All > Illinois > Bowel Cancer

GRT-C901 for Colorectal Cancer

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Orlando Health, Orlando, FLColorectal CancerGRT-C901 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a new cancer treatment regime that includes two new drugs alongside existing ones, to see if it is more effective than the existing treatment. The primary objective is to see if the new regime extends progression-free survival.

Treatment Effectiveness

Effectiveness Progress

1 of 3

Similar Trials

1
SD-101
1
Axitinib 5 MG
1
SRF388

Study Objectives

5 Primary · 17 Secondary · Reporting Duration: Phase 2 up to 27 months, Phase 3 up to 60 months

Month 27
Phase 2: Antitumor activity measured by number of patients with ≥50% decrease from baseline in circulating tumor DNA (ctDNA)
Phase 2: Antitumor activity of maintenance therapy combining GRT-C901/GRT-R902 with checkpoint inhibitors and fluoropyrimidine/bevacizumab
Phase 2: Molecular response defined as ≥ 50% decrease from baseline in circulating tumor DNA (ctDNA)
Month 60
Phase 2 and 3: Deepening of Response
Month 60
Phase 2 and 3: Duration of Response
Month 60
Phase 2 and 3: Progression-free Survival per RECIST v1.1 and iRECIST as assessed by the investigator
Month 60
Phase 3: Progression-free Survival per Immune-based Response Evaluation Criteria in Solid Tumors (iRECIST) as assessed by blinded independent review committee (IRC)
Phase 3: Progression-free Survival per RECIST v1.1 as assessed by blinded IRC
Month 60
Phase 2 and 3: Clinical Benefit Rate (CBR)
Phase 2 and 3: Clinical benefit rate (CBR) as defined by the proportion of patients with best overall response of stable disease (SD), PR or CR using RECIS v1.1 or immune-based SD (iSD), iPR, or iCR by iRECIST.
Phase 2 and 3: Deepening of Response the proportion of patients who have a BOR of SD or PR during the VPS and who convert from SD to PR or CR, or from PR to CR after start of the study treatment and/or SOC maintenance treatment in the STS per RECIST v1.1
Phase 2 and 3: Duration of response (DOR) defined by time from the first objective response of PR or PR until disease progression or death
Phase 2 and 3: Incidence of adverse events (AEs), immune-related AEs, treatment-related AEs, serious AEs, AEs leading to death, AEs leading to dose delays, and AEs leading to discontinuation of study treatment
Phase 2 and 3: Incidence of treatment-emergent adverse events (TEAEs), immune-related AEs, treatment-related AEs, serious AEs, AEs leading to death, AEs leading to dose delays, and AEs leading to discontinuation of study treatment
Phase 2 and 3: Overall Response Rate
Phase 2 and 3: Overall Survival
Phase 2 and 3: Overall Survival as time from randomization to death from any cause
Month 60
Phase 2 and 3: Progression-free survival per RECIST v1.1 and iRECIST as assessed by the investigator
Day 28
Phase 2 and 3: Success of Vaccine Manufacture
Phase 2 and 3: The feasibility of manufacturing a patient-specific vaccine defined by the proportion of patients for whom vaccine was successfully manufactured from those randomized to the vaccine arm.
Up to 60 months
Phase 3: Progression-free survival per Immune-based Response Evaluation Criteria in Solid Tumors (iRECIST) as assessed by blinded independent review committee (IRC)
Phase 3: Progression-free survival per RECIST v1.1 as assessed by blinded IRC

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Similar Trials

1
SD-101
1
Axitinib 5 MG
2
SRF388

Trial Design

2 Treatment Groups

Control Arm
1 of 2
Vaccine Arm
1 of 2

Active Control

Experimental Treatment

665 Total Participants · 2 Treatment Groups

Primary Treatment: GRT-C901 · No Placebo Group · Phase 2 & 3

Vaccine ArmExperimental Group · 8 Interventions: Fluoropyrimidine, Oxaliplatin, GRT-C901, GRT-R902, Atezolizumab, Ipilimumab, Fluoropyrimidine plus leucovorin, Bevacizumab · Intervention Types: Drug, Drug, Drug, Drug, Drug, Drug, Drug, Drug
Control ArmActiveComparator Group · 4 Interventions: Fluoropyrimidine, Oxaliplatin, Fluoropyrimidine plus leucovorin, Bevacizumab · Intervention Types: Drug, Drug, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Oxaliplatin
FDA approved
GRT-C901
2019
Completed Phase 2
~30
GRT-R902
2019
Completed Phase 2
~30
Atezolizumab
FDA approved
Ipilimumab
FDA approved
Bevacizumab
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: phase 2 up to 27 months, phase 3 up to 60 months

Who is running the clinical trial?

Gritstone Bio, Inc.Lead Sponsor
5 Previous Clinical Trials
223 Total Patients Enrolled
Gritstone Oncology, Inc.Lead Sponsor
5 Previous Clinical Trials
223 Total Patients Enrolled
Gritstone bio, Inc.Lead Sponsor
8 Previous Clinical Trials
647 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 6 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
References

Frequently Asked Questions

Are there any other ongoing or previous clinical trials involving GRT-C901?

"There are 1254 ongoing clinical trials investigating GRT-C901. Of these, 293 have reached Phase 3 status. Many of the trials related to GRT-C901 are located in Guangzhou, Guangdong; however, there are 63018 total research sites running similar experiments." - Anonymous Online Contributor

Unverified Answer

To what purpose is GRT-C901 most often employed?

"GRT-C901 has shown efficacy in treating cancers that have progressed after treatment with fluoropyrimidine, oxaliplatin and irinotecan. Additionally, it can also ameliorate metastatic ureter urothelial carcinoma, malignant neoplasms, and persistent cervical cancer." - Anonymous Online Contributor

Unverified Answer

Are we still enrolling patients for this experiment?

"The trial is recruiting patients, with the most recent update to the clinicaltrials.gov listing being on 10/27/2022. It was initially posted on 2/12/2022." - Anonymous Online Contributor

Unverified Answer

From how many different sites is this experiment being coordinated?

"Presently, this study is recruiting patients from 51 medical facilities. These include Prisma Health in Greenville, South Carolina; Sansum Clinic - USOR in Santa Barbara, California; Allegheny General Hospital in Pittsburgh, Pennsylvania; and 48 other locations." - Anonymous Online Contributor

Unverified Answer

How many people are being enrolled in this trial?

"In order to carry out this clinical trial, 665 individuals that meet the pre-determined inclusion criteria must agree to participate. These potential participants are sourced from different locations, two of which being Prisma Health in Greenville, South Carolina and Sansum Clinic - USOR in Santa Barbara, California." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top