Trial · NCT03058289
A Phase 1/2 Safety Study of Intratumorally Dosed INT230-6
NCT03058289, Phase 1, Phase 2, Completed, Intensity Therapeutics, Inc.; results first posted 2024-08-13
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Phase 1/2 Safety Study of Intratumorally Dosed INT230-6. Trials, record NCT03058289. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03058289
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Phase 1/2 Safety Study of Intratumorally Dosed INT230-6
- NCT number
- NCT03058289
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 111 participants, actual
- Lead sponsor
- Intensity Therapeutics, Inc.
- Conditions
- Breast Cancer, Head and Neck Cancer, Squamous Cell Carcinoma, Lymphoma, Pancreatic Cancer, Liver Cancer, Colon Cancer, Lung Cancer, Bile Duct Cancer, Chordoma of Sacrum, Sarcoma
- Interventions
- INT230-6, anti-PD-1 antibody, anti-CTLA-4 antibody
- First posted
- 2017-02-20
- Last updated
- 2025-02-27
- Results first posted
- 2024-08-13
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Rate and Severity of Treatment-emergent Adverse Events ≥ Grade 3 Attributed to Study Drug Using the NCI Common Terminology Criteria for Adverse Events (CTCAE v.4.03) (Scale 1 to 5) | Up to 5 years | The primary objective is to assess the safety and tolerability of single and multiple intratumoral doses of INT230-6 in subjects with advanced or recurrent malignancies. This will be assessed by the rate of ≥ grade 3 AE's attributed to INT230-6 and not the underlying disease. NCI Common Terminology Criteria for Adverse Events (CTCAE v.4.03) (Scale 1 (least severe) to 5 (most severe)) All recorded adverse events will be listed and tabulated by system organ class, preferred term, and dose and coded according to the most current version of MedDRA. The incidence of adverse events will be tabulated and reviewed for potential significance and clinical importance. Adverse Events will be summarized for all reported data and by study period: a) up to and including 28 days post last dose of initial treatment, and b) from first dose of re-initiation of treatment, for subjects who re-initiate study therapy while in follow-up, up to 28 days post-dose of the last re-treatment dose. |
| Secondary | Preliminary Efficacy: Assess the Preliminary Efficacy of INT230-6 by Measuring the Disease Control Rate (DCR) Based on the Response Evaluation Criteria in Solid Tumors (RECIST) and Immune RECIST (iRECIST) Criteria, | Up to 5 years | Assess the preliminary efficacy of INT230-6 by measuring the disease control rate (CR+PR+SD) as assessed by iRECIST. Complete response (CR) and partial response (PR) will be defined for injected tumors followed per RECIST 1.1 utilizing target lesions. Progressive disease will be determined by clinical or radiological deterioration leading to the subject being taken off-treatment at the discretion of the investigator. Stable disease (SD) is defined as any adequate assessment not considered CR, PR, or progression. |
| Secondary | Determine Pharmacokinetic Parameter Peak Plasma (Cmax in ng/mL) of Each of the 3 Main Components of INT230-6. | T = 1 hour after first dose | Characterize the peak plasma profile for the three INT230-6 components after single and then multiple IT tumor site injections for safety purposes. Timepoints for sample collection were T = 1 Hours after dosing. Mean dose volume categories that were used to summarize data were as follows: 2 mL (range 0 to 3.5 mL) 5 mL (range 3.6 to 6 mL) 10 mL (range \>6 to 12 mL) 17 mL (range \>12 to 24 mL) 30 mL (range \>24 mL to 44 mL) 68 mL (range \>44 to 98 mL) 118 mL (range \>98 to 175 mL) |
