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Phase 1a: Subjects will receive escalating doses of INV-1120 orally once a day until un-acceptable toxicity or disease progression. Three to six patients will be enrolled per cohort to evaluate the safety and pharmacokinetics for each dose level. After the last patient in each cohort completes Cycle 1 (DLT observation period of 28 days), the Safety Evaluation Team (SET) will evaluate the safety data and pharmacokinetic collected from Cycle 1, and make the decision whether to escalate the dose before opening the second cohort.

Phase 1b: Subjects will receive escalating and de-escalating doses of INV-1120 orally once a day in combination with pembrolizumab until un-acceptable toxicity or disease progression, and DLT observation period of 21 days.

INV-1120 is an investigational selective and potent small molecule indicated for the treatment of solid malignancies including, but not limited to colorectal, breast, pancreatic, lung and liver cancers.

INV-1120

Pembrolizumab will be administered as a dose of 200 mg on Day 1 of each 3-week treatment cycle.

radhika Shah, MD

Karyn Burnworth

Costantine Albany, MD

Angela Galindo

Amita Patnaik, MD

Karla Hagerty

John Sarantopoulos, MD

Phase 1, open-label dose-escalation study to determine the MTD of INV-1120 and RP2D, and to assess the DLT of INV-1120 as a single agent or in the combination with pembrolizumab. The safety, tolerability, and PK of INV-1120 as a single agent or in the combination with pembrolizumab will be assessed in adult patients with advanced solid tumors.

Phase 1a: it is anticipated that approximately 36 patients will be enrolled in the dose escalation phase as a single agent of the study. Additionally, up to 9 additional patients may be enrolled to confirm the safety of patients treated at the maximum tolerated dose (MTD)/recommended phase 2 dose (RP2D).

Phase 1b: approximately 36-42 patients will be enrolled in the dose escalation and de-escalation phases in the combination with pembrolizumab. One or more combination dose levels that could represent the combination RP2D will be expanded to a total of 12-15 patients to confirm safety and tolerability of the combination.

An Open-Label Study of INV-1120 as a Single Agent and in Combination With Pembrolizumab in Adult Patients With Advanced Solid Tumors

A Phase 1a/1b, Multi-Center, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Evidence of Antitumor Activity of INV-1120 as a Single Agent and in Combination With Pembrolizumab in Adult Patients With Advanced Solid Tumors

To characterize investigator defined ORR using iRECIST

To characterize investigator defined PFS using iRECIST

To characterize investigator defined DOR using iRECIST

To evaluate dose limiting toxicities (DLTs) of INV-1120 in patients with advanced cancer and to establish a recommended Phase 2 dose (RP2D)

To determine RP2D, and to assess DLT of the combination of INV-1120 and pembrolizumab administered to adult patients with advanced solid tumors.

To determine the pharmacokinetics (PK) using AUC of INV-1120 after a single dose and at steady state after multiple doses

To determine the pharmacokinetics (PK) using AUC of INV-1120 after a single dose and at steady state after multiple doses in combination with pembrolizumab

To determine the pharmacokinetics (PK) using Cmax of INV-1120 after a single dose and at steady state after multiple doses

To determine the pharmacokinetics (PK) using Cmax of INV-1120 after a single dose and at steady state after multiple doses in combination with pembrolizumab

To characterize Investigator defined ORR, PFS and DOR using RECIST v1.1

To analyze the safety profile of INV-1120 as a single agent by AE, clinical lab test results, ECG and Vital signs changes

To analyze the safety profile of the combination of INV-1120 and pembrolizumab by AE, clinical lab test results, ECG and Vital signs changes

Spots Global Cancer Trial Database for ionova bio

Every month we try and update this database with for ionova bio cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for ionova bio

Every month we try and update this database with for ionova bio cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for ionova bio cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.