TT-4 and TT-10 as Single Agents and in Combination in Subjects With Advanced Selected Solid Tumors and Pleural Mesothelioma

Conditions: Renal Cell Cancer, Castrate Resistant Prostate Cancer, Non Small Cell Lung Cancer, Pleural Mesothelioma Malignant

Summary

Eligibility Criteria

To be eligible for inclusion in the dose escalation cohorts or expansion cohorts in this study, participants must meet all of the following criteria: 1. Male or female participants must be ≥18 years of age on the day of signing the ICF. 2. Participants or their legal representative must be able to provide written informed consent to participate in the study prior to the performance of any study-specific procedures. 3. Diagnosis of histologically or cytologically confirmed advanced selected solid tumors: All Cohorts 1. RCC: Participants with locally advanced or metastatic RCC who have previously received at least two prior standard of care systemic regimens for advanced disease. Prior exposure to a checkpoint inhibitor and/or vascular endothelial growth factor (VEGF) targeted therapy is permitted but not required. Prior HIF-2α inhibitor therapy is permitted and may count toward the number of prior systemic regimens. 2. CRPC: Participants with metastatic CRPC who have previously received a second-generation hormonal agent (unless contraindicated) and a taxane-based chemotherapy. 3. Non-small cell lung cancer (NSCLC): Participants with metastatic NSCLC that are intolerant or resistant to standard systemic therapy or for whom no standard therapy is available. Prior exposure to platinum-based chemotherapy should be limited to no more than two prior cytotoxic chemotherapy regimens (e.g. platinum doublets, docetaxel, gemcitabine, vinorelbine, taxanes) administered for advanced/metastatic disease. Adjuvant or neoadjuvant chemotherapy does not count toward this limit. Cohort C Only d. PM: Participants with unresectable, metastatic PM with any subtype that have progressed after, or are intolerant to, at least one line of standard systemic therapy (e.g., platinum-pemetrexed ± immune checkpoint inhibitor) and ≤3 prior lines of systemic therapy (biologic or chemotherapy are allowed). Maintenance therapy after 4-6 cycles of front-line chemotherapy is still considered 1 line of therapy and is not considered 2 separate therapies. 4. Eastern Cooperative Oncology Group (ECOG) performance status (PS) score 0 - 2 a. Participants with ECOG PS 2 must have performance decline attributable to cancer rather than comorbid conditions, in the judgment of the investigator. 5. Have measurable disease per RECIST 1.1 (Eisenhauer et al 2009) except as specified below and as assessed by the local site investigator/radiology. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions. 1. PM: modified RECIST (mRECIST) (Nowak et al 2018) will be applied for malignant pleural mesothelioma 2. Measurable CRPC: Prostate Cancer Working Group 3 (PCWG3; Scher et al 2016). Participants with CRPC who have metastatic disease that is non-measurable are eligible if screening PSA ≥2.0 ng/mL and with Sponsor approval 6. Failure to respond to standard therapy, or for whom no appropriate therapies are available (based on the judgment of the investigator) 7. Consent to baseline biopsy, with the following exceptions: 1. Participants whose only site(s) of disease are in areas considered moderate or high risk, as defined in Section 7.2.9 may be enrolled without a fresh biopsy with Sponsor approval; 2. Archival tissue may be submitted in lieu of a fresh biopsy if collected within 6 months of screening and without intervening systemic therapy. 8. Participants must have adequate hematologic function based on the following: 1. ANC ≥1.5 × 109/L 2. Platelet count ≥100 × 109/L 3. Hemoglobin ≥9.0 g/dL 9. Participants must have adequate hepatic function based on the following: 1. Total bilirubin \

Source: ClinicalTrials.gov (NCT04969315). StuddyBuddy aggregates publicly available trial information.