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First-in-Human Evaluation of GRN-300 in Subjects With Recurrent Ovarian, Primary Peritoneal, and Fallopian Tube Cancers.

Primary Purpose

Ovarian Tumors

Status
Active
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
GRN-300
Paclitaxel
Sponsored by
Green3Bio, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ovarian Tumors

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age ≥ 18 years.
  • Diagnosis of recurrent ovarian, primary peritoneal or fallopian tube epithelial cancer, or metastatic solid tumors. Histologic or cytologic confirmation of the original tumor by MD Anderson Cancer Center Pathology is required.
  • Patients must have measurable disease defined as at least one lesion that can be accurately measured in at least one dimension as defined by RECIST 1.1.
  • Prior therapy: Patients must have received at least one prior second-line treatment for persistent / recurrent disease but may have received any number of prior treatments.
  • ECOG score of 0-1.
  • Adequate bone marrow, liver and renal function.

Exclusion Criteria:

  • Patients who have undergone major surgery ≤ 4 weeks prior to starting study drug.
  • Patients with known hypersensitivity to paclitaxel or residual Grade 2 or higher neuropathy (excluded from Phase IB portion only).
  • Use of any cytotoxic chemotherapy or investigational drugs, biologics, or devices within 21 days prior to study enrollment.
  • Women who are pregnant or breastfeeding.
  • Known history of human immunodeficiency virus (HIV) infection or current chronic or active hepatitis B or C infection requiring treatment with antiviral therapy.
  • Known CNS metastases or leptomeningeal disease.
  • Gastrointestinal dysfunction that may affect oral drug absorption (e.g., intermittent or chronic bowel obstruction, short gut, etc.).
  • Subjects with thrombotic, embolic, venous, or arterial events, such as cerebrovascular accident (including transient ischemic attacks) deep vein thrombosis or pulmonary embolism within six months of start of study treatment.
  • Other medical co-morbidities that in the investigator's judgment would increase the risks of participation
  • QTc >480 msec be excluded from the study

Sites / Locations

  • MD Anderson Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Part 1 (Phase 1a): Single Arm, Open Label (GRN-300 single-agent)

Part 2 (Phase 1b): Single Arm, Open Label (GRN-300 plus paclitaxel)

Arm Description

Part 1 of the study will determine the safety of continuous twice a day oral dosing of GRN-300, with each cycle consisting of 28 days of treatment. The number of administered cycles will depend on the tolerability of each dose level and the severity and occurrence of side effects and DLTs. The maximal tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of GRN-300 as a single agent will be determined. The overall duration of Part 1 will be approximately 24-36 months, depending on the rate of enrollment and the number of subjects enrolled.

The study will determine the safety of continuous twice a day oral dosing of GRN-300, with each cycle consisting of 28 days of treatment, in combination with intravenously administered paclitaxel weekly x 3 during each 28-day cycle. The number of administered cycles will depend on the tolerability of each dose level and the severity and occurrence of side effects and DLTs. The maximal tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of GRN-300 in combination with paclitaxel will be determined. The overall duration of Part 2 will be approximately 12-18 months, depending on the rate of enrollment and the number of subjects enrolled. Part 2 will commence following determination of the MTD and RP2D of single-agent GRN-300 in Part 1. Overall duration of the study will be approximately 36-48 months, depending on the rate of enrollment and number of subjects enrolled.

Outcomes

Primary Outcome Measures

Part 1 (Phase 1A) - Determination of the MTD and the RP2D of GRN-300 single-agent based on evaluation of the DLT in the study population.
• Determination of the recommended Phase II dose (RP2D) of GRN-300 in the study population.
Part 1 (Phase 1A) - Number of participants with treatment-related adverse events as assessed by CTCAE v5.0.
• To investigate the safety of repeated 28-day cycles of daily oral GRN-300 therapy in subjects with recurrent or metastatic ovarian, fallopian tube, and primary peritoneal cancer or other advanced solid tumors, based on the number of participants with treatment-related adverse events as assessed by CTCAE v5.0.
Part 2 (Phase 1B) - Determination of the MTD and the RP2D of GRN-300 with paclitaxel based on evaluation of the DLT in the study population
• Determination of the recommended Phase II dose (RP2D) of GRN-300 in combination with weekly paclitaxel in the study population.
Part 2 (Phase 1B) - Number of participants with treatment-related adverse events as assessed by CTCAE v5.0.
• To investigate the safety of repeated 28-day cycles of daily oral GRN-300 therapy in combination with weekly paclitaxel x 3 in subjects with recurrent or metastatic ovarian, fallopian tube, and primary peritoneal cancer or other advanced solid tumors, based on the number of participants with treatment-related adverse events as assessed by CTCAE v5.0.

