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Clinical trials
catalyst calendar across sponsors →Studies where GRTX is the lead sponsor, as filed with ClinicalTrials.gov. Completion dates are the sponsor's own projected windows and are revised as a study runs. Active studies first, then completed and stopped — newest readout first within each.
17 interventional · 8 with posted results
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| Study | Phase | Status | Interventions | Conditions | Enrollment | Primary completion | Updated |
|---|---|---|---|---|---|---|---|
| Phase 2b Study of GC4711 in Combination With SBRT for Nonmetastatic Pancreatic CancerNCT04698915results2024-05-21Overall SurvivalRandomized · Open-label · TreatmentStudy Protocol and Statistical Analysis Plan ↗ | Phase 2 | Terminatedsponsor's stated reason: Futility Analysis | Drug: Drug GC4711, Placebo | SBRT, Borderline Resectable Pancreatic Cancer, Unresectable Pancreatic Cancer | 177 | 2023-11-30actual | 2024-05-21 |
| Phase I/II Study of SBRT and GC4711 for Centrally Located or Large NSCLCNCT04476797results2024-04-03Percent of Patients With a Complete Response or Partial In-field Tumor Response Based on the RECIST 1.1 Criteria Through 6 Months Following SBRT.Randomized · Triple-masked · TreatmentStudy Protocol and Statistical Analysis Plan ↗ | Phase 1/2 | Terminatedsponsor's stated reason: Development GC4711 was halted after the lead study in pancreatic cancer was stopped early due to meeting the requirements of a futility analysis | Drug: GC4711 +SBRT, Placebo +SBRT | SBRT, NSCLC, Non-metastatic | 47 | 2023-11-28actual | 2024-04-30 |
| Effects of Intravenous GC4419 on the Incidence and Severity of Esophagitis Due to Chemoradiotherapy for Lung CancerNCT04225026results2023-03-23Number of Subjects With of Acute Radiation Esophagitis (Defined as Grade >/= 2; NCI CTCAE Version 5) Through the End of Chemoradiotherapy for Non-Small Cell Lung (NSCLC) or Small Cell Lung Cancer (SCLC) When Avasopasem Was Added.Open-label · TreatmentStudy Protocol and Statistical Analysis Plan ↗ | Phase 2 | Terminatedsponsor's stated reason: Lack of study enrollment | Drug: GC4419 (avasopasem manganese) | Esophagitis | 39 | 2021-12-28actual | 2023-03-23 |
| ROMAN: Phase 3 Trial Investigating the Effects of GC4419 on Radiation Induced Oral Mucositis in Head/Neck Cancer PatientsNCT03689712results2023-04-13Cumulative Incidence of Severe Oral MucositisRandomized · Quadruple-masked · Supportive careStudy Protocol and Statistical Analysis Plan ↗ | Phase 3 | Completed | Drug: GC4419 90mg, Placebo | Oral Mucositis | 455 | 2021-08-13actual | 2023-10-24 |
| A Trial of GC4419 in Patients With Critical Illness Due to COVID-19NCT04555096results2022-03-1828 Day All-cause MortalityRandomized · Quadruple-masked · TreatmentStudy Protocol and Statistical Analysis Plan ↗ | Phase 2 | Terminatedsponsor's stated reason: Participants are no longer receiving intervention | Drug: GC4419, Placebo | Covid19, SARS-CoV-2 Infection | 16 | 2021-05-28actual | 2022-03-18 |
| Ph 2 Open Label Study of GC4419 to Reduce SOM Associated With Chemoradiotherapy for Head and Neck CancerNCT04529850results2022-08-16Incidence of Treatment Emergent AE'sOpen-label · PreventionStudy Protocol and Statistical Analysis Plan ↗ | Phase 2 | Completed | Drug: Drug: GC4419, Cisplatin · Radiation: Intensity-modulated radiation therapy (IMRT) | Head and Neck Cancer, Oral Mucositis | 38 | 2021-03-10actual | 2022-08-16 |
| Study to Evaluate the Effects of Renal Impairment on the Pharmacokinetics, Safety and Tolerability of GC4419NCT05412472Pharmacokinetic (PK) profile for GC4419 (in plasma): AUC0-tNon-randomized · Open-label · Treatment | Phase 1 | Completed | Drug: GC4419 | Renal Impairment | 26 | 2021-01-30actual | 2022-06-09 |
| Pilot Dose Escalation Trial of Stereotactic Body Radiation Therapy (SBRT) in Combination With GC4419 in Pancreatic CancerNCT03340974results2023-12-15CTCAE Grade 3 or 4 Gastro-intestinal (GI) Toxicities or Death Within 90 Days From the Start of TherapyRandomized · Quadruple-masked · TreatmentStudy Protocol and Statistical Analysis Plan ↗ | Phase 1/2 | Completed | Drug: GC4419, Placebo · Radiation: Stereotactic Radiation Therapy (SBRT) 50 Gy, Stereotactic Radiation Therapy (SBRT) 55 Gy | Pancreatic Cancer, Stereotactic Body Radiation Therapy | 42 | 2020-08-21actual | 2023-12-15 |
