A Phase 1/2 interventional study of TSD-001 in Bladder Cancer Cell Transitional, Non-Muscle Invasive Bladder Cancer and Bladder Cancer, sponsored by Lipac Oncology LLC. Completed at 5 sites in United States. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2025-06-27.
Sponsored by Lipac Oncology LLC · Phase 1/2, Interventional, and Treatment
This is a single-arm, phase 1/2a study of formulated paclitaxel in subjects with low-grade, noninvasive papillary carcinoma (stage Ta) of the bladder.
Part 1 of the study will enroll 6 subjects (3 per cohort) with low-grade, stage Ta transitional cell carcinoma (TCC) of the bladder who will receive escalating doses of paclitaxel formulated as TSD-001 every 2 weeks for 6 treatments until Dose Limiting Toxicity (or until the Maximum Deliverable Dose) is observed (Maximum Tolerated Dose established).
Part 2 of the study will enroll an additional 10 subjects with low-grade, stage Ta (uni-or multifocal) TCC of the bladder who will receive weekly TSD-001 for 6 weeks at the highest nontoxic dose (i.e., MTD) established in part 1 of the study. May meet definition of low grade without histological tissue diagnosis if on cystoscopic assessment they have a solitary papillary tumor.
Part 3 of the study will continue to track subjects enrolled in Parts 1 and 2 to determine rates of disease-free survival.
294 studies on the registry are indexed under Non-Muscle Invasive Bladder Neoplasms; 126 are open to participants now.
This study's enrollment of 15 is below the median of 62 across 231 interventional studies indexed under Non-Muscle Invasive Bladder Neoplasms.
Browse Non-Muscle Invasive Bladder Neoplasms studies →This is the only study on the registry with Lipac Oncology LLC as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Reproductive potential
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Part 1, Cohort 1: For the first 3 subjects enrolled, the initial dose will be 10 mg in Sterile Water for Injection (SWFI). TSD-001 will be retained in the bladder for 2 hours (1 hour or more will be acceptable, depending on subject's tolerability of the procedure). If Dose Limiting Toxicity(DLT) does not develop, intravesical instillation 14 days later will be titrated up according to the schedule (25, 50, 75, 100, 150 mg in SWFI) until DLT (defined as any grade 3 or 4 toxicity or prolonged \[greater than 14 days\] grade 2 toxicity) is observed.
Drug: TSD-001
Part 1, Cohort 1: For the next 3 subjects enrolled, the initial dose will be 90 mg in SWFI. TSD-001 will be retained in the bladder for 2 hours (1 hour or more will be acceptable, depending on subject's tolerability of the procedure). If DLT does not develop, intravesical instillation 14 days later will be titrated up according to the schedule (180, 270, 360, 450, and 540 mg in SWFI) until DLT (defined as any grade 3 or 4 toxicity or prolonged \[greater than 14 days\] grade 2 toxicity) is observed. If no DLT is observed in the first 6 subjects (cohorts 1 and 2) after titration up to 540 mg, then the maximum deliverable dose (MDD) will be defined and dose recommended for part 2 of the study.
Drug: TSD-001
In part 2, the dose will be selected as the MTD/MDD, established in part 1 and provided weekly via the intravesical route. During part 2, up to 10 additional subjects will receive intravesical instillations of TSD-001 via urethral catheterization of the urinary bladder at the MTD/MDD established in part 1 at weekly intervals for 6 consecutive weeks. TSD-001 will be retained in the bladder for 2 hours (1 hour or more will be acceptable, depending on subject's tolerability of the procedure).
Drug: TSD-001
Administered via intravesical instillation.
Also known as: Proliposomal Intravesical Paclitaxel
Part 1: Maximum Tolerated Dose or Maximum Deliverable Dose (MDD)
Dose immediately preceding the dose at which DLT occurs or when a MDD is reached.
Time frame: 12 weeks
Part 2: Marker Lesion Response Rate
Determine the marker lesion response rate at final assessment visit for subjects that received the MDD established in part 1.
Time frame: 12 weeks (Cohort 1) or 15 weeks (Cohort 2)
Part 1: Determine Paclitaxel Concentrations
Determine the local (bladder urine) and systemic (peripheral blood) paclitaxel concentrations before and after intravesical exposure to TSD-001 at all doses. Blood and urine samples were collected 15 (± 15) minutes before and 2 hours (± 10 minutes) after each instillation. Results are presented for different dose levels administered during dose escalation. The remaining results are grouped by cohort.
