Back to search results

TT-10 and TT-4 for Advanced Solid Tumors

This study is testing two drugs, TT-10 and TT-4, alone and in combination, for people with advanced solid tumors like kidney cancer (Renal Cell Cancer), prostate cancer (Castrate Resistant Prostate Cancer), lung cancer (Non Small Cell Lung Cancer), head and neck cancer (Head and Neck Squamous Cell Carcinoma), and colon cancer (Colorectal Cancer). You might be able to join if standard treatments haven't worked or aren't an option for you. The main goals are to see how safe the drugs are, what side effects they cause, and to find the best dose. Researchers will also look for early signs of how well the treatments work. This study is looking for about 90 participants and is currently unclear about its recruitment status.

Study design
This is an open-label study, meaning you and your doctors will know which treatment you are receiving. It will involve a dose-escalation phase to find the best dose.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Safety will be measured through study completion, which is an average of 1 year.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04969315

TT-10 (PORT-6) and TT-4 (PORT-7) as Single Agents and in Combination in Subjects With Advanced Selected Solid Tumors

Recruiting
PHASE1Ages 18+InterventionalTreatment
Portage Biotech
~90 participants
Updated 2025-04-02 on ClinicalTrials.gov
What's tested:TT-10TT-4

At a glance

Recruiting sites
3 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of subjects with Dose Limiting Toxicities (DLTs) of TT-10, TT-4 and TT-10 + TT-4 during the dose escalation phase
Measured over 28 Days
+2 more outcomes measured

Conditions

Renal Cell Cancer
Castrate Resistant Prostate Cancer
Non Small Cell Lung Cancer
Head and Neck Squamous Cell Carcinoma
Colorectal Cancer (CRC)
Endometrial Cancer
Ovarian Cancer

Explore related trials

Colorectal CarcinomaEndometrial CarcinomaHead and Neck Squamous Cell CarcinomaLung Non-Small Cell CarcinomaMalignant Ovarian NeoplasmProstate CarcinomaRenal Cell CarcinomaSolid Neoplasm

Where it's being run

3 sites across 3 states
California1
Kentucky1
Texas1

Who to contact

Desa Rae E Stanton-Pastore, MS
[email protected]; [email protected]
1585-305-3850
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

ANC ≥ 1.5 x 109/L
Platelet count ≥ 100 x 109/L
Hemoglobin ≥ 9.0 g/dL 9. 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) 10. 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 11. 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 been naturally post-menopausal for at least 12 consecutive months for women \> 55 years of age). WCBP should be placed on effective birth control directly after testing negative for pregnancy; if not, then WCBP should have a UPT on Day 1 of every cycle, prior to study intervention administration. Any positive or indeterminant UPT result must be confirmed by serum.
Known history of HBV infection
As mandated by local health authority 7. 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 enrollment.
Known history of HCV infection
As mandated by local health authority 8. Participants who require immunosuppressive therapy including, but not limited to, treatment with corticosteroids in pharmacologic doses (equivalent to ≥ 10 mg prednisone daily), cyclosporine, mycophenolate, azathioprine, methotrexate, adalimumab, infliximab, vedolizumab, tofacitinib, dupilumab, rituximab, etc. or systemic steroids (except for steroid use as cortisol replacement therapy in documented adrenal insufficiency) 9. Participants requiring administration of drugs known to be strong inhibitors or inducers of CYP3A4, 2C9 or 2C19 10. 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 are recommended to be taken either 4 hours before or 2 hours after dosing of TT 10 (PORT 6) or PORT-7. 11. Ongoing systemic bacterial, fungal or viral infections at Screening

What this trial measures

  • Number of subjects with Dose Limiting Toxicities (DLTs) of TT-10, TT-4 and TT-10 + TT-4 during the dose escalation phase28 Days

    All toxicities will be graded using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0

  • Define the maximum tolerated dose (MTD) or phase 2 recommended dose of TT-10, TT-4 and TT-10 + TT-4 during the dose escalation phaseThrough study completion, an average of 1 year

    To confirm the maximum tolerated dose (MTD) of TT-10, TT-4 and TT-10 + TT-4, defined as the highest dose level at which \<2 out of 6 participants experience a dose-limiting toxicity

  • Expansion cohort primary objective - safetyThrough study completion, an average of 1 year

    Incidence and severity of treatment-related adverse events (TRAEs) in participants treated at the recommended phase 2 dose in the expansion phase