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NCT06866795
A Phase 1 Open-Label, Dose-Escalation and Dose-Expansion Study Evaluating the Safety, Pharmacokinetics and Clinical Activity of Orally Administered GT-220F in Subjects With Metastatic Castration Resistant Prostate Cancer (mCRPC)
Phase 1 trial testing GT-220F capsule in Metastatic Castration Resistant Prostate Cancer in 42 participants. Not yet recruiting.
1 December 2025
Quick facts
| Lead sponsor | Geode Therapeutics Inc. |
|---|---|
| Phase | Phase 1 |
| Status | Not yet recruiting |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | sequential |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 42 |
| Start date | 1 July 2025 |
| Primary completion | 1 December 2025 |
| Estimated completion | 1 December 2025 |
Drugs / interventions tested
- GT-220F capsule — full drug profile →
Conditions studied
- Metastatic Castration Resistant Prostate Cancer — all drugs for Metastatic Castration Resistant Prostate Cancer →
Sponsor
Geode Therapeutics Inc. — full company profile →
Who can join
18 and older, male only, with Metastatic Castration Resistant Prostate Cancer. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Dose Limiting Toxicity (DLT)
Time frame: at the end of Cycle 1 (each cycle is 28 days)
Number and severity of dose limiting toxicity during Cycle 1 of GT-220F administration during dose escalation -
Maximum Tolerated Dose (MTD)
Time frame: at the end of Cycle 1 (each cycle is 28 days)
Maximum tolerated dose, determined by the occurrence of dose limiting toxicities during Cycle 1 of GT-220F administration -
Recommended Phase 2 Dose
Time frame: at the end of Cycle 1 (each cycle is 28 days)
Recommended Phase 2 dose, determined by evaluation of maximum tolerated dose, dose limiting toxicities, and pharmacokinetics during Cycle 1 of GT-220F administration -
Adverse Events
Time frame: from date of randomization to date of progression, assessed up to 50 weeks
Adverse events, characterized by type, frequency and relationship to the intervention (GT-220F) during administration of GT-220F and for 30 days after stopping administration of GT-220F
Sponsor's own description
The goal of this clinical trial is to test GT-220F in patients with metastatic castration resistant prostate cancer and learn about the best dose required for further study. Participants will be adults with metastatic castration resistant prostate cancer. The main questions the study aims to answer are: 1) What medical problems do participants have when taking GT-220F? 2) What dose strength is best to use in further clinical trials? Participants will be asked to * take GT-220F every day * take medical tests every week
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06866795
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Metastatic Castration Resistant Prostate Cancer
Currently open trials in the same condition.
- NCT07093801 — Observational Study on Lutetium (177Lu) Vipivotide Tetraxetan to Treat Metastatic Castration Resistant Prostate Cancer · recruiting
- NCT06830850 — A Trial of HRS-5041-103 to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of HRS-5041 in Subjects With · Phase 1 · recruiting
- NCT06517719 — Real-world Experience With Lutetium Vipivotide Tetraxetan in Metastatic Castration Resistant Prostate Cancer · recruiting
- NCT05219500 — Targeted Alpha Therapy With 225Actinium-Prostate Specific Membrane Antigen (PSMA)-I&T of Castration-resISTant Prostate C · Phase 2 · active not recruiting
- NCT04729114 — A Safety and Dose-finding Study of PRL-02 Depot in Men With Advanced Prostate Cancer · Phase 1 · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06866795 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Geode Therapeutics Inc.
- Last refreshed: 4 March 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06866795.
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