Neoplasms

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Carcinoma

Carcinoma, Transitional Cell

Urinary Bladder Neoplasms

Urologic Diseases

Urinary Bladder Diseases

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Male Urogenital Diseases

Transitional Cell Carcinoma

Antineoplastic Agents

All Drugs and Chemicals

Docetaxel

Antibodies

Antibodies, Monoclonal

Immunoglobulins

Tubulin Modulators

Antimitotic Agents

IV infusion of docetaxel, 75 mg/m2, followed by IV infusion of vofatamab, 25 mg/kg, on day one of each 21-day cycle. One additional IV infusion of vofatamab (25 mg/kg) given on Day 8 of Cycle 1.

Dosing with vofatamab and docetaxel will continue in each patient until disease progression, unacceptable toxicity, death, or study exit, including withdrawal of patient consent or study termination. Docetaxel treatment beyond 12 cycles of therapy may be considered at the discretion of the treating investigator and Medical Monitor.

IV infusion of docetaxel, 75 mg/m2, followed by IV infusion of placebo on day one of each 21-day cycle.

One additional IV infusion of placebo given on Day 8 of Cycle 1. Dosing of docetaxel and placebo will continue in each patient until disease progression, unacceptable toxicity, death, or study exit, including withdrawal of patient consent or study termination. Docetaxel treatment beyond 12 cycles of therapy may be considered at the discretion of the treating investigator and Medical Monitor

IV infusion vofatamab, 25 mg/kg on day one each 21-day cycle. One additional IV infusion of vofatamab (25 mg/kg) given on Day 8 of Cycle 1.

Dosing of vofatamab will continue in each patient until disease progression, unacceptable toxicity, death, or study exit, including withdrawal of patient consent or study termination.

Vofatamab

Placebo

Rainier Therapeutics

This is a Phase 1/2(b), sequential, dose escalation, open-label, randomized expansion, multicenter, efficacy and safety study of vofatamab alone or in combination with docetaxel, or versus docetaxel in FGFR3 mutant/fusion subjects with Stage IV, locally advanced or metastatic UCC who have relapsed after, or are refractory to at least one prior line of chemotherapy. This study is divided into 3 phases: Phase 1b (Cohort 1), Phase 2 (Cohorts 2 and 3), and Phase 2b (Monotherapy Expansion Phase and Randomized Phase).

This is a Phase 1/2(b), sequential, dose escalation, open-label, randomized expansion, multicenter, efficacy and safety study of vofatamab alone or in combination with docetaxel, or versus docetaxel in FGFR3 mutant/fusion subjects with Stage IV, locally advanced or metastatic UCC who have relapsed after, or are refractory to at least one prior line of chemotherapy. Vofatamab is a novel monoclonal antibody specific for fibroblast growth factor receptor 3 (FGFR3) that is being developed to target FGFR3-positive tumors.

This study is divided into 3 phases: Phase 1b (Cohort 1), Phase 2 (Cohorts 2 and 3), and Phase 2b (Monotherapy Expansion Phase and Randomized Phase).

Dose Escalation, Expansion Study of Vofatamab (B-701) in Treatment of Locally Advanced or Metastatic Urothelial Cell Carcinoma

A Dose Escalation, Expansion Study of Vofatamab (B-701) Alone, Plus Docetaxel, or Versus Docetaxel in Subjects With Locally Advanced or Metastatic Urothelial Cell Carcinoma Who Have Relapsed After, or Are Refractory to Standard Therapy

Efficacy of vofatamab plus docetaxel, compared with docetaxel plus placebo, and vofatamab alone as measured by PFS; measured from randomization to first occurrence of disease progression (per RECIST v1.1) or death, whichever occurs first. A patient has had to receive at least one vofatamab dose. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.

IV infusion of docetaxel, 75 mg/m2, followed by IV infusion of vofatamab, 25 mg/kg, on day one of each 21-day cycle. One additional IV infusion of vofatamab (25 mg/kg) given on Day 8 of Cycle 1.

