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Phase I/IIa Oncology

Case study
Phase I/IIa Oncology: Fast European Execution Under Tight Timelines

A US-based clinical-stage biotechnology company developing a first-in-class anti-tumor agent initiated a Phase I/IIa clinical trial as part of a global development program. The investigational product was evaluated as a first-line treatment for metastatic solid tumors, with the primary objective of determining the Maximum Tolerated Dose (MTD). The planned recruitment target for this early-phase study was 25 patients.

The Challenge

The sponsor faced high operational and strategic pressure to deliver results within extremely tight timelines. Rapid study start-up and efficient patient recruitment were critical, as delays would have a direct impact on downstream development decisions and the overall commercialization strategy. To succeed, the sponsor required a CRO with deep therapeutic expertise, operational agility, and proven ability to execute early-phase oncology studies efficiently in Europe.

Aggressive start-up and recruitment timelines

MTD determination critical for next development steps

Need for strong early-phase oncology expertise and access to key opinion leaders (KOLs)

The APICES Approach

APICES proposed an ambitious yet realistic execution strategy, focused on speed, quality, and cost efficiency.

Key elements of the approach included:

  1. Optimized single-country strategy (Spain) to accelerate timelines while maintaining full operational control and cost efficiency
  2. Early protocol optimization, leveraging input from APICES medical monitors and leading oncology KOLs to strengthen study design and feasibility
  3. Fast EC & Regulatory Authority pathway, enabled by centralized Ethics Committee selection and parallel submissions
  4. Selection of four high-performing oncology sites, based on data-driven feasibility assessments and established investigator relationships
  5. Dedicated early-phase Project Management and CRA team, supported by an independent Data Safety Monitoring Board (DSMB) to ensure continuous safety oversight 

This integrated approach allowed APICES to compress timelines without compromising data quality or patient safety.

patients recruited as planned

Rapid site activation and seamless study execution

High sponsor satisfaction, leading to APICES being selected as a strategic partner for subsequent development phases

The successful delivery of this Phase I/IIa study positioned the sponsor to confidently progress to the next stages of clinical development, while reinforcing APICES’ role as a trusted partner for early-phase oncology programs in Europe.

More about the study:

www.clinicaltrials.gov

NCT number: NCT04827953