TerminatedPhase 1, PHASE2Results posted

A Study of ALT-801 in Patients With Bacillus Calmette-Guerin (BCG) Failure Non-Muscle Invasive Bladder Cancer

A Phase Ib/II Study of ALT-801 in Patients With Bacillus Calmette-Guerin (BCG) Failure Non-muscle Invasive Bladder Cancer

Lead sponsor

Altor BioScience

Asset

Pemvidutide

Subcutaneous · GLP-1 / glucagon dual

Listed sites

Recruiting sites

Actual enrollment

Study population

Oncology

Eligibility highlights

•EF ≤50%

Primary endpoints

•Safety Profile•Disease Response Rate

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT01625260

Org study IDCA-ALT-801-01-12

Timeline

Milestones

Study start2012-03-30actual

Study first posted2012-06-21estimated

Primary completion2018-03-08actual

Study completion2018-03-08actual

Last update posted2024-07-19actual

Results first posted2024-07-19actual

Assets

Investigational agents

Pemvidutide

Who this study enrolls

Oncology

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersNot accepted

Eligibility criteria

ENTRY CRITERIA:

DISEASE CHARATERISTICS:

•Histologically confirmed high-risk (high grade Ta, T1 or carcinoma in situ, tumor >4 cm or multi-focal) transitional cell carcinoma s/p TURBT with no remaining resectable disease within 4 weeks of study entry

•Intolerant of treatment with BCG or failure (refractory or relapsing) of at least one prior treatment with BCG

•Refuse or intolerant of a radical cystectomy

•No Evidence of regional and/or distant metastasis

PRIOR/CONCURRENT THERAPY:

•No concurrent radiotherapy, other chemotherapy, or other immunotherapy

•No scheduled radiotherapy, chemotherapy, other immunotherapy, or surgery before the scheduled response evaluation

•Must have recovered from side effects of prior treatments

•No concurrent use of other investigational agents

PATIENT CHARACTERISTICS:

Age

• ≥ 18 years

Performance Status

• ECOG 0, 1, or 2

Bone Marrow Reserve

•Absolute neutrophil count (AGC/ANC) ≥ 1,000/uL

•Platelets ≥ 100,000/uL

•Hemoglobin ≥ 8 g/dL

Renal Function

• Glomerular Filtration Rate (GFR) ≥ 50mL/min

Hepatic Function

•Total bilirubin ≤ 2.0 X ULN

•AST, ALT, ALP ≤ 3.0 X ULN

Cardiovascular

•No congestive heart failure < 6 months

•No severe/unstable angina pectoris < 6 months

•No myocardial infarction < 6 months

•No history of ventricular arrhythmias

•No NYHA Class > II CHF

•No uncontrollable supraventricular arrhythmias

•No history of a ventricular arrhythmia

•No other clinical signs of severe cardiac dysfunction

•Normal Transthoracic Echocardiogram (TTE) is required for patients who have history of EKG abnormalities, CHF, coronary artery disease or other cardiac disease, or have history of having received adriamycin or doxorubicin

•No patients with a left ventricular ejection fraction (LVEF) of less than 50%

Pulmonary

• Normal clinical assessment of pulmonary function

Other

•Negative serum pregnancy test if female and of childbearing potential

•Women who are not pregnant or nursing

•Subjects, both females and males, with reproductive potential must agree to use effective contraceptive measures for the duration of the study

•No known autoimmune disease other than corrected hypothyroidism

•No known prior organ allograft or allogeneic transplantation

•Not HIV positive

•No active systemic infection requiring parenteral antibiotic therapy

•No ongoing systemic steroid therapy required

•No history or evidence of uncontrollable CNS disease

•No psychiatric illness/social situation

•No other illness that in the opinion of the investigator would exclude the subject from participating in the study

•Must provide informed consent and HIPAA authorization and agree to comply with all protocol-specified procedures and follow-up evaluations

Endpoints (6)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Other clinical outcomes

Cardiovascular outcomes

Safety / tolerability / PK

Cardiovascular outcomes

1 endpoint

Secondary/protocol endpoint

Overall Survival

Time frame:From start of study treatment to up to 3 years

All-cause death

time to event, event

SNOMED 419620001

Posted result

Group	Median · Months	95% CI
0.06 mg/kg ALT-801 With 1000 mg/m^2 Gemcitabine	NA	7.5 - NA
0.08 mg/kg ALT-801 With 1000 mg/m^2 Gemcitabine	NA	21.2 - NA

Safety / tolerability / PK

1 endpoint

Primary/protocol endpoint

Safety Profile

Time frame:12 weeks

event count, event

Posted result

Group	Number · Number of DLTs	95% CI
0.06 mg/kg ALT-801 With 1000 mg/m^2 Gemcitabine	2	-
0.08 mg/kg ALT-801 With 1000 mg/m^2 Gemcitabine	1	-

Other clinical outcomes

4 endpoints

Primary/protocol endpoint/low confidence

Disease Response Rate

Time frame:From start of study treatment to up to 13 weeks

threshold achievement, improvement

Posted result

Group	Number · percentage of participants	95% CI
0.06 mg/kg ALT-801 With 1000 mg/m^2 Gemcitabine	43	9.9 - 81.6
0.08 mg/kg ALT-801 With 1000 mg/m^2 Gemcitabine	67	9.4 - 99.2

Secondary/protocol endpoint/low confidence

Duration of Response

Time frame:From confirmed complete response to up to 3 years

time to event, event

componentsdisease progression, All-cause death

SNOMED 419620001

Posted result

Group	Median · Months	95% CI
0.06 mg/kg ALT-801 With 1000 mg/m^2 Gemcitabine	NA	5.2 - NA
0.08 mg/kg ALT-801 With 1000 mg/m^2 Gemcitabine	2.1	1.2 - NA

Secondary/protocol endpoint

Progression-free Survival

Time frame:From start of study treatment to up to 3 years

time to event, event

Posted result

Group	Median · Months	95% CI
0.06 mg/kg ALT-801 With 1000 mg/m^2 Gemcitabine	3.4	1.7 - NA
0.08 mg/kg ALT-801 With 1000 mg/m^2 Gemcitabine	2.9	2.7 - NA

Secondary/protocol endpoint

Event-free Survival

Time frame:From start of study treatment to up to 3 years

time to event, event

componentstumor progression, disease recurrence, bladder resection or irradiation, other anti bladder cancer therapy, All-cause death

Posted result

Group	Median · Months	95% CI
0.06 mg/kg ALT-801 With 1000 mg/m^2 Gemcitabine	3.4	1.7 - NA
0.08 mg/kg ALT-801 With 1000 mg/m^2 Gemcitabine	2.9	2.7 - NA

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 6, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 6, 2026 snapshot.