedule for SGN-ALPV (Parts A and B)

Secondary objectives 3

1. To assess the immunogenicity of SGN-ALPV
2. To assess the pharmacokinetics (PK) of SGN-ALPV
3. To assess the antitumor activity of SGN-ALPV

Conditions and MedDRA coding

gastroesophageal junction [GEJ] carcinoma

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. Participants must have one of the following histologically or cytologically confirmed metastatic or unresectable tumor types: Part A and Part 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 advanced 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.
2. 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
3. Aged 18 years or older.
4. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
5. Measurable disease per the RECIST v1.1 at baseline

Exclusion criteria 4

1. 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.
2. Known active central nervous system metastases.
3. Previous receipt of an MMAE-containing agent or an agent targeting ALPP or ALPPL2.
4. Pre-existing neuropathy ≥ Grade 2 per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 3

1. Type, incidence, severity, seriousness, and relatedness of adverse events (AEs) and type, incidence, and severity of laboratory abnormalities
2. Incidence of dose-limiting toxicities (DLTs)
3. Incidence of DLTs and cumulative safety by dose level

Secondary endpoints 8

1. Incidence of antidrug antibodies (ADAs)
2. Estimates of PK parameters including area under the concentration-time curve (AUC), maximum concentration (Cmax), time to Cmax (Tmax), apparent terminal half-life (t½), and trough concentration (Ctrough). Additional parameters may be evaluated as necessary
3. Objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
4. Duration of objective response (DOR)
5. Progression-free survival (PFS)
6. Overall survival (OS)
7. CA-125 response rate according to Gynecological Cancer Intergroup (GCIG) criteria (subjects with ovarian cancer only)
8. Combined RECIST/CA-125 overall response rate according to GCIG (subjects with ovarian cancer only)

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Seagen Inc.

Sponsor organisation

Seagen Inc.

Address

21823 30th Drive Southeast

City

Bothell

Postcode

98021-3907

Country

United States

Scientific contact point

Organisation

Seagen Inc.

Contact name

Suzanne McGoldrick

Public contact point

Organisation

Seagen Inc.

Contact name

Seagen Clinical Trial Information

Locations

3 EU/EEA countries · 4 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Oversight and notifications

Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77

Temporary halts 2 · Art. 38 CTR

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Summary of results Art. 37(4) CTR

Layperson summary Annex V

Documents 4 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

7 submissions — initial application plus substantial / non-substantial modifications