Clinical trial · Interventional
A Study of a Personalized Neoantigen Cancer Vaccine
An International Phase 1/2 Study of GRT-C901/GRT-R902, a Neoantigen Cancer Vaccine, in Combination With Immune Checkpoint Blockade for Patients With Advanced Solid Tumors
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to evaluate the safety, dose, immunogenicity and early clinical activity of GRT-C901 and GRT-R902, a personalized neoantigen cancer vaccine, in combination with nivolumab and ipilimumab, in patients with metastatic non-small cell lung cancer, microsatellite stable colorectal cancer, gastroesophageal adenocarcinoma, and metastatic urothelial cancer.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Gastroesophageal Adenocarcinoma | — | UNRESOLVED | — |
| Non Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
| Urothelial Carcinoma | Urothelial Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| GRT-C901 | Biological | — | UNRESOLVED |
| GRT-R902 | Biological | — | UNRESOLVED |
| ipilimumab | Biological | Ipilimumab | ALIAS |
| nivolumab | Biological | Nivolumab | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Phase 1
- description
- * GRT-C901 * GRT-R902 * nivolumab * ipilimumab
- interventionNames
- Biological: GRT-C901
- Biological: GRT-R902
- Biological: nivolumab
- Biological: ipilimumab
- type
- EXPERIMENTAL
- label
- Phase 2 Cohorts
- description
- * GRT-C901 * GRT-R902 * nivolumab * ipilimumab
- interventionNames
- Biological: GRT-C901
- Biological: GRT-R902
- Biological: nivolumab
- Biological: ipilimumab
Primary outcomes (3)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Provide a signed and dated informed consent form prior to initiation of study-specific procedures. * Patients with the indicated advanced or metastatic solid tumor as follows: 1. NSCLC who are planned for or have received no more than 1 cycle of systemic treatment with cytotoxic, platinum-based chemotherapy (note: patients who have received anti-PD-(L)1 monotherapy are eligible) 2. GEA who are planned for or have received no more than 1 cycle of systemic treatment with cytotoxic, platinum-based chemotherapy 3. mUC who are planned for or have received no more than 1 cycle of systemic treatment with cytotoxic, platinum-based chemotherapy 4. CRC-MSS who are receiving first line systemic therapy or who are planned for or have received no more than 1 cycle of second line systemic therapy including a fluoropyrimidine and oxaliplatin or irinotecan * 18 years of age or older * ECOG Performance Status 0 or 1 * Lesion amenable to biopsy * Measurable disease according to RECIST v1.1 * Have adequate organ function, as measured by laboratory values (criteria listed in protocol) Exclusion Criteria: * Tumors with genetic characteristics as follows: 1. For NSCLC, patients with a known genetic driver alteration in EGFR, ALK, ROS1, RET, or TRK 2. For CRC and GEA, patients with known MSI-high disease based on institutional standard 3. For CRC, patients with a known BRAF V600E mutation or patients with peritoneal carcinomatosis and for GEA, patients with peritoneal carcinomatosis as their only evidence of disease * Patients with known central nervous system (CNS) metastases and/or carcinomatous meningitis * Known exposure to chimpanzee adenovirus or any history of anaphylaxis in reaction to a vaccination or allergy or hypersensitivity to study drug components * Bleeding disorder (eg., factor deficiency, coagulopathy) or history of significant bruising or bleeding following IM injections or blood draws Complete inclusion and exclusion criteria are listed in the clinical study protocol.
References
Publications (1)
- DERIVEDPalmer CD, Rappaport AR, Davis MJ, Hart MG, Scallan CD, Hong SJ, Gitlin L, Kraemer LD, Kounlavouth S, Yang A, Smith L, Schenk D, Skoberne M, Taquechel K, Marrali M, Jaroslavsky JR, Nganje CN, Maloney E, Zhou R, Navarro-Gomez D, Greene AC, Grotenbreg G, Greer R, Blair W, Cao MD, Chan S, Bae K, Spira AI, Roychowdhury S, Carbone DP, Henick BS, Drake CG, Solomon BJ, Ahn DH, Mahipal A, Maron SB, Johnson B, Rousseau R, Yelensky R, Liao CY, Catenacci DVT, Allen A, Ferguson AR, Jooss K. Individualized, heterologous chimpanzee adenovirus and self-amplifying mRNA neoantigen vaccine for advanced metastatic solid tumors: phase 1 trial interim results. Nat Med. 2022 Aug;28(8):1619-1629. doi: 10.1038/s41591-022-01937-6. Epub 2022 Aug 15. PMID 35970920