What the trial was testing
The InnovaTV 201 enrolled 195 patients with solid tumors. The study was sponsored by Seagen and tracked outcomes across the full group of patients who matched the trial's eligibility profile.
It was an early-stage trial — researchers are still confirming safety and getting an early look at how well the treatment works. Trials at this stage are designed to produce evidence regulators and physicians can act on — not just observations to follow up later.
What the results showed
16% tumor response rate across heavily pretreated solid tumors.
The Lancet Oncology · 2019 · NCT02001623
These findings — that across multiple advanced solid tumors in this first-in-human dose-finding study — were published in the The Lancet Oncology and represent the headline result of the study.
Researchers tracked outcomes across 195 patients enrolled in the trial. The result was consistent enough across the group that the team felt confident reporting it.
What this means for patients
For patients with solid tumors, this result changes the calculus on what to ask their care team about. Whether it changes day-to-day care depends on factors like disease subtype, prior treatments, and where the patient is in their care journey.
What you can do now
Tisotumab vedotin (Tivdak) is FDA-approved for advanced cervical cancer that has progressed after chemotherapy and is available now. Eye-related side effects are notable and require an eye care plan during treatment. Ask a gynecologic oncologist if it fits your case.
Eligibility for the treatments mentioned above depends on specific test results and clinical history. Bring this summary, the trial name, and your most recent labs or pathology report to your next visit.
Open solid tumors trials
A Non-interventional, International, Multicentre Clinical Research Study to Build the Largest Collection of Multimodal Data (Including Clinical Data, Imaging Data and Omics Data) in Oncology
Cancer is amongst the leading causes of disease-related morbidity and mortality. A major challenge in cancer treatment is the development of biology-informed, personalised treatment strategies. Recent advances in artificial intelligence (AI) and next-generation sequencing (NGS) technologies have shed further insights into disease biology and treatment pathways, thus identifying new, precision medicine-based therapeutic opportunities. The biological mechanisms leading to cancer development and progression arise from complex and plastic networks of dysregulated cellular programs involving many signalling pathways and effector molecules. Cancer cells alter their surrounding environment via cell-cell interactions with non-tumor cells or by secreting cytokines, chemokines and other factors. This reprogramming of the tumour microenvironment (TME) is critical for cancer progression, invasion, and metastasis. Moreover, there are increasing studies that show that both innate and adaptive immune cell types contribute to tumorigenesis and treatment resistance when present within the TME. Understanding the crosstalk between cancer cells and the surrounding TME will inform on mechanisms of sensitivity and resistance to treatment, including immunotherapy (IO) and targeted therapies. Spatially resolved-Omics is an emerging field that characterises cell types by gene/protein expressions within their spatial context in the tissue organisation. Recent high profile spatial transcriptomics studies have uncovered specific cell identities that define the surrounding TME. The MOSAIC study, a collaborative initiative across industry and top oncology hospitals, proposes to go way beyond current cancer molecular profiling projects by combining the generation and analysis of multiple data modalities (3 essential mandatory modalities: Clinical Data, Hematoxylin and Eosin (H\&E) microscopic image, Spatial transcriptomics; up to 3 high priority data modalities depending on technical feasibility and sample size: bulk Ribonucleic Acid Sequencing (RNAseq), bulk Whole Exome Sequencing (WES), Single-cell transcriptomics; and potentially other optional data modalities and follow-up experiments such as single-cell omics, immunohistochemistry and spatial proteomics or other molecular profiling of proteins and molecules) on a minimum of 2,000 tumour samples across a different cancer indications. This will generate broad molecular and cellular profiling data of the tumour and its microenvironment from cancer patients, integrated with clinical data, at an unprecedented scale and resolution. This study will enroll patients diagnosed with one of the eligible cancer indications and for which a formalin fixed paraffin embedded (FFPE) tumor sample from already performed biopsy and/or surgical resection is available within their local pathology archive or their affiliate centers archives. The MOSAIC study expects to have a strong impact for patients in terms of new targeted therapeutic drug discovery, identification of patient subgroups requiring either specific treatment or broader clinical care and identification of novel treatment response and resistance mechanisms.
A Study of IDE849 in Patients With DLL3 Expressing Tumors Including Small Cell Lung Cancer
This is Phase 1/2, multicenter, clinical study to evaluate the safety, efficacy, PK, and immunogenicity of IDE849 in subjects with DLL3-expressing tumors including SCLC.