Metastatic Castration-resistant Prostate CancerPhase 1NCT07423117
A Study of ITC-6146RO in Patients With Advanced or Metastatic Cancer Who Have Failed Standard Therapy
A Phase 1 study testing ITC-6146RO in people with Metastatic Castration-resistant Prostate Cancer and Non-small Cell Lung Cancer, run by IntoCell, Inc at 3 sites in South Korea.
Trial summary
The study consists of Phase 1a (dose escalation) and Phase 1b (dose expansion). In Phase 1a, sequential cohorts of subjects will receive escalating doses of ITC-6146RO to determine maximum tolerated dose (MTD) and/or optimal biological dose (OBD). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Castration-resistant Prostate Cancer, Non-small Cell Lung Cancer, Triple Negative Breast Cancer
- What is being tested?
- ITC-6146RO
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 3 sitesSouth Korea
- Study dates
- 24 Mar 2026to 31 Dec 2029
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult males and females aged ≥ 19 years (Korea) or ≥ 18 years (United States)
- Patients must be individuals who have voluntarily agreed to participate in the study after receiving a detailed explanation and fully understanding the nature of the clinical trial, and who have provided written informed consent.
- Pathological confirmation of malignancy and evidence of metastatic or surgically unresectable disease
- Patients must have at least one evaluable or measurable lesion based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST version 1.1). However, for patients with prostate cancer, eligibility will be determined based on Prostate Cancer Working Group 3 (PCWG3)
- Patients who have received standard therapies and have no remaining clinically available approved treatment options.
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Estimated life expectancy of ≥ 3 months
Who cannot join
- Inability to comply with study and follow-up procedures
- Patients with a prior history of anticancer therapy before the first dose
- History of another active malignancy within the past 3 years
- Patients with central nervous system metastases, leptomeningeal disease, or spinal cord compression.
- Patients who are currently participating in a clinical trial or have participated in a clinical trial involving a medical device or investigational product within 28 days prior to the first administration of ITC-6146RO
- Has prior treatment with duocarmycin-containing agents
Show all 13Show fewer
- Pregnancy, lactation, or breastfeeding
- Known Human immunodeficiency virus (HIV), Hepatitis C virus (HCV) and Hepatitis B virus (HBV) infection with active disease exception of the following conditions.
- Tuberculosis with active disease
- Active infection necessitating systemic therapy
- Prior allogenic bone marrow transplantation or solid organ transplantation
- History of autoimmune disease, treatment with systemic immunosuppressive medications
- Patients with clinically significant pulmonary disease
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea3 sites
Severance Hospital
Seoul, Seoul, 03722
Asan Medical Center
Seoul, Seoul, 05505
Samsung Medical Center
Seoul, Seoul, 06351
About this study
Official title: A Phase 1a/b, Open-label, Multicenter, First-in-human, Dose Escalation/Expansion Study With Multiple Cohorts to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumor Efficacy of ITC-6146RO in Patients With Advanced or Metastatic Cancer Who Have Failed Standard Therapy
The study consists of Phase 1a (dose escalation) and Phase 1b (dose expansion). In Phase 1a, sequential cohorts of subjects will receive escalating doses of ITC-6146RO to determine maximum tolerated dose (MTD) and/or optimal biological dose (OBD).
In Phase 1b, the recommended phase 2 dose (RP2D) chosen from Phase 1a will be evaluated to further investigate safety, tolerability, pharmacokinetic (PK) and anti-tumor efficacy of ITC-6146RO.
- Conditions
- Metastatic Castration-resistant Prostate Cancer, Non-small Cell Lung Cancer, Triple Negative Breast Cancer, Metastatic Solid Tumor
- Being tested
- ITC-6146RO
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Triple Negative Breast Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ITC-6146RODrug
ITC-6146RO will be administered as an intravenous (IV) infusion at protocol-specified dose levels and schedules in Phase 1a (dose escalation) and Phase 1b (dose expansion).