Dosing with vofatamab and docetaxel will continue in each patient until disease progression, unacceptable toxicity, death, or study exit, including withdrawal of patient consent or study termination. Docetaxel treatment beyond 12 cycles of therapy may be considered at the discretion of the treating investigator and Medical Monitor.

Vofatamab

Docetaxel

Vofatamab Plus Docetaxel

IV infusion vofatamab, 25 mg/kg on day one each 21-day cycle. One additional IV infusion of vofatamab (25 mg/kg) given on Day 8 of Cycle 1.

Dosing of vofatamab will continue in each patient until disease progression, unacceptable toxicity, death, or study exit, including withdrawal of patient consent or study termination.

Vofatamab

IV infusion of docetaxel, 75 mg/m2, followed by IV infusion of placebo on day one of each 21-day cycle.

One additional IV infusion of placebo given on Day 8 of Cycle 1. Dosing of docetaxel and placebo will continue in each patient until disease progression, unacceptable toxicity, death, or study exit, including withdrawal of patient consent or study termination. Docetaxel treatment beyond 12 cycles of therapy may be considered at the discretion of the treating investigator and Medical Monitor

Docetaxel

Placebo

Placebo Plus Docetaxel

Total

Age, Categorical

Sex: Female, Male

Race (NIH/OMB)

No patients were enrolled in the placebo plus docetaxel group.

Chief Medical Officer

Mut/Fus Phase 1

Wild Type Phase 1

Mut/Fus Phase 2

Mut/Fus Phase 2 Monotherapy

Mut/Fus Phase 2b Monotherapy

Primary Efficacy Outcome: Progression Free Survival (PFS)

Overall Study

Symptoms and General Pathology

Kidney Diseases

Neoplasm Metastasis

Kidney Calculi

Nephrolithiasis

Calculi

Hyperoxaluria

Neoplastic Processes

Pathological Conditions, Anatomical

Urolithiasis

Urinary Calculi

Five (5) capsules of placebo by mouth (PO) three times per day (TID) with meals

Five (5) capsules of ALLN-177 (1,500 units per capsule) PO TID with meals

ALLN-177 7,500 units (5 capsules) PO TID with meals

ALLN-177

Annamaria Kausz, MD MS

Evaluate the safety, tolerability, and efficacy of 28 days of treatment with ALLN-177 for reducing urinary oxalate excretion in patients with secondary hyperoxaluria and kidney stones.

This is a multicenter, randomized, double-blind, placebo controlled study to evaluate the efficacy of ALLN 177 compared with placebo in reducing the urinary excretion of oxalate in subjects with secondary hyperoxaluria and kidney stones. ALLN-177 is an orally administered form of oxalate decarboxylase. The goal of therapy with ALLN-177 is to reduce urinary oxalate excretion by decreasing the absorption of oxalate from the gastrointestinal tract.

Eligible subjects will be randomized to 28 days of treatment with ALLN-177 (7,500 units) or placebo three times daily with meals. Urinary oxalate excretion will be assessed by 24-hr urine collections throughout the study.

The study allows for approximately 66 subjects. The number of enrolled subjects may be increased to a maximum of 100 following an interim analysis.

Evaluate the Effect of ALLN-177 in Reducing Urinary Oxalate in Patients With Secondary Hyperoxaluria and Kidney Stones Over 28 Days

A Phase 2, Multicenter, Randomized, Placebo-controlled, Double-blind Study to Evaluate the Efficacy and Safety of ALLN-177 Treatment Over 28 Days in Patients With Secondary Hyperoxaluria and Kidney Stones

Allena Pharmaceuticals

Test Meal

Annamaria Kausz, MD, MS

Identify individuals with greater absorption of oxalate based on increase in urinary oxalate excretion in response to a controlled oxalate-rich test meal.

