A Study of SGN-B7H4V in Advanced Solid Tumors

Seagen

Status and phase: Enrolling; Phase 1

Conditions: Ovarian Neoplasms; Adenoid Cystic Carcinoma; Hormone Receptor Positive Breast Neoplasms; Fallopian Tube Neoplasms; Triple Negative Breast Neoplasms; Carcinoma, Non-Small-Cell Lung; Peritoneal Neoplasms; HER2 Negative Breast Neoplasms; Cholangiocarcinoma; Gallbladder Carcinoma; Endometrial Neoplasms

Treatments: Drug: SGN-B7H4V; Drug: Pembrolizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT05194072

SGNB7H4V-001

C5761001 (Other Identifier)

2021-002107-35 (EudraCT Number)

2023-503389-22 (Registry Identifier)

Details and patient eligibility

About

The purpose of the study is to test the safety of the medicine called SGN-B7H4V alone and with pembrolizumab in participants with solid tumors. It will also look at the side effects of this medicine. A side effect is anything a medicine does to the body besides treating the disease.

This study is seeking for participants who either have cancer:

• that has spread in the body near where it started (locally advanced) and cannot be removed (unresectable),
• has spread through the body (metastatic), or have some cancer left over after surgery.

This study will have five parts.

• Parts A and B of the study will find out how much SGN-B7H4V should be given to participants.
• Part C will use the amount found in Parts A and B to find out how safe SGN-B7H4V is and if it works to treat solid tumor cancers.
• Part D will find out if and how much SGN-B7H4V can be given with pembrolizumab.
• Part E will use the amount found in Part D to find out how safe SGN-B7H4V with pembrolizumab is and if it works to treat triple negative breast cancer.

Enrollment: 572 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

For Parts A, B, and C:

• Participants must have one of the following histologically or cytologically confirmed locally advanced unresectable or metastatic solid tumor types:

  • High-grade serous epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer
  • HER2-negative, HR positive breast cancer
  • Triple-negative breast cancer (TNBC)
  • Endometrial carcinoma
  • Non-small cell lung cancer (Squamous cell carcinoma [SqCC], Adenocarcinoma [AC])
  • Cholangiocarcinoma or gallbladder carcinoma
  • Adenoid cystic carcinoma (ACC) For Part D: Participants must have histologically or cytologically confirmed locally advanced unresectable or metastatic TNBC.

For Part E:

• Cohort E1: Participants must have histologically or cytologically confirmed locally advanced unresectable or metastatic TNBC and must have CPS≥10 by local testing

• Cohort E2: Participants must have histologically or cytologically confirmed locally advanced unresectable or metastatic TNBC and must have CPS<10 by local testing

• Cohort E3: Participants must have triple negative breast cancer with residual disease following neoadjuvant therapy and definitive surgery

  • Parts A and B: Participants must have disease that is relapsed or refractory or be intolerant to SOC therapies, and, in the judgement of the investigator, should have no appropriate SOC therapeutic option
  • Part C: Participants must have disease that is relapsed or refractory or be intolerant to SOC therapies.
  • Part D and E1/E2: Participants must have had no prior treatment for locally advanced unresectable or metastatic TNBC
  • Part E3: Participants must have completed at least 6 cycles of neoadjuvant therapy for locally advanced unresectable or metastatic TNBC
  • Tumor tissue is required for enrollment.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
  • Measurable disease per RECIST version 1.1 at baseline (not applicable for E3 participants).

Exclusion criteria

• History of another malignancy within 3 years before the first dose of study drug. 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. Participants with previously treated brain metastases may participate provided they:

  • are clinically stable for at least 4 weeks prior to study entry after brain metastasis treatment
  • have no new or enlarging brain metastases
  • and are off corticosteroids prescribed for symptoms associated with brain metastases for at least 7 days prior to the first dose of study treatment.

• Carcinomatous meningitis

• Previous receipt of an MMAE-containing agent or an agent targeting B7-H4

• Pre-existing neuropathy ≥ Grade 2 per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0

• Corneal disease or injury requiring treatment or active monitoring

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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572 participants in 2 patient groups

SGN-B7H4V (Parts A, B, and C)

Experimental group

Description:

SGN-B7H4V monotherapy

Treatment:

Drug: SGN-B7H4V

SGN-B7H4V and Pembrolizumab (Parts D and E)

Experimental group

Description:

SGN-B7H4V in combination with Pembrolizumab.

Treatment:

Drug: Pembrolizumab

Drug: SGN-B7H4V