Actively Recruiting
TT-10 (PORT-6) and TT-4 (PORT-7) as Single Agents and in Combination in Subjects With Advanced Selected Solid Tumors
Led by Portage Biotech · Updated on 2025-04-02
90
Participants Needed
3
Research Sites
236 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this clinical trial is to evaluate TT-10, TT-4 and TT-10 + TT-4, (Dual Blockade) in participants with advanced selected solid tumors, who have failed or are not eligible for standard of care. The main questions it aims to answer are: 1. To evaluate the safety and tolerability of TT-10, TT-4 and TT-10 + TT-4, (Dual Blockade) 2. To determine the maximum tolerated dose or the recommended phase 2 dose of TT-10, TT-4 and TT-10 + TT-4, (Dual Blockade) 3. To obtain a preliminary estimate of efficacy of TT-10, TT-4 and TT-10 + TT-4, (Dual Blockade) in advanced solid tumors.
CONDITIONS
Official Title
TT-10 (PORT-6) and TT-4 (PORT-7) as Single Agents and in Combination in Subjects With Advanced Selected Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must be at least 18 years old
- Able to provide written informed consent before any study procedures
- Diagnosis of advanced selected solid tumors as specified for each cohort, including RCC, CRPC, NSCLC, SCCHN, CRC, endometrial cancer, or ovarian cancer
- For RCC, previously received at least two systemic regimens including VEGF-targeted and checkpoint inhibitor therapy
- For CRPC, previously received a second-generation hormonal agent and taxane-based chemotherapy unless contraindicated
- For SCCHN, incurable advanced or metastatic disease progressed after platinum-based chemotherapy and/or checkpoint inhibitor therapy
- For NSCLC, metastatic disease intolerant or resistant to standard therapy or no standard therapy available
- Measurable disease per RECIST 1.1 or non-measurable metastatic CRPC with PSA ≥ 2.0 ng/mL and sponsor approval
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Failure to respond or not eligible for standard therapies as judged by investigator
- Consent to baseline biopsy or archival tissue if appropriate
- Adequate hematologic function: ANC ≥ 1.5 x 10^9/L, platelets ≥ 100 x 10^9/L, hemoglobin ≥ 9.0 g/dL
- Adequate hepatic function: total bilirubin < 1.5 x ULN (except Gilbert's syndrome), ALT/AST ≤ 2.5 x ULN (≤ 5 x ULN with hepatic metastases)
- Adequate renal function: serum creatinine ≤ 1.5 x ULN or creatinine clearance ≥ 60 mL/min
- For women of childbearing potential, negative pregnancy test and use of effective contraception during study and 120 days after last dose
- Ability to adhere to study schedule and protocols
- Ability to swallow capsules
You will not qualify if you...
- Major surgery within 4 weeks before screening
- Active central nervous system (CNS) metastases (except treated, stable, and off corticosteroids; leptomeningeal metastases excluded)
- Radiotherapy within 2 weeks before study intervention start, with full recovery and no pneumonitis
- Anti-cancer therapy within 4 weeks before study start (2 weeks for short-acting drugs), all toxicities resolved to Grade 0-1
- HIV infection
- Hepatitis B surface antigen positive without antiviral therapy or detectable viral load
- Hepatitis C infection with detectable viral load or incomplete curative therapy
- Need for immunosuppressive therapy including high-dose corticosteroids or systemic steroids (except cortisol replacement)
- Use of strong CYP3A4, 2C9, or 2C19 inhibitors or inducers
- Use of gastric pH modifying drugs such as proton-pump inhibitors or H2 blockers (antacids allowed with timing restrictions)
- Active systemic bacterial, fungal, or viral infections at screening
- Live vaccine administration within 6 weeks of first dose (COVID-19 mRNA vaccines allowed)
- Baseline corrected QT interval > 470 ms (unless bundle branch block present)
- Prior surgery or gastrointestinal conditions affecting drug absorption
- Pregnancy or breastfeeding
- Concurrent active malignancy except certain skin or cervical cancers
- History of interstitial lung disease or related conditions requiring steroids
- Peptic ulcer or gastrointestinal bleeding within 6 months prior to screening
- Recent history (6 months) of stroke, unstable angina, myocardial infarction, or ventricular arrhythmia requiring treatment
- Unstable or severe uncontrolled medical conditions that increase risk for participation
AI-Screening
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Trial Site Locations
Total: 3 locations
1
USC Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
Actively Recruiting
2
Norton Cancer Institute
Louisville, Kentucky, United States, 40241
Actively Recruiting
3
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
D
Desa Rae E Stanton-Pastore, MS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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