A study of PT-112 injection in patients with advanced tumors

A Phase 1, Open-Label, Study Evaluating the Safety, Pharmacokinetics, and Clinical Effects of Intravenously Administered PT-112 Injection in Patients with Advanced Solid Tumors and Subsequent Expansion Cohorts

Status

Active, not recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2021-001308-14-FR

Enrollment

109

Registered

2021-09-01

Start date

2023-02-27

Completion date

Unknown

Last updated

2024-12-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

metastatic Castration-Resistant Prostate Cancer MedDRA version: 20.0 Level: SOC Classification code 10029104 Term: Neoplasms benign, malignant and unspecified (incl cysts and polyps) System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Interventions

Product Name: PT-112 Injection (5 mg/mL) Product Code: PT-112 Pharmaceutical Form: Injection INN or Proposed INN: Imifoplatin CAS Number: 1339960-28-9 Current Sponsor code: PT-112 Concentration unit:

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: Expansion cohort D (metastatic Castration-Resistant Prostate Cancer): Documented current evidence of metastatic castration-resistant prostate cancer (mCRPC), Ongoing androgen deprivation therapy with a GnRH analog or a bilateral orchiectomy (i.e., surgical or medical castration), Serum testosterone level = 1.73 nmol/L (50 ng/dL) at screening, Patients who have received at least three prior intended life-prolonging therapies for metastatic disease, Progressive disease at study entry, defined as either / both of the following criteria that occurred on or after the most recent therapy: soft-tissue disease progression, defined by RECIST v1.1, Bone disease progression, defined by PCWG3 as = 2 new lesions confirmed on bone scan, Estimated life expectancy of =16 weeks, Adequate bone marrow, liver, and renal function, Must use a condom during study treatment and 6 months after the last dose of PT-112 when having intercourse with a pregnant woman or a woman of childbearing potential. Female partners of male patients also should use a highly effective form of contraception if they are of childbearing potential (Dose escalation and Cohorts A, B, and C have been closed). Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 18 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 72

Exclusion criteria

Exclusion criteria: Expansion cohort D (metastatic Castration-Resistant Prostate Cancer): Carcinomatous meningitis, Known brain metastases and/or active epidural disease (exceptions are described in protocol), Any minor surgical procedure within 450 ms, or patients with congenital long QT syndrome. (Dose escalation and Cohorts A, B, and C have been closed).

Design outcomes

Primary

Measure	Time frame
Main Objective: Expansion cohort D (metastatic Castration-Resistant Prostate Cancer): To define the recommended dose and schedule for PT-112 for pivotal studies, administered either as 250 mg/m2 on Days 1 and 15 of each 28-day cycle (Arm 2) or as 360 mg/m2 on Days 1 and 15 of Cycle 1, then 250 mg/m2 on Day 15 of each subsequent 28-day cycle (Arm 3), where the primary endpoint (benefit) is defined as DCR4. (Dose escalation and Cohorts A, B, and C have been closed).;Secondary Objective: Expansion cohort D (metastatic Castration-Resistant Prostate Cancer): assess treatment effects on individual disease manifestations, evaluated overall and for each treatment arm: determine Disease control rate (DCR) by disease manifestation, ORR in patients with RECIST-measurable disease, median duration of response (DOR) for soft (non bone) tissue lesions, % of patients who are CTC nonzero at baseline and with 0 CTCs/mL in one or more post-baseline samples, % of patients who have = 3 CTCs at baseline and = 3 CTCs in one or more post-baseline samples, percentage of patients achieving PSA50, median radiographic progression-free survival (rPFS), median OS, time to PSA progression by PCWG3 criteria, change in disease-related pain, number of TRAEs as a measure of safety and tolerability, pharmacokinetics of PT-112 following dosing on Days 1 and 15 of Cycle 1, exposure-response and exposure-safety relationships for PT-112. (Dose escalation and Cohorts A, B, and C have been closed).;Primary end point(s): Expansion cohort D (metastatic Castration-Resistant Prostate Cancer): Define the recommended dose and schedule for PT-112 for pivotal studies, administered either as 250 mg/m2 on Days 1 and 15 of each 28-day cycle (Arm 2) or as 360 mg/m2 on Days 1 and 15 of Cycle 1, then 250 mg/m2 on Day 15 of each subsequent 28-day cycle (Arm 3), where the primary endpoint (benefit) is defined as DCR4. ;Timepoint(s) of evaluation of this end point: End of study	—

