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GRT-C903 for Solid Tumors

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
The Ohio State University Comprehensive Cancer Center, Columbus, OHSolid Tumors+4 MoreGRT-C903 - Biological
Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary

This trial is testing a new cancer vaccine in combination with immune checkpoint blockade. The goal is to see if it is safe and works against various types of cancer.

Eligible Conditions
  • Shared Neoantigen-Positive Solid Tumors
  • Colorectal Cancer
  • Solid Tumors
  • Non-Small Cell Lung Cancer
  • Pancreatic Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

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1
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D3S-001

Study Objectives

3 Primary · 6 Secondary · Reporting Duration: Up to approximately 4 years

Month 12
Measure the immune response to the neoantigens encoded by GRT-C903 and GRT-R904
Month 27
Incidence of adverse events (AEs), serious adverse events (SAEs), and dose limiting toxicities (DLTs)
Month 27
Clinical benefit rate (CBR) using RECIST v1.1
Duration of response (DOR) using RECIST v1.1
Objective Response Rate (ORR) in Phase 1 using RECIST v1.1
Objective Response Rate (ORR) in Phase 2 using RECIST v1.1
Year 4
Overall survival (OS)
Progression-free survival (PFS)
Month 6
Identify the recommended Phase 2 dose (RP2D) of GRT-C903 and GRT-R904

Trial Safety

Safety Progress

1 of 3

Similar Trials

1
Pembrolizumab
1
TAS2940
1
D3S-001

Trial Design

2 Treatment Groups

Phase 2
1 of 2
Phase 1
1 of 2

Experimental Treatment

39 Total Participants · 2 Treatment Groups

Primary Treatment: GRT-C903 · No Placebo Group · Phase 1 & 2

Phase 2Experimental Group · 4 Interventions: ipilimumab, nivolumab, GRT-R904, GRT-C903 · Intervention Types: Biological, Biological, Biological, Biological
Phase 1Experimental Group · 4 Interventions: ipilimumab, nivolumab, GRT-R904, GRT-C903 · Intervention Types: Biological, Biological, Biological, Biological
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ipilimumab
FDA approved
Nivolumab
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to approximately 4 years

Who is running the clinical trial?

Gritstone Oncology, Inc.Lead Sponsor
5 Previous Clinical Trials
849 Total Patients Enrolled
Gritstone Bio, Inc.Lead Sponsor
5 Previous Clinical Trials
849 Total Patients Enrolled
Gritstone bio, Inc.Lead Sponsor
8 Previous Clinical Trials
1,273 Total Patients Enrolled
Bristol-Myers SquibbIndustry Sponsor
2,514 Previous Clinical Trials
3,945,301 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 2 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have a certain type of advanced or metastatic cancer and have received specific treatments as the first-line therapy. If you have pancreatic cancer, you have received chemotherapy as your first-line therapy. If you have any other type of cancer, you have received all available treatments for your cancer type and have not responded. Your cancer has specific genetic mutations that can be targeted with the study drug. You have a good performance status and your organs are functioning well based on laboratory tests. You also have measurable disease according to specific criteria.
References

Frequently Asked Questions

What are the main maladies that GRT-C903 has been shown to improve?

"GRT-C903 can be used as a treatment for patients that have undergone anti-angiogenic therapy, those with malignant neoplasms, and patients with unresectable melanoma." - Anonymous Online Contributor

Unverified Answer

What other data is available on GRT-C903?

"GRT-C903 was first studied in 2009 at Texas Children's Hospital. As of now, 360 studies have completed. There are 796 trials that are still recruiting patients, a majority of which are located in Phoenix, Arizona." - Anonymous Online Contributor

Unverified Answer

How many research centers are coordinating this investigation?

"This clinical trial has 13 active sites, which are located in Phoenix, Nashville, Houston, and other cities." - Anonymous Online Contributor

Unverified Answer

How many participants are being recruited for this trial?

"Yes, this is an ongoing trial that has currently enrolled 144 patients from 13 different sites. The study's original posting was on July 18th, 2019 with the latest update being September 10th of 2020." - Anonymous Online Contributor

Unverified Answer

Are people still able to sign-up for this experiment?

"The trial, which was initially posted on July 18th 2019 and last updated September 10th 2020 according to clinicaltrials.gov, is presently looking for participants." - 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.

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