Metastatic Castration-Resistant Prostate CancerPhase 2NCT06842498
A Study of FG-3246 in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC)
A Phase 2 study testing FG-3246 in people with Metastatic Castration-Resistant Prostate Cancer, run by Kyntra Bio at 23 sites in United States.
Trial summary
The purpose of this study is to evaluate the safety, efficacy, tolerability, and pharmacokinetics (PK) of FG-3246, a cluster of differentiation 46 (CD46) targeting antibody-drug conjugate (ADC), in the treatment of participants with mCRPC who have progressed following treatment with one prior second-generation… 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?
- FG-3246
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 23 sitesUnited States
- Study dates
- 22 Feb 2026to 31 Mar 2028
- Phase
- Phase 2
- 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
- Participant must have histological, and/or cytological confirmation of prostate adenocarcinoma on all prior tumor biopsies.
- Participant with soft tissue disease and a safely accessible soft tissue tumor lesion(s) must agree to biopsy of a primary or metastatic lesion during screening. Alternatively, participant may provide a suitable archival biopsy of a primary or metastatic lesion.
- Participant must have serum testosterone levels <50 nanograms (ng)/deciliter (dL) during screening.
- Participant is required to have progressed on no more than one prior treatment with a second generation ARSI (abiraterone acetate, enzalutamide, apalutamide, or darolutamide) initiated in either the castration-sensitive or castration-resistant setting.
- Participant must have progressive mCRPC following last treatment at screening.
- Participant must have ≥1 metastatic lesion that is present on baseline Computed Tomography (CT), Magnetic Resonance Imaging (MRI), or bone scan obtained ≤28 days prior to randomization.
- Participant must have adequate organ function during screening.
Who cannot join
- Participant has received previous treatment with a therapeutic targeting CD46.
- Participant has small cell neuroendocrine carcinoma (pure or mixed) on any prior histologic evaluation of primary or metastatic lesion.
- Participant has progressed on more than one prior second-generation ARSI in any setting or has received more than two prior second-generation ARSIs in any setting.
- Participants must not have received recent anticancer treatments before enrollment. Ongoing supportive or hormonal therapies are allowed if they were started well before randomization and are continued without change.
- Participant has received any prior radiation therapy within 14 days prior to randomization.
- Participant has a known actionable mutation or gene alteration, for example, BRCA1 mutation, for which approved therapies are available, for example, PARP inhibitors, unless these therapies are not appropriate for the participant as determined by the investigator or the participant refuses such therapy.
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- Participant has National Cancer institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) ≥Grade 2 peripheral neuropathy at the time of screening from any etiology.
- Participant has received any prior chemotherapy; however, one prior taxane-based chemotherapy in the castration-sensitive setting is allowed if completed >12 months before randomization.
- Participant has known hypersensitivity to the components of FG-3246 or its analogs or a history of allergic or anaphylactic reaction to human, humanized, or chimeric monoclonal antibodies.
- Participant has diagnosis with any other malignancy in the past 5 years, except for adequately treated basal cell or squamous cell carcinoma of the skin.
- Participant requires treatment with a strong cytochrome P450 3A4 (CYP3A4) inhibitor or inducer drug that cannot be safely discontinued.
- NOTE: Other protocol-defined inclusion/exclusion may apply.
Trial locations and contacts
23 sites in 1 country. Contact the study team or a site near you to ask about taking part.
23 sites in 1 country
United States23 sites, 23 recruiting
- Recruiting
New Mexico Oncology Hematology Consultants, Ltd.