Secondary Outcome Measures

Part 1 (Phase 1A) - Determination of GRN-300 monotherapy PK profile (Cmax).
• To evaluate the pharmacokinetic (PK) profile of GRN-300 after oral administration of a single dose and at steady state. - Maximum plasma concentration (Cmax)
Part 1 (Phase 1A) - Determination of GRN-300 monotherapy PK profile (tmax).
• To evaluate the pharmacokinetic (PK) profile of GRN-300 after oral administration of a single dose and at steady state. - Time to Cmax (tmax)
Part 1 (Phase 1A) - Determination of GRN-300 monotherapy PK profile (t1/2).
• To evaluate the pharmacokinetic (PK) profile of GRN-300 after oral administration of a single dose and at steady state. - Terminal half-life (t1/2)
Part 1 (Phase 1A) - Determination of GRN-300 monotherapy PK profile (AUC0-t).
• To evaluate the pharmacokinetic (PK) profile of GRN-300 after oral administration of a single dose and at steady state. - Area under the plasma concentration-time curve from zero to the last measurable concentration (AUC0-t)
Part 1 (Phase 1A) - Determination of GRN-300 monotherapy PK profile (AUC0-Inf).
• To evaluate the pharmacokinetic (PK) profile of GRN-300 after oral administration of a single dose and at steady state. - Area under the plasma concentration-time curve from zero to infinity (AUC0-Inf)
Part 1 (Phase 1A) - Determination of GRN-300 monotherapy PK profile (CL/F).
• To evaluate the pharmacokinetic (PK) profile of GRN-300 after oral administration of a single dose and at steady state. - Apparent oral clearance (CL/F)
Part 1 (Phase 1A) - Determination of GRN-300 monotherapy PK profile (Vz/F).
• To evaluate the pharmacokinetic (PK) profile of GRN-300 after oral administration of a single dose and at steady state. - Apparent volume of distribution during terminal distribution phase (Vz/F)
Part 1 (Phase 1A) - Estimation of the clinical activity of single agent GRN-300 (ORR)
• Overall response rate (ORR) per investigator assessment using RECIST v1.1 defined as the percentage of subjects having a best overall response (BOR) of complete response (CR) or partial response (PR)
Part 1 (Phase 1A) - Estimation of the clinical activity of single agent GRN-300 (DCR)
• Disease control rate (DCR) per investigator assessment using RECIST v1.1 defined as the percentage of subjects having a BOR of CR, PR, or stable disease (SD) ≥ 4 months (4 cycles, 28 days each)
Part 2 (Phase 1B) - Determination of GRN-300 plus paclitaxel PK profile (Cmax).
• To evaluate the PK profile of GRN-300 and paclitaxel following administration of a single dose of each and at steady state. - Maximum plasma concentration (Cmax)
Part 2 (Phase 1B) - Determination of GRN-300 plus paclitaxel PK profile (tmax).
• To evaluate the PK profile of GRN-300 and paclitaxel following administration of a single dose of each and at steady state. - Time to Cmax (tmax)
Part 2 (Phase 1B) - Determination of GRN-300 plus paclitaxel PK profile (t1/2).
• To evaluate the PK profile of GRN-300 and paclitaxel following administration of a single dose of each and at steady state. - Terminal half-life (t1/2)
Part 2 (Phase 1B) - Determination of GRN-300 plus paclitaxel PK profile (AUC0-t).
• To evaluate the PK profile of GRN-300 and paclitaxel following administration of a single dose of each and at steady state. - Area under the plasma concentration-time curve from zero to the last measurable concentration (AUC0-t)
Part 2 (Phase 1B) - Determination of GRN-300 plus paclitaxel PK profile (AUC0-Inf).
• To evaluate the PK profile of GRN-300 and paclitaxel following administration of a single dose of each and at steady state. - Area under the plasma concentration time curve from zero to infinity (AUC0-Inf)
Part 2 (Phase 1B) - Determination of GRN-300 plus paclitaxel PK profile (CL/F).
• To evaluate the PK profile of GRN-300 and paclitaxel following administration of a single dose of each and at steady state. - Apparent oral clearance (CL/F)
Part 2 (Phase 1B) - Determination of GRN-300 plus paclitaxel PK profile (Vz/F).
• To evaluate the PK profile of GRN-300 and paclitaxel following administration of a single dose of each and at steady state. - Apparent volume of distribution during terminal distribution phase (Vz/F)
Part 2 (Phase 1B) - Estimation of the clinical activity of GRN-300 plus paclitaxel (ORR).
• Overall response rate (ORR) per investigator assessment using RECIST v1.1 defined as the percentage of subjects having a best overall response (BOR) of complete response (CR) or partial response (PR)
Part 2 (Phase 1B) - Estimation of the clinical activity of GRN-300 plus paclitaxel (DCR).
• DCR per investigator assessment using RECIST v.1.1 defined as the percentage of subjects having a BOR of CR, PR, or SD ≥ 4 months (4 cycles, 28 days each)