| Study group | Role | What they receive |
|---|---|---|
| Phase 1a/b | Experimental | The study consists of a Phase 1a dose-escalation part and a Phase 1b dose-expansion part. Receives: Drug: ITC-6146RO |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase 1a (Dose Escalation) Incidence of Adverse Events (AEs)
Grade 3 and 4 AEs, Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Dose-limiting toxicities (DLTs) and AEs leading to discontinuation of study treatment, Evaluation of all-grade cardiac, renal, and pulmonary AEs , n, (%)
Measured: Through study completion (Up to 2 years)
Phase 1b (Dose Expansion) Incidence of AEs
Grade 3 and 4 AEs, TEAEs, SAEs and AEs leading to discontinuation of study treatment, Evaluation of all-grade cardiac, renal, and pulmonary AEs, n, %
Measured: Through study completion (Up to 2 years)
Secondary outcomes (25)
Phase 1a (Dose Escalation) Maximum Tolerated Dose (MTD) or Optimal Biological Dose (OBD) of ITC-6146RO
MTD/OBD will be reported as the final selected dose level for further investigation from Phase 1a dose escalation. MTD is determined by DLTs observed during the prespecified DLT observation period, and OBD is determined by meeting prespecified biological activity criteria (as defined in the protocol).
Measured: Through study completion (Up to 2 years)
Phase 1a (Dose Escalation) Area Under the Plasma Concentration-Time Curve From Time 0 to the Last Quantifiable Concentration (AUClast) After Single-Dose Administration of ITC-6146RO
Plasma AUClast following a single dose of ITC-6146RO will be calculated from plasma concentration-time data and summarized descriptively.
Measured: Through study completion (Up to 2 years)
Phase 1a (Dose Escalation) Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity (AUCinf) After Single-Dose Administration of ITC-6146RO
Plasma AUCinf following a single dose of ITC-6146RO will be calculated from plasma concentration-time data and summarized descriptively.
Measured: Through study completion (Up to 2 years)
Phase 1a (Dose Escalation) Maximum Observed Plasma Concentration (Cmax) After Single-Dose Administration of ITC-6146RO
Plasma Cmax following a single dose of ITC-6146RO will be calculated from plasma concentration-time data and summarized descriptively.
Measured: Through study completion (Up to 2 years)
Phase 1a (Dose Escalation) Terminal Elimination Half-life (t1/2) After Single-Dose Administration of ITC-6146RO
Plasma terminal elimination half-life (t1/2) following a single dose of ITC-6146RO will be calculated from plasma concentration-time data and summarized descriptively.
Measured: Through study completion (Up to 2 years)
Phase 1a (Dose Escalation) Time to Maximum Observed Plasma Concentration (Tmax) After Single-Dose Administration of ITC-6146RO
Plasma Tmax following a single dose of ITC-6146RO will be calculated from plasma concentration-time data and summarized descriptively.
Measured: Through study completion (Up to 2 years)
Phase 1a (Dose Escalation) Apparent Clearance (CL) After Single-Dose Administration of ITC-6146RO
Plasma apparent clearance (CL) following a single dose of ITC-6146RO will be calculated from plasma concentration-time data and summarized descriptively.
Measured: Through study completion (Up to 2 years)
Phase 1a (Dose Escalation) Apparent Volume of Distribution (Vz) After Single-Dose Administration of ITC-6146RO
Plasma apparent volume of distribution (Vz) following a single dose of ITC-6146RO will be calculated from plasma concentration-time data and summarized descriptively.
Measured: Through study completion (Up to 2 years)
Phase 1a (Dose Escalation) Area Under the Plasma Concentration-Time Curve From Time 0 to the Last Quantifiable Concentration (AUClast) After Multiple-Dose Administration of ITC-6146RO
Plasma AUClast following multiple-dose administration of ITC-6146RO will be calculated from plasma concentration-time data and summarized descriptively.
Measured: Through study completion (Up to 2 years)
Phase 1a (Dose Escalation) Maximum Observed Plasma Concentration at Steady State (Cmax,ss) After Multiple-Dose Administration of ITC-6146RO
Plasma Cmax,ss (as applicable) following multiple-dose administration of ITC-6146RO will be calculated from plasma concentration-time data and summarized descriptively.
Measured: Through study completion (Up to 2 years)
Phase 1a (Dose Escalation) Trough Plasma Concentration at Steady State (Ctrough,ss) After Multiple-Dose Administration of ITC-6146RO
Plasma Ctrough,ss (as applicable) following multiple-dose administration of ITC-6146RO will be calculated from plasma concentration-time data and summarized descriptively.
