A Study of Tinengotinib (TT-00420) in Combination With Standard Treatments in People With Prostate Cancer

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
Memorial Sloan Kettering Cancer Center
Study ID
NCT06457919
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Tinengotinib — DRUG
    Tinengotinib will be administered daily for 28-day cycles. A flat dose of 10 mg PO once daily.
  • abiraterone acetate with prednisone — DRUG
    Abiraterone acetate 1000 mg PO QD in combination with prednisone 5 mg PO once or twice daily (QD or BID)
  • Enzalutamide — DRUG
    Enzalutamide 160 mg PO QD

Study Details

The purpose of this study is to find out whether tinengotinib in combination with abiraterone acetate and prednisone or enzalutamide is a safe treatment that causes few or mild side effects in people with metastatic castration-resistant prostate cancer (mCRPC).

Key Dates

Start date
Jun 4, 2024
Status verified
Jun 2026
Primary completion
Jun 30, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
50 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Tinengotinib with abiraterone acetate/prednisone
    Tinengotinib will be administered daily for 28-day cycles. A flat dose of 10 mg PO once daily will be administered unless dose de-escalation is required in Phase 1b. Participants will receive tinengotinib with abiraterone acetate 1000 mg PO QD in combination with prednisone 5 mg PO once or twice daily (QD or BID)
  • Experimental: Tinengotinib with enzalutamide
    Tinengotinib will be administered daily for 28-day cycles. A flat dose of 10 mg PO once daily will be administered unless dose de-escalation is required in Phse 1b. Participants will receive Tinengotinib in combination with enzalutamide 160 mg PO QD.

Primary Outcome Measure

RP2D [ Time Frame: From the start of study treatment through the DLT window (28 days) ]

Central Contacts

Locations (12)

FacilityCityStateZIPSite coordinators
Yale University (Data Collection Only)New HavenConnecticut06511
Samir Zaidi, MD, PhD
[email protected]
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)Basking RidgeNew Jersey07920
Wassim Abida, MD, PhD
646-442-4633
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)MiddletownNew Jersey07748
Wassim Abida, MD, PhD
646-442-4633
Memorial Sloan Kettering Bergen (Limited Protocol Activities)MontvaleNew Jersey07645
Wassim Abida, MD, PhD
646-442-4633
Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)CommackNew York11725
Wassim Abida, MD, PhD
646-442-4633
Memorial Sloan Kettering Westchester (Limited Protocol Activities)HarrisonNew York10604
Wassim Abida, MD, PhD
646-442-4633
Columbia UniversityNew YorkNew York10032
Mark Stein, MD
212-305-5098
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065
Wassim Abida, MD, PhD
646-442-4633
Michael Morris, MD
646-422-4469
Memorial Sloan Kettering Nassau (Limited Protocol Activities)UniondaleNew York11553
Wassim Abida, MD, PhD
646-442-4633
Duke UniversityDurhamNorth Carolina27710
Hannah Dzimitrowicz McManus, MD
919-668-6688
Oregon Health & Science UniversityPortlandOregon97239
Alexandra Sokolova, MD
503-346-1500
Thomas Jefferson University HospitalPhiladelphiaPennsylvania19107
Raghava Levaka, MD
215-890-3030

Find similar trials in New Haven, CT

By condition
Prostate cancer
By specialty
OncologyProstate oncologyMen's healthUrology
By research site
Yale University (Data Collection Only)· New Haven, CTMemorial Sloan Kettering Basking Ridge (Limited Protocol Activities)· Basking Ridge, NJMemorial Sloan Kettering Monmouth (Limited Protocol Activities)· Middletown, NJMemorial Sloan Kettering Bergen (Limited Protocol Activities)· Montvale, NJMemorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)· Commack, NYMemorial Sloan Kettering Westchester (Limited Protocol Activities)· Harrison, NY

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