| Secondary | Determine Key Pharmacokinetic Parameter, Area Under the Curve (AUC) (ng/mL) of Each of the 3 Main Components of INT230-6. | T= 0, 1, 3, 6, 24 Hours after dosing | Characterize the pharmacokinetic AUC profile of each of the three INT230-6 components for AUC after single IT tumor site injection for safety purposes. Timepoints for sample collection were T = 0, 1, 3, 6, 24 Hours after dosing. Mean dose volume categories that were used to summarize data were as follows: 2 mL (range 0 to 3.5 mL) 5 mL (range 3.6 to 6 mL) 10 mL (range \>6 to 12 mL) 17 mL (range \>12 to 24 mL) 30 mL (range \>24 mL to 44 mL) 68 mL (range \>44 to 98 mL) 118 mL (range \>98 to 175 mL) |
| Secondary | Key Pharmacokinetic Parameters, Half Live (Hours) of Each of the 3 Main Components of INT230-6. | T= 0, 1, 3, 6, 24 hours | Characterize the half life of each of the three INT230-6 components after single and multiple IT tumor site injections for safety purposes. Timepoints for sample collection were T = 0, 1, 3, 6, 24 Hours after dosing. Mean dose volume categories that were used to summarize data were as follows: 2 mL (range 0 to 3.5 mL) 5 mL (range 3.6 to 6 mL) 10 mL (range \>6 to 12 mL) 17 mL (range \>12 to 24 mL) 30 mL (range \>24 mL to 44 mL) 68 mL (range \>44 to 98 mL) 118 mL (range \>98 to 175 mL) |
| Other | Exploratory: Control or Regression of Non Injected Tumors by Measurement of Length (in Centimeters) Radio-graphically Using Computer Tomography or Magnetic Resonance Imaging. | Up to 18 months | Characterize response in non-injected lesions (up to 5) using length (cm) as the key parameter for measurement. |
| Other | Exploratory: Blood, Genetic and Tissue Biomarker Identification From Cell Flow Phenotyping, Tissue Analysis, Genetic SNP Analysis. | Up to 2 months | Evaluate various tumor and anti-tumor immune response biomarkers from blood, tumor tissue that may correlate with tumor response. Flow and tissue panels may include Live-Dead, CD3, CD4, CD8, FoxP3, Ki-67, ICOS, DAPI, PD-1, LAG-3, TIM-3, CTLA-4 and analysis of blood serum cytokine such as Th1/Th2, IFN-γ, IL-1β, IL-2, IL-4, IL-6, IL-8, IL-10, IL-12 p70, IL-13, and TNF-α. |
| Other | Exploratory: Overall Subject Outcome | Up to 3 years | Evaluate overall response by iRECIST including survival |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Rate and Severity of Treatment-emergent Adverse Events ≥ Grade 3 Attributed to Study Drug Using the NCI Common Terminology Criteria for Adverse Events (CTCAE v.4.03) (Scale 1 to 5) | Up to 5 years | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Preliminary Efficacy: Assess the Preliminary Efficacy of INT230-6 by Measuring the Disease Control Rate (DCR) Based on the Response Evaluation Criteria in Solid Tumors (RECIST) and Immune RECIST (iRECIST) Criteria, | Up to 5 years | The cohorts A1/B1/EA/EC/EC2/EC3 were all INT230-6 Monotherapy Treatment and used to evaluate safety. DEC/DEC2 were INT230-6+Pembrolizumab were also used to evaluate safety. Per the Statistical Analysis Plan (SAP) the monotherapy cohorts were combined to evaluate efficacy in relation to total tumor burden (TTB) at doses of \<40%TTB or ≥40%TTB for DCR. Per the SAP the pembrolizumab cohorts were combined to evaluate DCR. | percentage (DCR) | NUMBER |
| SECONDARY | Determine Pharmacokinetic Parameter Peak Plasma (Cmax in ng/mL) of Each of the 3 Main Components of INT230-6. | T = 1 hour after first dose | The pharmacokinetic (PK) analysis aggregated subjects into groups by the dose given per convention according to our SAP and PK plan. Characterization of Patients who received similar doses (2mL, 5mL, 10mL, 18 mL, 30 mL, 68 mL, 118 mL, etc.) from all the cohorts were aggregated per the plan. This methodology of grouping (as described in the PK report produces meaningful API and excipient blood concentration profiles and determines conventional PK parameters for those agents. | ng/mL | MEAN |
