INBRX-109 for Chondrosarcoma

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
NEXT Oncology - Virginia, Fairfax, VAChondrosarcoma+7 MoreINBRX-109 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a new drug, INBRX-109, which is a recombinant humanized tetravalent antibody targeting the human death receptor 5 (DR5). This is the first time this drug is being tested in humans. The trial has three parts.

Eligible Conditions
  • Chondrosarcoma
  • Sarcoma
  • Solid Tumors
  • Mesothelioma
  • Stomach Cancer
  • Colorectal Cancer
  • Pancreatic Adenocarcinoma
  • Ewing Sarcoma

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 5 Secondary · Reporting Duration: Up to 2 years

Up to 2 years
Anti-tumor activity of INBRX-109
Area under the serum concentration time curve (AUC) of INBRX-109
Frequency and severity of adverse events of INBRX-109
Immunogenicity of INBRX-109
Maximum Tolerated Dose (MTD) and/or Recommended Phase 2 Dose (RP2D) of INBRX-109
Maximum observed serum concentration (Cmax) of INBRX-109
Time to Cmax (Tmax) of INBRX-109
Trough observed serum concentration (Ctrough) of INBRX-109

Trial Safety

Safety Progress

1 of 3

Trial Design

11 Treatment Groups

Combination Expansion Colorectal Adenocarcinoma
1 of 11
Dose Escalation
1 of 11
Expansion Malignant Pleural Mesothelioma
1 of 11
Expansion Gastric Adenocarcinoma
1 of 11
Expansion Colorectal Adenocarcinoma
1 of 11
Expansion Sarcomas
1 of 11
Combination Expansion Malignant Pleural Mesothelioma
1 of 11
Combination Expansion Pancreatic Adenocarcinoma
1 of 11
Combination Expansion Ewing Sarcoma
1 of 11
Expansion Solid Tumors
1 of 11
Combination Expansion SDH-deficient solid tumors or GIST
1 of 11

Experimental Treatment

240 Total Participants · 11 Treatment Groups

Primary Treatment: INBRX-109 · No Placebo Group · Phase 1

Combination Expansion Colorectal AdenocarcinomaExperimental Group · 3 Interventions: INBRX-109, 5-fluorouracil, Irinotecan · Intervention Types: Drug, Drug, Drug
Dose Escalation
Drug
Experimental Group · 1 Intervention: INBRX-109 · Intervention Types: Drug
Expansion Malignant Pleural Mesothelioma
Drug
Experimental Group · 1 Intervention: INBRX-109 · Intervention Types: Drug
Expansion Gastric Adenocarcinoma
Drug
Experimental Group · 1 Intervention: INBRX-109 · Intervention Types: Drug
Expansion Colorectal Adenocarcinoma
Drug
Experimental Group · 1 Intervention: INBRX-109 · Intervention Types: Drug
Expansion Sarcomas
Drug
Experimental Group · 1 Intervention: INBRX-109 · Intervention Types: Drug
Combination Expansion Malignant Pleural MesotheliomaExperimental Group · 4 Interventions: Carboplatin, INBRX-109, Cisplatin, Pemetrexed · Intervention Types: Drug, Drug, Drug, Drug
Combination Expansion Pancreatic AdenocarcinomaExperimental Group · 3 Interventions: INBRX-109, 5-fluorouracil, Irinotecan · Intervention Types: Drug, Drug, Drug
Combination Expansion Ewing SarcomaExperimental Group · 3 Interventions: INBRX-109, Irinotecan, Temozolomide · Intervention Types: Drug, Drug, Drug
Expansion Solid Tumors
Drug
Experimental Group · 1 Intervention: INBRX-109 · Intervention Types: Drug
Combination Expansion SDH-deficient solid tumors or GISTExperimental Group · 2 Interventions: INBRX-109, Temozolomide · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Carboplatin
FDA approved
Cisplatin
FDA approved
Pemetrexed
FDA approved
Fluorouracil
FDA approved
Irinotecan
FDA approved
Temozolomide
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 2 years

Who is running the clinical trial?

Inhibrx, Inc.Lead Sponsor
4 Previous Clinical Trials
865 Total Patients Enrolled
1 Trials studying Chondrosarcoma
201 Patients Enrolled for Chondrosarcoma
Klaus Wagner, CMOStudy DirectorInhibrx, Inc.
Vasily Andrianov, MDStudy DirectorInhibrx, Inc.
4 Previous Clinical Trials
865 Total Patients Enrolled
1 Trials studying Chondrosarcoma
201 Patients Enrolled for Chondrosarcoma

Eligibility Criteria

Age 18+ · All Participants · 5 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
The trial is looking for people with certain types of cancer including mesothelioma, stomach, colorectal or pancreatic cancer, and specific types of sarcoma or solid tumors who have already tried standard treatments with no success or have no other treatment options available.

Frequently Asked Questions

What is the extent of the geographic scope for this clinical trial?

"This study is being run in multiple locations, with Heather Keaney leading the charge at New York's centre, Memorial Sloan Kettering Cancer Center located in Scottsdale and HonorHealth Research Institute based out of Chicago. A further 14 sites are also taking part." - Anonymous Online Contributor

Unverified Answer

What applications does INBRX-109 have in medical treatments?

"INBRX-109 is frequently used to treat initial stages of cancer. Additionally, it can be employed as a therapeutic agent for patients suffering from small cell lung cancer (sclc), advanced testicular cancers, and progression disease." - Anonymous Online Contributor

Unverified Answer

Has INBRX-109 been explored in any other clinical experiments?

"INBRX-109 was initially investigated in 1997 by City of Hope Comprehensive Cancer Center. Currently, there are 2742 concluded studies and 1681 active trials happening at multiple sites around New York City." - Anonymous Online Contributor

Unverified Answer

Has INBRX-109 attained regulatory authorization from the U.S. Food and Drug Administration?

"Our team at Power have assigned the safety of INBRX-109 a score of 1, in accordance with its status as an initial Phase 1 trial. This indicates that there is only limited information around both efficacy and safety." - Anonymous Online Contributor

Unverified Answer

Approximately how many participants have been recruited for this trial?

"Inhibrx, Inc., the sponsor of this study, requires a total of 240 participants that conform to the inclusion criteria. The research will be conducted at Heather Keaney in New York and Memorial Sloan Kettering Cancer Center in Arizona." - Anonymous Online Contributor

Unverified Answer

Are there any opportunities for individuals to sign up and participate in this research?

"Correct. Clinicaltrials.gov reveals that this research project, first posted on October 10th 2018, is actively seeking participants for recruitment. A total of 240 patients are required from 16 separate medical centres." - Anonymous Online Contributor

Unverified Answer

What objectives is this research venture hoping to realize?

"This two-year clinical trial is designed to assess the intensity and frequency of any adverse reactions associated with INBRX-109. In addition, immunogenicity, peak serum concentration (Cmax) and trough observed serum concentration (Ctrough) for this medication will be measured as secondary outcomes." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.