Time frame: 10 weeks
Part 2: Determine Paclitaxel Concentrations
Determine the systemic (peripheral blood) paclitaxel concentrations 15 (± 15) minutes before, and 2 hours (± 10 minutes) after the third intravesical instillation (Week 2) of TSD-001.
Time frame: Week 2 (pre and post dose)
Part 3: Rates of Recurrence/Disease-Free Survival in Part 1 Subjects Only at 12 and 24 Months
Long-term follow-up to determine when histological tissue diagnosis evidence of recurrence occurs for subjects after complete TURBT and exposure to TSD-001 in part 1. Cystoscopic surveillance was performed every 3 months from the last endoscopic assessment in part 1 until 24 months (from initial TURBT and instillation). Part 2 subjects, different than part 1 subjects, were followed for marker lesion response and did not have standardized TURBT timing to use as a baseline and so are not included in these reported RFS rates. Recurrence-free survival is no histological evidence of transitional cell carcinoma (TCC) recurrence in the time outlined for the TCC risk level.
Time frame: 2 years
| Milestone | TSD-001 Administration Part 1, Cohort 1 | TSD-001 Administration Part 1, Cohort 2 | TSD-001 Administration Part 2, Cohort 1 | TSD-001 Administration Part 2, Cohort 2 |
|---|---|---|---|---|
| Started | 3 | 3 | 6 | 3 |
| Completed | 1 | 3 | 6 | 3 |
| Not completed | 2 | 0 | 0 | 0 |
| Withdrew: Sponsor discontinuation - ip issue for investigation (bacterial endotoxin level) | 2 | 0 | 0 | 0 |
Dose immediately preceding the dose at which DLT occurs or when a MDD is reached.
| mg | TSD-001 Administration Part 1, Cohort 1 | TSD-001 Administration Part 1, Cohort 2 |
|---|---|---|
| Part 1: Maximum Tolerated Dose or Maximum Deliverable Dose (MDD) | NA | 360 |
Determine the marker lesion response rate at final assessment visit for subjects that received the MDD established in part 1.
| Participants | TSD-001 Administration Part 2, Cohort 1 | TSD Administration Part 2, Cohort 2 |
|---|---|---|
| Complete Response | 0 | 1 |
| Partial Response | 3 | 1 |
| Marker Lesion Response | 3 | 2 |
Determine the local (bladder urine) and systemic (peripheral blood) paclitaxel concentrations before and after intravesical exposure to TSD-001 at all doses. Blood and urine samples were collected 15 (± 15) minutes before and 2 hours (± 10 minutes) after each instillation. Results are presented for different dose levels administered during dose escalation. The remaining results are grouped by cohort.
| ug/L | TSD-001 Administration Part 1, Cohort 1: Day 1: 10 mg | TSD-001 Administration Part 1, Cohort 1: Week 2: 25 mg | TSD-001 Administration Part 1, Cohort 1: Week 4: 50 mg | TSD-001 Administration Part 1, Cohort 1: Week 6: 75 mg | TSD-001 Administration Part 1, Cohort 1: Week 8: 100 mg | TSD-001 Administration Part 1, Cohort 1: Week 10: 150 mg | TSD-001 Administration Part 1, Cohort 2: Day 1: 90 mg | TSD-001 Administration Part 1, Cohort 2: Week 2: 180 mg | TSD-001 Administration Part 1, Cohort 2: Week 4: 270 mg | TSD-001 Administration Part 1, Cohort 2: Week 6: 360 mg | TSD-001 Administration Part 1, Cohort 2: Week 8: 450 mg | TSD-001 Administration Part 1, Cohort 2: Week 10: 540 mg |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Predose Urine - Paclitaxel Concentration in Urine collected 15 minutes before | 0 ± 0 | 0 ± 0 | 0 ± 0 | 0 ± 0 | 0 ± 0 | 0 | 0 ± 0 | .8 ± 1.4 | 0 ± 0 | 0 ± 0 | 0 ± 0 | 0 ± 0 |
| Postdose Urine - Paclitaxel Concentration in Urine collected 2 hrs post | 19367 ± 4341 | 72933 ± 50497 | 189667 ± 73433 | 287333 ± 134016 | 436000 | 446000 | 241000 ± 35539 | 699000 ± 272567 | 686667 ± 167861 | 1161667 ± 760795 | 1800000 ± 606300 | 1886333 ± 1317354 |
| Predose Plasma - Paclitaxel Concentration in Plasma collected 15 minutes before | 0 ± 0 | 0 ± 0 | 0 ± 0 | 0 ± 0 | 0 | 0 | 0 ± 0 | 0 ± 0 | 0 ± 0 | 0 ± 0 | 0 ± 0 | 0 ± 0 |
| Postdose Plasma - Paclitaxel Concentration in Plasma collected 2 hrs post | 0 ± 0 | 0 ± 0 | 0 ± 0 | 0 ± 0 | 0 | 0 | 0 ± 0 | 0 ± 0 | 0 ± 0 | 0 ± 0 | 0 ± 0 | 0 ± 0 |
Determine the systemic (peripheral blood) paclitaxel concentrations 15 (± 15) minutes before, and 2 hours (± 10 minutes) after the third intravesical instillation (Week 2) of TSD-001.
