Study of JANX007 in Subjects With Metastatic Castration-Resistant Prostate Cancer (ENGAGER-PSMA-01)

NCT05519449
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Phase
Phase 1
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Recruitment status
Recruiting
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Participants
272
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Lead sponsor
Janux Therapeutics
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Start date
2022-09-15
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Number of sites
36
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Summary
This study is a first-in-human, Phase 1, open-label, multicenter study to assess the safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD), and the preliminary efficacy of JANX007 in adults with metastatic castration-resistant prostate cancer (mCRPC).
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Short title
Study of JANX007 in Subjects With Metastatic Castration-Resistant Prostate Cancer (ENGAGER-PSMA-01)
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Official title
A Phase 1, Open-Label, Multicenter Study of JANX007 in Subjects With Metastatic Castration-Resistant Prostate Cancer
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Control arm
Open label
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Recruiting
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Phase
Phase 1
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Study type
Interventional
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Completion date
2028-12-01
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First posted
2022-08-29
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Registry last updated
2026-08-13
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Primary completion date
2027-07-01
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Start date
2022-09-15
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Participants
272
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Participant count basis
Estimated
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Planned participants
272
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Protocol amendments
7
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Number of sites
36
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Data monitoring committee
Yes
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Registry sponsor category
Industry
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Lead sponsor
Janux Therapeutics
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Source registry
ClinicalTrials.gov
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Registry ID
NCT05519449
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ClinicalTrials.gov ID
NCT05519449
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Registry record
Open registry record
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Allocation
Not randomised
Model
Sequential
Purpose
Treatment
Masking
No masking
Sources for study design
clinicaltrials.gov

  1. Incidence of Dose Limiting Toxicities (DLT)

    Timeframe: 3 years

  2. Incidence of Adverse Events (AE) and Serious Adverse Events (SAE)

    Timeframe: 3 years

  1. Area under the concentration time curve to infinity of JANX007 (AUC0-inf)

    Timeframe: Pre-dose and at multiple timepoints post-dose on Days 1, 2, 4, 8, 9, 15, 16, 18 up to end of treatment (Up to 3 years)

  2. Maximum observed concentration of JANX007 (Cmax)

    Timeframe: Pre-dose and at multiple timepoints post-dose on Days 1, 2, 4, 8, 9, 15, 16, 18 up to end of treatment (Up to 3 years)

  3. Number of participants who develop anti-drug antibodies against JANX007

    Timeframe: Up to 3 years

  4. Duration of Response

    Timeframe: Up to 3 years

    Time from documentation of complete response or partial response to disease progression using RECIST v1.1 and PCWG3

  5. Prostate Specific Antigen (PSA) response

    Timeframe: Up to 3 years

    Best reduction in PSA level achieved confirmed by a second PSA test ≥21 days later

  6. Radiographic Progression Free Survival (rPFS)

    Timeframe: Up to 3 years

    Time from treatment initiation to radiographic evidence of disease progression using RECIST v1.1 and PCWG3

  7. Overall Response Rate

    Timeframe: Up to 3 years

    Proportion of participants who achieve a complete response or partial response using RECIST v1.1 and PCWG3

  8. Overall Survival

    Timeframe: Up to 3 years

    Time from treatment initiation until death from any cause

Sources for outcomes
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Sex
Male
Age groups
Adults, Older adults
Minimum age
18 Years
Maximum age
100 Years
Healthy volunteers
No

  • Male ≥18 years of age at the time of signing informed consent
  • Histologically or cytologically confirmed adenocarcinoma of the prostate
  • For Dose Escalation and Backfill: Having mCRPC that progressed after at least one novel anti-androgen therapy and at least one taxane containing regimen. Participants who have actively refused a taxane containing regimen or are medically unsuitable to receive taxane are eligible
  • Adequate organ function
  • For Monotherapy Expansion Part a: Have received ≤ 2 anti-androgen therapies in either the HSPC or CRPC setting and no more than 1 prior taxane regimen in the HSPC or CRPC setting. Participants who have actively refused a taxane regimen or are medically unsuitable to receive taxane are eligible.
  • For Monotherapy Expansion Part b: Have received ≤ 2 anti-androgen therapies in either the HSPC or CRPC settings
  • For Monotherapy Expansion Part d: Have received ≤ 1 anti-androgen therapy and a poly(ADP-ribose) polymerase (PARP) inhibitor for mCRPC and have progressed following treatment with the PARP inhibitor
  • For Combination Expansion: Have received ≤ 1 anti-androgen therapy other than darolutamide in the HSPC setting and ≤ 1 taxane in the mCRPC setting. Participants who have actively refused a taxane regimen or are medically unsuitable to receive taxane are eligible.

