Pembrolizumab for Sarcoma

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Sarcoma+19 MorePembrolizumab - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a new drug, ONC-392, as a possible treatment for advanced or metastatic solid tumors and non-small cell lung cancers. The trial will test different doses of the drug to see what is safe and what works best. The trial will also test ONC-392 in combination with another drug, pembrolizumab.

Eligible Conditions
  • Stomach Cancer
  • Sarcoma
  • Hormone-Refractory Prostate Cancer
  • Pancreatic Cancer
  • Gastroesophageal Junction Adenocarcinoma
  • Salivary Gland Cancer
  • Metastatic Breast Cancer
  • Adenoid Cystic Carcinoma
  • Advanced Solid Tumors
  • Esophageal Cancer
  • Cutaneous Neuroendocrine Carcinoma
  • Non-Small Cell Lung Cancer
  • Metastatic Colorectal Cancer
  • Small Cell Lung Cancer
  • Ovarian Cancer
  • Cervical Cancer
  • Kidney Cancer
  • Bladder Cancer
  • Metastatic Melanoma
  • Head and Neck Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

4 Primary · 5 Secondary · Reporting Duration: 1 year

1 year
Objective Response Rate (ORR)
Overall Survival (OS)
Progression Free Survival (PFS)
12 weeks
The serum half life of the study drug, ONC-392, in combination therapy with Pembrolizumab.
The serum half life of the study drug, ONC-392, in monotherapy.
21 days
Dose limiting toxicity (DLT) in monotherapy
Maximal tolerable dose (MTD) in monotherapy
Recommended Phase II Dose (RP2D)
One year
Rate of treatment related adverse events (TRAE) according to CTCAE v5.0

Trial Safety

Trial Design

3 Treatment Groups

ONC-392 in combination with Osimertinib
1 of 3
ONC-392 Treatment as single agent
1 of 3
ONC-392 in combination with pembrolizumab
1 of 3

Experimental Treatment

468 Total Participants · 3 Treatment Groups

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

ONC-392 in combination with OsimertinibExperimental Group · 2 Interventions: Osimertinib, ONC-392 · Intervention Types: Drug, Drug
ONC-392 Treatment as single agent
Drug
Experimental Group · 1 Intervention: ONC-392 · Intervention Types: Drug
ONC-392 in combination with pembrolizumabExperimental Group · 2 Interventions: Pembrolizumab, ONC-392 · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Osimertinib
FDA approved
Pembrolizumab
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 1 year

Who is running the clinical trial?

OncoC4, Inc.Lead Sponsor
3 Previous Clinical Trials
748 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,099 Previous Clinical Trials
41,145,319 Total Patients Enrolled
449 Trials studying Sarcoma
236,017 Patients Enrolled for Sarcoma
Tianhong Li, MDPrincipal InvestigatorUniversity of California, Davis

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have histological or cytological diagnosis of NSCLC or any other type of carcinoma or sarcomas, progressive metastatic disease, or progressive locally advanced disease not amenable to local therapy.
Patients with advanced/metastatic solid tumors of any histology are eligible for this study.
You have cancer of the pancreas, triple negative breast cancer, non small cell lung cancer, melanoma, head and neck cancer, ovarian cancer, and other solid tumors.
Patients with recurrent or metastatic adenoid cystic carcinoma with disease progression within 12 months are eligible.
You are 18 or older and a male or female.
Patient must have a performance status of 0 or 1 on the ECOG Performance Scale.
References