Kartos Therapeutics, Inc.
This study evaluates Navtemadlin (KRT-232) in combination with Pembrolizumab as a maintenance therapy in patients with locally advanced and metastatic non small cell lung cancer.
Non Small Cell Lung Cancer
Navtemadlin
Navtemadlin Placebo
Pembrolizumab
Phase 1
Phase 2
This is a 2 part, phase 1b/2, maintenance study for patients who have achieved a partial response (PR) or complete response (CR) after completion of up to 4 cycles of a combination platinum-based chemotherapy plus CPI regimen. Phase 1b is a 3+3 dose escalation design that will be used to determine the maximum tolerated dose (MTD) and/or the recommended phase 2 dose (RP2D) of navtemadlin in combination with pembrolizumab. A Safety Review Committee (SRC) will review the safety data during the dose escalation to decide on dose escalation and/or exploration of intermediate doses. Phase 2 will evaluate the efficacy and safety of the RP2D of navtemadlin plus pembrolizumab compared to navtemadlin placebo plus pembrolizumab. Each Arm will have approximately 40 subjects enrolled for a total of approximately 80 subjects. Eligible subjects will be randomized 1:1. This part of the study has a randomized, controlled, double-blind design. A stratified, permuted-block randomization scheme will be used for treatment allocation.
Study Type : | Interventional |
Estimated Enrollment : | 0 participants |
Masking: | Quadruple |
Primary Purpose: | Treatment |
Official Title: | A Two-Part, Phase 1b/2, Multicenter, Open-Label, Dose Escalation and Double-Blind, Randomized, Placebo-Controlled, Dose Expansion Study of the Safety, Efficacy and Pharmacokinetics of Navtemadlin Plus Pembrolizumab as Maintenance Therapy in Subjects With Locally Advanced and Metastatic Non-Small Cell Lung Cancer |
Actual Study Start Date : | June 2023 |
Estimated Primary Completion Date : | June 2025 |
Estimated Study Completion Date : | June 2027 |
Arm | Intervention/treatment |
---|---|
Experimental: Navtemadlin in combination with pembrolizumab Navtemadlin will be administered orally, once daily (QD), on days 1-7 in a 21-day cycle. Pembrolizumab will be administered intravenously on Day 1 of a 21-day cycle. |
Drug: Navtemadlin Drug: Pembrolizumab |
Placebo Comparator: Navtemadlin placebo in combination with pembrolizumab Navtemadlin placebo will be administered orally, once daily (QD), on days 1-7 in a 21-day cycle. Pembrolizumab will be administered intravenously on Day 1 of a 21-day cycle. |
Drug: Navtemadlin Placebo Drug: Pembrolizumab |
Ages Eligible for Study: | 18 Years |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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