| A Study Designed to Evaluate the Safety and Pharmacokinetics of Intravenously Administered Superoxide Dismutase Mimetic GC4711 in Healthy VolunteersNCT03762031Incidence of Treatment-Emergent Adverse Events and Laboratory AbnormalitiesRandomized · Quadruple-masked · Treatment | Phase 1 | Completed | Drug: GC4711 30mg, GC4711 60mg, GC4711 90mg, GC4711 120mg, Placebo, GC4711 75mg, GC4711 105mg | Healthy | 70 | 2020-03-04actual | 2020-08-14 |
| A Phase 1 Study of the Safety and Pharmacokinetics of GC4711 (Oral Capsule) Compared to GC4419 (IV Infusion) and GC4711 (IV Infusion) in Healthy VolunteersNCT03099824Incidence of Treatment-Emergent Adverse Events and Laboratory AbnormalitiesNon-randomized · Open-label · Treatment | Phase 1 | Completed | Drug: GC4711 Oral Capsule G-101, IV GC4419, GC4711 Oral Capsule G-101, GC4711 Oral Capsule G-101, GC4711 Oral Capsule G-111, GC4711 Oral Capsule G-112, GC4711 Oral Capsule G-119, GC4711 Oral Capsule G-125, IV GC4711 | Healthy Volunteers | 56 | 2020-01-27actual | 2021-03-02 |
| Study to Evaluate the Effects of 90 mg Intravenous Infusions of GC4419 on the Single Dose Pharmacokinetics of Dextromethorphan in Healthy Adult SubjectsNCT03792971Pharmacokinetic (PK) profile for dextromethorphan (DM) (in plasma): AUC0-tOpen-label · Treatment | Phase 1 | Completed | Drug: Dextromethorphan HBr, GC4419 | Healthy | 13 | 2019-02-15actual | 2019-06-19 |
| A Study Designed to Compare the Safety and Pharmacokinetics of Intravenously Administered Superoxide Dismutase Mimetic GC4711 and GC4419 in Healthy VolunteersNCT03194139Frequency, duration, and severity of adverse events (AEs)Randomized · Quadruple-masked · Treatment | Phase 1 | Completed | Drug: GC4711 30 mg IV, GC4711 50 mg IV, GC4419 45 mg IV | Healthy Volunteers, Healthy | 36 | 2017-12-24actual | 2018-02-14 |
| A Study to Investigate the Absorption, Metabolism, Excretion, and Mass Balance of GC4419 in Healthy Adult SubjectsNCT03163173Mass balance of GC4419Open-label · Treatment | Phase 1 | Completed | Drug: GC4419 | Healthy Volunteers, Healthy | 6 | 2017-10-13actual | 2017-11-17 |
| A Phase 1, Randomized, Placebo-and Positive-Controlled Crossover Study to Determine the Effect of Single-Dose GC4419 on QTc Interval in Healthy VolunteersNCT03164109Change in QT interval corrected for heart rate using the Fridericia formula (QTcF)Randomized · Quadruple-masked · Treatment | Phase 1 | Completed | Drug: GC4419 IV, Placebo, Oral moxifloxacin | Healthy Volunteers, Healthy | 28 | 2017-10-13actual | 2017-11-17 |
| A Study of the Effects of GC4419 on Radiation Induced Oral Mucositis in Patients With Head/Neck CancerNCT02508389results2021-09-20Duration (in Days) of Radiation Induced Severe Oral Mucositis (OM) Per World Health Organization (WHO) CriteriaRandomized · Quadruple-masked · Supportive careStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2 | Completed | Drug: Low Dose GC4419: 30mg/day, High Dose GC4419: 90mg/day, Placebo, Cisplatin · Radiation: Intensity-Modulated Radiation Therapy | Radiation Induced Oral Mucositis | 223 | 2017-09-18actual | 2021-09-20 |
| A Study of the Safety, Tolerability and Pharmacokinetics of Orally-administered GC4702 in Healthy VolunteersNCT03096756Incidence of Treatment-Emergent Adverse Events and Laboratory AbnormalitiesRandomized · Triple-masked · Supportive care | Phase 1 | Completed | Drug: GC4702 dry powder, GC4702 lipid suspension, GC4702 lipid suspension - Part 2 · Other: GC4419 IV, Placebo Dry Powder, Placebo lipid suspension, Fed Condition, Fasting Condition | Healthy Volunteer | 48 | Dec 2016actual | 2017-04-04 |
| A Phase 1 Dose Escalation Study of GC4419 in Combination With Chemoradiation for Squamous Cell Cancer of the Head & NeckNCT01921426Frequency and Severity of Adverse Events Resulting from GC4419Open-label · Supportive care | Phase 1 | Completed | Drug: GC4419 | Squamous Cell Carcinoma of the Oral Cavity, Squamous Cell Carcinoma of the Oropharynx | 30 | Jul 2015actual | 2016-09-22 |
Primary completion is the date the sponsor filed with the registry — their own projection, revised whenever they revise it, unless the row is marked actual.
Source: ClinicalTrials.gov, retrieved 2026-08-19