A Study Evaluating the Safety, Pharmacokinetics, and Clinical Effects of Intravenously Administered PT-112 Injection in Subjects With Advanced Solid Tumors and Subsequent Dose Expansion Cohorts

Advanced Solid Tumors Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02266745
• Other study ID #: PT-112-101
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: July 2014
• Est. completion date: April 1, 2025

Study information

• Verified date: April 2024
• Source: Promontory Therapeutics Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a Phase 1/2, open-label, multi-center, non-randomized, dose-escalation study to be conducted in two parts: the Dose Escalation Phase and the Dose Expansion Phase. The Dose Escalation Phase will determine the Maximum Tolerated Dose (MTD) and recommended Phase 2 dose(s) (RP2D) of PT-112 Injection and evaluate its safety and tolerability, and PK (pharmacokinetics). The Dose Escalation Phase is complete and no longer enrolling. The Dose Expansion Phase has two cohorts: one cohort for the study of PT-112 in patients with thymoma and thymic carcinoma (Cohort A), and one cohort for the study of PT-112 in metastatic castrate-resistant prostate cancer (mCRPC) (Cohort D).

Description:

This is a Phase 1/2, open-label, multi-center, non-randomized, dose-escalation study to be conducted in two parts: the Dose Escalation Phase, and the Dose Expansion Phase The Dose Escalation Phase and the Dose Expansion Thymoma Cohort are complete and no longer enrolling. The Dose Expansion Phase of the study of PT-112 in metastatic castrate-resistant prostate cancer (mCRPC) is open and enrolling.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 109
• Est. completion date: April 1, 2025
• Est. primary completion date: August 1, 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Key Inclusion Criteria:

• Male >/= 18 years of age
• Histologically or cytologically confirmed adenocarcinoma of the prostate.
• Document current evidence of metastatic castration-resistant prostate cancer (mCRPC), where metastatic status is defined as having documented metastatic lesion(s) on either bone scan or CT/MRI scan.
• Patients who have received at least three prior intended life-prolonging therapies for metastatic disease.
• Eastern Collaborative Oncology Group (ECOG) Performance Status of 0-1.
• Progressive disease, either measurable on physical examination or imaging by Response Evaluation Criteria in Solid Tumors (RECIST v1.1) or PCWG3 or by informative tumor marker(s).
• Adequate organ function based on laboratory values.
• If there is a known history of brain metastases, either treated or untreated, the disease must be stable.

Key Exclusion Criteria:

• Any cytotoxic chemotherapy within 21 days prior to initiation of study drug.
• Any immunomodulatory drug therapy, anti-neoplastic hormonal therapy, immunosuppressive therapy, corticosteroids, or growth factor treatment within 14 days prior to initiation of study drug.
• Bone marrow reserve which is not adequate for participation in this trial.
• Radiotherapy within 14 days prior to baseline.
• Fraction of radiotherapy to >25 % of active bone marrow.
• Major surgery within 28 days prior to initiation of study drug.

Related Conditions & MeSH terms

• Advanced Solid Tumors
• CRPC
• Genital Neoplasms, Male
• mCRPC
• Metastatic Castrate-resistant Prostate Cancer
• Neoplasms
• Neoplasms by Site
• Prostatic Neoplasms
• PT-112
• Urogenital Neoplasms

Intervention

Drug:
• PT-112 Injection

Locations

Country	Name	City	State
France	Besançon	Besançon
France	Bordeaux	Bordeaux
France	Caen	Caen
France	Clermont-Ferrand	Clermont-Ferrand
France	Marseille	Marseille
France	Nice	Nice
France	Paris	Paris
France	Rennes	Rennes
United States	Albuquerque	Albuquerque	New Mexico
United States	Colorado	Aurora	Colorado
United States	Boston	Boston	Massachusetts
United States	Brooklyn	Brooklyn	New York
United States	Duarte	Duarte	California
United States	Durham	Durham	North Carolina
United States	University of Texas MD Anderson Cancer Center	Houston	Texas
United States	Indianapolis	Indianapolis	Indiana
United States	Jacksonville	Jacksonville	Florida
United States	Minneapolis	Minneapolis	Minnesota
United States	New York	New York	New York
United States	Omaha	Omaha	Nebraska
United States	Orlando	Orlando	Florida
United States	Arizona	Phoenix	Arizona
United States	Rochester	Rochester	Minnesota
United States	Seattle	Seattle	Washington
United States	Tucson	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Promontory Therapeutics Inc.

Countries where clinical trial is conducted

United States,  France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Initial design: Comparison of two dose levels, administered on Days 1 and 15 of each 28-day cycle:	[ ] Define the recommended dose level for PT-112 for pivotal studies based on the risk/benefit ratio across Arms 1, 2 and 3.; Cohort D only	28-day cycle
Primary	Modified design: Define the recommended dose and schedule for PT-112 for pivotal studies	Define the recommended dose and schedule for PT-112 for pivotal studies.; Cohort D only	28-day cycle
Secondary	Disease Control Rate by disease manifestation, evaluated using PCWG3-modified RECIST criteria	Cohort D only	up to 24 months
Secondary	Objective Response Rate (ORR) in patients with RECIST-measurable disease, evaluated using PCWG3-modified RECIST criteria	Cohort D only	up to 24 months
Secondary	Median duration of response (DOR) as defined by PCWG3-modified RECIST criteria	Cohort D only	up to 24 months
Secondary	Percentage of patients achieving PSA50 as defined by PCWG3 criteria	Cohort D only	up to 24 months
Secondary	Percentage of patients who are CTC nonzero at baseline and with 0 CTCs/mL in one or more post-baseline samples (i.e., CTC0)	Cohort D only	up to 24 months
Secondary	Percentage of patients who have = 3 CTCs at baseline and = 3 CTCs in one or more post-baseline samples (i.e., CTC conversion)	Cohort D only	up to 24 months
Secondary	Median radiographic progression free survival (rPFS) by PCWG3 criteria	Cohort D only	up to 24 months
Secondary	Median overall survival (OS)	Cohort D only	up to 24 months
Secondary	Time to PSA progression by PCWG3 criteria	Cohort D only	up to 24 months
Secondary	Change in disease related pain based on ACS Daily Pain Diary assessment	Cohort D only	up to 24 months