Metastatic Castration Resistant Prostate CancerPhase 1NCT06866795
Phase 1 Clinical Study of GT-220F in Subjects With Metastatic Castration Resistant Prostate Cancer (mCRPC)
A Phase 1 study testing GT-220F capsule in people with Metastatic Castration Resistant Prostate Cancer, run by Geode Therapeutics Inc..
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Metastatic Castration Resistant Prostate Cancer
- What is being tested?
- GT-220F capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- No sites listed yet
- Study dates
- Jul 2025to Dec 2025
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- 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.
- Subjects must have received at least one previous AR pathway inhibitor (enzalutamide, apalutamide, darolutamide, abiraterone acetate) for biochemically recurrent or metastatic prostate cancer.
- Ongoing ADT with a lutenizing hormone releasing hormone agonist/antagonist or bilateral orchiectomy that results in serum testosterone < 50 ng/dL.
- 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).
- Subjects must have recovered to grade ≥ 2 or pre-treatment baseline from clinically significant toxic effects of prior therapy.
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- ECOG performance status >2
- Subjects must have adequate organ and marrow function as defined below:
- absolute neutrophil count ≥ 1,500/mcL
- hemoglobin ≥ 9g/dL
- platelets ≥ 75,000/mcL
- total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) (subjects with Gilbert syndrome are allowed if direct bilirubin within normal limits)
- AST(SGOT)/ALT(SGPT) ≤ 3 x institutional ULN
- creatinine ≤ 1.5 xULM mg/dL OR a calculated creatinine clearance ≥50mL/min.
- Left ventricular ejection fraction at least 50% by echocardiogram or multigated acquisition scan.
- Subjects with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, subjects should be class 2B or better.
- Men who partner with a woman of childbearing potential must agree to use effective, dual contraceptive methods (i.e., a condom, with female partner using oral, injectable or barrier method) while on study drug and for 4 months afterward.
- Ability to understand and the willingness to sign a written informed consent document.
Who cannot join
- Evidence of oncogenic mutations in PIK3CA, RAS or receptor tyrosine kinase (RTK) genes (EGFR, ALK).
- Subjects who have had prior treatment with PI3K inhibitors with beta and/or delta isoform activity: GSK2636771, AZD 8186, idelalisib, copanlisib, duvelisib, umbralisib.
- Subjects who have had any cancer-directed immunomodulatory or molecularly-targeted agent or monoclonal antibody within 14 days prior to initiation of study drug.
- Subjects who have used any investigational agents within 28 days or 5 half-lives from study initiation, whichever is shorter.
- 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.
- 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.
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- Subjects who have had major surgery within 28 days prior to registration.
- Subjects with a history of allergic reactions attributed to compounds of similar chemical or biologic composition to GT-220F.
- Subjects with known human immunodeficiency virus or acquired immunodeficiency syndrome-related illness.
- 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.
- Pulmonary embolism within 1 month prior to initiation of study drug.
- Unstable cardiac dysrhythmias or persistent prolongation of the QTc (Fridericia) interval to >470msec.
- Evidence of Grade ≥ 2 intracranial hemorrhage.
- Subjects with any severe, acute, or chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation or study drug administration, may interfere with the informed consent process and/or with compliance with the requirements of the study, or may interfere with the interpretation of study results and, in the Investigator's opinion, would make the subject inappropriate for entry into this study.
- Subjects with uncontrolled intercurrent illness, including active or clinically unstable bacterial, viral or fungal infection requiring systemic therapy.
- Subjects with difficulty swallowing/unable to swallow pills; malabsorption syndrome; refractory nausea and vomiting, chronic gastrointestinal (GI) disease or previous significant bowel resection with clinically significant sequelae that would preclude adequate absorption of study drug.
