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New treatment option for Renal Cell Cancer
Official title TT-10 (PORT-6) and TT-4 (PORT-7) as Single Agents and in Combination in Subjects With Advanced Selected Solid Tumors
ClinicalTrials.gov ID: NCT04969315
What this study is testing
What is TT-10?
TT-10 is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for renal cell cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- To be eligible for inclusion in the dose escalation cohorts or expansion cohorts in this study, participants must meet all of the following criteria:
- Participants must be ≥18 years of age.
- Participants or their legal representative must be able to provide written informed consent to participate in the study prior to the performance of...
- Diagnosis of histologically or cytologically confirmed advanced selected solid tumors: Cohort A - TT-10 dose escalation:
- RCC: Participants with locally advanced or metastatic RCC that have previously received at least two prior systemic regimens, including vascular...
You likely can't join if
- are met
- Administration of a live vaccine within 6 weeks of first dose of study intervention. Messenger ribonucleic acid (mRNA) vaccines for the prevention of...
- Baseline QT interval corrected with Fridericia's method (QTcF) \> 470 ms (average of triplicate readings) a. NOTE: Criterion does not apply to...
- Prior surgery or gastrointestinal dysfunction that may affect drug absorption (eg, gastric bypass surgery, gastrectomy)
- Female participants who are pregnant or breastfeeding
- Concurrent active malignancy other than non-melanoma skin cancer, carcinoma in situ of the cervix or prostate intraepithelial neoplasia
See the full eligibility criteria
Who can join
- To be eligible for inclusion in the dose escalation cohorts or expansion cohorts in this study, participants must meet all of the following criteria:
- Participants must be ≥18 years of age.
- Participants or their legal representative must be able to provide written informed consent to participate in the study prior to the performance of any study-specific procedures.
- Diagnosis of histologically or cytologically confirmed advanced selected solid tumors: Cohort A - TT-10 dose escalation:
- RCC: Participants with locally advanced or metastatic RCC that have previously received at least two prior systemic regimens, including vascular endothelial growth factor (VEGF)-targeted therapy and checkpoint inhibitor...
- CRPC: Participants with metastatic CRPC who have previously received a second-generation hormonal agent (unless contraindicated) and a taxane-based chemotherapy.
- SCCHN: Participants with advanced or metastatic SCCHN that is incurable by surgery or radiotherapy and that has progressed during or after a platinum-based chemotherapy and/or checkpoint inhibitor therapy (separately or...
- NSCLC: Participants with metastatic NSCLC that is intolerant or resistant to standard therapy or for which no standard therapy is available Cohort B - TT-4 dose escalation:
- CRC: Participants with metastatic CRC that is intolerant or resistant to standard therapy or for which no standard therapy is available
- CRPC: Participants with metastatic CRPC who have previously received a second-generation hormonal agent (unless contraindicated) and a taxane-based chemotherapy
- NSCLC: Participants with metastatic NSCLC that is intolerant or resistant to standard therapy or for which no standard therapy is available
- Endometrial cancer: Participants with metastatic endometrial cancer that is intolerant or resistant to standard therapy or for which no standard therapy is available
- Ovarian cancer: Participants with metastatic ovarian cancer that is intolerant or resistant to standard therapy or for which no standard therapy is available Cohort C- TT-10 + TT- 4 dose escalation and expansion: a. The...
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) score 0 - 1
- Have measurable disease per RECIST 1.1 as assessed by the local site investigator/radiology. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such...
- Failure to respond to standard therapy, or for whom no appropriate therapies are available (based on the judgment of the investigator)
- Consent to baseline biopsy, with the following exceptions:
- Participants whose only site(s) of disease are in areas considered moderate or high risk may be enrolled without a fresh biopsy with Sponsor approval;
- Archival tissue may be submitted in lieu of a fresh biopsy if collected within 6 months of screening and without intervening systemic therapy.
