Conditions

Ovarian Tumors

Outcome Measures

Primary Outcomes (4)

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.
24 months
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.
24 months
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.
24 months
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.
24 months

Secondary Outcomes (18)

Part 1 (Phase 1A) - Determination of GRN-300 monotherapy PK profile (Cmax).
24 months
Part 1 (Phase 1A) - Determination of GRN-300 monotherapy PK profile (tmax).
24 months
Part 1 (Phase 1A) - Determination of GRN-300 monotherapy PK profile (t1/2).
24 months
Part 1 (Phase 1A) - Determination of GRN-300 monotherapy PK profile (AUC0-t).
24 months
Part 1 (Phase 1A) - Determination of GRN-300 monotherapy PK profile (AUC0-Inf).
24 months
+13 more secondary outcomes

Other Outcomes (1)

Part 1 and 2: progression free survival (PFS)
48 months

Study Arms (2)

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

EXPERIMENTAL

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.

Drug: GRN-300

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

EXPERIMENTAL

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.

Interventions

GRN-300Drug

A salt-inducible kinase (SIK) inhibitor

Also known as: SIK2/3 Inhibitor

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

PaclitaxelDrug

Microtubule inhibitor

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

Sponsors & Collaborators

Green3Bio, Inc.
Industrylead

Study Sites (1)

MD Anderson Cancer Center

Houston, Texas, 77030, United States

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

Paclitaxeltaxane

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital Neoplasms

Study Officials

Siqing Fu, MD, PhD
M.D. Anderson Cancer Center
PRINCIPAL INVESTIGATOR

Study Stopped

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (4)

Secondary Outcomes (18)

Other Outcomes (1)

Study Arms (2)

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

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

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

You may not qualify if:

Intervention Hierarchy (Ancestors)

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (4)

Secondary Outcomes (18)

Other Outcomes (1)

Study Arms (2)

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

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

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

You may not qualify if:

Intervention Hierarchy (Ancestors)

Data Sharing

Source record

Locations