Albuquerque, New Mexico, 87109
Daisy Sanchez, 505-842-8171, research@nmohc.com
- Recruiting
Winship Cancer Institute, Emory University
Atlanta, Georgia, 30322
Emily Setser, 404-778-4968, emily.setser@emory.edu
- Recruiting
Bioresearch Partner - Aventura
Aventura, Florida, 33180
Angelo Gousse, 833-489-4968, agoussemd@bioresearchpartner.com
- Recruiting
University of Virginia Comprehensive Cancer Center
Charlottesville, Virginia, 22908
Clinical Trials Navigator, 434-982-0539, uvacancertrials@hscmail.mcc.virginia.edu
- Recruiting
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
Pedro Barata, 801-585-0255, Pedro.Barata@UHhospitals.org
- Recruiting
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
Amy Rowell, 214-645-9688, amy.rowell@utsouthwestern.edu
- Recruiting
Duke University Medical Center - Duke Cancer Center
Durham, North Carolina, 27710
Andrew Armstrong, 919-668-4667, andrew.armstrong@duke.edu
- Recruiting
Western Regional Medical Center - City of Hope Phoenix Goodyear
Goodyear, Arizona, 85338
Firas Shada, 847-342-6910, fshadad@coh.org
- Recruiting
Bioresearch Partner - Hialeah
Hialeah, Florida, 33013
Luis Rangel, 833-489-4968, lrangel@bioresearchpartner.com
- Recruiting
Oncology Consultants
Houston, Texas, 77030
Julio Peguero, 713-600-0900, jpeguero@oncologyconsultants.com
- Recruiting
VA Greater Los Angeles Healthcare System
Los Angeles, California, 90073
Matthew Rettig, 310-478-3711 ext. 44761, matthew.rettig@va.gov
- Recruiting
UCLA Clark Urology Center
Los Angeles, California, 90095
Ankush Sachdeva, 310-794-3452, asachdeva@mednet.ucla.edu
- Recruiting
Biogenix Molecular, LLC
Miami, Florida, 33165
Jerry Joseph, 786-791-1799, jjoseph@cira-health.com
- Recruiting
Carolina Urologic Research Center
Myrtle Beach, South Carolina, 29572
Kate Valipour, 843-449-1010 ext. 5268, kate.valipour@startresearch.com
- Recruiting
Henry-Joyce Cancer Clinic
Nashville, Tennessee, 37232
Clinical Trials Office, Vanderbilt-Ingram Cancer Center, 800-811-8480, CIP@VUMC.ORG
- Recruiting
New Haven Hospital - Yale Cancer Center
New Haven, Connecticut, 06519
Amanda Davis, 475-321-7899, Amanda.Davis@yale.edu
- Recruiting
East Jefferson General Hospital Metairie
New Orleans, Louisiana, 70112
Sarah Bigelow, 504-988-6123, sbigelow@tulane.edu
- Recruiting
University of California San Francisco
San Francisco, California, 94158
Daniel Avins, 415-514-4222, daniel.avins@ucsf.edu
- Recruiting
HonorHealth Research Institute
Scottsdale, Arizona, 85258
Amy Malensek, 480-323-1791, amalensek@honorhealth.com
- Recruiting
Fred Hutchinson Cancer Center
Seattle, Washington, 98109
Michael Schweizer, 206-606-6252, schweize@uw.edu
- Recruiting
University of Washington Medical Center
Seattle, Washington, 98195
Michael Schweizer, 206-606-6252, schweize@uw.edu
- Recruiting
Northwest Medical Specialties, PLLC - Tacoma
Tacoma, Washington, 98405
Patricia Walsh, 253-428-8700, pwalsh@nwmsonline.com
- Recruiting
The University of Arizona Cancer Center - North Campus
Tucson, Arizona, 85719
Alana Sudkamp, 520-621-5895, alanamsudkamp@arizona.edu
About this study
Official title: A Phase 2 Dose Optimization Trial Evaluating a CD46-Targeted Antibody-Drug Conjugate (FG-3246) in Patients With Metastatic Castration-Resistant Prostate Cancer
The purpose of this study is to evaluate the safety, efficacy, tolerability, and pharmacokinetics (PK) of FG-3246, a cluster of differentiation 46 (CD46) targeting antibody-drug conjugate (ADC), in the treatment of participants with mCRPC who have progressed following treatment with one prior second-generation androgen receptor signaling inhibitor (ARSI) in any setting and no prior taxane therapy in the mCRPC setting.
- Being tested
- FG-3246
- Keywords
- FG-3246, FOR46, mCRPC, CRPC, CD46, Prostate cancer, Antibody-drug conjugate, Metastatic prostate cancer, FibroGen, ADC, Kyntra, Kyntra Bio, KYNB
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FG-3246Drug
Also called FOR46
FG-3246 will be administered per schedule specified in the arm description.
