Trial · NCT00496860

Safety and Efficacy Study of ALT-801 to Treat Progressive Metastatic Malignancies

NCT00496860, Phase 1, Completed, Altor BioScience; results first posted 2013-07-15

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Safety and Efficacy Study of ALT-801 to Treat Progressive Metastatic Malignancies. Trials, record NCT00496860. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00496860

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Safety and Efficacy Study of ALT-801 to Treat Progressive Metastatic Malignancies
NCT number: NCT00496860
Status: Completed
Phases: Phase 1
Enrollment: 26 participants, actual
Lead sponsor: Altor BioScience
Conditions: Progressive Metastatic Malignancies
Interventions: ALT-801
First posted: 2007-07-04
Last updated: 2013-07-22
Results first posted: 2013-07-15

Source ClinicalTrials.gov

Registered outcomes5

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	The Safety and Toxicity of ALT-801 in Patients With Progressive Metastatic Malignancies	18 months	Number of serious adverse events per cohort
Primary	The Maximum-tolerated Dose (MTD) of ALT-801	18 months	Number of dose limiting toxicities (DLTs). A DLT is a toxicity that results in patient withdrawal from the study as defined in the protocol.
Secondary	Clinical Antitumor Response to ALT-801	24 months	Number of subjects with a complete response (CR), partial response (PR) or stable disease (SD). CR is defined as disappearance of all tumor lesions selected for measurement. PR is defined as at least 30% decrease in the sum of all tumor lesions selected for measurement. Stable disease is defined as neither sufficient tumor shrinkage to qualify for PR nor sufficient tumor increase to qualify for progressive disease (PD) which is defined as at least 20% increase the sum of the all tumor lesions selected for measurement.
Secondary	ALT-801 Induced Cell-mediated Immune Responses	24 months	Number of tumor-responsive (interferon-gamma positive (IFNg+)) immune cells in blood post dosing
Secondary	Immunogenicity of ALT-801	24 months	Titer of anti-drug Abs at week 4

Source ClinicalTrials.gov

Outcomes5

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Units	Measured as
PRIMARY	The Safety and Toxicity of ALT-801 in Patients With Progressive Metastatic Malignancies	18 months	Events	NUMBER
PRIMARY	The Maximum-tolerated Dose (MTD) of ALT-801	18 months	events	NUMBER
SECONDARY	Clinical Antitumor Response to ALT-801	24 months	participants	NUMBER
SECONDARY	ALT-801 Induced Cell-mediated Immune Responses	24 months	IFNg spots per million PMBCs	MEAN
SECONDARY	Immunogenicity of ALT-801	24 months	titer	MEAN

Source ClinicalTrials.gov

Results by group15

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
The Safety and Toxicity of ALT-801 in Patients With Progressive Metastatic Malignancies	ALT-801 0.015 mg/kg/Dose	0		Events
The Safety and Toxicity of ALT-801 in Patients With Progressive Metastatic Malignancies	ALT-801 0.040 mg/kg/Dose	2		Events
The Safety and Toxicity of ALT-801 in Patients With Progressive Metastatic Malignancies	ALT-801 0.080 mg/kg/Dose	4		Events
The Maximum-tolerated Dose (MTD) of ALT-801	ALT-801 0.015 mg/kg/Dose	0		events
The Maximum-tolerated Dose (MTD) of ALT-801	ALT-801 0.040 mg/kg/Dose	1		events
The Maximum-tolerated Dose (MTD) of ALT-801	ALT-801 0.080 mg/kg/Dose	2		events
Clinical Antitumor Response to ALT-801	ALT-801 0.015 mg/kg/Dose	2		participants
Clinical Antitumor Response to ALT-801	ALT-801 0.040 mg/kg/Dose	5		participants
Clinical Antitumor Response to ALT-801	ALT-801 0.080 mg/kg/Dose	3		participants
ALT-801 Induced Cell-mediated Immune Responses	ALT-801 0.015 mg/kg/Dose	6433	Standard Error 2847	IFNg spots per million PMBCs

1 to 10 of 15Source ClinicalTrials.gov

See all 15 results by group

Participant flow9

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	ALT-801 0.015 mg/kg/Dose	4
Overall Study	STARTED	ALT-801 0.040 mg/kg/ Dose	16
Overall Study	STARTED	ALT-801 0.080 mg/kg/Dose	6
Overall Study	COMPLETED	ALT-801 0.015 mg/kg/Dose	3
Overall Study	COMPLETED	ALT-801 0.040 mg/kg/ Dose	15
Overall Study	COMPLETED	ALT-801 0.080 mg/kg/Dose	6
Overall Study	NOT COMPLETED	ALT-801 0.015 mg/kg/Dose	1
Overall Study	NOT COMPLETED	ALT-801 0.040 mg/kg/ Dose	1
Overall Study	NOT COMPLETED	ALT-801 0.080 mg/kg/Dose	0

Source ClinicalTrials.gov

Adverse events177

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Rhinitis	Immune system disorders	ALT-801 0.015 mg/kg/Dose	1	4	1
other	Rhinitis	Immune system disorders	ALT-801 0.040 mg/kg/Dose	1	16	1
other	Rhinitis	Immune system disorders	ALT-801 0.080 mg/kg/Dose	0	6	0
other	Hemoglobin	Blood and lymphatic system disorders	ALT-801 0.015 mg/kg/Dose	2	4	2
other	Hemoglobin	Blood and lymphatic system disorders	ALT-801 0.040 mg/kg/Dose	12	16	12
other	Hemoglobin	Blood and lymphatic system disorders	ALT-801 0.080 mg/kg/Dose	3	6	3
other	Lymphopenia	Blood and lymphatic system disorders	ALT-801 0.015 mg/kg/Dose	0	4	0
other	Lymphopenia	Blood and lymphatic system disorders	ALT-801 0.040 mg/kg/Dose	7	16	7
other	Lymphopenia	Blood and lymphatic system disorders	ALT-801 0.080 mg/kg/Dose	2	6	2
other	Platelets	Blood and lymphatic system disorders	ALT-801 0.015 mg/kg/Dose	3	4	3

1 to 10 of 177Source ClinicalTrials.gov

See all 177 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	ALT-801 0.015 mg/kg/Dose
Total, all-cause mortality	ALT-801 0.040 mg/kg/Dose
Total, all-cause mortality	ALT-801 0.080 mg/kg/Dose
Total, other adverse events	ALT-801 0.015 mg/kg/Dose	4	4
Total, other adverse events	ALT-801 0.040 mg/kg/Dose	16	16
Total, other adverse events	ALT-801 0.080 mg/kg/Dose	6	6
Total, serious adverse events	ALT-801 0.015 mg/kg/Dose	0	4
Total, serious adverse events	ALT-801 0.040 mg/kg/Dose	2	16
Total, serious adverse events	ALT-801 0.080 mg/kg/Dose	4	6

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
21994418	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00496860

GET https://conductscience.org/api/trials/v1/NCT00496860/events?page=2

API reference For AI assistants