A Phase II Open -Label Safety and Efficacy Study of combination IP in patients with progressed advanced malignancies
Case study
2.3 million new cases of lung cancer are expected worldwide in 2024, continuing the trend of lung cancer being the most common cancer worldwide, accounting for approximately 12-13% of all new cancer diagnoses globally.
At Aixial Group, we are committed to lung cancer research and better outcomes for patients worldwide. With 41 clinical trials spanning from early-stage to late-stage studies across APAC, Europe and North America, we are pushing the boundaries of treatment for better outcomes. Check out our case study to see how we have supported our sponsors!
A Phase II Open-Label, Safety And Preliminary Efficacy Study Of [IP] In Combination With [IP] In Patients With Advanced Malignancies Who Have Progressed On [X, prior therapy]
Targeted Clinical Indications
- Non-small cell lung cancer
- Renal cell carcinoma
- Bladder cancer
- Pancreatic cancer
- Melanoma
Trial Design
Two parts
- Part A – first 12 patients (all comers) with Safety Review Committee meetings after 4, 8 and 12th patients to discuss safety and DLTs
- Part B – assessment of safety and primary efficacy in up to 120 patients (recruitment in cohorts with a maximum of 30 patients per tumour type)
Sites and Dates
- 5 US Sites
- 2018 – Present
Products
- Monoclonal antibody
- Live biotherapeutic agent
Challenges with Mitigations
- Recruitment
- Challenge with initial sample shipments managed by sites; mitigated by implementing logistics management lead by Aixial Group and overseen by CRA from collection to receipt at the central lab
- Time to turn-around documentation by the sponsor was initially delayed but improved through Aixial Group helping the sponsor to prioritize and understand potential risks
Successes
- Strong CRO partnership with site team; supporting sites with screening activity, routine calls, increased site visits frequency, education on IP and study as well as CRA availability to site
- Prompt Safety Review Committee meeting with a minimal pause in recruitment.
- Collaborative approach to working with the sponsor
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