Measured: Through study completion (Up to 2 years)
Phase 1a (Dose Escalation) Average Plasma Concentration Over the Dosing Interval at Steady State (Cav,τ) After Multiple-Dose Administration of ITC-6146RO
Plasma Cav,τ (as applicable) following multiple-dose administration of ITC-6146RO will be calculated from plasma concentration-time data and summarized descriptively.
Measured: Through study completion (Up to 2 years)
Phase 1a (Dose Escalation) Terminal Elimination Half-life at Steady State (t1/2,ss) After Multiple-Dose Administration of ITC-6146RO
Plasma terminal elimination half-life at steady state (t1/2,ss) (as applicable) following multiple-dose administration of ITC-6146RO will be calculated from plasma concentration-time data and summarized descriptively.
Measured: Through study completion (Up to 2 years)
Phase 1a (Dose Escalation) Time to Maximum Observed Plasma Concentration at Steady State (Tmax,ss) After Multiple-Dose Administration of ITC-6146RO
Plasma Tmax,ss (as applicable) following multiple-dose administration of ITC-6146RO will be calculated from plasma concentration-time data and summarized descriptively.
Measured: Through study completion (Up to 2 years)
Phase 1a (Dose Escalation) Apparent Clearance at Steady State (CLss) After Multiple-Dose Administration of ITC-6146RO
Plasma apparent clearance at steady state (CLss) (as applicable) following multiple-dose administration of ITC-6146RO will be calculated from plasma concentration-time data and summarized descriptively.
Measured: Through study completion (Up to 2 years)
Phase 1a (Dose Escalation) Apparent Volume of Distribution at Steady State (Vss) After Multiple-Dose Administration of ITC-6146RO
Plasma apparent volume of distribution at steady state (Vss) (as applicable) following multiple-dose administration of ITC-6146RO will be calculated from plasma concentration-time data and summarized descriptively.
Measured: Through study completion (Up to 2 years)
Phase 1a (Dose Escalation) Accumulation Ratio After Multiple-Dose Administration of ITC-6146RO
Accumulation ratio (as applicable) following multiple-dose administration of ITC-6146RO will be calculated from plasma concentration-time data and summarized descriptively.
Measured: Through study completion (Up to 2 years)
Phase 1a (Dose Escalation) Peak-to-Trough Fluctuation (PTF) After Multiple-Dose Administration of ITC-6146RO
Peak-to-trough fluctuation (PTF) (as applicable) following multiple-dose administration of ITC-6146RO will be calculated from plasma concentration-time data and summarized descriptively.
Measured: Through study completion (Up to 2 years)
Phase 1a (Dose Escalation) Incidence of Anti-Drug Antibodies (ADAs) to ITC-6146RO
Percentage of participants with detectable ADAs to ITC-6146RO (ADA-positive) based on a validated immunoassay.
Measured: Through study completion (Up to 2 years)
Phase 1b (Dose Expansion) Population Pharmacokinetic (PopPK) Parameters of ITC-6146RO
PopPK parameters (e.g.,clearance and volume of distribution) will be estimated using PopPK modeling based on measured ITC-6146RO concentrations.
Measured: Through study completion (Up to 2 years)
Phase 1b (Dose Expansion) Incidence of Anti-Drug Antibodies (ADAs) and Neutralizing Antibodies (NAbs) to ITC-6146RO
Percentage of participants with detectable ADAs, including NAbs, to ITC-6146RO, as determined by validated immunoassay and neutralization assays (as applicable).
