NCT04762225

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

A Phase 1/2 Open-Label Multi-Center Study to Characterize the Safety and Tolerability of RPTR-168 in Patients With Relapsed/Refractory HPV-16 E6/E7 Positive Tumors and Melanoma

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Repertoire Immune Medicines · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Head and Neck Squamous Cell Carcinoma
• Melanoma
• Cervical Cancer

Interventions

Type	Name	Description
BIOLOGICAL	RPTR-168	Escalating doses of RPTR-168 as a monotherapy

Timeline

• Start date: 2021-05-10
• Primary completion: 2022-09-14
• Completion: 2022-10-11
• First posted: 2021-02-21
• Last updated: 2022-12-06

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study