PROCLAIM-CX-2009: A Trial to Find Safe and Active Doses of an Investigational Drug CX-2009 for Patients With Selected Solid Tumors

• ClinicalTrials.gov Identifier: NCT03149549
• Recruitment Status: Terminated
• First Posted: May 11, 2017
• Results First Posted: January 5, 2024
• Last Update Posted: January 5, 2024
• Sponsor: CytomX Therapeutics
• Information provided by (Responsible Party): CytomX Therapeutics

Tracking Information

• First Submitted Date: May 4, 2017
• First Posted Date: May 11, 2017
• Results First Submitted Date: October 1, 2021
• Results First Posted Date: January 5, 2024
• Last Update Posted Date: January 5, 2024
• Actual Study Start Date: June 1, 2017
• Actual Primary Completion Date: September 10, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: March 4, 2022)

The Number of Subjects Experiencing a Dose Limiting Toxicity at Various Dose Levels When Given CX-2009 as a Monotherapy [ Time Frame: 21 days for the Q3W schedule, 28 days for the Q2W schedule ]

All AEs will be captured according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03 and considered for assessment of DLTs as outlined by the criteria in Protocol Table 5.

• Original Primary Outcome Measures (submitted: May 9, 2017): The number of subjects experiencing a dose limiting toxicity at various dose levels when given CX-2009 as a monotherapy [ Time Frame: 21 days (dose limiting toxicity period) ]

Current Secondary Outcome Measures (submitted: January 4, 2023)

Subjects Experiencing Anti-cancer Activity (ORR) at Various Dose Levels When Given CX-2009 as a Monotherapy [ Time Frame: Median total on-study follow-up of 18.4 weeks. ]

Efficacy will be assessed via objective response rate (ORR) by RECIST version 1.1. ORR is defined as the percentage of patients with complete response (CR) or partial response (PR) on two consecutive tumor assessments with scan dates at least 4 weeks apart according to RECIST (version 1.1, refer to SAP section 13.1.1). Complete criteria for RECIST 1.1 are provided as an appendix to the protocol. > > For as long as a subject continues follow-up for response in the study, CT/MRI/Tumor assessment are to be conducted every 8 (+/- 1) weeks from the first dose of CX 2009 with assessment for response per > RECIST Version 1.1

• Original Secondary Outcome Measures (submitted: May 9, 2017): The percentage of subjects experiencing anti-cancer activity (ORR) at various dose levels when given CX-2009 as a monotherapy [ Time Frame: 2 years ]
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: PROCLAIM-CX-2009: A Trial to Find Safe and Active Doses of an Investigational Drug CX-2009 for Patients With Selected Solid Tumors
• Official Title: A Phase 1-2, Open-Label, Dose-Finding, Proof of Concept, First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of CX-2009 in Adults With Metastatic or Locally Advanced Unresectable Solid Tumors (PROCLAIM-CX-2009)

Brief Summary

The purpose of this first-in-human study of CX-2009 is to characterize the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and antitumor activity of CX-2009 in adult subjects with metastatic or locally advanced unresectable solid tumors. PROCLAIM: PRObody CLinical Assessment In Man CX-2009 clinical trial 001

PROBODY is a trademark of CytomX Therapeutics, Inc

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 1; Phase 2
• Study Design: Allocation: Non-Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Solid Tumor, Adult
• Breast Cancer
• Non Small Cell Lung Cancer
• Head and Neck Cancer
• Ovarian Cancer

Intervention

Drug: CX-2009

CX-2009 Monotherapy

Study Arms

• Experimental: CX-2009 Monotherapy: 21-Day Dosing Regimen-Escalation
  Dose escalation and determination
  Intervention: Drug: CX-2009
• Experimental: CX-2009 Monotherapy: 21-Day Dosing Regimen-Determination
  Additional enrollment into previously cleared monotherapy dose levels
  Intervention: Drug: CX-2009
• Experimental: CX-2009 Monotherapy: 21-Day Dosing Regimen-Expansion
  Dose expansion
  Intervention: Drug: CX-2009
• Experimental: CX-2009 Monotherapy: 14-Day Dosing Regimen-Expansion
  Dose escalation and determination in selected tumor types
  Intervention: Drug: CX-2009

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: July 17, 2020): 99
• Original Estimated Enrollment (submitted: May 9, 2017): 150
• Actual Study Completion Date: September 10, 2020
• Actual Primary Completion Date: September 10, 2020 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

1. Histologically confirmed diagnosis of metastatic or locally advanced unresectable tumors
2. Patients demonstrating disease progression after treatment with available therapies that are known to confer clinical benefit, or who are intolerant to treatment,
3. Agreement to provide mandatory archival tissue or fresh biopsy.
4. At least 18 years of age.

Exclusion Criteria:

1. Active or chronic corneal disorder, history of corneal transplantation, active herpetic keratitis, and active ocular conditions requiring ongoing treatment/monitoring
2. Serious concurrent illness, including clinically relevant active infection
3. History of or current active autoimmune diseases
4. Significant cardiac disease such as recent myocardial infarction
5. History of multiple sclerosis or other demyelinating disease, Eaton-Lambert syndrome (para-neoplastic syndrome), history of hemorrhagic or ischemic stroke within the last 6 months, or alcoholic liver disease;
6. Non-healing wound(s) or ulcer(s) except for ulcerative lesions caused by the underlying neoplasm;
7. History of severe allergic or anaphylactic reactions to previous monoclonal antibody therapy;
8. Currently receiving anticoagulation therapy with warfarin;
9. Major surgery (requiring general anesthesia) within 3 months prior to dosing.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Netherlands, Spain, United Kingdom, United States

Administrative Information

• NCT Number: NCT03149549
• Other Study ID Numbers: CTMX-M-2009-001
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: CytomX Therapeutics
• Original Responsible Party: Same as current
• Current Study Sponsor: CytomX Therapeutics
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Monika Vainorius, MD; CytomX Therapeutics

• PRS Account: CytomX Therapeutics
• Verification Date: January 2024