NCT04389632

A Study of Sigvotatug Vedotin in Advanced Solid Tumors

Recruiting now Phase 1 Last updated 7 April 2026

What this trial tests

Phase 1 trial testing sigvotatug vedotin in Carcinoma, Non-Small Cell Lung in 1,006 participants. Currently enrolling.

Timeline

8 June 2020

Primary endpoint
16 June 2027

22 March 2029

Quick facts

Lead sponsor	Seagen, a wholly owned subsidiary of Pfizer
Phase	Phase 1
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	na
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	1,006
Start date	8 June 2020
Primary completion	16 June 2027
Estimated completion	22 March 2029
Sites	155 locations across France, Taiwan, United Kingdom, South Korea, Switzerland, United States, Spain

Drugs / interventions tested

• sigvotatug vedotin (sigvotatug-vedotin) — full drug profile →
• pembrolizumab (pembrolizumab) — full drug profile →
• cisplatin (cisplatin) — full drug profile →
• carboplatin (Carboplatin) — full drug profile →

Conditions studied

• Carcinoma, Non-Small Cell Lung — all drugs for Carcinoma, Non-Small Cell Lung →
• Squamous Cell Carcinoma of Head and Neck — all drugs for Squamous Cell Carcinoma of Head and Neck →
• HER2 Negative Breast Neoplasms — all drugs for HER2 Negative Breast Neoplasms →
• Esophageal Squamous Cell Carcinoma — all drugs for Esophageal Squamous Cell Carcinoma →

Sponsor

Seagen, a wholly owned subsidiary of Pfizer — full company profile →

Who can join

18 and older, any sex, with Carcinoma, Non-Small Cell Lung or Squamous Cell Carcinoma of Head and Neck. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This trial will look at a drug called sigvotatug vedotin (SGN-B6A) alone and with pembrolizumab, with or without chemotherapy, to find out whether it is safe for people who have solid tumors. It will study sigvotatug vedotin to find out what its side effects are. A side effect is anything the drug does besides treating cancer. It will also study whether sigvotatug vedotin works to treat solid tumors.

The study will have four parts.

* Part A of the study will find out how much sigvotatug vedotin should be given to participants.
* Part B will use the dose found in Part A to find out how safe sigvotatug vedotin is and if it works to treat solid tumors.
* Part C of the study will find out how safe sigvotatug vedotin is in combination with these other drugs.
* Part D will include people who have not received treatment. This part of the study will find out how safe sigvotatug vedotin is in combination with these other drugs and if these combinations work to treat solid tumors.
* In Parts C and D, participants will receive sigvotatug vedotin with either:

* Pembrolizumab or,
* Pembrolizumab and carboplatin, or
* Pembrolizumab and cisplatin.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Targeting integrin pathways: mechanisms and advances in therapy.
   Pang X, He X, Qiu Z, Zhang H, et al · · 2023 · cited 704× · PMID 36588107 · DOI 10.1038/s41392-022-01259-6
2. Emerging therapeutic opportunities for integrin inhibitors.
   Slack RJ, Macdonald SJF, Roper JA, Jenkins RG, et al · · 2022 · cited 394× · PMID 34535788 · DOI 10.1038/s41573-021-00284-4
3. Antibody-Drug Conjugates for Cancer Therapy.
   Hafeez U, Parakh S, Gan HK, Scott AM. · · 2020 · cited 283× · PMID 33081383 · DOI 10.3390/molecules25204764
4. Targeting cancer with antibody-drug conjugates: Promises and challenges.
   Dean AQ, Luo S, Twomey JD, Zhang B. · · 2021 · cited 145× · PMID 34291723 · DOI 10.1080/19420862.2021.1951427
5. Marine Natural Products in Clinical Use.
   Haque N, Parveen S, Tang T, Wei J, et al · · 2022 · cited 101× · PMID 36005531 · DOI 10.3390/md20080528
6. Targeting Integrins for Cancer Therapy - Disappointments and Opportunities.
   Bergonzini C, Kroese K, Zweemer AJM, Danen EHJ. · · 2022 · cited 93× · PMID 35356286 · DOI 10.3389/fcell.2022.863850
7. Harnessing the tumor microenvironment: targeted cancer therapies through modulation of epithelial-mesenchymal transition.
   Glaviano A, Lau HS, Carter LM, Lee EHC, et al · · 2025 · cited 90× · PMID 39806516 · DOI 10.1186/s13045-024-01634-6
8. Emerging Targets in Non-Small Cell Lung Cancer.
   Liu L, Soler J, Reckamp KL, Sankar K. · · 2024 · cited 21× · PMID 39337530 · DOI 10.3390/ijms251810046