Measured: Through study completion (Up to 2 years)
Phase 1a/b (Dose Escalation, Dose Expansion) Objective Response Rate (ORR) by Investigator per RECIST v1.1
ORR will be assessed by the investigator per RECIST v1.1
Measured: Through study completion (Up to 2 years)
Phase 1a/b (Dose Escalation, Dose Expansion) Duration of Response (DoR) by Investigator per RECIST v1.1
DoR will be assessed by the investigator per RECIST v1.1
Measured: Through study completion (Up to 2 years)
Phase 1a/b (Dose Escalation, Dose Expansion) Time to Response (TTR) by Investigator per RECIST v1.1
TTR will be assessed by the investigator per RECIST v1.1
Measured: Through study completion (Up to 2 years)
Phase 1a/b (Dose Escalation, Dose Expansion) Progression-Free Survival (PFS) by Investigator per RECIST v1.1
PFS will be assessed by the investigator per RECIST v1.1
Measured: Through study completion (Up to 2 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2026
- Study start24 Mar 2026
- Primary completion30 Jun 2027 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Castration-resistant Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IntoCell, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07423117
- Sponsor's protocol ID
- ITC06P1-P01
- Status last verified
- Nov 2026
- First submitted
- 4 Feb 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1a/b, Open-label, Multicenter, First-in-human, Dose Escalation/Expansion Study With Multiple Cohorts to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumor Efficacy of ITC-6146RO in Patients With Advanced or Metastatic Cancer Who Have Failed Standard Therapy
- ClinicalTrials.gov ID
- NCT07423117
- Acronym / sponsor ID
- ITC06P1-P01
- Conditions
- Metastatic Castration-resistant Prostate Cancer, Non-small Cell Lung Cancer, Triple Negative Breast Cancer, Metastatic Solid Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- IntoCell, IncIndustry (pharma, biotech, devices)
- Study start
- 24 Mar 2026 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 20 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study consists of Phase 1a (dose escalation) and Phase 1b (dose expansion). In Phase 1a, sequential cohorts of subjects will receive escalating doses of ITC-6146RO to determine maximum tolerated dose (MTD) and/or optimal biological dose (OBD).
In Phase 1b, the recommended phase 2 dose (RP2D) chosen from Phase 1a will be evaluated to further investigate safety, tolerability, pharmacokinetic (PK) and anti-tumor efficacy of ITC-6146RO.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Phase 1a/b | Experimental | Drug: ITC-6146ROThe study consists of a Phase 1a dose-escalation part and a Phase 1b dose-expansion part. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Adult males and females aged ≥ 19 years (Korea) or ≥ 18 years (United States)
- Patients must be individuals who have voluntarily agreed to participate in the study after receiving a detailed explanation and fully understanding the nature of the clinical trial, and who have provided written informed consent.
- Pathological confirmation of malignancy and evidence of metastatic or surgically unresectable disease
- Patients must have at least one evaluable or measurable lesion based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST version 1.1). However, for patients with prostate cancer, eligibility will be determined based on Prostate Cancer Working Group 3 (PCWG3)
- Patients who have received standard therapies and have no remaining clinically available approved treatment options.
Key exclusion criteria (13 listed)
- Inability to comply with study and follow-up procedures
- Patients with a prior history of anticancer therapy before the first dose
- History of another active malignancy within the past 3 years
- Patients with central nervous system metastases, leptomeningeal disease, or spinal cord compression.
- Patients who are currently participating in a clinical trial or have participated in a clinical trial involving a medical device or investigational product within 28 days prior to the first administration of ITC-6146RO
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ITC-6146ROITC-6146RO will be administered as an intravenous (IV) infusion at protocol-specified dose levels and schedules in Phase 1a (dose escalation) and Phase 1b (dose expansion). | Drug | Phase 1a/b |
Primary outcome
Phase 1a (Dose Escalation) Incidence of Adverse Events (AEs)
Time frame: Through study completion (Up to 2 years)
Grade 3 and 4 AEs, Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Dose-limiting toxicities (DLTs) and AEs leading to discontinuation of study treatment, Evaluation of all-grade cardiac, renal, and pulmonary AEs , n, (%)
Phase 1b (Dose Expansion) Incidence of AEs
Time frame: Through study completion (Up to 2 years)
