Trial · NCT01514188

Preliminary Efficacy and Safety of INNO-206 Compared to Doxorubicin in Advanced Soft Tissue Sarcoma

NCT01514188, Phase 2, Completed, ImmunityBio, Inc.; results first posted 2024-05-29

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Preliminary Efficacy and Safety of INNO-206 Compared to Doxorubicin in Advanced Soft Tissue Sarcoma. Trials, record NCT01514188. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01514188

On this page

Trial

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

Title: Preliminary Efficacy and Safety of INNO-206 Compared to Doxorubicin in Advanced Soft Tissue Sarcoma
NCT number: NCT01514188
Status: Completed
Phases: Phase 2
Enrollment: 126 participants, actual
Lead sponsor: ImmunityBio, Inc.
Conditions: Metastatic Soft Tissue Sarcoma, Locally Advanced Soft Tissue Sarcoma, Unresectable Soft Tissue Sarcoma
Interventions: INNO-206, Doxorubicin
First posted: 2012-01-23
Last updated: 2024-05-29
Results first posted: 2024-05-29

Source ClinicalTrials.gov

Registered outcomes5

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

List	Outcome	Time frame	Description
Primary	Progression-free Survival	Approximately 24 months	Progression-free survival is defined as the interval from the date of registration (ie, assignment of subject number) to the earliest date of documented evidence of recurrent or progressive disease, or the date of death due to any cause, whichever occurs first. Progressive Disease is defined as: 20% increase in the sum of the longest diameter of target lesions from the smallest sum of the longest diameter recorded since the treatment started; the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of 1 new lesion is also considered progression.
Secondary	Overall Survival	Approximately 35 months	Overall survival was measured from the date of registration (ie, assignment of subject number) to the date of death due to any cause, or the date of last contact.
Secondary	Progression-free Survival at 4 and 6 Months	Month 4 and 6
Secondary	Objective Overall Response Rate (ORR)	Approximately 24 months	Objective Overall Response will be evaluated using the Response Evaluation Criteria In Solid Tumors 1.1 (RECIST 1.1). Changes (i.e., improvements) in tumor measurements from baseline values will be assigned a status of CR or PR. Objective response measurements will comprise the sum of CR plus PR. Complete Response (CR): disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm). Partial Response (PR): 30% decrease in the sum of the longest diameter of target lesions, from the baseline sum longest diameter.
Secondary	Number of Participants With Treatment-related Toxicities (Adverse Events)	30 days after last dose, up to 136 days (6 cycles of treatment plus 30 days)	Treatment will continue every 21 days until tumor progression is observed, 6 cycles of treatment are completed or unacceptable toxicity occurs.

Source ClinicalTrials.gov

Outcomes5

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Progression-free Survival	Approximately 24 months		Days	MEDIAN
SECONDARY	Overall Survival	Approximately 35 months		Days	MEDIAN
SECONDARY	Progression-free Survival at 4 and 6 Months	Month 4 and 6	126 subjects were randomized to the intent to treat population, whereas 123 were in the safety population.~3 subjects were randomized, but not treated.	percentage of participants	NUMBER
SECONDARY	Objective Overall Response Rate (ORR)	Approximately 24 months		Percentage of Subjects	NUMBER
SECONDARY	Number of Participants With Treatment-related Toxicities (Adverse Events)	30 days after last dose, up to 136 days (6 cycles of treatment plus 30 days)		Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group12

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

Outcome	Group	Category	Value	Spread	Units
Progression-free Survival	Doxorubicin		83	95% Confidence Interval 48 to 132	Days
Progression-free Survival	INNO-206		170	95% Confidence Interval 92 to 246	Days
Overall Survival	Doxorubicin		434	95% Confidence Interval 261 to 627	Days
Overall Survival	INNO-206		480	95% Confidence Interval 394 to NA	Days
Progression-free Survival at 4 and 6 Months	Doxorubicin	Percentage of participants at 4 Months (%)	40.8	95% Confidence Interval 24.5 to 56.5	percentage of participants
Progression-free Survival at 4 and 6 Months	INNO-206	Percentage of participants at 4 Months (%)	60	95% Confidence Interval 47.9 to 70.1	percentage of participants
Progression-free Survival at 4 and 6 Months	Doxorubicin	Percentage of participants at 6 Months (%)	22.9	95% Confidence Interval 10.0 to 38.9	percentage of participants
Progression-free Survival at 4 and 6 Months	INNO-206	Percentage of participants at 6 Months (%)	45.7	95% Confidence Interval 33.7 to 57.0	percentage of participants
Objective Overall Response Rate (ORR)	Doxorubicin		0	95% Confidence Interval 0 to 9.3	Percentage of Subjects
Objective Overall Response Rate (ORR)	INNO-206		25	95% Confidence Interval 16 to 35.9	Percentage of Subjects

1 to 10 of 12Source ClinicalTrials.gov

See all 12 results by group

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Doxorubicin	40
Overall Study	STARTED	INNO-206	83
Overall Study	COMPLETED	Doxorubicin	17
Overall Study	COMPLETED	INNO-206	50
Overall Study	NOT COMPLETED	Doxorubicin	23
Overall Study	NOT COMPLETED	INNO-206	33

Source ClinicalTrials.gov

Adverse events136

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
other	Nausea	Gastrointestinal disorders	Doxorubicin	11	40
other	Nausea	Gastrointestinal disorders	INNO-206	38	83
other	Stomatitis	Gastrointestinal disorders	Doxorubicin	5	40
other	Stomatitis	Gastrointestinal disorders	INNO-206	28	83
other	Vomiting	Gastrointestinal disorders	Doxorubicin	7	40
other	Vomiting	Gastrointestinal disorders	INNO-206	19	83
other	Constipation	Gastrointestinal disorders	Doxorubicin	2	40
other	Constipation	Gastrointestinal disorders	INNO-206	12	83
other	Diarrhoea	Gastrointestinal disorders	Doxorubicin	7	40
other	Diarrhoea	Gastrointestinal disorders	INNO-206	7	83

1 to 10 of 136Source ClinicalTrials.gov

See all 136 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Doxorubicin	26	40
Total, all-cause mortality	INNO-206	40	83
Total, other adverse events	Doxorubicin	32	40
Total, other adverse events	INNO-206	79	83
Total, serious adverse events	Doxorubicin	8	40
Total, serious adverse events	INNO-206	33	83

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
26378637	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 comparisons3

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

Comparison	Source
Doxorubicin vs INNO-206: Number of Participants With Treatment-related Toxicities (Adverse Events)	Trial comparisons
Doxorubicin vs INNO-206: deaths from any cause	Trial comparisons
Doxorubicin vs INNO-206: serious adverse events	Trial comparisons

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/NCT01514188

GET https://conductscience.org/api/trials/v1/NCT01514188/events?page=2

API reference For AI assistants