Drugs / AVA6000
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1 | NCT04969835 | Jul 2021 → Jun 2026 overdue | breast cancer, ovarian carcinoma, soft tissue sarcoma, tumor of salivary gland +1 | Avacta Life Sciences Ltd | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 23
| Date | Issuer | Release |
|---|---|---|
| 2026-06-25 | Avacta Life Sciences Ltd | Results Avacta Reports Platform-Validating Data with Faridoxorubicin during BIO International Conference avacta.com ↗
Responses were reported from two of the patient cohorts studied, SGC and soft tissue sarcoma (STS). |
| 2026-06-25 | Avacta Life Sciences Ltd | Regulatory Avacta Announces U.S. FDA Agreement on Pivotal Trial Design for AVA6000 in Patients with Salivary Gland Cancer avacta.com ↗ |
| 2026-06-01 | Avacta Life Sciences Ltd | Results Avacta presents updated clinical data showing encouraging early efficacy signals for AVA6000 in salivary gland cancers at ASCO 2026 avacta.com ↗
We are particularly encouraged by signs of efficacy in patients with salivary gland cancers (SGC and the consistency of these data from Phase 1a and 1b support the potential for this agent to move to later stage trials. |
| 2026-02-03 | Avacta Life Sciences Ltd | Results Avacta announces two key clinical updates to its faridoxorubicin program avacta.com ↗
Dosing in the Phase 1 clinical trial escalated to a dose of nearly 4x the conventional dose of doxorubicin and the maximum cumulative exposure of released doxorubicin was increased to 550 mg/m 2 during the trial with no severe cardiac toxicity observed. |
| 2025-12-17 | Avacta Life Sciences Ltd | Results Faridoxorubicin (AVA6000) Phase 1b cohort demonstrates clinically meaningful tumor shrinkage in patients with salivary gland cancers avacta.com ↗
The data show confirmed partial and minor responses, consistent with data previously reported from the Phase 1a part of the study. |
| 2025-10-19 | Avacta Life Sciences Ltd | Results Avacta Therapeutics presents compelling Phase 1a data for faridoxorubicin and the pre|CISION® platform at the European Society of Medical Oncology Annual Congress avacta.com ↗
Faridoxorubicin treatment data demonstrate favorable safety and tolerability across both the every three weeks and every two weeks dosing regimens. |
| 2025-06-19 | Avacta Life Sciences Ltd | Results New Response in the FAP-Dox (AVA6000) Phase 1b Trial avacta.com ↗
Avacta Therapeutics (AIM: AVCT), a life sciences company developing innovative, targeted oncology drugs, today announces a new partial response observed in a patient with salivary gland cancer (SGC) in the dose expansion phase of the FAP-Dox (AVA6000) Phase 1b trial. |
| 2025-04-28 | Avacta Life Sciences Ltd | Results Avacta Therapeutics Presents Data from Lead pre|CISION® Candidate FAP-Dox (AVA6000) at the 2025 AACR Annual Meeting avacta.com ↗
Today’s clinical results mark the achievement of a proof-of-concept milestone with our proprietary pre|CISION ® platform demonstrating meaningful activity, |
| 2025-03-07 | Avacta Life Sciences Ltd | Results Avacta Announces Promising Early Efficacy and Safety Data for AVA6000 in the Phase 1a Dose Escalation and Ongoing Enrollment in the Phase 1b Expansion Cohorts avacta.com ↗
Promising early efficacy and safety signals are observed in the Phase 1a trial. |
| 2025-03-07 | Avacta Life Sciences Ltd | Results Avacta Announces Agreement to Sell Launch Diagnostics and a Corporate Update avacta.com ↗
Together, these findings in the clinic underscore the potential for the next assets in the pipeline to be highly differentiated and have potential for enhanced activity compared with traditional oncology therapeutics. |
| 2025-01-16 | Avacta Life Sciences Ltd | Results Avacta Announces Positive New Data from the AVA6000 Phase 1 trial Demonstrating Clinically Meaningful Tumor Shrinkage in Patients with Salivary Gland Cancers avacta.com ↗
The data demonstrates robust and meaningful tumor shrinkage in patients with salivary gland cancers, a disease with no standard therapy defined in the metastatic setting. |
| 2024-09-14 | Avacta Life Sciences Ltd | Results Avacta Reports Updated Phase 1 Clinical Data of AVA6000 at the European Society for Medical Oncology (ESMO) Congress Demonstrating Multiple Ongoing, Durable Responses in Solid Tumors avacta.com ↗