Grade 3 and 4 AEs, TEAEs, SAEs and AEs leading to discontinuation of study treatment, Evaluation of all-grade cardiac, renal, and pulmonary AEs, n, %
25 secondary outcomes
Phase 1a (Dose Escalation) Maximum Tolerated Dose (MTD) or Optimal Biological Dose (OBD) of ITC-6146RO
Time frame: Through study completion (Up to 2 years)
Phase 1a (Dose Escalation) Area Under the Plasma Concentration-Time Curve From Time 0 to the Last Quantifiable Concentration (AUClast) After Single-Dose Administration of ITC-6146RO
Time frame: Through study completion (Up to 2 years)
Phase 1a (Dose Escalation) Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity (AUCinf) After Single-Dose Administration of ITC-6146RO
Time frame: Through study completion (Up to 2 years)
Phase 1a (Dose Escalation) Maximum Observed Plasma Concentration (Cmax) After Single-Dose Administration of ITC-6146RO
Time frame: Through study completion (Up to 2 years)
Phase 1a (Dose Escalation) Terminal Elimination Half-life (t1/2) After Single-Dose Administration of ITC-6146RO
Time frame: Through study completion (Up to 2 years)
Phase 1a (Dose Escalation) Time to Maximum Observed Plasma Concentration (Tmax) After Single-Dose Administration of ITC-6146RO
Time frame: Through study completion (Up to 2 years)
Phase 1a (Dose Escalation) Apparent Clearance (CL) After Single-Dose Administration of ITC-6146RO
Time frame: Through study completion (Up to 2 years)
Phase 1a (Dose Escalation) Apparent Volume of Distribution (Vz) After Single-Dose Administration of ITC-6146RO
Time frame: Through study completion (Up to 2 years)
Phase 1a (Dose Escalation) Area Under the Plasma Concentration-Time Curve From Time 0 to the Last Quantifiable Concentration (AUClast) After Multiple-Dose Administration of ITC-6146RO
Time frame: Through study completion (Up to 2 years)
Phase 1a (Dose Escalation) Maximum Observed Plasma Concentration at Steady State (Cmax,ss) After Multiple-Dose Administration of ITC-6146RO
Time frame: Through study completion (Up to 2 years)
Phase 1a (Dose Escalation) Trough Plasma Concentration at Steady State (Ctrough,ss) After Multiple-Dose Administration of ITC-6146RO
Time frame: Through study completion (Up to 2 years)
Phase 1a (Dose Escalation) Average Plasma Concentration Over the Dosing Interval at Steady State (Cav,τ) After Multiple-Dose Administration of ITC-6146RO
Time frame: Through study completion (Up to 2 years)
Phase 1a (Dose Escalation) Terminal Elimination Half-life at Steady State (t1/2,ss) After Multiple-Dose Administration of ITC-6146RO
Time frame: Through study completion (Up to 2 years)
Phase 1a (Dose Escalation) Time to Maximum Observed Plasma Concentration at Steady State (Tmax,ss) After Multiple-Dose Administration of ITC-6146RO
Time frame: Through study completion (Up to 2 years)
Phase 1a (Dose Escalation) Apparent Clearance at Steady State (CLss) After Multiple-Dose Administration of ITC-6146RO
Time frame: Through study completion (Up to 2 years)
Phase 1a (Dose Escalation) Apparent Volume of Distribution at Steady State (Vss) After Multiple-Dose Administration of ITC-6146RO
Time frame: Through study completion (Up to 2 years)
Phase 1a (Dose Escalation) Accumulation Ratio After Multiple-Dose Administration of ITC-6146RO
Time frame: Through study completion (Up to 2 years)
Phase 1a (Dose Escalation) Peak-to-Trough Fluctuation (PTF) After Multiple-Dose Administration of ITC-6146RO
Time frame: Through study completion (Up to 2 years)
Phase 1a (Dose Escalation) Incidence of Anti-Drug Antibodies (ADAs) to ITC-6146RO
Time frame: Through study completion (Up to 2 years)
Phase 1b (Dose Expansion) Population Pharmacokinetic (PopPK) Parameters of ITC-6146RO
Time frame: Through study completion (Up to 2 years)
Phase 1b (Dose Expansion) Incidence of Anti-Drug Antibodies (ADAs) and Neutralizing Antibodies (NAbs) to ITC-6146RO
Time frame: Through study completion (Up to 2 years)
Phase 1a/b (Dose Escalation, Dose Expansion) Objective Response Rate (ORR) by Investigator per RECIST v1.1
Time frame: Through study completion (Up to 2 years)
Phase 1a/b (Dose Escalation, Dose Expansion) Duration of Response (DoR) by Investigator per RECIST v1.1
Time frame: Through study completion (Up to 2 years)
Phase 1a/b (Dose Escalation, Dose Expansion) Time to Response (TTR) by Investigator per RECIST v1.1
Time frame: Through study completion (Up to 2 years)
Phase 1a/b (Dose Escalation, Dose Expansion) Progression-Free Survival (PFS) by Investigator per RECIST v1.1
Time frame: Through study completion (Up to 2 years)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ITC-6146RO in people with Metastatic Castration-resistant Prostate Cancer and Non-small Cell Lung Cancer, run by IntoCell, Inc at 3 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase 1a (Dose Escalation) Incidence of Adverse Events (AEs) (time frame: Through study completion (Up to 2 years)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.