- Participants must have adequate hematologic function based on the following:
- ANC ≥ 1.5 x 109/L
- Platelet count ≥ 100 x 109/L
- Hemoglobin ≥ 9.0 g/dL
- Participants must have adequate hepatic function based on the following:
- Total bilirubin \< 1.5 x upper limit of normal (ULN) (unless elevated due to Gilbert's syndrome)
- ALT/AST ≤ 2.5 x ULN (≤ 5 x ULN for participants with known hepatic metastases)
- Participants must have adequate renal function based on the following:
- Serum creatinine ≤ 1.5 x ULN; or
- Serum creatinine clearance ≥ 60 mL/min, as determined by Cockcroft-Gault equation
- For women of childbearing potential (WCBP): negative urine pregnancy test (UPT) within 1 week before first treatment (WCBP defined as a sexually mature woman who has not undergone surgical sterilization or who has not...
- Ability to adhere to the study visit schedule and all protocol requirements
- Must be able to swallow capsules Participants will be excluded from the study if they satisfy any of the following criteria at the Screening visit unless otherwise stated: Participants are to be excluded from the study...
- Major surgery within 4 weeks prior to Screening
- Participants with active CNS metastases; however, participants who have undergone radiation and/or surgery for the treatment of CNS metastases, who are neurologically stable and who are no longer taking pharmacologic...
- Has received prior radiotherapy within 2 weeks of start of study intervention. Participants must have recovered from all radiation-related toxicities, not require corticosteroids and not have had radiation pneumonitis...
- Prior anti-cancer therapy within 4 weeks prior to the start of study intervention. A 2 week washout is acceptable for short-acting drugs (eg, tyrosine kinase inhibitors). Any treatment-related toxicities must be...
- Human immunodeficiency virus (HIV)-infected participants
- Participants who are hepatitis B surface antigen positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV viral load prior to enrollment. Note...
- Known history of HBV infection
- As mandated by local health authority
- Participants with a history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at Screening. Note: Participants must have completed curative antiviral therapy at least 4 weeks prior to...
- Known history of HCV infection
- As mandated by local health authority
- Participants who require immunosuppressive therapy including, but not limited to, treatment with corticosteroids in pharmacologic doses (equivalent to ≥ 10 mg prednisone daily), cyclosporine, mycophenolate...
- Participants requiring administration of drugs known to be strong inhibitors or inducers of CYP3A4, 2C9 or 2C19
- Participants requiring drugs that modify gastric pH, such as proton-pump inhibitors (PPIs) or H2 blockers. Antacids, such as calcium carbonate or aluminum hydroxide-based products, will be allowed during the study, but...
- Ongoing systemic bacterial, fungal or viral infections at Screening a. NOTE: Participants on antimicrobial, antifungal or antiviral prophylaxis are not specifically excluded if all other inclusion/
What rules you out
- are met
- Administration of a live vaccine within 6 weeks of first dose of study intervention. Messenger ribonucleic acid (mRNA) vaccines for the prevention of Coronavirus Disease 2019 (COVID-19) infection are permitted.
- Baseline QT interval corrected with Fridericia's method (QTcF) \> 470 ms (average of triplicate readings) a. NOTE: Criterion does not apply to participants with a right or left bundle branch block.
- Prior surgery or gastrointestinal dysfunction that may affect drug absorption (eg, gastric bypass surgery, gastrectomy)
- Female participants who are pregnant or breastfeeding
- Concurrent active malignancy other than non-melanoma skin cancer, carcinoma in situ of the cervix or prostate intraepithelial neoplasia
- Past medical history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis which required steroid treatment, or any evidence of clinically active interstitial lung disease
- History of peptic ulcer and/or gastrointestinal bleed within the past 6 months prior to Screening
- History of stroke, unstable angina, myocardial infarction or ventricular arrhythmia requiring medication or mechanical control within the last 6 months prior to Screening
- Unstable or severe uncontrolled medical condition (eg, unstable cardiac function, unstable pulmonary condition including pneumonitis and/or interstitial lung disease, uncontrolled diabetes) or any important medical...
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
- Louisville, Kentucky, United States
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States; Louisville, Kentucky, United States; Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.