| SECONDARY | Determine Key Pharmacokinetic Parameter, Area Under the Curve (AUC) (ng/mL) of Each of the 3 Main Components of INT230-6. | T= 0, 1, 3, 6, 24 Hours after dosing | The pharmacokinetic (PK) analysis aggregated subjects into groups by the dose given per convention according to our SAP and PK plan. Characterization of Patients who received similar doses (2mL, 5mL, 10mL, 18 mL, 30 mL, 68 mL, 118 mL, etc.) from all the cohorts were aggregated per the plan. This methodology of grouping (as described in the PK report produces meaningful API and excipient blood concentration profiles and determines conventional PK parameters for those agents. | ng/mL | MEAN |
| SECONDARY | Key Pharmacokinetic Parameters, Half Live (Hours) of Each of the 3 Main Components of INT230-6. | T= 0, 1, 3, 6, 24 hours | The pharmacokinetic (PK) analysis aggregated subjects into groups by the dose given per convention according to our SAP and PK plan. Characterization of Patients who received similar doses (2mL, 5mL, 10mL, 18 mL, 30 mL, 68 mL, 118 mL, etc.) from all the cohorts were aggregated per the plan. This methodology of grouping (as described in the PK report produces meaningful API and excipient blood concentration profiles and determines conventional PK parameters for those agents. | Hours | MEAN |
| OTHER_PRE_SPECIFIED | Exploratory: Control or Regression of Non Injected Tumors by Measurement of Length (in Centimeters) Radio-graphically Using Computer Tomography or Magnetic Resonance Imaging. | Up to 18 months | |||
| OTHER_PRE_SPECIFIED | Exploratory: Blood, Genetic and Tissue Biomarker Identification From Cell Flow Phenotyping, Tissue Analysis, Genetic SNP Analysis. | Up to 2 months | |||
| OTHER_PRE_SPECIFIED | Exploratory: Overall Subject Outcome | Up to 3 years |
Source ClinicalTrials.gov
Results by group154
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Rate and Severity of Treatment-emergent Adverse Events ≥ Grade 3 Attributed to Study Drug Using the NCI Common Terminology Criteria for Adverse Events (CTCAE v.4.03) (Scale 1 to 5) | Monotherapy: Cohort A1 | 0 | Participants | ||
| Rate and Severity of Treatment-emergent Adverse Events ≥ Grade 3 Attributed to Study Drug Using the NCI Common Terminology Criteria for Adverse Events (CTCAE v.4.03) (Scale 1 to 5) | Monotherapy: Cohort B1 | 0 | Participants | ||
| Rate and Severity of Treatment-emergent Adverse Events ≥ Grade 3 Attributed to Study Drug Using the NCI Common Terminology Criteria for Adverse Events (CTCAE v.4.03) (Scale 1 to 5) | Monotherapy: Cohort EA | 1 | Participants | ||
| Rate and Severity of Treatment-emergent Adverse Events ≥ Grade 3 Attributed to Study Drug Using the NCI Common Terminology Criteria for Adverse Events (CTCAE v.4.03) (Scale 1 to 5) | Monotherapy: Cohort EC | 2 | Participants | ||
| Rate and Severity of Treatment-emergent Adverse Events ≥ Grade 3 Attributed to Study Drug Using the NCI Common Terminology Criteria for Adverse Events (CTCAE v.4.03) (Scale 1 to 5) | Monotherapy: Cohort EC-2 | 4 | Participants | ||
| Rate and Severity of Treatment-emergent Adverse Events ≥ Grade 3 Attributed to Study Drug Using the NCI Common Terminology Criteria for Adverse Events (CTCAE v.4.03) (Scale 1 to 5) | Monotherapy: Cohort EC3 | 0 | Participants | ||
| Rate and Severity of Treatment-emergent Adverse Events ≥ Grade 3 Attributed to Study Drug Using the NCI Common Terminology Criteria for Adverse Events (CTCAE v.4.03) (Scale 1 to 5) | INT 230-6 Combined With Pembrolizumab (Cohort DEC) | 1 | Participants | ||
| Rate and Severity of Treatment-emergent Adverse Events ≥ Grade 3 Attributed to Study Drug Using the NCI Common Terminology Criteria for Adverse Events (CTCAE v.4.03) (Scale 1 to 5) | INT 230-6 Combined With Pembrolizumab (Cohort DEC2) | 6 | Participants | ||