Full Information

First Posted
December 24, 2020
Last Updated
April 9, 2023
Sponsor
Green3Bio, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04711161
Brief Title
First-in-Human Evaluation of GRN-300 in Subjects With Recurrent Ovarian, Primary Peritoneal, and Fallopian Tube Cancers.
Official Title
Ph 1/1B Evaluation of the Safety, Pharmacokinetics and Efficacy of GRN-300, a Salt-inducible Kinase Inhibitor, Alone and in Combination With Paclitaxel, in Recurrent Ovarian, Primary Peritoneal, and Fallopian Tube Cancers.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 21, 2020 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
March 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Green3Bio, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The study consists of two parts based on the administration of single-agent GRN-300 or in combination with paclitaxel. Part 1 (Phase IA) will test the tolerability of continuous twice a day dosing of oral GRN-300, a salt-inducible kinase inhibitor, with each cycle consisting of 28 days of treatment. The number of administered cycles will depend on the tolerability of each dose level and the severity and occurrence of dose limiting toxicities (DLTs) or adverse events. Part 2 (Phase IB) will test the tolerability of continuous 28-day cycles of GRN-300 in combination with weekly paclitaxel given 3 of 4 weeks per month (x 3). Overall duration of the study will be approximately 48 months, depending on the rate of enrollment and number of subjects enrolled.
Detailed Description
Part 1: Phase 1A Primary objectives: Determination of the maximum tolerated dose (MTD), if applicable, and recommended Phase II dose (RP2D) of GRN-300 in the study population. To investigate the safety and tolerability of repeated 28-day cycles of oral GRN-300 therapy in subjects with persistent or recurrent, locally non-resectable or metastatic ovarian, fallopian tube, and primary peritoneal cancer or other advanced solid tumors. Secondary objectives: To evaluate the pharmacokinetic (PK) profile of GRN-300 after oral administration of a single dose and at steady state. To estimate the clinical activity of GRN-300 monotherapy by determining the following: Overall response rate (ORR) per investigator assessment using RECIST v1.1 defined as the percentage of subjects having a best overall response (BOR) of complete response (CR) or partial response (PR) Disease control rate (DCR) per investigator assessment using RECIST v1.1 defined as the percentage of subjects having a BOR of CR, PR, or stable disease (SD) ≥ 4 months (4 cycles, 28 days each). Part 2: Phase 1B Primary objectives: Determination of the RP2D of GRN-300 in combination with weekly paclitaxel given 3 of 4 weeks per month (x 3) in the study population. To investigate the safety and tolerability of repeated 28-day cycles of daily oral GRN-300 therapy in combination with weekly paclitaxel x 3 in subjects with persistent or recurrent, locally non-resectable or metastatic, ovarian, fallopian tube, and primary peritoneal cancer, where treatment with paclitaxel is appropriate. Secondary objectives: To evaluate the PK profile of GRN-300 and paclitaxel following administration of a single dose of each and at steady state. To estimate the clinical activity of GRN-300 in combination with paclitaxel by determining the following: Overall response rate (ORR) per investigator assessment using RECIST v1.1 defined as the percentage of subjects having a best overall response (BOR) of complete response (CR) or partial response (PR) DCR per investigator assessment using RECIST v.1.1 defined as the percentage of subjects having a BOR of CR, PR, or SD ≥ 4 months (4 cycles, 28 days each). Exploratory Translational Objectives for Both Study Parts: To estimate progression free survival (PFS) per investigator assessment using RECIST v1.1 for subjects who received continuous GRN-300 and weekly paclitaxel x 3. Evaluate exploratory biomarkers of target engagement and treatment response

