CompletedPhase 1, PHASE2Results posted

A Study of ALT-801 in Combination With Cisplatin and Gemcitabine in Muscle Invasive or Metastatic Urothelial Cancer

A Phase Ib/II Trial of ALT-801 in Combination With Cisplatin and Gemcitabine in Muscle Invasive or Metastatic Urothelial Cancer

Lead sponsor

Altor BioScience

Asset

Pemvidutide

Subcutaneous · GLP-1 / glucagon dual

Listed sites

Recruiting sites

Actual enrollment

Study population

Oncology

Eligibility highlights

Primary endpoints

•Maximum Tolerated Dose (MTD) and/or the Recommended Dose (RD) for Dose•Treatment-emergent AEs (any)•Objective Response Rate in Treated Patients

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 IDNCT01326871

Org study IDCA-ALT-801-01-10

Timeline

Milestones

Study first posted2011-03-31estimated

Study start2011-09-06actual

Primary completion2016-04-11actual

Study completion2016-04-11actual

Results first posted2024-05-14actual

Last update posted2024-06-25actual

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:

•Muscle invasive or metastatic urothelial cancer of bladder, ureters, renal pelvis, and urethra

•Histologically or cytologically confirmed with a clinical plan that would potentially include cisplatin* plus gemcitabine systemic therapy or with disease refractory to a first-line platinum-based therapy (as defined in the protocol).

* Does not apply to patients screened for Phase II expansion

•Surgically incurable

PRIOR/CONCURRENT THERAPY:

•No concurrent radiotherapy, other chemotherapy, or other immunotherapy

•Must have recovered from side effects of prior treatments

•If prior Proleukin® treatment, must have had a clinical benefit

•No use of other investigational agents within 30 days of start or concurrently

PATIENT CHARACTERISTICS:

Age

•≥ 18 years

Performance Status

•ECOG 0 or 1

Bone Marrow Reserve

•Absolute neutrophil count (AGC/ANC) ≥ 1,500/uL

•Platelets ≥ 100,000/uL

•Hemoglobin ≥ 10g/dL

Renal Function

•Glomerular Filtration Rate (GFR):

-≥ 50mL/min/1.73m^2 for cisplatin-containing regimen

-≥ 40mL/min/1.73m^2 for non-cisplatin-containing regimen

Hepatic Function

•Total bilirubin ≤ 1.5 X ULN

•AST, ALT, ALP ≤ 2.5 X ULN, or ≤ 5.0 X ULN (if liver metastases exists)

•PT INR ≤ 1.5 X ULN

Cardiovascular

•No congestive heart failure < 6 months

•No unstable angina pectoris < 6 months

•No myocardial infarction < 6 months

•No history of ventricular arrhythmias

•No NYHA Class > II CHF

•Normal cardiac stress test required for subjects who are ≥ 50 years old, or have a history of EKG abnormalities, or have symptoms of cardiac ischemia or arrhythmia

•No uncontrolled hypertension

Pulmonary

•Not receiving chronic medication for asthma

•Normal clinical assessment of pulmonary function

Hematologic

•No evidence of bleeding diathesis or coagulopathy

Other

•Negative serum pregnancy test if female and of childbearing potential

•No women who are 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 CNS disease (Controlled brain metastases treated with radiation therapy or surgery where the disease has been clinically stable for a period of a least 3 months before screening is allowed)

•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 (3)

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

Safety / tolerability / PK

Other clinical outcomes

Safety / tolerability / PK

2 endpoints

Primary/protocol endpoint

Maximum Tolerated Dose (MTD) and/or the Recommended Dose (RD) for Dose Expansion of ALT-801 in Combination With Cisplatin and Gemcitabine or ALT-801 in Combination With Gemcitabine Alone

Time frame:8 weeks

descriptive

Posted result

Group	Number · mg/kg Recommended Dose	95% CI
ALT-801: 0.04 mg/kg, 0.06 mg/kg	0.06	-

Primary/protocol endpoint

Number of Participants With Adverse Events

Time frame:8 weeks

Treatment-emergent AEs (any)

event count, event

Posted result

Group	Participants	95% CI
ALT-801 0.04 mg/kg With Cisplatin and Gemcitabine	3	-
ALT-801 0.06 mg/kg With Cisplatin and Gemcitabine	49	-
ALT-801 0.06 mg/kg With Gemcitabine	16	-

Other clinical outcomes

1 endpoint

Primary/protocol endpoint/low confidence

Objective Response Rate in Treated Patients

Time frame:12 weeks

threshold achievement, improvement

Posted result

Group	Number · percentage of participants	95% CI
ALT-801 0.04 mg/kg With Cisplatin and Gemcitabine	100	29 - 100
ALT-801 0.06 mg/kg With Cisplatin and Gemcitabine	47	33 - 62
ALT-801 0.06 mg/kg With Gemcitabine	6	0 - 30

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.