| Rate and Severity of Treatment-emergent Adverse Events ≥ Grade 3 Attributed to Study Drug Using the NCI Common Terminology Criteria for Adverse Events (CTCAE v.4.03) (Scale 1 to 5) | INT 230-6 Combined With Ipilimumab (Cohort FEC) | 2 | Participants | ||
Preliminary Efficacy: Assess the Preliminary Efficacy of INT230-6 by Measuring the Disease Control Rate (DCR) Based on the Response Evaluation Criteria in Solid Tumors (RECIST) and Immune RECIST (iRECIST) Criteria, | Monotherapy (Cohorts A1/B1/EA/EC/EC2/EC3) [Dosed >/= 40%TTB] | 83.3 | percentage (DCR) |
1 to 10 of 154Source ClinicalTrials.gov
See all 154 results by groupParticipant flow27
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Monotherapy: Cohort A1 | 6 | |
| Overall Study | STARTED | Monotherapy: Cohort B1 | 4 | |
| Overall Study | STARTED | Monotherapy: Cohort EA | 4 | |
| Overall Study | STARTED | Monotherapy: Cohort EC | 21 | |
| Overall Study | STARTED | Monotherapy: Cohort EC-2 | 20 | |
| Overall Study | STARTED | Monotherapy: Cohort EC3 | 9 | |
| Overall Study | STARTED | INT 230-6 Combined With Pembrolizumab (Cohort DEC) | 6 | |
| Overall Study | STARTED | INT 230-6 Combined With Pembrolizumab (Cohort DEC2) | 22 | |
| Overall Study | STARTED | INT 230-6 Combined With Ipilimumab (Cohort FEC) | 18 | |
| Overall Study | COMPLETED | Monotherapy: Cohort A1 | 1 |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 participant flowAdverse events783
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 | Wound Infection | Infections and infestations | Monotherapy: (Cohort A1) | 1 | 6 | |
| other | Wound Infection | Infections and infestations | Monotherapy: (Cohort B1) | 0 | 4 | |
| other | Wound Infection | Infections and infestations | Monotherapy: (Cohort E-A) | 0 | 4 | |
| other | Wound Infection | Infections and infestations | Monotherapy: (Cohort E-C) | 0 | 21 | |
| other | Wound Infection | Infections and infestations | Monotherapy: (Cohort EC-2) | 0 | 20 | |
| other | Wound Infection | Infections and infestations | Monotherapy: (Cohort EC3) | 0 | 9 | |
| other | Wound Infection | Infections and infestations | INT230-6 Combined With Pembrolizumab (Cohorts DEC) | 0 | 8 | |
| other | Wound Infection | Infections and infestations | INT230-6 Combined With Pembrolizumab (Cohorts DEC2) | 0 | 22 | |
| other | Wound Infection | Infections and infestations | INT 230-6 Combined With Ipilimumab (Cohort FEC) | 0 | 18 | |
| other | Blister | Skin and subcutaneous tissue disorders | Monotherapy: (Cohort A1) | 1 | 6 |
1 to 10 of 783Source ClinicalTrials.gov
See all 783 adverse eventsAdverse event totals27
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Monotherapy: (Cohort A1) | 0 | 6 |
| Total, all-cause mortality | Monotherapy: (Cohort B1) | 0 | 4 |
| Total, all-cause mortality | Monotherapy: (Cohort E-A) | 0 | 4 |
| Total, all-cause mortality | Monotherapy: (Cohort E-C) | 0 | 21 |
| Total, all-cause mortality | Monotherapy: (Cohort EC-2) | 0 | 20 |
| Total, all-cause mortality | Monotherapy: (Cohort EC3) | 0 | 9 |
| Total, all-cause mortality | INT230-6 Combined With Pembrolizumab (Cohorts DEC) | 0 | 8 |
| Total, all-cause mortality | INT230-6 Combined With Pembrolizumab (Cohorts DEC2) | 0 | 22 |
| Total, all-cause mortality | INT 230-6 Combined With Ipilimumab (Cohort FEC) | 0 | 18 |
| Total, other adverse events | Monotherapy: (Cohort A1) | 4 | 6 |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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.
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.
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Read this trial from software.
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