OR2805 for Liposarcoma

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Liposarcoma+10 MoreOR2805 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial will study a new cancer drug to see if it is safe and effective.

Eligible Conditions
  • Liposarcoma
  • Leiomyosarcoma
  • Breast Cancer
  • Melanoma
  • Cancer
  • Non-Small Cell Lung Cancer
  • Solid Tumors
  • Metastatic Cancer
  • Advanced Solid Tumors
  • Head and Neck Squamous Cell Carcinoma (HNSCC)

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

3 Primary · 4 Secondary · Reporting Duration: Day 1 of dosing through every 90 after the last dose.

Day 21
Pharmacokinetics of OR2805
Day 1
Disease Control Rate (DCR)
Objective Response Rate (ORR)
Progression Free Survival (PFS)
Day 21
Dose-limiting Toxicity
Day 90
Recommended Dose and Regimen (mono and combination therapy)
Safety and Tolerability

Trial Safety

Safety Progress

1 of 3

Trial Design

7 Treatment Groups

OR2805 monotherapy and combination therapy dose-escalation phase (Part A)
1 of 7
OR2805 monotherapy and combination therapy dose-expansion phase (Part B)
1 of 7
OR2805 biological effects phase (Part C)
1 of 7
Biological effects phase (Part D)
1 of 7
OR2805 monotherapy dose-escalation phase (Part A)
1 of 7
OR2805 monotherapy dose-expansion phase (Part B)
1 of 7
OR2805 + PD-1 inhibitor mini-dose-escalation and expansion phase (Part C)
1 of 7

Experimental Treatment

172 Total Participants · 7 Treatment Groups

Primary Treatment: OR2805 · No Placebo Group · Phase 1 & 2

OR2805 monotherapy and combination therapy dose-escalation phase (Part A)Experimental Group · 3 Interventions: Cemiplimab, Docetaxel, OR2805 · Intervention Types: Drug, Drug, Drug
OR2805 monotherapy and combination therapy dose-expansion phase (Part B)Experimental Group · 3 Interventions: Cemiplimab, Docetaxel, OR2805 · Intervention Types: Drug, Drug, Drug
OR2805 biological effects phase (Part C)
Drug
Experimental Group · 1 Intervention: OR2805 · Intervention Types: Drug
Biological effects phase (Part D)
Drug
Experimental Group · 1 Intervention: OR2805 · Intervention Types: Drug
OR2805 monotherapy dose-escalation phase (Part A)
Drug
Experimental Group · 1 Intervention: OR2805 · Intervention Types: Drug
OR2805 monotherapy dose-expansion phase (Part B)
Drug
Experimental Group · 1 Intervention: OR2805 · Intervention Types: Drug
OR2805 + PD-1 inhibitor mini-dose-escalation and expansion phase (Part C)Experimental Group · 3 Interventions: OR2805, Nivolumab, Pembrolizumab · Intervention Types: Drug, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cemiplimab
2015
Completed Phase 1
~710
Docetaxel
1995
Completed Phase 4
~8840
Nivolumab
FDA approved
Pembrolizumab
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: day 1 of dosing through every 90 after the last dose.

Who is running the clinical trial?

OncoResponse, Inc.Lead Sponsor

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have signed a written consent prior to participating in this study.
You are a male or female aged 18 to 100 years.
You have a histological or cytological diagnosis of any type of carcinoma, sarcoma, or melanoma with progressive metastatic disease, or progressive locally advanced disease not amenable to local therapy.
Subjects must have experienced PD on an established standard medical anti-cancer therapy for a given tumor type or have been intolerant to such therapy, or in the opinion of the Investigator have been considered ineligible for a particular form of standard therapy on medical grounds and must have no available demonstrated curative or life-prolonging therapies