Trial Title:
A Study of Tinengotinib (TT-00420) in Combination With Standard Treatments in People With Prostate Cancer
NCT ID:
NCT06457919
Condition:
Prostate Cancer
Conditions: Official terms:
Prostatic Neoplasms
Prednisone
Abiraterone Acetate
Conditions: Keywords:
Tinengotinib (TT-00420)
Androgen Receptor Signaling Inhibitors (ARSIs)
TIP Study: Tinengotinib In Prostate Cancer
Prostate Cancer Clinical Trials Consortium, LLC (PCCTC)
24-103
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Intervention model description:
In the Phase 1b portion of the study, participants will be enrolled sequentially in
cohorts of 3 for each studied combination. The recommended Phase II dose (RP2D) of each
combination will be estimated separately based on the de-escalation rules.
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Tinengotinib
Description:
Tinengotinib will be administered daily for 28-day cycles. A flat dose of 10 mg PO once
daily.
Arm group label:
Tinengotinib with abiraterone acetate/prednisone
Other name:
TT-00420
Intervention type:
Drug
Intervention name:
abiraterone acetate
Description:
Abiraterone acetate 1000 mg PO QD
Arm group label:
Phase 1b dose of tinengotinib (RP2D) with abiraterone acetate/prednisone or enzalutamide
Arm group label:
Tinengotinib with abiraterone acetate/prednisone
Intervention type:
Drug
Intervention name:
Prednisone or Enzalutamide
Description:
Prednisone 5 mg PO once or twice daily (QD or BID) or enzalutamide 160 mg PO QD
Arm group label:
Phase 1b dose of tinengotinib (RP2D) with abiraterone acetate/prednisone or enzalutamide
Arm group label:
Tinengotinib with abiraterone acetate/prednisone
Intervention type:
Drug
Intervention name:
Tinengotinib
Description:
The recommended phase 2 dose (RP2D).
Arm group label:
Phase 1b dose of tinengotinib (RP2D) with abiraterone acetate/prednisone or enzalutamide
Other name:
TT-00420
Summary:
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).
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Participants ≥ 18 years old, with signed informed consent
- Histologically confirmed carcinoma of the prostate (neuroendocrine differentiation
is allowed, but pure small cell carcinoma is not permitted)
- Metastatic disease documented by at least 2 bone lesions on whole body radionuclide
bone scan, or soft tissue disease documented by computed tomography (CT)
scan/magnetic resonance imaging (MRI). Note: Metastatic disease seen only on PET
imaging does not qualify.
- Current ongoing therapy and observed tolerance with full standard dose of
abiraterone acetate (1000 mg QD) or enzalutamide (160 mg QD) at the time of study
entry, started at least 90 days before consent. An interruption of dosing of a
maximum of 30 days is permitted prior to resuming the agent. Please note: Patients
who are on a reduced dose or are intolerant of abiraterone acetate or enzalutamide
will not be eligible for study participation.
- Progressive disease on enzalutamide or abiraterone acetate documented by PCWG3
criteria for study entry. Progressive disease is defined as at least one of the
following:
1. PSA progression defined as a minimum of 2 rising PSA levels with a minimum of a
1-week interval between each determination, reaching a minimum PSA value of 1.0
ng/mL.
2. Nodal or visceral progression as defined by PCWG3-modified RECIST 1.1
3. Appearance of 2 or more new lesions on a bone scan
- At least one of the following at study entry:
1. RECIST 1.1 measurable disease at baseline; i.e., soft tissue tumor lesions or
pathologically enlarged lymph nodes that can be accurately measured in at least
one dimension OR
2. a PSA of 2.0 ng/mL or above
- Participants must be medically or surgically castrated with ongoing androgen
deprivation therapy (ADT) for ≥90 days or have documented history of bilateral
orchiectomy.
- ECOG 0 - 2
- Adequate organ function confirmed at screening, as evidenced by:
- Absolute neutrophil count ≥ 1.5 × 10^9 /L
- Hemoglobin ≥ 9 g/dL
- Platelets ≥ 75 × 10^9 /L
- Aspartate aminotransferase (AST/SGOT) and alanine aminotransferase (ALT/SGPT) ≤
2.5 × upper limit of normal (ULN) or ≤ 5.0 × ULN if liver metastases are
present
- Total bilirubin ≤ 1.5 × ULN; or < 2.5 × ULN if Gilbert syndrome or disease
involving liver
- Creatinine clearance >30 mL/min (Cockcroft-Gault formula)
- Adequate blood coagulation function as evidence by an international normalized
ratio (INR) ≤ 1.5 unless participant is on anticoagulants
- Tumor biopsy during screening is required if safe and feasible.
