NCT03815682

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Oct 2018

Longer than P75 for phase_1

Geographic Reach
1 country

7 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 24, 2018

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 14, 2019

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 24, 2019

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 7, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 11, 2022

Completed
Last Updated

December 6, 2022

Status Verified

December 1, 2022

Enrollment Period

3.9 years

First QC Date

January 14, 2019

Last Update Submit

December 2, 2022

Conditions

Solid TumorLymphoma

Keywords

HPV-16 E6/E7 positive solid tumorsMelanoma

Outcome Measures

Primary Outcomes (6)

  • Number of subjects with dose limiting toxicities

    Safety of RPTR-147:1 as a monotherapy

    At the end of cycle 1 (Each cycle is 28 days)

  • Number of subjects with dose limiting toxicities

    Safety of RPTR-147:1 in combination with pembrolizumab

    At the end of cycle 1 (Each cycle is 21 days)

  • Number of subjects with dose limiting toxicities

    Safety of RPTR-147:2 as a monotherapy

    At the end of cycle 1 (Each cycle is 21 days)

  • Frequency of dose interruptions

    Tolerability of RPTR-147:1 as a monotherapy

    At the end of cycle 1 (Each cycle is 28 days)

  • Frequency of dose interruptions

    Tolerability of RPTR-147:1 in combination with pembrolizumab

    At the end of cycle 1 (Each cycle is 21 days)

  • Frequency of dose interruptions

    Tolerability of RPTR-147:2 in patients with HPV positive tumors

    At the end of cycle 1 (Each cycle is 21 days)

Secondary Outcomes (5)

  • Best overall response

    Baseline through approximately 6 months after RPTR-147 last dose as monotherapy and in combination with pembrolizumab

  • Progression free survival

    Baseline through approximately 6 months after RPTR-147 last dose as monotherapy and in combination with pembrolizumab

  • Maximum observed serum concentration of RPTR-147 as monotherapy and in combination with pembrolizumab

    Baseline through approximately 1 year

  • Area under the serum concentration-time curve

    Baseline through approximately 1 year

  • Immunogenicity of RPTR-147 as monotherapy and in combination with pembrolizumab

    Pre-dose through approximately 1 year after RPTR-147/Pembrolizumab last dose

Study Arms (3)

RPTR-147:1

EXPERIMENTAL

Arm A: Escalating doses of RPTR-147:1 as a monotherapy in solid tumors and lymphomas

Biological: Arm A: RPTR-147:1

RPTR-147:1 and Pembrolizumab

EXPERIMENTAL

Arm B: Escalating doses of RPTR-147:1 in combination with Pembrolizumab in patients with solid tumors and lymphomas

Biological: Arm B: RPTR-147:1 and Pembrolizumab

RPTR-147:2

EXPERIMENTAL

Arm C: Escalating doses of RPTR-147:2 in patients with HPV-16 positive tumors

Biological: Arm C: RPTR-147:2

Interventions

Arm A: RPTR-147:1BIOLOGICAL

Escalating doses of RPTR-147:1 as a monotherapy

RPTR-147:1
Arm B: RPTR-147:1 and PembrolizumabBIOLOGICAL

Escalating doses of RPTR-147:1 in combination with Pembrolizumab

RPTR-147:1 and Pembrolizumab
Arm C: RPTR-147:2BIOLOGICAL

Escalating doses of RPTR-147:2 in patients with HPV positive tumors

RPTR-147:2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (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 (or ≥16 years at Dana Farber Cancer Institute).
  • Histologically- or cytologically-confirmed relapsed/refractory metastatic or locally-advanced solid tumor or lymphoma whose disease has progressed despite all appropriate curative or life-prolonging treatments, are intolerant to these therapies or have refused standard treatment.
  • Cohort enrollment may be limited to potentially immune-responsive tumor types meeting the above criterion during the first approximately 2 weeks of the enrollment period of each cohort due to their potential to respond to and activate RPTR-147:1:
  • NSCLC
  • Melanoma
  • Clear cell cancer of the kidney
  • HNSCC
  • Urothelial cancer
  • Lymphoma
  • Sarcomas
  • Ovarian Cancer
  • Based upon emerging data that will be discussed during the Safety Review Committee meetings, the patient population may be further limited based other factors
  • Patient must have documented HLA-typing results that meet the study requirements. The list of eligible HLA alleles will be updated on an ongoing basis by the Sponsor.
  • +16 more criteria

You may not qualify if:

  • Patients eligible for this study must not meet any of the following criteria:
  • Previously identified hypersensitivity to components of RPTR-147 or excipients.
  • Pembrolizumab combination Arm B only - Has severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients.
  • Patients with T-cell lymphomas or small lymphocytic lymphoma.
  • Presence of active central nervous system (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 first dose of study treatment.
  • Has received prior radiotherapy within 2 weeks of start of study treatment. 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. For any interim radiotherapy received after the baseline tumor assessment, 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) \>3 x ULN, except for patients that have tumor involvement of the liver, who are excluded if ALT \>5 x ULN
  • Absolute neutrophil count ≤1.0 x 109/L
  • ≥0.5 x 109/L and increasing following prior myelosuppressive treatment will be eligible
  • Screening Period 1 Only: Absolute lymphocyte count ≤1.0 x 109/L for solid tumor patients or ≤7.0 x 108/L for lymphoma patients prior to the apheresis procedure.
  • Platelet count ≤75 x 109/L absent platelet transfusion for 2 weeks
  • Hemoglobin (Hgb) ≤9 g/dL absent RBC transfusion for 2 weeks
  • +56 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

City of Hope

Duarte, California, 91010, United States

Location

Yale Cancer Center

New Haven, Connecticut, 06511, United States

Location

Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

Location

Carolina BioOncology Institute

Huntersville, North Carolina, 28078, United States

Location

Sarah Cannon Research Institute

Nashville, Tennessee, 37203, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

LymphomaMelanoma

Interventions

pembrolizumab

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesNeuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • David Spriggs, MD

    Repertoire Immune Medicines

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

January 14, 2019

First Posted

January 24, 2019

Study Start

October 24, 2018

Primary Completion

September 7, 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(7)