| ug/L | TSD-001 Administration Part 2, Cohort 1 | TSD-001 Administration Part 2, Cohort 2 |
|---|---|---|
| Predose | 0 ± 0 | 0 ± 0 |
| Postdose | 0 ± 0 | 0 ± 0 |
Long-term follow-up to determine when histological tissue diagnosis evidence of recurrence occurs for subjects after complete TURBT and exposure to TSD-001 in part 1. Cystoscopic surveillance was performed every 3 months from the last endoscopic assessment in part 1 until 24 months (from initial TURBT and instillation). Part 2 subjects, different than part 1 subjects, were followed for marker lesion response and did not have standardized TURBT timing to use as a baseline and so are not included in these reported RFS rates. Recurrence-free survival is no histological evidence of transitional cell carcinoma (TCC) recurrence in the time outlined for the TCC risk level.
| Participants | TSD-001 Administration Part 1, Cohort 1: Long-term Follow-up (Part 3) | TSD-001 Administration Part 1, Cohort 2: Long-term Follow-up (Part 3) |
|---|---|---|
| One Year — Disease-Free | 3 | 2 |
| One Year — Recurrence Occurred | 0 | 1 |
| Two Year — Disease-Free | 3 | 2 |
| Two Year — Recurrence Occurred | 0 | 1 |
Collected over For Part 1 patients, the time period for adverse event collection was 16 weeks after the first treatment. For Part 2 patients, the time period for adverse event collection was 13 Weeks after the first treatment. During part 3, AEs continued from part 1 or part 2 will be followed until resolution, stabilization, or end of study, but no new AEs will be recorded (excepts SAEs). So, the total time frame was 2 years from the first treatment.. Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| TSD-001 Administration Part 1, Cohort 1 | 0/3 (0%) | 0/3 (0%) | 3/3 (100%) |
| TSD-001 Administration Part 1, Cohort 2 | 0/3 (0%) | 0/3 (0%) | 2/3 (66.7%) |
| TSD-001 Administration Part 2, Cohort 1 | 0/6 (0%) | 0/6 (0%) | 6/6 (100%) |
| TSD-001 Administration Part 2, Cohort 2 | 0/3 (0%) | 1/3 (33.3%) | 2/3 (66.7%) |
| TD-001 Part 3 (Long-term Surveillance) | 0/10 (0%) | 1/10 (10%) | 1/10 (10%) |
| Event | TSD-001 Administration Part 1, Cohort 1 | TSD-001 Administration Part 1, Cohort 2 | TSD-001 Administration Part 2, Cohort 1 | TSD-001 Administration Part 2, Cohort 2 | TD-001 Part 3 (Long-term Surveillance) |
|---|---|---|---|---|---|
| acute pyelonephritisInfections and infestations | 0/3 | 0/3 | 0/6 | 1/3 | 0/10 |
| Extraperitoneal Bladder abscessRenal and urinary disorders | 0/3 | 0/3 | 0/6 | 0/3 | 1/10 |
| Event | TSD-001 Administration Part 1, Cohort 1 | TSD-001 Administration Part 1, Cohort 2 | TSD-001 Administration Part 2, Cohort 1 | TSD-001 Administration Part 2, Cohort 2 | TD-001 Part 3 (Long-term Surveillance) |
|---|---|---|---|---|---|
| NauseaGastrointestinal disorders | 0/3 | 0/3 | 4/6 | 0/3 | 0/10 |
| FatigueGeneral disorders | 0/3 | 1/3 | 3/6 | 1/3 | 0/10 |
| Urinary tract infectionInfections and infestations | 1/3 | 0/3 | 3/6 | 1/3 | 0/10 |
| ConstipationGastrointestinal disorders | 1/3 | 0/3 | 0/6 | 0/3 | 1/10 |
| DyspepsiaGastrointestinal disorders | 0/3 | 0/3 | 0/6 | 1/3 | 0/10 |
| Herpes zosterInfections and infestations | 0/3 | 0/3 | 0/6 | 1/3 | 0/10 |
