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Phase 1 Clinical Study of GT-220F in Subjects With Metastatic Castration Resistant Prostate Cancer (mCRPC) | Clinical Trials | Clareo Health

NOT_YET_RECRUITINGPHASE1

Phase 1 Clinical Study of GT-220F in Subjects With Metastatic Castration Resistant Prostate Cancer (mCRPC)

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)

NCT06866795•Geode Therapeutics Inc.

View on ClinicalTrials.gov

Summary

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

Eligibility

Age

18 - No limit years

Sex

MALE

Healthy Volunteers

Inclusion Criteria

•1. Males ≥ 18 years of age. Because no dosing or adverse event data are currently available on the use of GT-220F in subjects \<18 years of age, children are excluded from this study.
•2. In Dose Escalation (Part 1) Only - subjects must have histologically confirmed recurrent or progressive metastatic castration resistant prostate cancer (mCRPC). In Dose Expansion (Part 2) Only - subjects must have histologicaly confirmed recurrent or progressive mCRPC with alterations in the PTEN gene (mutations or deletions) or PIK3CB gene (activating mutations or amplifications) as determined by Next-Generation Sequencing.
•3. Subjects must have received at least one previous AR pathway inhibitor (enzalutamide, apalutamide, darolutamide, abiraterone acetate) for biochemically recurrent or metastatic prostate cancer.
•4. Ongoing ADT with a lutenizing hormone releasing hormone agonist/antagonist or bilateral orchiectomy that results in serum testosterone \< 50 ng/dL.
•5. Subjects must have shown evidence of radiological and/or prostate specific antigen (PSA) progression. For PSA progression, there must be at least 2 sequential rises at a minimum of 1-week intervals. The first PSA value must be ≥ 2 ng/mL. Progression of measurable disease (RECIST 1.1 criteria) or presence of at least two new bone lesions (Prostate Cancer Working Group 3 criteria).
•6. Subjects must have recovered to grade ≥ 2 or pre-treatment baseline from clinically significant toxic effects of prior therapy.
•7. ECOG performance status \>2
•8. Subjects must have adequate organ and marrow function as defined below:
•1. absolute neutrophil count ≥ 1,500/mcL
•2. hemoglobin ≥ 9g/dL
+8 more criteria

Exclusion Criteria

•1. Evidence of oncogenic mutations in PIK3CA, RAS or receptor tyrosine kinase (RTK) genes (EGFR, ALK).
•2. Subjects who have had prior treatment with PI3K inhibitors with beta and/or delta isoform activity: GSK2636771, AZD 8186, idelalisib, copanlisib, duvelisib, umbralisib.
•3. Subjects who have had any cancer-directed immunomodulatory or molecularly-targeted agent or monoclonal antibody within 14 days prior to initiation of study drug.
•4. Subjects who have used any investigational agents within 28 days or 5 half-lives from study initiation, whichever is shorter.
•5. Subjects who have increasing corticosteroid requirement or a dose \>6 mg per day of dexamethasone or equivalent dose of other corticosteroids within 7 days prior to study initiation.
•6. Subjects who received radiation therapy within 4 weeks prior to enrollment, unless there is surgical confirmation of recurrent disease or evidence of new enhancing recurrent disease outside of the prior radiotherapy treatment field.
•7. Subjects who have had major surgery within 28 days prior to registration.
•8. Subjects with a history of allergic reactions attributed to compounds of similar chemical or biologic composition to GT-220F.
•9. Subjects with known human immunodeficiency virus or acquired immunodeficiency syndrome-related illness.
•10. Subjects with any of the following within 6 months prior to initiation of study drug: uncontrolled congestive heart failure (New York Heart Association Classification 3 or 4), angina, myocardial infarction, cerebrovascular accident, coronary/peripheral artery bypass graft surgery, transient ischemic attack.
+7 more criteria

Key Dates

Start Date

July 1, 2025

Primary Completion Date

December 1, 2025

Completion Date

December 1, 2025

Last Updated

March 10, 2025

Enrollment

ESTIMATED participants

Conditions

Metastatic Castration Resistant Prostate Cancer

Interventions

GT-220F capsule

DRUG

Contacts

Haiying Peng

CONTACT

6178233851 haiying.peng@geodetx.com

Jean J. Zhao, PhD

CONTACT

jean.zhao@geodetx.com

AB-3028, a Programmable Circuit T Cell Therapy in Patients With Castration Resistant Prostate Cancer (CRPC)

NCT07285694

Metastatic Castration Resistant Prostate Cancer (mCRPC)

View study

RECRUITINGPHASE1

A Trial of HRS-5041-103 to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of HRS-5041 in Subjects With Metastatic Castration-resistant Prostate Cancer

NCT06830850

Metastatic Castration Resistant Prostate Cancer

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RECRUITING

Real-world Experience With Lutetium Vipivotide Tetraxetan in Metastatic Castration Resistant Prostate Cancer

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 10, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Phase 1 Clinical Study of GT-220F in Subjects With Metastatic Castration Resistant Prostate Cancer (mCRPC)

Inclusion Criteria

Exclusion Criteria

AB-3028, a Programmable Circuit T Cell Therapy in Patients With Castration Resistant Prostate Cancer (CRPC)

A Trial of HRS-5041-103 to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of HRS-5041 in Subjects With Metastatic Castration-resistant Prostate Cancer

Real-world Experience With Lutetium Vipivotide Tetraxetan in Metastatic Castration Resistant Prostate Cancer

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