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Tumors

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Model Description
GRN-300 single-agent and in combination with paclitaxel.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
73 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Part 1 (Phase 1a): Single Arm, Open Label (GRN-300 single-agent)
Arm Type
Experimental
Arm Description
Part 1 of the study will determine the safety of continuous twice a day oral dosing of GRN-300, with each cycle consisting of 28 days of treatment. The number of administered cycles will depend on the tolerability of each dose level and the severity and occurrence of side effects and DLTs. The maximal tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of GRN-300 as a single agent will be determined. The overall duration of Part 1 will be approximately 24-36 months, depending on the rate of enrollment and the number of subjects enrolled.
Arm Title
Part 2 (Phase 1b): Single Arm, Open Label (GRN-300 plus paclitaxel)
Arm Type
Experimental
Arm Description
The study will determine the safety of continuous twice a day oral dosing of GRN-300, with each cycle consisting of 28 days of treatment, in combination with intravenously administered paclitaxel weekly x 3 during each 28-day cycle. The number of administered cycles will depend on the tolerability of each dose level and the severity and occurrence of side effects and DLTs. The maximal tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of GRN-300 in combination with paclitaxel will be determined. The overall duration of Part 2 will be approximately 12-18 months, depending on the rate of enrollment and the number of subjects enrolled. Part 2 will commence following determination of the MTD and RP2D of single-agent GRN-300 in Part 1. Overall duration of the study will be approximately 36-48 months, depending on the rate of enrollment and number of subjects enrolled.
Intervention Type
Drug
Intervention Name(s)
GRN-300
Other Intervention Name(s)
SIK2/3 Inhibitor
Intervention Description
A salt-inducible kinase (SIK) inhibitor
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Other Intervention Name(s)
Taxane
Intervention Description
Microtubule inhibitor
Primary Outcome Measure Information:
Title
Part 1 (Phase 1A) - Determination of the MTD and the RP2D of GRN-300 single-agent based on evaluation of the DLT in the study population.
Description
• Determination of the recommended Phase II dose (RP2D) of GRN-300 in the study population.
Time Frame
24 months
Title
Part 1 (Phase 1A) - Number of participants with treatment-related adverse events as assessed by CTCAE v5.0.
Description
• To investigate the safety of repeated 28-day cycles of daily oral GRN-300 therapy in subjects with recurrent or metastatic ovarian, fallopian tube, and primary peritoneal cancer or other advanced solid tumors, based on the number of participants with treatment-related adverse events as assessed by CTCAE v5.0.
Time Frame
24 months
Title
Part 2 (Phase 1B) - Determination of the MTD and the RP2D of GRN-300 with paclitaxel based on evaluation of the DLT in the study population
Description
• Determination of the recommended Phase II dose (RP2D) of GRN-300 in combination with weekly paclitaxel in the study population.
Time Frame
24 months
Title
Part 2 (Phase 1B) - Number of participants with treatment-related adverse events as assessed by CTCAE v5.0.
Description
• To investigate the safety of repeated 28-day cycles of daily oral GRN-300 therapy in combination with weekly paclitaxel x 3 in subjects with recurrent or metastatic ovarian, fallopian tube, and primary peritoneal cancer or other advanced solid tumors, based on the number of participants with treatment-related adverse events as assessed by CTCAE v5.0.
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Part 1 (Phase 1A) - Determination of GRN-300 monotherapy PK profile (Cmax).
Description
• To evaluate the pharmacokinetic (PK) profile of GRN-300 after oral administration of a single dose and at steady state. - Maximum plasma concentration (Cmax)
Time Frame
24 months
Title
Part 1 (Phase 1A) - Determination of GRN-300 monotherapy PK profile (tmax).
