TT-10 as a Single Agent in Subjects With Advanced Selected Solid Tumors

Status Active, not recruiting

Clinical Trial Summary

The purpose of this study is to evaluate the safety and tolerability of orally administered TT-10 in subjects with advanced selected solid tumors. The dose escalation portion of the study will determine the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) of TT-10.

Clinical Trial Description

Multicenter, open-label dose-escalation Phase I/II clinical study, designed to evaluate the safety, tolerability, PK, PD, anti-tumor activity, and efficacy of TT-10 in subjects diagnosed with advanced Renal cell cancer (RCC), castrate resistant prostate cancer (CRPC) and Non-small cell lung cancer (NSCLC); who have failed or are not eligible for standard of care treatment. The study will be conducted in two phases. Dose escalation (Phase 1) will be to determine the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D), safety and tolerability of TT-10 in subjects with advanced subjects diagnosed with advanced Renal cell cancer (RCC), castrate resistant prostate cancer (CRPC) and Non-small cell lung cancer (NSCLC); who have failed or are not eligible for standard of care treatment. Dose expansion (Phase 2) will be to further explore the safety and tolerability of the MTD and/or RP2D, PK, PD, anti-tumor activity, and efficacy of TT-10. ;

Study Design

Related Conditions & MeSH terms

Carcinoma, Renal Cell
Castrate Resistant Prostate Cancer
Head and Neck Squamous Cell Carcinoma
Non Small Cell Lung Cancer
Renal Cell Cancer
Squamous Cell Carcinoma of Head and Neck

Clinical Trial Details

NCT number	NCT04969315
Study type	Interventional
Source	Portage Biotech
Contact
Status	Active, not recruiting
Phase	Phase 1/Phase 2
Start date	June 23, 2023
Completion date	August 14, 2025

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05094804` - A Study of OR2805, a Monoclonal Antibody Targeting CD163, Alone and in Combination With Anticancer Agents	Phase 1/Phase 2
Recruiting	`NCT05707286` - Pilot Study to Determine Pro-Inflammatory Cytokine Kinetics During Immune Checkpoint Inhibitor Therapy
Recruiting	`NCT04258137` - Circulating DNA to Improve Outcome of Oncology PatiEnt. A Randomized Study	N/A
Completed	`NCT01945021` - Phase II Safety and Efficacy Study of Crizotinib in East Asian Patients With ROS1 Positive, ALK Negative Advanced NSCLC	Phase 2
Completed	`NCT04487457` - Prospective Study to Evaluate the Blood Kinetics of Immune Cells and Immunosuppressive Cytokines After Exposure to an Immunity Checkpoint Inhibitor (ICI): Study of the Impact of Chemotherapy
Terminated	`NCT04022876` - A Study of ALRN-6924 for the Prevention of Chemotherapy-induced Side Effects (Chemoprotection)	Phase 1
Recruiting	`NCT05898763` - TEIPP Immunotherapy in Patients With NSCLC	Phase 1/Phase 2
Recruiting	`NCT05532696` - Phase 1b/2 Study to Evaluate ABT-101 in Solid Tumor and NSCLC Patients	Phase 1/Phase 2
Completed	`NCT04311034` - A Study of RC48-ADC in Subjects With Advanced Non-small Cell Lung Cancer	Phase 1/Phase 2
Active, not recruiting	`NCT03177291` - Pirfenidone Combined With Standard First-Line Chemotherapy in Advanced-Stage Lung NSCLC	Phase 1
Terminated	`NCT03257722` - Pembrolizumab + Idelalisib for Lung Cancer Study	Phase 1/Phase 2
Completed	`NCT00349089` - Trial on Refinement of Early Stage Lung Cancer Adjuvant Therapy	Phase 2
Completed	`NCT05116891` - A Phase 1/2 Study of CAN04 in Combination With Different Chemotherapy Regimens in Subjects With Advanced Solid Tumors	Phase 1/Phase 2
Recruiting	`NCT04571632` - Clinical Trial of SBRT and Systemic Pembrolizumab With or Without Avelumab/Ipilimumab+ Dendritic Cells in Solid Tumors	Phase 2
Terminated	`NCT03599518` - DS-1205c With Gefitinib for Metastatic or Unresectable Epidermal Growth Factor Receptor (EGFR)-Mutant Non-Small Cell Lung Cancer	Phase 1
Not yet recruiting	`NCT06020989` - Lazertinib and Chemotherapy Combination in EGFR-mutant NSCLC Patients Without ctDNA Clearance After lead-in Lazertinib Monotherapy	Phase 2
Withdrawn	`NCT03982134` - PDR001 + Panobinostat for Melanoma and NSCLC	Phase 1
Withdrawn	`NCT03574649` - QUILT-2.024: Phase 2 Neoadjuvant, Consolidation, and Adjuvant Combination NANT Immunotherapy Versus Standard of Care in Subjects With Resectable Non-small Cell Lung Cancer	Phase 2
Withdrawn	`NCT02844140` - DE-CT in Lung Cancer Proton Therapy	N/A
Terminated	`NCT02628535` - Safety Study of MGD009 in B7-H3-expressing Tumors	Phase 1