NCT03607955

Paclitaxel + Carboplatin With AVB-S6-500 in Women With Stage III or IV Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer Receiving Neoadjuvant Chemotherapy

Withdrawn Phase 1 Last updated 29 September 2021

What this trial tests

Phase 1 trial testing AVB-S6-500 in Epithelial Ovarian Cancer. Withdrawn.

Timeline

30 June 2021

Primary endpoint
31 August 2024

31 August 2029

Quick facts

Lead sponsor	Washington University School of Medicine
Phase	Phase 1
Status	Withdrawn
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Start date	30 June 2021
Primary completion	31 August 2024
Estimated completion	31 August 2029

Drugs / interventions tested

• AVB-S6-500 — full drug profile →
• Paclitaxel — full drug profile →
• Carboplatin (Carboplatin) — full drug profile →
• Tissue from Diagnostic Laparoscopy
• Tissue from Core biopsy
• Interval Debulking
• Peripheral blood
• Ascites collection

Conditions studied

• Epithelial Ovarian Cancer — all drugs for Epithelial Ovarian Cancer →
• Primary Peritoneal Carcinoma — all drugs for Primary Peritoneal Carcinoma →
• Fallopian Tube Cancer — all drugs for Fallopian Tube Cancer →

Sponsor

Washington University School of Medicine

Who can join

18 and older, female only, with Epithelial Ovarian Cancer or Primary Peritoneal Carcinoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The receptor tyrosine kinase AXL is a pathway that plays a crucial role in metastasis and chemoresistance. Overexpression of AXL has been associated with metastasis, recurrence, and chemoresistance in various cancer including ovarian cancer\[16, 17\]}. Targeting AXL is an attractive approach because it is overexpressed among patients with epithelial ovarian cancer and strongly associated with advanced stages, high grade cancer and shorter median survival time. AVB-S6-500 is a potent AXL inhibitor by binding to the ligand Gas6. Pre-clinical studies found that AVB-S6-500 was efficacious in ovarian cancer xenograft tumor models. Interventions which would increase the proportion of patients achieving pCR in this patient population could impact survival favorably and are of interest for study.

Publications & conference data

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

1. Targeting Tyro3, Axl and MerTK (TAM receptors): implications for macrophages in the tumor microenvironment.
   Myers KV, Amend SR, Pienta KJ. · · 2019 · cited 333× · PMID 31088471 · DOI 10.1186/s12943-019-1022-2
2. The Role of the Receptor Tyrosine Kinase Axl in Carcinogenesis and Development of Therapeutic Resistance: An Overview of Molecular Mechanisms and Future Applications.
   Wium M, Ajayi-Smith AF, Paccez JD, Zerbini LF. · · 2021 · cited 56× · PMID 33806258 · DOI 10.3390/cancers13071521
3. AXL as a Target in Breast Cancer Therapy.
   Colavito SA. · · 2020 · cited 50× · PMID 32148495 · DOI 10.1155/2020/5291952
4. Barriers to Immunotherapy in Ovarian Cancer: Metabolic, Genomic, and Immune Perturbations in the Tumour Microenvironment.
   Johnson RL, Cummings M, Thangavelu A, Theophilou G, et al · · 2021 · cited 33× · PMID 34944851 · DOI 10.3390/cancers13246231
5. Metabolic reprogramming of efferocytosis in the tumour microenvironment: From apoptotic-cell clearance to therapeutic targeting.
   Yang Q, Yan J, Yang Q. · · 2026 · cited 1× · PMID 41601343 · DOI 10.1002/ctm2.70601
6. A fast-progressing orthotopic ovarian cancer model reveals synergistic antitumor effects of AXL-targeting nanobodies and Olaparib.
   Caro AA, Gordún Peiró A, Hadadi E, Berckmans Y, et al · · 2025 · PMID 41404332 · DOI 10.1016/j.gore.2025.101998