RPTR-147 in Patients With Selected Solid Tumors and Lymphomas

Phase 1

Terminated

• Conditions: Solid Tumor; Lymphoma

• Registration Number: NCT03815682
• Lead Sponsor: Repertoire Immune Medicines

Brief Summary

The purpose of this study is to assess the safety and tolerability of escalating doses of RPTR-147 as a monotherapy and in combination with Pembrolizumab in patients with selected solid tumors and lymphomas.

Detailed Description

This is a first-in-human, open-label, multicenter, dose escalation study designed to determine the safety and tolerability of RPTR-147 as a monotherapy and in combination with Pembrolizumab in patients with selected solid tumors or lymphomas.

The study will include 2 dosing periods: A Dose Escalation (Phase 1) followed by an Expansion (Phase 2).

Study Timeline

• Study Start: 2018-10-24
• Study First Submitted: 2019-01-14
• Study First Submitted QC: 2019-01-23
• Study First Posted: 2019-01-24
• Primary Completion: 2022-09-07
• Study Completion: 2022-10-11
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-02
• Last Update Posted: 2022-12-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 23

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Frequency of dose interruptions	At the end of cycle 1 (Each cycle is 21 days)	Tolerability of RPTR-147:2 in patients with HPV positive tumors
Number of subjects with dose limiting toxicities	At the end of cycle 1 (Each cycle is 21 days)	Safety of RPTR-147:2 as a monotherapy

Secondary Outcome Measures

Name	Time	Method
Immunogenicity of RPTR-147 as monotherapy and in combination with pembrolizumab	Pre-dose through approximately 1 year after RPTR-147/Pembrolizumab last dose	Number of subject with anti-RPTR-147/Pembrolizumab antibodies
Area under the serum concentration-time curve	Baseline through approximately 1 year	Area under the serum concentration-time curve
Best overall response	Baseline through approximately 6 months after RPTR-147 last dose as monotherapy and in combination with pembrolizumab	Per modified RECIST v1.1 (solid tumor) or Lugano classification (lymphoma)
Progression free survival	Baseline through approximately 6 months after RPTR-147 last dose as monotherapy and in combination with pembrolizumab	Per modified RECIST v1.1 (solid tumor) or Lugano classification (lymphoma)
Maximum observed serum concentration of RPTR-147 as monotherapy and in combination with pembrolizumab	Baseline through approximately 1 year	Maximum observed serum concentration

Trial Locations

Locations (7)

City of Hope; 🇺🇸 Duarte, California, United States

Yale Cancer Center; 🇺🇸 New Haven, Connecticut, United States

Dana Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States

Karmanos Cancer Institute; 🇺🇸 Detroit, Michigan, United States

Carolina BioOncology Institute; 🇺🇸 Huntersville, North Carolina, United States

Sarah Cannon Research Institute; 🇺🇸 Nashville, Tennessee, United States

MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States