Unmet Needs in Advanced Solid Tumors:

Advanced solid tumors present significant challenges in oncology, and several key unmet needs persist across various cancer types. These unmet needs span the spectrum of cancer care, from diagnosis and treatment to supportive care and survivorship.

1. Treatment Resistance and Recurrence:

• Many advanced solid tumors develop resistance to existing therapies, leading to disease recurrence and poor prognosis. This is a major unmet need in cancers like non-small cell lung cancer (NSCLC), colorectal cancer, prostate cancer, pancreatic cancer, triple-negative breast cancer (TNBC), head and neck squamous cell carcinoma (HNSCC), urothelial carcinoma (UC), and glioblastoma multiforme (GBM). Research efforts are focused on understanding the mechanisms of resistance and developing novel therapeutic strategies to overcome it, including targeted therapies, immunotherapy, and combination approaches.

2. Limited Treatment Options for Specific Subpopulations:

• Certain patient populations with advanced solid tumors face limited treatment options due to specific disease characteristics, comorbidities, or age. For example, patients with HER2-positive advanced breast cancer with brain metastases or cardiac dysfunction, elderly or frail patients, and those with leptomeningeal disease often have limited treatment choices. Similarly, patients with advanced-stage head and neck cancers (HNC) and drug-resistant epilepsy (DRE) experience significant symptom burden and limited effective therapies. Addressing the unmet needs of these specific subpopulations requires tailored treatment strategies and increased clinical trial enrollment.

3. Supportive Care and Quality of Life:

• Patients with advanced solid tumors and their caregivers experience a range of unmet supportive care needs, including psychological support, information needs, financial assistance, and help with daily living activities. Studies have highlighted the need for improved supportive care services to address these needs and enhance the quality of life for patients and their families. This is particularly important in advanced cancers where symptom burden is high and patients face significant physical and emotional challenges.

4. Early Detection and Diagnosis:

• Early detection and diagnosis of solid tumors remain a challenge, particularly for aggressive cancers like pancreatic cancer and brain tumors. Late diagnosis often leads to limited treatment options and poorer outcomes. Research efforts are focused on developing more accurate and accessible diagnostic tools and biomarkers to facilitate earlier diagnosis and improve treatment outcomes.

5. Health Disparities and Access to Care:

• Racial/ethnic minorities, low-income individuals, and those living in rural areas often face disparities in access to quality cancer care, leading to unmet needs and poorer outcomes. Addressing these disparities requires systemic changes to improve access to screening, diagnosis, treatment, and supportive care services for all populations.

6. Financial Toxicity:

• The high cost of cancer care can lead to financial toxicity, which can significantly impact patients' quality of life and adherence to treatment. This is a major unmet need for many patients with advanced solid tumors, particularly those with limited financial resources. Strategies to mitigate financial toxicity and improve access to affordable cancer care are needed.

7. Clinical Trial Design and Patient Enrollment:

• Clinical trials are essential for developing new and improved cancer therapies. However, challenges in clinical trial design and patient enrollment can hinder progress. There is a need for more innovative clinical trial designs that are inclusive of diverse patient populations and address the specific needs of patients with advanced solid tumors.

8. Addressing Unmet Needs of Caregivers:

• Caregivers of patients with advanced solid tumors play a crucial role in providing support and care. However, they also experience a range of unmet needs, including psychological distress, information needs, and practical support. Addressing the unmet needs of caregivers is essential to ensure their well-being and enable them to continue providing care for their loved ones.

9. Long-Term Survivorship:

• As cancer treatments improve and survival rates increase, there is a growing need for supportive care services to address the long-term physical and psychosocial needs of cancer survivors. This includes managing late effects of treatment, providing psychological support, and addressing financial and practical challenges.

10. Development of More Effective and Less Toxic Therapies:

• A major unmet need in advanced solid tumors is the development of more effective and less toxic therapies. This includes targeted therapies, immunotherapy, and combination approaches that can improve treatment outcomes and minimize side effects. Research efforts are focused on identifying novel drug targets and developing innovative treatment strategies to address this need.

OBI-902 is not mentioned in the provided text. However, information is available for OBI-999, a novel antibody-drug conjugate.

OBI-999 was initially studied in a Phase 1 trial for advanced solid tumors including breast, gastric, pancreatic, and lung cancers. The recommended Phase 2 dose was determined to be 1.2 mg/kg every 3 weeks.

A Phase 2 cohort expansion study is currently enrolling patients with pancreatic, colorectal, and other cancers expressing high levels of Globo H. This suggests that OBI-999 is being investigated specifically for these cancer types beyond the initial broader category of advanced solid tumors. The provided text does not specify the intervention models for these trials, but given the context, it is likely a single-arm, open-label study design similar to the initial Phase 1 trial.