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

NCT02266745 | Active Not Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: PT-112-101
• Study Type: interventional
• Target: 109
• Locations: 2 countries
• Sites: 25

Brief 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).

Conditions

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

Keywords

PT-112

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (10)

• Disease Control Rate by disease manifestation, evaluated using PCWG3-modified RECIST criteria

  up to 24 months

• Objective Response Rate (ORR) in patients with RECIST-measurable disease, evaluated using PCWG3-modified RECIST criteria

  up to 24 months

• Median duration of response (DOR) as defined by PCWG3-modified RECIST criteria

  up to 24 months

• Percentage of patients achieving PSA50 as defined by PCWG3 criteria

  up to 24 months

• Percentage of patients who are CTC nonzero at baseline and with 0 CTCs/mL in one or more post-baseline samples (i.e., CTC0)

  up to 24 months

Study Arms (3)

Arm 1: PT-112 injection

EXPERIMENTAL

Arm 1: PT-112 Injection, administered by intravenous infusion, biweekly 360 mg/m2

Drug: PT-112 Injection

Arm 2: PT-112 injection

EXPERIMENTAL

Arm 2: PT-112 Injection, administered by intravenous infusion, biweekly 250 mg/m2

Drug: PT-112 Injection

Arm 3: PT-112 injection

EXPERIMENTAL

Arm 3: PT-112 Injection, administered by intravenous infusion, 360 mg/m2 for two doses, 250 mg/m2 for subsequent doses

Drug: PT-112 Injection

Interventions

PT-112 Injection DRUG

Also known as: PT-112

Arm 1: PT-112 injection; Arm 2: PT-112 injection; Arm 3: PT-112 injection

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Promontory Therapeutics Inc.: lead

Study Sites (25)

Arizona

Phoenix, Arizona, 85054, United States

Location

Tucson

Tucson, Arizona, 85719, United States

Location

Duarte

Duarte, California, 91010, United States

Location

Colorado

Aurora, Colorado, 80045, United States

Location

Jacksonville

Jacksonville, Florida, 32224, United States

Location

Orlando

Orlando, Florida, 32806, United States

Location

Indianapolis

Indianapolis, Indiana, 46202, United States

Location

Boston

Boston, Massachusetts, 02215, United States

Location

Minneapolis

Minneapolis, Minnesota, 55426, United States

Location

Rochester

Rochester, Minnesota, 55905, United States

Location

Omaha

Omaha, Nebraska, 68130, United States

Location

Albuquerque

Albuquerque, New Mexico, 87190, United States

Location

Brooklyn

Brooklyn, New York, 11215, United States

Location

New York

New York, New York, 10065, United States

Location

Durham

Durham, North Carolina, 27705, United States

Location

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Seattle

Seattle, Washington, 19024, United States

Location

Besançon

Besançon, France

Location

Bordeaux

Bordeaux, France

Location

Caen

Caen, France

Location

Clermont-Ferrand

Clermont-Ferrand, France

Location

Marseille

Marseille, France

Location

Nice

Nice, France

Location

Paris

Paris, France

Location

Rennes

Rennes, France

Location

Related Publications (1)

• Karp DD, Camidge DR, Infante JR, Ames TD, Price MR, Jimeno J, Bryce AH. Phase I study of PT-112, a novel pyrophosphate-platinum immunogenic cell death inducer, in advanced solid tumours. EClinicalMedicine. 2022 May 27;49:101430. doi: 10.1016/j.eclinm.2022.101430. eCollection 2022 Jul.

  PMID: 35747193 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site

Condition Hierarchy (Ancestors)

Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications

Study Officials

• Daniel D. Karp, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Subjects enrolled in Cohort D Part 2 will be randomized.

Study Record Dates

• First Submitted: October 13, 2014
• First Posted: October 17, 2014
• Study Start: July 1, 2014
• Primary Completion: August 1, 2024
• Study Completion: April 1, 2025
• Last Updated: April 5, 2024

Record last verified: 2024-04

Locations

FR (8); US (17)