A Study of SGN-B7H4V in Advanced Solid Tumors

• Research type

  Research Study

• Full title

  A Phase 1 Study of SGN-B7H4V in Advanced Solid Tumors

• IRAS ID

  1004991

• Contact name

  Natalya Nazarenko

• Contact email

  EU-Regulatory@seagen.com

• Sponsor organisation

  Seagen Inc.

• Eudract number

  2021-002107-35

• Clinicaltrials.gov Identifier

  NCT05194072

• Research summary

  SGNB7H4V-001 is a phase 1 open label multi centre study designed to evaluate the effectiveness of an experimental medication called SGN-B7H4V. This study will be completed over in 3 parts. In Part A, we will test SGN-B7H4V to find the best dose and schedule (dose escalation). In Part B of the study, we may use the information we learned in Part A to keep studying the best dose and schedule for SGN-B7H4V (dose optimisation). In Part C of the study, we use what we learned about the best dose and schedule to test how SGN-B7H4V works to treat some types of cancer (dose expansion).

  SGN-B7H4V is a type of medication called an antibody drug conjugate or ADC. ADCs usually have 2 parts.
  • Antibody: Antibodies are part of your immune system. Usually they help protect you from getting sick. In SGN-B7H4V, we are using an antibody designed to find and stick to the cancer cells in your body.
  • Drug: The drug is the part of the ADC that kills cells. The cell-killing part of SGN-B7H4V is a chemotherapy medication called monomethyl auristatin E (MMAE).
  In SGN-B7H4V, the antibody part is designed to stick to cancer cells so that the medication part can kill them.

  Approximately 355 people will participate in this study from around the world. Participants will remain in the study until their cancer gets worse, they decide to withdraw, they have an adverse reaction to the study medication or the study comes to an end.
  To be eligible for the study participants must be aged over 18 and have a diagnosis of one of the following types of cancer that has advanced, spread to other parts of your body, or cannot be removed with surgery:
  • High-grade cancer of the ovaries or fallopian tubes or primary peritoneal cancer
  • HER2-negative, hormone-receptor positive breast cancer
  • Triple-negative breast cancer (HER2-negative, hormone-receptor negative breast cancer)
  • Endometrial cancer
  • Squamous non-small cell lung cancer (sq-NSCLC)
  • Cholangiocarcinoma or gallbladder cancer

• REC name

  South Central - Oxford C Research Ethics Committee

• REC reference

  22/SC/0089

• Date of REC Opinion

  6 May 2022

• REC opinion

  Further Information Favourable Opinion