| Study group | Role | What they receive |
|---|---|---|
| FG-3246 1.8 mg/kg | Experimental | Participants will receive FG-3246 1.8 milligrams (mg)/kilogram (kg) administered via intravenous (IV) infusion on Day 1 of each 21-day treatment cycle (every 3 weeks [Q3W]) until radiographic progression, unacceptable safety and tolerability, participant or investigator decision to stop treatment, other withdrawal criteria are met, or sponsor decision to close the study. Receives: Drug: FG-3246 |
| FG-3246 2.4 mg/kg | Experimental | Participants will receive FG-3246 2.4 mg/kg administered via IV infusion on Day 1 of each 21-day treatment cycle (Q3W) until radiographic progression, unacceptable safety and tolerability, participant or investigator decision to stop treatment, other withdrawal criteria are met, or sponsor decision to close the study. Receives: Drug: FG-3246 |
| FG-3246 2.7 mg/kg | Experimental | Participants will receive FG-3246 2.7 mg/kg administered via IV infusion on Day 1 of each 21-day treatment cycle (Q3W) until radiographic progression, unacceptable safety and tolerability, participant or investigator decision to stop treatment, other withdrawal criteria are met, or sponsor decision to close the study. Receives: Drug: FG-3246 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiographic Progression-free Survival (rPFS) By Investigator Assessment Per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and Prostate Cancer Clinical Trials Working Group 3 (PCWG3) Criteria
Measured: Until radiographic progression is noted (up to approximately 25 months)
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Measured: From first dose until 28 days after last dose (up to approximately 25 months)
Maximum Plasma Concentration (Cmax) of FG-3246, Total Anti-cluster of Differentiation 46 Antibody (CD46), and Free Monomethyl Auristatin E (MMAE)
Measured: Within each 21 day treatment cycle from Cycle 1 through 28 days post last dose (up to approximately 25 months)
Secondary outcomes (13)
rPFS Rate at 6 Months (rPFS6) Per RECIST v1.1 and PCWG3 Criteria
Measured: Month 6
rPFS Rate at 12 Months (rPFS12) Per RECIST v1.1 and PCWG3 Criteria
Measured: Month 12
Confirmed Objective Response Rate (ORR) Per RECIST v1.1 and PCWG3 Criteria
Measured: From first dose up to approximately 25 months
Duration of Response (DoR) Per RECIST v1.1 and PCWG3 Criteria
Measured: From first dose up to approximately 25 months
Confirmed PSA50 Response Rate: Percentage of Participants Achieving a Decline in Prostate-specific Antigen (PSA) ≥50% From Baseline
Measured: Up to approximately 25 months
Confirmed PSA90 Response Rate: Percentage of Participants Achieving a Decline in PSA ≥90% From Baseline
Measured: Up to approximately 25 months
Composite Response Rate (CRR) Per RECIST 1.1 and PCWG3 Criteria
Measured: Up to approximately 25 months
PSA Progression-free Survival (PFS)
Measured: Up to approximately 25 months
Disease Control Rate (DCR) per RECIST 1.1 and PCWG3 Criteria
Measured: Up to approximately 25 months
Clinical Benefit Rate (CBR) per RECIST 1.1 and PCWG3 Criteria
Measured: Up to approximately 25 months
Time to First Symptomatic Skeletal-related Event (SSRE)
Measured: Up to approximately 25 months
Overall Survival (OS)
Measured: Until death or up to approximately 25 months
Percentage of Participants Who Develop Anti-drug Antibodies (ADA) and Neutralizing Antibody (NAb) Against FG-3246
Measured: Within each 21 day treatment cycle from Cycle 1 through 28 days post last dose (up to approximately 25 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2025
- Study start22 Feb 2026
- Primary completion31 Mar 2028 (estimated)
- Study completion31 Mar 2028 (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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kyntra Bio
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06842498
- Sponsor's protocol ID
- FGCL-3246-112
- Status last verified
- Aug 2026
- First submitted
- 19 Feb 2025
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Dose Optimization Trial Evaluating a CD46-Targeted Antibody-Drug Conjugate (FG-3246) in Patients With Metastatic Castration-Resistant Prostate Cancer
- ClinicalTrials.gov ID
- NCT06842498
- Acronym / sponsor ID
- FGCL-3246-112
- Keywords
- FG-3246, FOR46, mCRPC, CRPC, CD46, Prostate cancer, Antibody-drug conjugate, Metastatic prostate cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Kyntra BioIndustry (pharma, biotech, devices)
- Study start
- 22 Feb 2026 (actual)
- Primary completion
- 31 Mar 2028 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 24 Feb 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 purpose of this study is to evaluate the safety, efficacy, tolerability, and pharmacokinetics (PK) of FG-3246, a cluster of differentiation 46 (CD46) targeting antibody-drug conjugate (ADC), in the treatment of participants with mCRPC who have progressed following treatment with one prior second-generation androgen receptor signaling inhibitor (ARSI) in any setting and no prior taxane therapy in the mCRPC setting.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| FG-3246 1.8 mg/kg | Experimental | Drug: FG-3246Participants will receive FG-3246 1.8 milligrams (mg)/kilogram (kg) administered via intravenous (IV) infusion on Day 1 of each 21-day treatment cycle (every 3 weeks [Q3W]) until radiographic progression, unacceptable safety and tolerability, participant or investigator decision to stop treatment, other withdrawal criteria are met, or sponsor decision to close the study. |
| FG-3246 2.4 mg/kg | Experimental | Drug: FG-3246Participants will receive FG-3246 2.4 mg/kg administered via IV infusion on Day 1 of each 21-day treatment cycle (Q3W) until radiographic progression, unacceptable safety and tolerability, participant or investigator decision to stop treatment, other withdrawal criteria are met, or sponsor decision to close the study. |
| FG-3246 2.7 mg/kg | Experimental | Drug: FG-3246Participants will receive FG-3246 2.7 mg/kg administered via IV infusion on Day 1 of each 21-day treatment cycle (Q3W) until radiographic progression, unacceptable safety and tolerability, participant or investigator decision to stop treatment, other withdrawal criteria are met, or sponsor decision to close the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Participant must have histological, and/or cytological confirmation of prostate adenocarcinoma on all prior tumor biopsies.
