A Study of ITC-6146RO in Patients With Advanced or Metastatic Cancer Who Have Failed Standard Therapy

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• Carcinoma, Non-Small-Cell Lung 6,488
• Triple Negative Breast Neoplasms 1,140
• Neoplasm Metastasis 3,517

Carcinoma, Non-Small-Cell Lung

6,488 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,632 are open to participants now.

This study's planned enrollment of 102 is above the median of 62 across 5,213 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.

Lead sponsor

This is the only study on the registry with IntoCell, Inc as lead sponsor.

Study arms

• Experimental
  Phase 1a/b

  The study consists of a Phase 1a dose-escalation part and a Phase 1b dose-expansion part.

  Drug: ITC-6146RO

Interventions

• DrugITC-6146RO

  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).

Primary outcomes

1. 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, (%)

   Time frame: Through study completion (Up to 2 years)

2. 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, %

   Time frame: Through study completion (Up to 2 years)

Secondary outcomes

1. 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).

   Time frame: Through study completion (Up to 2 years)

2. 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.

   Time frame: Through study completion (Up to 2 years)

3. 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.

   Time frame: Through study completion (Up to 2 years)

4. 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.

   Time frame: Through study completion (Up to 2 years)

5. 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.

   Time frame: Through study completion (Up to 2 years)

6. 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.

   Time frame: Through study completion (Up to 2 years)

7. 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.

   Time frame: Through study completion (Up to 2 years)

8. 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.

   Time frame: Through study completion (Up to 2 years)

9. 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.

   Time frame: Through study completion (Up to 2 years)

10. 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.

    Time frame: Through study completion (Up to 2 years)

11. 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.

    Time frame: Through study completion (Up to 2 years)

12. 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.

    Time frame: Through study completion (Up to 2 years)

13. 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.

    Time frame: Through study completion (Up to 2 years)

14. 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.

    Time frame: Through study completion (Up to 2 years)

15. 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.

    Time frame: Through study completion (Up to 2 years)

16. 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.

    Time frame: Through study completion (Up to 2 years)

17. 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.

    Time frame: Through study completion (Up to 2 years)

18. 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.

    Time frame: Through study completion (Up to 2 years)

19. 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.

    Time frame: Through study completion (Up to 2 years)

20. 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.

    Time frame: Through study completion (Up to 2 years)

21. 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).

    Time frame: Through study completion (Up to 2 years)

22. 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

    Time frame: Through study completion (Up to 2 years)

23. 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

    Time frame: Through study completion (Up to 2 years)

24. 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

    Time frame: Through study completion (Up to 2 years)

25. 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

    Time frame: Through study completion (Up to 2 years)

Other outcomes

1. Phase 1b (Dose Expansion) Association Between ITC-6146RO Pharmacokinetic Parameters and Efficacy and Safety Endpoints

   Correlation between ITC-6146RO pharmacokinetic (PK) parameters and selected efficacy, safety, and exploratory endpoints. Efficacy endpoints may include objective response rate (ORR) and progression-free survival (PFS). Associations will be evaluated using appropriate exposure-response analyses.

   Time frame: Through study completion (Up to 2 years)

2. Phase 1a/b (Dose Escalation, Dose Expansion) Overall Survival (OS)

   OS is defined as the time from randomization until death from any cause.

   Time frame: Through study completion (Up to 2 years)

3. Phase 1a/b (Dose Escalation, Dose Expansion) Association Between B7-H3 Expression in Tumor Tissue and Anti-Tumor Efficacy

   Correlation between B7-H3 expression in tumor tissue assessed by immunohistochemistry (IHC) and anti-tumor efficacy endpoints, including objective response rate (ORR) and progression-free survival (PFS). ORR is defined as the proportion of participants with confirmed complete or partial response, and PFS as time to disease progression or death per protocol-defined criteria. Associations will be evaluated using appropriate statistical methods. In participants with metastatic castration-resistant prostate cancer (mCRPC), PSA response rate (≥50% decline from baseline) and time to PSA progression will also be assessed.

   Time frame: Through study completion (Up to 2 years)