Measure

Time frame

Main Objective: Expansion cohort D (metastatic Castration-Resistant Prostate Cancer): To define the recommended dose and schedule for PT-112 for pivotal studies, administered either as 250 mg/m2 on Days 1 and 15 of each 28-day cycle (Arm 2) or as 360 mg/m2 on Days 1 and 15 of Cycle 1, then 250 mg/m2 on Day 15 of each subsequent 28-day cycle (Arm 3), where the primary endpoint (benefit) is defined as DCR4. (Dose escalation and Cohorts A, B, and C have been closed).;Secondary Objective: Expansion cohort D (metastatic Castration-Resistant Prostate Cancer): assess treatment effects on individual disease manifestations, evaluated overall and for each treatment arm: determine Disease control rate (DCR) by disease manifestation, ORR in patients with RECIST-measurable disease, median duration of response (DOR) for soft (non bone) tissue lesions, % of patients who are CTC nonzero at baseline and with 0 CTCs/mL in one or more post-baseline samples, % of patients who have = 3 CTCs at baseline and = 3 CTCs in one or more post-baseline samples, percentage of patients achieving PSA50, median radiographic progression-free survival (rPFS), median OS, time to PSA progression by PCWG3 criteria, change in disease-related pain, number of TRAEs as a measure of safety and tolerability, pharmacokinetics of PT-112 following dosing on Days 1 and 15 of Cycle 1, exposure-response and exposure-safety relationships for PT-112. (Dose escalation and Cohorts A, B, and C have been closed).;Primary end point(s): Expansion cohort D (metastatic Castration-Resistant Prostate Cancer): Define the recommended dose and schedule for PT-112 for pivotal studies, administered either as 250 mg/m2 on Days 1 and 15 of each 28-day cycle (Arm 2) or as 360 mg/m2 on Days 1 and 15 of Cycle 1, then 250 mg/m2 on Day 15 of each subsequent 28-day cycle (Arm 3), where the primary endpoint (benefit) is defined as DCR4. ;Timepoint(s) of evaluation of this end point: End of study

—

Secondary

Measure	Time frame
Secondary end point(s): Expansion cohort D (metastatic Castration-Resistant Prostate Cancer): • Disease control rate (DCR) by disease manifestation, defined as follows: - For patients with RECIST-evaluable disease, the percentage of patients with confirmed complete response (CR), confirmed partial response (PR), or disease stabilization (SD) lasting at least 4 months, based on tumor assessments by CT with contrast at baseline and after every 2 cycles (8±1 weeks) of treatment, evaluated using PCWG3-modified RECIST criteria; - For patients with bone-only disease that is not measurable by RECIST, disease control will be assessed by disease stabilization, defined as the absence of progression for at least 4 months (or 4 months or greater), progression being defined by 2 or more new lesions on the 8-week and the 16-week technetium bone scan (to exclude flare), or the first appearance of 2 or more new lesions on a scan performed at week 16 or later, when compared to week 8 baseline, and confirmed subsequently. Scans should be performed at baseline and after every 2 cycles (8±1 weeks) of treatment through the first 6 months, and every 3 cycles (12±1 weeks) thereafter, and evaluated by PCWG3 criteria; • Objective response rate (ORR) in patients with RECIST-measurable disease, defined as the percentage of patients achieving a confirmed PR and CR, based on tumor assessments by CT with contrast at baseline and after every 2 cycles (8±1 weeks) of treatment through the first 6 months, then every 3 cycles (12±1 weeks), evaluated using PCWG3-modified RECIST criteria; • The median duration of response (DOR) for soft tissue (non bone) lesions, calculated as from the first observation of response to the first observation of disease progression using PCWG3-modified RECIST criteria; • Percentage of patients who are CTC nonzero at baseline and with 0 CTCs/mL in one or more post-baseline samples (i.e., CTC0); • Percentage of patients who have = 3 CTCs at baseline and = 3 CTCs in one or	—

Measure

Time frame

Secondary end point(s): Expansion cohort D (metastatic Castration-Resistant Prostate Cancer): • Disease control rate (DCR) by disease manifestation, defined as follows: - For patients with RECIST-evaluable disease, the percentage of patients with confirmed complete response (CR), confirmed partial response (PR), or disease stabilization (SD) lasting at least 4 months, based on tumor assessments by CT with contrast at baseline and after every 2 cycles (8±1 weeks) of treatment, evaluated using PCWG3-modified RECIST criteria; - For patients with bone-only disease that is not measurable by RECIST, disease control will be assessed by disease stabilization, defined as the absence of progression for at least 4 months (or 4 months or greater), progression being defined by 2 or more new lesions on the 8-week and the 16-week technetium bone scan (to exclude flare), or the first appearance of 2 or more new lesions on a scan performed at week 16 or later, when compared to week 8 baseline, and confirmed subsequently. Scans should be performed at baseline and after every 2 cycles (8±1 weeks) of treatment through the first 6 months, and every 3 cycles (12±1 weeks) thereafter, and evaluated by PCWG3 criteria; • Objective response rate (ORR) in patients with RECIST-measurable disease, defined as the percentage of patients achieving a confirmed PR and CR, based on tumor assessments by CT with contrast at baseline and after every 2 cycles (8±1 weeks) of treatment through the first 6 months, then every 3 cycles (12±1 weeks), evaluated using PCWG3-modified RECIST criteria; • The median duration of response (DOR) for soft tissue (non bone) lesions, calculated as from the first observation of response to the first observation of disease progression using PCWG3-modified RECIST criteria; • Percentage of patients who are CTC nonzero at baseline and with 0 CTCs/mL in one or more post-baseline samples (i.e., CTC0); • Percentage of patients who have = 3 CTCs at baseline and = 3 CTCs in one or

—

Countries

France, United States

Contacts

Public ContactClinical Operations

Promontory Therapeutics Inc.

clinops@promontorytx.com+1332-206-4039

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026