RPTR-168 in Patients With Human Papillomavirus Strain 16 (HPV-16) E6/E7 Positive Tumors and Melanoma

Phase 1

Terminated

• Conditions: Melanoma; Head and Neck Squamous Cell Carcinoma; Cervical Cancer
• Interventions: Biological: RPTR-168

• Registration Number: NCT04762225
• Lead Sponsor: Repertoire Immune Medicines

Brief Summary

The purpose of this study is to assess the safety and tolerability of escalating doses of RPTR-168 as a monotherapy in patients with HPV-16 E6/E7 positive tumors (HNSCC, cervical) and melanoma.

Detailed Description

This is a phase 1/2, open-label, first-in-human, multi-center study to characterize the safety and tolerability of RPTR-168 administered i.v. as a monotherapy in patients with relapsed/refractory metastatic or locally-advanced HPV-16 E6/E7 positive tumors and melanoma.

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

Study Timeline

• Study First Submitted: 2021-02-16
• Study First Submitted QC: 2021-02-18
• Study First Posted: 2021-02-21
• Study Start: 2021-05-10
• Primary Completion: 2022-09-14
• 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: 7

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
RPTR-168	RPTR-168	Escalating doses of RPTR-168 as a monotherapy in HPV-16 E6/E7 positive tumors and melanoma.

Primary Outcome Measures

Name	Time	Method
Frequency of dose interruptions	At the end of the DLT period (28 days)	Tolerability of RPTR-168:2 as a monotherapy in patients with HPV-16 E6/E7 positive tumors
Number of subjects with dose limiting toxicities (DLT)	At the end of the DLT period (28 days)	Safety of RPTR-168:2 as a monotherapy in patients with HPV-16 E6/E7 positive tumors

Secondary Outcome Measures

Name	Time	Method
Progression free survival	Baseline through approximately 6 months after RPTR-168 last dose as monotherapy	Per modified RECIST v1.1 (solid tumor)
Best overall response	Baseline through approximately 6 months after RPTR-168 last dose as monotherapy	Per modified RECIST v1.1 (solid tumor)
Area under the serum concentration-time curve	Baseline through approximately 1 year	Area under the serum concentration-time curve
Immunogenicity of RPTR-168 as monotherapy	Pre-dose through approximately 1 year after RPTR-168 last dose	Number of subject with anti-RPTR-168 antibodies
Maximum observed serum concentration of RPTR-168 as monotherapy	Baseline through approximately 1 year	Maximum observed serum concentration

Trial Locations

Locations (4)

HonorHealth Research Institute; 🇺🇸 Scottsdale, Arizona, United States

University of Michigan Comprehensive Cancer Center; 🇺🇸 Ann Arbor, Michigan, United States

USC Norris Comprehensive Cancer Center; 🇺🇸 Los Angeles, California, United States

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