Overview
A China-based biotech partnered with Novotech on its first clinical trial, a Phase I/II dose-escalation and dose-expansion trial evaluating a novel tri-specific monoclonal antibody in patients with advanced solid tumors.
From the outset, the sponsor and Novotech worked closely together to advance an innovative oncology therapy through accelerated early-phase development. The Phase I/II study was designed to evaluate safety, tolerability, pharmacokinetics, and preliminary antitumor activity across multiple tumor types while meeting ambitious start-up and recruitment timelines. To achieve these goals, the sponsor sought a partner with deep oncology expertise, strong operational capabilities in Australia, and the agility to navigate the complexities of early-phase development.
Acting as an extension of the sponsor’s team, Novotech provided strategic and operational support throughout study start-up and execution. Through rapid ethics submissions, efficient approval coordination, proactive communication, and strong site engagement, Novotech helped accelerate recruitment across Australian sites. This collaborative approach enabled the study to exceed enrollment targets and reinforced the sponsor’s confidence as the program progressed into future development phases.
The Challenge
Early-phase oncology trials require close coordination across protocol finalization, ethics submissions, site activation, investigator engagement, and patient recruitment. For this Phase I/II advanced solid tumor study, the sponsor needed to maintain momentum from start-up through enrollment while operating within accelerated timelines.
Key challenges included:
- Accelerated start-up expectations following final protocol availability
- A need for rapid EC submission and approval coordination
- Intensive recruitment requirements across advanced solid tumor populations
- The importance of selecting sites with investigators experienced in the required tumor types
- Maintaining sponsor confidence during the company’s first study with Novotech
To meet these challenges, the sponsor required a partner capable of integrating regulatory expertise, operational execution, and strong investigator relationships to help drive efficient study start-up and early recruitment success in Australia.
Novotech’s Approach
Novotech implemented an execution-focused strategy to accelerate study start-up, strengthen site readiness, and support early recruitment success. Working closely with the sponsor and investigative sites, the team maintained momentum throughout study delivery.
Accelerated ethics and study start-up
To support the sponsor’s accelerated timelines, Novotech coordinated ethics committee submissions within one week of final protocol availability and managed approvals through an expedited start-up pathway. Despite a holiday closure period, ethics approval was achieved in under seven weeks, enabling rapid study activation.
Strategic oncology site selection
Novotech prioritized high-performing oncology sites with principal investigators experienced in the relevant tumor types. This therapeutic alignment strengthened feasibility planning and positioned sites to support efficient study execution and patient recruitment.
Recruitment-focused feasibility
Recruitment strategy was embedded into feasibility planning from the outset. By selecting sites with proven enrollment capability and access to appropriate patient populations, Novotech helped drive recruitment performance while maintaining study timelines.
Proactive investigator and site engagement
Novotech maintained close collaboration with investigators and site teams throughout recruitment, enabling proactive issue resolution and sustained enrollment momentum across Australian sites.
Comprehensive clinical operations support
Novotech provided end-to-end clinical operations support, including project management, IRB/EC submissions and regulatory coordination, site activation and start-up, site management, and clinical monitoring.
Outcomes
Through a closely coordinated partnership approach, Novotech helped the sponsor accelerate study start-up timelines and achieve recruitment results that exceeded initial expectations in Australia.
Key outcomes included:
- Ethics committee submission completed within one week of final protocol availability
- Ethics approval achieved in under seven weeks, despite a holiday closure period
- First patient milestone reached within two weeks of ethics approval
- First patient enrolled within one week of site activation
- 51 patients enrolled across Australian sites, surpassing the original enrollment target of 30 patients
- Phase I recruitment completed within seven months
- Recruitment delivered consistently over a 7.5-month period from February to September 2025
- Recruitment performance exceeded one patient per site per month, with an average of approximately seven patients enrolled per month in Australia
The successful delivery of the study strengthened the sponsor’s confidence in Novotech as a strategic oncology development partner. Building on the success of the Phase I/II program, Novotech is now supporting a larger Phase II study, with Phase III collaboration discussions already underway.
Study Footprint at a Glance
- Therapeutic area: Oncology
- Indication: Advanced solid tumors
- Phase: Phase I/II
- Study design: Dose-escalation and dose-expansion
- Investigational therapy: Tri-specific PD-1/VEGFA/CTLA-4 antibody
- Country: Australia
- Sites: 9 total; 6 active
- Study start: October 2024
- Planned end: January 2029
- Enrollment: 51 patients in Australia
- Original Australia target: 30 patients
- Recruitment period: February–September 2025
- Recruitment duration: 7.5 months
- Recruitment rate: More than one patient per site per month; approximately seven patients per month in Australia