Adults 15 to 80, any sex, with Metastatic Soft Tissue Sarcoma or Locally Advanced Soft Tissue Sarcoma. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Progression-free SurvivalPrimary· 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.
Group
Value
95% CI
Doxorubicin
83
48 – 132
INNO-206
170
92 – 246
Overall SurvivalSecondary· 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.
Group
Value
95% CI
Doxorubicin
434
261 – 627
INNO-206
480
394 – NA
Progression-free Survival at 4 and 6 MonthsSecondary· Month 4 and 6
Percentage of participants at 4 Months (%)
Group
Value
95% CI
Doxorubicin
40.8
24.5 – 56.5
INNO-206
60
47.9 – 70.1
Percentage of participants at 6 Months (%)
Group
Value
95% CI
Doxorubicin
22.9
10.0 – 38.9
INNO-206
45.7
33.7 – 57.0
Objective Overall Response Rate (ORR)Secondary· 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.
Group
Value
95% CI
Doxorubicin
0
0 – 9.3
INNO-206
25
16 – 35.9
Number of Participants With Treatment-related Toxicities (Adverse Events)Secondary· 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.
Group
Value
95% CI
Doxorubicin
29
INNO-206
75
Adverse events — posted to ClinicalTrials.gov
Time frame: All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported. 30 days after last dose, up to 136 days (6 cycles of treatment plus 30 days)..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This is a phase 2b, randomized, open-label, prospective, multicenter study comparing treatment with INNO 206 to doxorubicin in subjects with metastatic, locally advanced, or unresectable soft tissue sarcomas who have not been previously treated with any chemotherapy except potentially as adjuvant or neoadjuvant chemotherapy, and no evidence of tumor recurrence has occurred for at least 12 months.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
NCT01580397 — Pilot Phase 2 Study to Investigate the Preliminary Efficacy and Safety of INNO-206 in Advanced Pancreatic Cancer
· Phase 2
· completed
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by ImmunityBio, Inc.
Last refreshed: 29 May 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01514188.