Description
• To evaluate the pharmacokinetic (PK) profile of GRN-300 after oral administration of a single dose and at steady state. - Time to Cmax (tmax)
Time Frame
24 months
Title
Part 1 (Phase 1A) - Determination of GRN-300 monotherapy PK profile (t1/2).
Description
• To evaluate the pharmacokinetic (PK) profile of GRN-300 after oral administration of a single dose and at steady state. - Terminal half-life (t1/2)
Time Frame
24 months
Title
Part 1 (Phase 1A) - Determination of GRN-300 monotherapy PK profile (AUC0-t).
Description
• To evaluate the pharmacokinetic (PK) profile of GRN-300 after oral administration of a single dose and at steady state. - Area under the plasma concentration-time curve from zero to the last measurable concentration (AUC0-t)
Time Frame
24 months
Title
Part 1 (Phase 1A) - Determination of GRN-300 monotherapy PK profile (AUC0-Inf).
Description
• To evaluate the pharmacokinetic (PK) profile of GRN-300 after oral administration of a single dose and at steady state. - Area under the plasma concentration-time curve from zero to infinity (AUC0-Inf)
Time Frame
24 months
Title
Part 1 (Phase 1A) - Determination of GRN-300 monotherapy PK profile (CL/F).
Description
• To evaluate the pharmacokinetic (PK) profile of GRN-300 after oral administration of a single dose and at steady state. - Apparent oral clearance (CL/F)
Time Frame
24 months
Title
Part 1 (Phase 1A) - Determination of GRN-300 monotherapy PK profile (Vz/F).
Description
• To evaluate the pharmacokinetic (PK) profile of GRN-300 after oral administration of a single dose and at steady state. - Apparent volume of distribution during terminal distribution phase (Vz/F)
Time Frame
24 months
Title
Part 1 (Phase 1A) - Estimation of the clinical activity of single agent GRN-300 (ORR)
Description
• Overall response rate (ORR) per investigator assessment using RECIST v1.1 defined as the percentage of subjects having a best overall response (BOR) of complete response (CR) or partial response (PR)
Time Frame
24 months
Title
Part 1 (Phase 1A) - Estimation of the clinical activity of single agent GRN-300 (DCR)
Description
• Disease control rate (DCR) per investigator assessment using RECIST v1.1 defined as the percentage of subjects having a BOR of CR, PR, or stable disease (SD) ≥ 4 months (4 cycles, 28 days each)
Time Frame
24 months
Title
Part 2 (Phase 1B) - Determination of GRN-300 plus paclitaxel PK profile (Cmax).
Description
• To evaluate the PK profile of GRN-300 and paclitaxel following administration of a single dose of each and at steady state. - Maximum plasma concentration (Cmax)
Time Frame
24 months
Title
Part 2 (Phase 1B) - Determination of GRN-300 plus paclitaxel PK profile (tmax).
Description
• To evaluate the PK profile of GRN-300 and paclitaxel following administration of a single dose of each and at steady state. - Time to Cmax (tmax)
Time Frame
24 months
Title
Part 2 (Phase 1B) - Determination of GRN-300 plus paclitaxel PK profile (t1/2).
Description
• To evaluate the PK profile of GRN-300 and paclitaxel following administration of a single dose of each and at steady state. - Terminal half-life (t1/2)
Time Frame
24 months
Title
Part 2 (Phase 1B) - Determination of GRN-300 plus paclitaxel PK profile (AUC0-t).
Description
• To evaluate the PK profile of GRN-300 and paclitaxel following administration of a single dose of each and at steady state. - Area under the plasma concentration-time curve from zero to the last measurable concentration (AUC0-t)
Time Frame
24 months
Title
Part 2 (Phase 1B) - Determination of GRN-300 plus paclitaxel PK profile (AUC0-Inf).
Description
• To evaluate the PK profile of GRN-300 and paclitaxel following administration of a single dose of each and at steady state. - Area under the plasma concentration time curve from zero to infinity (AUC0-Inf)
Time Frame
24 months
Title
Part 2 (Phase 1B) - Determination of GRN-300 plus paclitaxel PK profile (CL/F).
Description
• To evaluate the PK profile of GRN-300 and paclitaxel following administration of a single dose of each and at steady state. - Apparent oral clearance (CL/F)
Time Frame
24 months
Title
Part 2 (Phase 1B) - Determination of GRN-300 plus paclitaxel PK profile (Vz/F).