Exclusion Criteria:
- The presence of any of the following criteria excludes a patient from participating
in the study:
- Pure small cell carcinoma
- Previous exposure to multi-TKI therapies.
- Uncontrolled hypertension (persistent systolic blood pressure ≥ 140 mm Hg and/or
diastolic blood pressure ≥ 90 mm Hg) or known coronary artery disease with angina.
Patients with known hypertension must be on antihypertensive medication with BPs
generally <140/90 to be eligible.
- History of congestive heart failure of Class II-IV New York Heart Association
criteria, or serious cardiac arrhythmia requiring treatment (except atrial
fibrillation, paroxysmal supraventricular tachycardia), history of myocardial
infarction within 6 months of study entry, or QT interval corrected by the
Fridericia correction formula (QTcF) >480 msec at screening.
- Any prior or concurrent malignancy whose natural history or treatment has the
potential to interfere with the safety or efficacy assessments.
- Symptomatic and/or untreated CNS metastases.
- Pre-existing duodenal stent or any gastrointestinal disorder or defect which would
interfere with absorption of study medication, as determined by the Investigator.
- Requirement for systemic therapy with either corticosteroids (>10 mg daily
prednisone equivalents) or immunosuppressive medications within 14 days before study
treatment start.
- Other anticancer therapies within 3 weeks of study treatment start, or within 5
half-lives of study treatment start for non-cytotoxic oral agents, whichever is
shorter; with the exception of androgen deprivation therapy, enzalutamide, or
abiraterone acetate which should be continued through study treatment.
- Palliative radiation within 2 weeks of study treatment start.
Gender:
Male
Gender based:
Yes
Gender description:
Prostate cancer
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Address:
City:
Basking Ridge
Zip:
07920
Country:
United States
Status:
Recruiting
Contact:
Last name:
Wassim Abida, MD, PhD
Phone:
646-442-4633
Facility:
Name:
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Address:
City:
Middletown
Zip:
07748
Country:
United States
Status:
Recruiting
Contact:
Last name:
Wassim Abida, MD, PhD
Phone:
646-442-4633
Facility:
Name:
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Address:
City:
Montvale
Zip:
07645
Country:
United States
Status:
Recruiting
Contact:
Last name:
Wassim Abida, MD, PhD
Phone:
646-442-4633
Facility:
Name:
Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)
Address:
City:
Commack
Zip:
11725
Country:
United States
Status:
Recruiting
Contact:
Last name:
Wassim Abida, MD, PhD
Phone:
646-442-4633
Facility:
Name:
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Address:
City:
Harrison
Zip:
10604
Country:
United States
Status:
Recruiting
Contact:
Last name:
Wassim Abida, MD, PhD
Phone:
646-442-4633
Facility:
Name:
Columbia University
Address:
City:
New York
Zip:
10032
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Mark Stein, MD
Phone:
212-305-5098
Facility:
Name:
Memorial Sloan Kettering Cancer Center
Address:
City:
New York
Zip:
10065
Country:
United States
Status:
Recruiting
Contact:
Last name:
Wassim Abida, MD, PhD
Phone:
646-442-4633
Contact backup:
Last name:
Samir Zaidi, MD, PhD
Phone:
646-888-3698
Facility:
Name:
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
Address:
City:
Uniondale
Zip:
11553
Country:
United States
Status:
Recruiting
Contact:
Last name:
Wassim Abida, MD, PhD
Phone:
646-442-4633
Facility:
Name:
Duke University
Address:
City:
Durham
Zip:
27710
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Hannah Dzimitrowicz McManus, MD
Phone:
919-668-6688
Facility:
Name:
Oregon Health & Science University
Address:
City:
Portland
Zip:
97239
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Alexandra Sokolova, MD
Phone:
503-346-1500
Facility:
Name:
Thomas Jefferson University Hospital
Address:
City:
Philadelphia
Zip:
19107
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Raghava Levaka, MD
Phone:
215-890-3030
Start date:
June 4, 2024
Completion date:
June 2027
Lead sponsor:
Agency:
Memorial Sloan Kettering Cancer Center
Agency class:
Other
Collaborator:
Agency:
TransThera Sciences
Agency class:
Other
Source:
Memorial Sloan Kettering Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06457919
http://www.mskcc.org/mskcc/html/44.cfm