| Pyelonephritis acuteInfections and infestations | 0/3 | 0/3 | 0/6 | 1/3 | 0/10 |
| Upper respiratory tract infectionInfections and infestations | 0/3 | 0/3 | 2/6 | 0/3 | 0/10 |
| Post procedural haematuriaInjury, poisoning and procedural complications | 0/3 | 1/3 | 0/6 | 0/3 | 0/10 |
| Blood urine presentInvestigations | 0/3 | 0/3 | 0/6 | 1/3 | 0/10 |
| Age, Continuous(years) | TSD-001 Administration Part 1, Cohort 1 | TSD-001 Administration Part 1, Cohort 2 | TSD-001 Administration Part 2, Cohort 1 | TSD Administration Part 2, Cohort 2 | Total |
|---|---|---|---|---|---|
| Mean | 75.33 ± 8.96 | 71.67 ± 5.51 | 57.50 ± 16.99 | 64.33 ± 17.79 | 65.27 ± 14.85 |
| Sex: Female, Male(Participants) | TSD-001 Administration Part 1, Cohort 1 | TSD-001 Administration Part 1, Cohort 2 | TSD-001 Administration Part 2, Cohort 1 | TSD Administration Part 2, Cohort 2 | Total |
|---|---|---|---|---|---|
| Female | 0 | 1 | 4 | 0 | 5 |
| Male | 3 | 2 | 2 | 3 | 10 |
| Race/Ethnicity, Customized(Participants) | TSD-001 Administration Part 1, Cohort 1 | TSD-001 Administration Part 1, Cohort 2 | TSD-001 Administration Part 2, Cohort 1 | TSD Administration Part 2, Cohort 2 | Total |
|---|---|---|---|---|---|
| Race/Ethnicity — White/ Not Hispanic or Latino | 3 | 2 | 4 | 3 | 12 |
| Race/Ethnicity — Asian/ Not Hispanic or Latino | 0 | 1 | 0 | 0 | 1 |
| Race/Ethnicity — White/ Hispanic or Latino | 0 | 0 | 2 | 0 | 2 |
| Region of Enrollment(participants) | TSD-001 Administration Part 1, Cohort 1 | TSD-001 Administration Part 1, Cohort 2 | TSD-001 Administration Part 2, Cohort 1 | TSD Administration Part 2, Cohort 2 | Total |
|---|---|---|---|---|---|
| United States | 3 | 3 | 6 | 3 | 15 |
| Non-Muscle Invasive Bladder Cancer Recurrent(Participants) | TSD-001 Administration Part 1, Cohort 1 | TSD-001 Administration Part 1, Cohort 2 | TSD-001 Administration Part 2, Cohort 1 | TSD Administration Part 2, Cohort 2 | Total |
|---|---|---|---|---|---|
| Yes | 1 | 2 | 6 | 3 | 12 |
| No | 2 | 1 | 0 | 0 | 3 |
| Number of Tumor Locations(Participants) | TSD-001 Administration Part 1, Cohort 1 | TSD-001 Administration Part 1, Cohort 2 | TSD-001 Administration Part 2, Cohort 1 | TSD Administration Part 2, Cohort 2 | Total |
|---|---|---|---|---|---|
| Solitary | 2 | 1 | 2 | 0 | 5 |
| Multifocal | 1 | 2 | 4 | 3 | 10 |
| Previous Intravesical Therapy(Participants) | TSD-001 Administration Part 1, Cohort 1 | TSD-001 Administration Part 1, Cohort 2 | TSD-001 Administration Part 2, Cohort 1 | TSD Administration Part 2, Cohort 2 | Total |
|---|---|---|---|---|---|
| Yes | 1 | 0 | 3 | 2 | 6 |
| No | 2 | 3 | 3 | 1 | 9 |
| European Association of Urology (EAU) Risk Stratification(Participants) | TSD-001 Administration Part 1, Cohort 1 | TSD-001 Administration Part 1, Cohort 2 | TSD-001 Administration Part 2, Cohort 1 | TSD Administration Part 2, Cohort 2 | Total |
|---|---|---|---|---|---|
| Low Risk | 2 | 0 | 0 | 0 | 2 |
| Intermediate Risk | 1 | 3 | 6 | 3 | 13 |
PDFs hosted by the registry, ClinicalTrials.gov.
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Non-Muscle Invasive Bladder Neoplasms →