- Participant with soft tissue disease and a safely accessible soft tissue tumor lesion(s) must agree to biopsy of a primary or metastatic lesion during screening. Alternatively, participant may provide a suitable archival biopsy of a primary or metastatic lesion.
- Participant must have serum testosterone levels <50 nanograms (ng)/deciliter (dL) during screening.
- Participant is required to have progressed on no more than one prior treatment with a second generation ARSI (abiraterone acetate, enzalutamide, apalutamide, or darolutamide) initiated in either the castration-sensitive or castration-resistant setting.
- Participant must have progressive mCRPC following last treatment at screening.
Key exclusion criteria (12 listed)
- Participant has received previous treatment with a therapeutic targeting CD46.
- Participant has small cell neuroendocrine carcinoma (pure or mixed) on any prior histologic evaluation of primary or metastatic lesion.
- Participant has progressed on more than one prior second-generation ARSI in any setting or has received more than two prior second-generation ARSIs in any setting.
- Participants must not have received recent anticancer treatments before enrollment. Ongoing supportive or hormonal therapies are allowed if they were started well before randomization and are continued without change.
- Participant has received any prior radiation therapy within 14 days prior to randomization.
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 |
|---|---|---|
| FG-3246Also: FOR46FG-3246 will be administered per schedule specified in the arm description. | Drug | FG-3246 1.8 mg/kg, FG-3246 2.4 mg/kg, FG-3246 2.7 mg/kg |
Primary outcome
Radiographic Progression-free Survival (rPFS) By Investigator Assessment Per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and Prostate Cancer Clinical Trials Working Group 3 (PCWG3) Criteria
Time frame: Until radiographic progression is noted (up to approximately 25 months)
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Time frame: From first dose until 28 days after last dose (up to approximately 25 months)
Maximum Plasma Concentration (Cmax) of FG-3246, Total Anti-cluster of Differentiation 46 Antibody (CD46), and Free Monomethyl Auristatin E (MMAE)
Time frame: Within each 21 day treatment cycle from Cycle 1 through 28 days post last dose (up to approximately 25 months)
13 secondary outcomes
rPFS Rate at 6 Months (rPFS6) Per RECIST v1.1 and PCWG3 Criteria
Time frame: Month 6
rPFS Rate at 12 Months (rPFS12) Per RECIST v1.1 and PCWG3 Criteria
Time frame: Month 12
Confirmed Objective Response Rate (ORR) Per RECIST v1.1 and PCWG3 Criteria
Time frame: From first dose up to approximately 25 months
Duration of Response (DoR) Per RECIST v1.1 and PCWG3 Criteria
Time frame: From first dose up to approximately 25 months
Confirmed PSA50 Response Rate: Percentage of Participants Achieving a Decline in Prostate-specific Antigen (PSA) ≥50% From Baseline
Time frame: Up to approximately 25 months
Confirmed PSA90 Response Rate: Percentage of Participants Achieving a Decline in PSA ≥90% From Baseline
Time frame: Up to approximately 25 months
Composite Response Rate (CRR) Per RECIST 1.1 and PCWG3 Criteria
Time frame: Up to approximately 25 months
PSA Progression-free Survival (PFS)
Time frame: Up to approximately 25 months
Disease Control Rate (DCR) per RECIST 1.1 and PCWG3 Criteria
Time frame: Up to approximately 25 months
Clinical Benefit Rate (CBR) per RECIST 1.1 and PCWG3 Criteria
Time frame: Up to approximately 25 months
Time to First Symptomatic Skeletal-related Event (SSRE)
Time frame: Up to approximately 25 months
Overall Survival (OS)
Time frame: Until death or up to approximately 25 months
Percentage of Participants Who Develop Anti-drug Antibodies (ADA) and Neutralizing Antibody (NAb) Against FG-3246
Time frame: Within each 21 day treatment cycle from Cycle 1 through 28 days post last dose (up to approximately 25 months)
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 17 Aug 2026.
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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.
23 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing FG-3246 in people with Metastatic Castration-Resistant Prostate Cancer, run by Kyntra Bio at 23 sites in United States.
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 7 inclusion and 12 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: looking for participants now, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Javier Moreno (415-978-1466, jmoreno@kyntrabio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiographic Progression-free Survival (rPFS) By Investigator Assessment Per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and Prostate Cancer Clinical Trials Working Group 3 (PCWG3) Criteria (time frame: Until radiographic progression is noted (up to approximately 25 months)). The study lists 3 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 17 Aug 2026.