NTX-301 Monotherapy in Advanced Solid Tumours and in Combination With Platinum-based Chemotherapy in Advanced Ovarian & Bladder Cancer and in Combination With Temozolomide in High-grade Glioma
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Advanced Solid Tumor
- High Grade Glioma
- Platinum Resistant Ovarian Cancer
- Platinum-Resistant Urothelial Carcinoma
- Type
- Interventional
- Phase
- Phase 1Phase 2
- Design
- Allocation: Non-RandomizedIntervention Model: Sequential AssignmentIntervention Model Description: Dose escalation to determine MTD/RP2D, then dose expansionMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
Dose Exploration (Phase 1a, n~25): This part of the study will assess the safety and tolerability of NTX-301 and to identify the Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D). It will initiate with a dose escalation using a 3+3 design. Combination Dose and Disease Expansion (Phase...
Dose Exploration (Phase 1a, n~25): This part of the study will assess the safety and tolerability of NTX-301 and to identify the Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D). It will initiate with a dose escalation using a 3+3 design. Combination Dose and Disease Expansion (Phase 1b-2a, n~60): The study will be expanded in specific subsets of patients with solid tumours and with combination therapy as follows: Arm 1 (Phase 1b, n~20): Dose Escalation, NTX-301 platinum-based doublet therapy Arm 2 (Phase 2a, n~40): Dose Expansion, NTX-301 platinum-based doublet therapy Patients with advanced ovarian & bladder cancer considered to be incurable by the investigator and for which available anti-cancer therapy has been exhausted will be enrolled for this component. Patients will be given NTX-301 at the MTD determined in Phase 1a. This will be combined with a platinum-based agent that will be administered by IV infusion. Optional Cohort -High-Grade Glioma Combination Dose & Disease Expansion (Phase 1b-2a, n~40) Arm 3 (Phase 1b, n~20): Dose Escalation, NTX-301 combination therapy with TMZ Arm 4 (Phase 2a, n~20): Dose Expansion, NTX-301 combination therapy with TMZ Patients with IDH1 mutated high-grade glioma that have commenced initial chemoradiotherapy with temozolomide and are yet to commence Temozolomide maintenance therapy will be enrolled for this component. Patients will be given NTX-301 at the MTD determined in Phase 1a. This will be combined with TMZ that will be administered orally.
Tracking Information
- NCT #
- NCT04851834
- Collaborators
- Pinotbio, Inc.
- Investigators
- Study Director: Rafael E. Curiel Xennials Therapeutics
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