Description
• To evaluate the PK profile of GRN-300 and paclitaxel following administration of a single dose of each and at steady state. - Apparent volume of distribution during terminal distribution phase (Vz/F)
Time Frame
24 months
Title
Part 2 (Phase 1B) - Estimation of the clinical activity of GRN-300 plus paclitaxel (ORR).
Description
• Overall response rate (ORR) per investigator assessment using RECIST v1.1 defined as the percentage of subjects having a best overall response (BOR) of complete response (CR) or partial response (PR)
Time Frame
24 months
Title
Part 2 (Phase 1B) - Estimation of the clinical activity of GRN-300 plus paclitaxel (DCR).
Description
• DCR per investigator assessment using RECIST v.1.1 defined as the percentage of subjects having a BOR of CR, PR, or SD ≥ 4 months (4 cycles, 28 days each)
Time Frame
24 months
Other Pre-specified Outcome Measures:
Title
Part 1 and 2: progression free survival (PFS)
Description
• To estimate progression free survival (PFS) per investigator assessment using RECIST v1.1 for subjects who received continuous GRN-300 single-agent or in combination with weekly paclitaxel x 3
Time Frame
48 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥ 18 years. Part 1 dose-escalation cohorts: Diagnosis of persistent or recurrent, locally non-resectable or metastatic ovarian, primary peritoneal or fallopian tube epithelial cancer, or advanced solid tumors of any other histology who have progressed on standard therapy and for whom no further effective therapy is available Part 1 dose-expansion cohort / Part 2 dose-escalation cohorts / Part 2 dose-expansion cohort: Diagnosis of persistent or recurrent, locally non-resectable or metastatic ovarian, primary peritoneal or fallopian tube epithelial cancer who have progressed on standard therapy and for whom no further effective therapy is available. Patients with advanced solid tumors of any other histology will not be eligible to be enrolled in these cohorts. Part 2 dose-escalation cohorts / Part 2 dose-expansion cohort: paclitaxel treatment for the tumor should be indicated Histologic or cytologic confirmation of the original tumor by Pathology assessment is required. Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension, as defined by RECIST 1.1. Prior therapy: Patients must have received at least one prior second-line treatment for persistent, recurrent, locally non-resectable or metastatic disease but may have received any number of prior treatments. Any unresolved toxicities from prior therapy should be no greater than NCI-CTCAE v5.0 Grade 1 at screening. Patients who are expected to survive a minimum of three months after the first administration of the study drug. Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0-1. Adequate bone marrow, liver and renal function. Exclusion Criteria: Patients who have undergone major surgery ≤ 4 weeks prior to starting study drug. Patients with known hypersensitivity to paclitaxel excluded from Part 2 paclitaxel combination only). Use of any cytotoxic chemotherapy or investigational drugs, biologics, or devices within 21 days prior to study enrollment. Women who are pregnant or breastfeeding. Known history of human immunodeficiency virus (HIV) infection or current chronic or active hepatitis B or C infection requiring treatment with antiviral therapy. Known CNS metastases or leptomeningeal disease. Gastrointestinal dysfunction that may affect oral drug absorption (e.g., intermittent or chronic bowel obstruction, short gut, etc.). Subjects with thrombotic, embolic, venous, or arterial events, such as cerebrovascular accident (including transient ischemic attacks) deep vein thrombosis or pulmonary embolism within six months of start of study treatment. Other medical co-morbidities that in the investigator's judgment would increase the risks of participation QTc >480 msec be excluded from the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Siqing Fu, MD, PhD
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

First-in-Human Evaluation of GRN-300 in Subjects With Recurrent Ovarian, Primary Peritoneal, and Fallopian Tube Cancers.

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