The results demonstrate that AVA6000 is well-tolerated across the every 2 weeks and every 3 weeks dosing schedules with early evidence of efficacy supported by ongoing and durable RECIST responses in patients with FAP high disease. |
| 2024-06-26 | Avacta Life Sciences Ltd | Results AGM Business Update avacta.com ↗
Avacta confirms that Arm 2 of the Phase 1 trial for AVA6000, a peptide drug conjugate form of doxorubicin chemotherapy, has successfully completed its second cohort without dose limiting toxicities observed. |
| 2024-05-23 | Avacta Life Sciences Ltd | Results Successful Completion of First Cohort and Dosing of Three Patients of the Second Cohort in Arm 2 of Avacta’s AVA6000 Phase 1 trial avacta.com ↗
First cohort successfully completed in Arm 2 with no adverse safety signals and initiation of FAPI-PET sub-study to better characterize the FAP-positive disease burden at the time of study entry in selected patients |
| 2024-04-09 | Avacta Life Sciences Ltd | Results Avacta Therapeutics Reports Data from the Ongoing Phase 1 Clinical Trial of AVA6000 at the AACR Annual Meeting Demonstrating Clinical Proof-of-Concept Showing Multiple Patient Responses avacta.com ↗
The results to date show that AVA6000, the first peptide drug conjugate in the Avacta pipeline, has a favorable safety profile with concentration of the warhead in the TME resulting in multiple responses in patients with high levels of Fibroblast Activation Protein (“FAP high ”), thus delivering clinical proof-of-concept for AVA6000 and proof-of-mechanism for the proprietary pre|CISION TM drug delivery platform. |
| 2024-03-21 | Avacta Life Sciences Ltd | Regulatory Update on AVA6000 Phase 1a Clinical Trial Progress avacta.com ↗
Avacta receives approval to enrol patients in the UK in the ongoing two-weekly dose escalation study |
| 2023-12-13 | Avacta Life Sciences Ltd | Results ALS-6000-101 Phase 1a Three-Weekly Dose Escalation Safety Study Data avacta.com ↗
AVA6000 has significantly improved the safety and tolerability of doxorubicin. |
| 2023-09-19 | Avacta Life Sciences Ltd | Results Successful Completion of ALS-6000-101 Sixth Dose Escalation and Clinical Update avacta.com ↗
Additionally, a tumour response (significant tumour volume reduction) has been confirmed in a patient with soft tissue sarcoma on the trial, and there are further indications of clinical activity in patients across other indications. |
| 2023-06-21 | Avacta Life Sciences Ltd | Results Successful Completion of Fifth Dose Escalation in AVA6000 Phase 1 Clinical Study avacta.com ↗
The data continue to show a very favourable safety profile for the tumour targeted chemotherapy and several patients in cohort 5 and earlier cohorts remain on treatment as their disease has not progressed. |
| 2023-01-17 | Avacta Life Sciences Ltd | Results Avacta Announces Successful Completion of Fourth Dose Escalation in AVA6000 Phase 1 Clinical Study avacta.com ↗
AVA6000 continues to be well tolerated by patients in cohort 4 with a marked reduction in the incidence and severity of the typical toxicities associated with the standard doxorubicin chemotherapy administration. |
| 2022-09-05 | Avacta Life Sciences Ltd | Regulatory AVA6000 receives Orphan Drug Designation from the US Food and Drug Administration avacta.com ↗ |
| 2021-11-29 | Avacta Life Sciences Ltd | Regulatory Avacta Announces FDA Approval of its Investigational New Drug (IND) Application for AVA6000 avacta.com ↗
The FDA has completed its 30-day review of Avacta’s IND application, which was submitted ahead of schedule in October 2021, and has concluded that the Group may proceed with its proposed clinical investigation. |
| 2021-09-30 | Avacta Life Sciences Ltd | Regulatory Interim Results for the Period Ended 30 June 2021 and Business Update avacta.com ↗
Avacta Therapeutics Division becomes a clinical stage oncology drug company receiving approval from the MHRA for its phase I, first-in-human clinical study for AVA6000 pro-doxorubicin with the dosing of the first patient at the Royal Marsden Hospital in August 2021. |
All press releases naming this drug 37 releases
Evidence & citations 2 cited values
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | AVA6000 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04969835 ↗ |
| Route | Intravenous | “administered intravenously” NCT04969835 ↗ |