  • Prior solid organ transplant
  • Prior treatment with PSMA-targeted CAR-T cell therapy or PSMA-CD3, PSMA-CD28 or other CD3 T-cell engaging bispecific antibodies or radioligand therapy
  • Clinically significant cardiovascular disease
  • For Monotherapy Expansion Part a: Prior receipt of any treatment other than an ARPI or taxane in the mCRPC setting
  • For Monotherapy Expansion Part b: Prior receipt of any treatment other than an anti-androgen therapy or prior receipt of a taxane containing regimen or more than 1 prior line of therapy for mCRPC
  • For Monotherapy Part d: More than 1 prior line of therapy for mCRPC or prior receipt of any treatment other than an anti-androgen therapy and PARP inhibitor for mCRPC or prior receipt of a taxane in the mCRPC setting
  • For Combination expansion: More than 1 prior line of therapy for mCRPC or prior receipt of any treatment other than a taxane for mCRPC or prior receipt of Darolutamide or prior receipt of a taxane for HSPC
  • Active clinically significant infection (bacterial, viral, fungal, mycobacteria or other)
  • Any medical condition or clinical laboratory abnormality likely to interfere with assessment of safety or efficacy of study treatment
Sources for eligibility
clinicaltrials.gov

  • University of Alabama at Birmingham HospitalBirmingham, United StatesRecruiting
  • Mayo ClinicPhoenix, United StatesRecruiting
  • USC Norris Comprehensive Cancer CenterLos Angeles, United StatesRecruiting
  • UCLA Department of MedicineLos Angeles, United StatesRecruiting
  • Hoag Memorial Hospital PresbyterianNewport Beach, United StatesRecruiting
  • University of California Davis Comprehensive Cancer CenterSacramento, United StatesRecruiting
  • UCSF Helen Diller Family Comprehensive Cancer CenterSan Francisco, United StatesRecruiting
  • Yale New Haven HospitalNew Haven, United StatesRecruiting
  • Mayo ClinicJacksonville, United StatesRecruiting
  • University of Chicago Medical CenterChicago, United StatesRecruiting
  • University of Maryland Greenebaum Comprehensive Cancer CenterBaltimore, United StatesRecruiting
  • University of Minnesota Medical CenterMinneapolis, United StatesRecruiting
  • Mayo ClinicRochester, United StatesRecruiting
  • Washington University School of MedicineSt Louis, United StatesRecruiting
  • Northwell Health R.J. Zuckerberg Cancer HospitalLake Success, United StatesRecruiting
  • NYU Langone Health Long IslandMineola, United StatesRecruiting
  • NYU Langone HealthNew York, United StatesRecruiting
  • Memorial Sloan Kettering Cancer CenterNew York, United StatesRecruiting
  • Weill Cornell MedicineNew York, United StatesRecruiting
  • Montefiore Medical CenterThe Bronx, United StatesRecruiting
  • University of Cincinnati Medical CenterCincinnati, United StatesRecruiting
  • The Ohio State UniversityColumbus, United StatesRecruiting
  • Penn State Milton S. Hershey Medical CenterHershey, United StatesRecruiting
  • Thomas Jefferson University Honickman CenterPhiladelphia, United StatesRecruiting
  • UPMC Hillman Cancer CenterPittsburgh, United StatesRecruiting

And 11 more, listed on the interactive page.

Sources for sites
clinicaltrials.gov

Other registry identifiers

  • ENGAGER-PSMA-01
Sources for references
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Conditions (2)

Targets (1)