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

NCT04762225 | Terminated Phase 1 FDA Drug

• 1 other identifier: PRIME-102
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 4

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.

Conditions

Head and Neck Squamous Cell Carcinoma; Melanoma; Cervical Cancer

Keywords

Adoptive cellular therapy; Cell therapy; Cytokine; Interleukin 12 (IL-12)

Outcome Measures

Primary Outcomes (4)

• Number of subjects with dose limiting toxicities (DLT)

  Safety of RPTR-168:1 as a monotherapy in patients with melanoma

  At the end of the DLT period (28 days)

• Number of subjects with dose limiting toxicities (DLT)

  Safety of RPTR-168:2 as a monotherapy in patients with HPV-16 E6/E7 positive tumors

  At the end of the DLT period (28 days)

• Frequency of dose interruptions

  Tolerability of RPTR-168:1 as a monotherapy in patients with melanoma

  At the end of the DLT period (28 days)

• Frequency of dose interruptions

  Tolerability of RPTR-168:2 as a monotherapy in patients with HPV-16 E6/E7 positive tumors

  At the end of the DLT period (28 days)

Secondary Outcomes (5)

• Best overall response

  Baseline through approximately 6 months after RPTR-168 last dose as monotherapy

• Progression free survival

  Baseline through approximately 6 months after RPTR-168 last dose as monotherapy

• Maximum observed serum concentration of RPTR-168 as monotherapy

  Baseline through approximately 1 year

• Area under the serum concentration-time curve

  Baseline through approximately 1 year

• Immunogenicity of RPTR-168 as monotherapy

  Pre-dose through approximately 1 year after RPTR-168 last dose

Study Arms (1)

RPTR-168

EXPERIMENTAL

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

Biological: RPTR-168

Interventions

RPTR-168 BIOLOGICAL

Escalating doses of RPTR-168 as a monotherapy

RPTR-168

Eligibility Criteria

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

You may qualify if:

• Be willing and able to provide written informed consent for the trial.
• Written informed consent must be obtained prior to any study procedures.
• Age ≥18 years.
• Patients must have one of the following histologically- or cytologically-confirmed, relapsed/refractory, and metastatic or locally advanced solid tumor types and their disease must have has progressed despite all appropriate curative or life-prolonging treatments, unless they are intolerant to these therapies or have refused standard treatment.
• Malignant melanoma for RPTR-168:1 therapy. Patients with non-cutaneous melanoma must have PRAME positive tumor, as determined by a qualified laboratory. For patients with PRAME negative tumors, the Investigator must consult with the Sponsor medical monitor about the suitability of an individual patient for enrollment.
• HPV-16 E6/E7 positive tumors for RPTR-168:2 therapy.
• Failure to respond to standard therapy, or for whom no appropriate therapies are available (based on the judgment of the Investigator).
• For melanoma patients, the definition of failure to respond an approved therapy for recurrent or metastatic disease is the following:
• Tumor refractory to or progressing following prior PD-1/PD-L1 therapy alone or in combination with an anti-CTLA-4 agent unless the patient was deemed ineligible for such treatment.
• If a subject is BRAF V600E/K positive, they must have received an approved BRAF- targeted regimen prior to entering the study, unless the patient was deemed ineligible for such treatment.
• Prior adjuvant therapy cannot be used to define prior treatment failure.
• For head and neck cancer patients, the definition of failure to respond to standard therapy is tumor refractory to or progressing following approved first- and second-line therapy for metastatic or recurrent disease consisting of one or more of the following:
• PD-1/PD-L1 therapy alone or in combination unless the patient was deemed ineligible for such treatment.
• Cetuximab therapy alone or in combination unless the patient was deemed ineligible for such treatment.
• Prior adjuvant or neo-adjuvant therapy cannot be used to define prior treatment failure.

You may not qualify if:

• Patients eligible for this study must not meet any of the following criteria:
• Previously identified hypersensitivity to components of the study treatment or excipients.
• Presence of active CNS disease and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable, i.e., without evidence of progression for at least 4 weeks by repeat imaging (note that the repeat imaging should be performed during study screening), clinically stable, and without requirement of steroid treatment for at least 14 days prior to study entry.
• Has received prior radiotherapy within 2 weeks prior to study entry. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (≤2 weeks of radiotherapy) to non-CNS disease. The target lesions must not be irradiated.
• Patient having out of range laboratory values defined as:
• Creatinine clearance (calculated using Cockcroft-Gault formula, or measured) \<40 mL/min
• Total bilirubin \>1.5 x upper limit of normal (ULN), except for patients with Gilbert's syndrome who are excluded if total bilirubin \>3.0 x ULN or direct bilirubin \>1.5 x ULN
• Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST) \>2 x ULN, except for patients that have tumor involvement of the liver, who are excluded if ALT and AST \>3 x ULN. ALT and AST up to 5x ULN may be considered with documented discussion and approval from sponsor.
• Absolute neutrophil count (ANC) ≤1.0 x 109/L
• Platelet count ≤75 x 109/L absent platelet transfusion for 2 weeks
• Hemoglobin (Hgb) ≤9 g/dL absent RBC transfusion for 2 weeks
• Coagulation (prothrombin time \[PT\] or international normalized ratio \[INR\] and partial thromboplastin time \[PTT\] or activated partial thromboplastin time \[aPTT\])
• \- \>1.5 × ULN unless participant is receiving anticoagulant therapy as long as PT/INR and PTT/aPTT is within therapeutic range of intended use of anticoagulants
• Potassium, magnesium, calcium or phosphate abnormality \> Grade 1 (CTCAE v5.0) despite appropriate oral replacement therapy:
• Serum triglycerides \>500 mg/dL due to potential interference with cell separation methods

Sponsors & Collaborators

• Repertoire Immune Medicines: lead

Study Sites (4)

HonorHealth Research Institute

Scottsdale, Arizona, 85258, United States

Location

USC Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

Location

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109, United States

Location

Carolina BioOncology Institute

Huntersville, North Carolina, 28078, United States

Location

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck; Melanoma; Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases; Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• David Spriggs, MD

  Repertoire Immune Medicines

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2021
• First Posted: February 21, 2021
• Study Start: May 10, 2021
• Primary Completion: September 14, 2022
• Study Completion: October 11, 2022
• Last Updated: December 6, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)