This was a prospective 4-day study of oxalate absorption in subjects with secondary hyperoxaluria. Subjects visited the research center three times for outpatient visits (Screening, Test Day 3, Day 4).

Subjects were instructed to follow a low-oxalate diet, consuming only study-specified food choices that had low or no oxalate and controlled calcium content Days 1 through 4 (Baseline Period through the Day 4 clinic visit) and, on Test Day 3, consumed an oxalate-rich test meal.

Subjects performed three 24-hour urine collections during Screening, Baseline Day 2, and Test Day 3. Test Day 3 included the oxalate-rich test meal and the subject collected a 24-hour urine separated into 4 urine collection intervals. (Pre-test meal, post-test meal to 4 hours, 4-6 hours post test meal and remaining time to complete 24 hours).

A Pilot Study of Oxalate Absorption in Secondary Hyperoxaluria

Percent of oxalate absorption normalized by baseline was calculated by 100\*\[UOx/test - UOx/baseline\]/Ox intake from the test meal.

Percent of Oxalate absorption by test interval was calculated as the urinary oxalate excretions (mg) during the test interval divided by the amount of oxalate in the test meal.

Urinary oxalate (UOx) excretion was normalized to units of mg/g creatinine by dividing the UOx in mg by the creatinine value in g from the same collection. Percent change from baseline for UOx/Cr from Baseline was calculated by 100 \* \[UOx/Cr for the test interval - UOx/Cr at Baseline\] / UOx/Cr at Baseline.

Since no investigational product was administered; no drug-related adverse events (AEs) occurred. The investigator assessed AEs by intensity (severity) and causality in relation to the study intervention, which was the study diet. Any untoward symptoms or worsening of medical conditions reported during the study were recorded as AEs.

The Enrolled Set included all subjects who were determined to be eligible for the study after screening assessments and were enrolled in the study.

Enrolled Set

Age, Continuous

BMI (kg/m^2)

Estimated glomerular filtration rate

Hyperoxaluria Classification

Number of Kidney Stone Episodes at Study Entry

Allena Medical Affairs

Enrolled set which included all enrolled subjects

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Dose Escalation, Expansion Study of Vofatamab (B-701) in Treatment of Locally Advanced or Metastatic Urothelial Cell Carcinoma	NCT02401542	Locally Advance... Urinary Bladder... Urological Dise...	Vofatamab Docetaxel Placebo	18 Years -	Rainier Therapeutics
Evaluate the Effect of ALLN-177 in Reducing Urinary Oxalate in Patients With Secondary Hyperoxaluria and Kidney Stones Over 28 Days	NCT02547805	Secondary Hyper... Nephrolithiasis Hyperoxaluria Kidney Stones Dietary Hyperox...	ALLN-177 Placebo	18 Years -	Allena Pharmaceuticals
A Pilot Study of Oxalate Absorption in Secondary Hyperoxaluria	NCT03095885	Secondary Hyper... Nephrolithiasis Hyperoxaluria Kidney Stones	Test Meal	18 Years -	Allena Pharmaceuticals
A Multicentre Study on Features of the Gut Microbiota of Patients With Critical Chronic Diseases in China	NCT05638269	Essential Hyper... Liver Cancer Nasopharyngeal ... Pancreatic Canc... Lung Cancer Chronic Kidney ... Acute Coronary ... Epilepsy Gastric Cancer Primary Aldoste... Subclinical hyp...	no intervention	18 Years - 75 Years	Zhujiang Hospital
A Multicentre Study on Features of the Gut Microbiota of Patients With Critical Chronic Diseases in China	NCT05638269	Essential Hyper... Liver Cancer Nasopharyngeal ... Pancreatic Canc... Lung Cancer Chronic Kidney ... Acute Coronary ... Epilepsy Gastric Cancer Primary Aldoste... Subclinical hyp...	no intervention	18 Years - 75 Years	Zhujiang Hospital

Spots Global Cancer Trial Database for urological diseases