- Another cancer for which they are receiving active treatment.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Jean J. Zhao, PhD contact
About this study
Official title: 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)
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
- Being tested
- GT-220F capsule
- Keywords
- prostate cancer, metastatic prostate cancer, castration resistant prostate cancer, PTEN-loss, mCRPC, PTEN-deficient, PI3K, PI3Kbeta
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GT-220F capsuleDrug
Also called 9-((R)-1-((3,5-difluorophenyl)amino)ethyl)-7-((R)-3-(dimethylamino)pyrrolidine-1-carbonyl)-2-morpholino-4H-pyrido[1,2-a]pyrimidin-4-one fumarate
GT-220F capsule for oral administration
| Study group | Role | What they receive |
|---|---|---|
| GT-220F Dose Level 1 | Experimental | GT-220F 50mg, oral capsule, once a day Receives: Drug: GT-220F capsule |
| GT-220F Dose Level 2 | Experimental | GT-220F increased dose level to be determined, oral capsule, once or twice a day Receives: Drug: GT-220F capsule |
| GT-220F Dose Level 3 | Experimental | GT-220F increased dose level to be determined (if needed), oral capsule, once or twice a day Receives: Drug: GT-220F capsule |
| GT-220F Dose Level 4 | Experimental | GT-220F increased dose level to be determined (if needed), oral capsule, once or twice a day Receives: Drug: GT-220F capsule |
| GT-220F Dose Level 5 | Experimental | GT-220F increased dose level to be determined (if needed), oral capsule, once or twice a day Receives: Drug: GT-220F capsule |
| GT-220F Dose Expansion | Experimental | GT-220F recommended phase 2 dose, oral capsule, once or twice a day Receives: Drug: GT-220F capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose Limiting Toxicity (DLT)
Number and severity of dose limiting toxicity during Cycle 1 of GT-220F administration during dose escalation
Measured: at the end of Cycle 1 (each cycle is 28 days)
Maximum Tolerated Dose (MTD)
Maximum tolerated dose, determined by the occurrence of dose limiting toxicities during Cycle 1 of GT-220F administration
Measured: at the end of Cycle 1 (each cycle is 28 days)
Recommended Phase 2 Dose
Recommended Phase 2 dose, determined by evaluation of maximum tolerated dose, dose limiting toxicities, and pharmacokinetics during Cycle 1 of GT-220F administration
Measured: at the end of Cycle 1 (each cycle is 28 days)
Adverse Events
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
Measured: from date of randomization to date of progression, assessed up to 50 weeks
Secondary outcomes (12)
Objective tumor response rate (ORR)
The number of subjects achieving objective response [complete response (CR) and partial response (PR)] divided by number of subjects who initiate treatment
Measured: from date of randomization to date of progression, assessed up to 50 weeks
Duration of objective tumor response (DOR)
The duration of objective response will be measured from the time measurement criteria are met for complete reponse or partial response (whichever is first recorded) until the first date that recurrent or progressive disease (PD) is documented
Measured: from date of randomization to date of progression, assessed up to 50 weeks
Disease control rate (DCR)
The percentage of patients who experience complete response, partial response, or stable disease (SD)
Measured: from date of randomization to date of progression, assessed up to 50 weeks
Radiographic progression-free survival (PFS)
Time from treatment initiation to the earlier of (1) disease progression by RECIST1.1 and/or Prostate Cancer Working Group 3 criteria or (2) death due to to any cause.
Measured: from date of randomization to date of progression, assessed up to 50 weeks
Prostate specific antigen measurements - change from baseline
Proportion of patients achieving 30%, 50% or 90% reduction in prostate specific antigen (PSA) measurement from baseline.
Measured: from date of randomization to date of progression, assessed up to 50 weeks
Area under the curve (AUC)
Pharmacokinetic assessment of area under the curve (AUC) for GT-220F and GT-220F-M1 (active metabolite)
Measured: 22 days from baseline
Maximum plasma concentration (Cmax)
Pharmacokinetic assessment of maximum plasma concentration (Cmax) for GT-220F and GT-220F-M1 (active metabolite)
Measured: 22 days from baseline
Trough plasma concentration (Cmin)
Pharmacokinetic assessment of trough plasma concentration (Cmin) for GT-220F and GT-220F-M1 (active metabolite)
Measured: 22 days from baseline
Time to maximum plasma concentration (Tmax)
Pharmacokinetic assessment of time to maximum plasma concentration (Tmax) for GT-220F and GT-220F-M1 (active metabolite)
Measured: 22 days from baseline
Plasma half-life (T1/2)
Pharmacokinetic assessment of plasma half-life (T1/2) for GT-220F and GT-220F-M1 (active metabolite)
Measured: 22 days from baseline
Plasma clearance (CL)
Pharmacokinetic assessment of plasma clearance (CL) for GT-220F and GT-220F-M1 (active metabolite)
Measured: 22 days from baseline
Volume of distribution
Pharmacokinetic assessment of volume of distribution for GT-220F and GT-220F-M1 (active metabolite)
Measured: 22 days from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2025
- Study startJul 2025 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Castration Resistant Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Geode Therapeutics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alok Tewari, MD, PhD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06866795
- Sponsor's protocol ID
- GT-220F-101
- Status last verified
- Mar 2025
- First submitted
- 28 Feb 2025
- Last updated
- 10 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT06866795
- Acronym / sponsor ID
- GT-220F-101
- Keywords
- prostate cancer, metastatic prostate cancer, castration resistant prostate cancer, PTEN-loss, mCRPC, PTEN-deficient, PI3K, PI3Kbeta
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Geode Therapeutics Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2025 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 10 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| GT-220F Dose Level 1 | Experimental | Drug: GT-220F capsuleGT-220F 50mg, oral capsule, once a day |
| GT-220F Dose Level 2 | Experimental | Drug: GT-220F capsuleGT-220F increased dose level to be determined, oral capsule, once or twice a day |
| GT-220F Dose Level 3 | Experimental | Drug: GT-220F capsuleGT-220F increased dose level to be determined (if needed), oral capsule, once or twice a day |
| GT-220F Dose Level 4 | Experimental | Drug: GT-220F capsuleGT-220F increased dose level to be determined (if needed), oral capsule, once or twice a day |
| GT-220F Dose Level 5 | Experimental | Drug: GT-220F capsuleGT-220F increased dose level to be determined (if needed), oral capsule, once or twice a day |
| GT-220F Dose Expansion | Experimental | Drug: GT-220F capsuleGT-220F recommended phase 2 dose, oral capsule, once or twice a day |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- 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.
- 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.
- Subjects must have received at least one previous AR pathway inhibitor (enzalutamide, apalutamide, darolutamide, abiraterone acetate) for biochemically recurrent or metastatic prostate cancer.
- Ongoing ADT with a lutenizing hormone releasing hormone agonist/antagonist or bilateral orchiectomy that results in serum testosterone < 50 ng/dL.
- 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).
Key exclusion criteria (17 listed)
- Evidence of oncogenic mutations in PIK3CA, RAS or receptor tyrosine kinase (RTK) genes (EGFR, ALK).
- Subjects who have had prior treatment with PI3K inhibitors with beta and/or delta isoform activity: GSK2636771, AZD 8186, idelalisib, copanlisib, duvelisib, umbralisib.
- Subjects who have had any cancer-directed immunomodulatory or molecularly-targeted agent or monoclonal antibody within 14 days prior to initiation of study drug.
- Subjects who have used any investigational agents within 28 days or 5 half-lives from study initiation, whichever is shorter.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GT-220F capsuleAlso: 9-((R)-1-((3,5-difluorophenyl)amino)ethyl)-7-((R)-3-(dimethylamino)pyrrolidine-1-carbonyl)-2-morpholino-4H-pyrido[1,2-a]pyrimidin-4-one fumarateGT-220F capsule for oral administration | Drug | GT-220F Dose Expansion, GT-220F Dose Level 1, GT-220F Dose Level 2, GT-220F Dose Level 3, GT-220F Dose Level 4, GT-220F Dose Level 5 |
Primary outcome
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
12 secondary outcomes
Objective tumor response rate (ORR)
Time frame: from date of randomization to date of progression, assessed up to 50 weeks
Duration of objective tumor response (DOR)
Time frame: from date of randomization to date of progression, assessed up to 50 weeks
Disease control rate (DCR)
Time frame: from date of randomization to date of progression, assessed up to 50 weeks
Radiographic progression-free survival (PFS)
Time frame: from date of randomization to date of progression, assessed up to 50 weeks
Prostate specific antigen measurements - change from baseline
Time frame: from date of randomization to date of progression, assessed up to 50 weeks
Area under the curve (AUC)
Time frame: 22 days from baseline
Maximum plasma concentration (Cmax)
Time frame: 22 days from baseline
Trough plasma concentration (Cmin)
Time frame: 22 days from baseline
Time to maximum plasma concentration (Tmax)
Time frame: 22 days from baseline
Plasma half-life (T1/2)
Time frame: 22 days from baseline
Plasma clearance (CL)
Time frame: 22 days from baseline
Volume of distribution
Time frame: 22 days from baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jean J. Zhao, PhD contact
Alok Tewari, MD, PhD principal investigator
Dana-Farber Cancer Institute
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GT-220F capsule in people with Metastatic Castration Resistant Prostate Cancer, run by Geode Therapeutics Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Haiying Peng (6178233851, haiying.peng@geodetx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose Limiting Toxicity (DLT) (time frame: at the end of Cycle 1 (each cycle is 28 days)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2025.