INBRX-109 for Solid Tumors

Recruiting at 36 trial locations

Overseen By Varun Monga, MD

Age: Any Age

Sex: Any

Trial Phase: Phase 1

Sponsor: Inhibrx, Inc.

Must not be taking: DR5 agonists

Disqualifiers: Hematologic malignancies, CNS tumors, liver diseases, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

321 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial requires that you have not received any anticancer therapy within 4 weeks or within 5 half-lives prior to the first dose of the study treatment. This suggests you may need to stop certain medications before participating, but the protocol does not specify all medications.

What is the purpose of this trial?

This trial tests INBRX-109, a protein that attaches to harmful cells and signals the body to destroy them. It targets patients with conditions involving DR5, like certain cancers.

Research Team

Clinical Lead

Principal Investigator

Inhibrx Biosciences, Inc

Eligibility Criteria

This trial is for adults with advanced or inoperable solid tumors, including various sarcomas and specific cancers like mesothelioma and pancreatic adenocarcinoma. Participants must have tried standard treatments without success or have no beneficial standard options available. They should be physically able to perform daily activities (with some limitations) and have their major organs functioning well. People with recent severe liver disease, infections needing antibiotics, prior DR5 agonist exposure, other cancer treatments within the last month, certain heart conditions, or known sensitivity to the study drugs cannot join.

Inclusion Criteria

My cancer is advanced, cannot be surgically removed, and does not respond to standard treatments.

I am between 12 and 84 years old with Ewing sarcoma, or 18 and 84 with GIST.

My blood, liver, and kidney functions meet the required health standards.

Exclusion Criteria

I do not have active brain tumors or cancer spread to the brain.

I haven't had any radiotherapy in the last 4 weeks or liver-directed therapy in the last 12 months.

I haven't had liver disease caused by a virus or toxin in the last year.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

INBRX-109 will be escalated (3+3 design) in subjects with locally advanced or metastatic solid tumors including sarcomas.

Varies

Combination Expansion

Subjects with specific cancer types will be treated with INBRX-109 in combination with various chemotherapies.

Varies

Single-Agent Expansion

Subjects with specific cancer types will be treated with single-agent INBRX-109 at either the MTD or RP2D.

Varies

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 8 years

Treatment Details

Interventions

• INBRX-109

Trial Overview The trial is testing INBRX-109, a new antibody targeting death receptor 5 on cancer cells. It's given alongside existing chemotherapy drugs: carboplatin, cisplatin, pemetrexed, fluorouracil (5-FU), irinotecan, and temozolomide. The study has three parts but isn't randomizing patients; instead it progressively includes more participants as safety data emerges.

Participant Groups

Group I: Expansion Solid Tumors (Complete) Experimental Treatment 1 Intervention

Subjects with Solid tumors and high BMI will be treated with single-agent INBRX-109 at either the MTD or RP2D.

Group II: Expansion Sarcomas (Complete) Experimental Treatment 1 Intervention

Subjects with certain sarcoma subtypes will be treated with single-agent INBRX-109 at either the MTD or RP2D.

Group III: Expansion Malignant Pleural Mesothelioma (Complete) Experimental Treatment 1 Intervention

Subjects with malignant pleural mesothelioma will be treated with single-agent INBRX-109 at either the MTD or RP2D.

Group IV: Expansion Gastric Adenocarcinoma (Complete) Experimental Treatment 1 Intervention

Subjects with gastric adenocarcinoma will be treated with single-agent INBRX-109 at either the MTD or RP2D.

Group V: Expansion Colorectal Adenocarcinoma (Complete) Experimental Treatment 1 Intervention

Subjects with colorectal (CRC) adenocarcinoma will be treated with single-agent INBRX-109 at either the MTD or RP2D.

Group VI: Dose Escalation (Complete) Experimental Treatment 1 Intervention

INBRX-109 will be escalated (3+3 design) in subjects with locally advanced or metastatic solid tumors including sarcomas.

Group VII: Combination Expansion SDH-deficient solid tumors or GIST (Complete) Experimental Treatment 2 Interventions

Subjects with SDH-deficient solid tumors or GIST will be treated with INBRX-109 in combination with temozolomide

Group VIII: Combination Expansion Pancreatic Adenocarcinoma (Complete) Experimental Treatment 3 Interventions

Subjects with pancreatic adenocarcinoma will be treated with INBRX-109 in combination with 5FU/irinotecan based chemotherapy

Group IX: Combination Expansion Malignant Pleural Mesothelioma (Complete) Experimental Treatment 4 Interventions

Subjects with malignant pleural mesothelioma will be treated with INBRX-109 in combination with chemotherapies (carboplatin, cisplatin, carboplatin and pemetrexed, or cisplatin and pemetrexed)

Group X: Combination Expansion Ewing Sarcoma Experimental Treatment 3 Interventions

Subjects with Ewing Sarcoma will be treated with INBRX-109 in combination with irinotecan and temozolomide

Group XI: Combination Expansion Colorectal Adenocarcinoma Experimental Treatment 3 Interventions

Subjects with colorectal adenocarcinoma will be treated with INBRX-109 in combination with FOLFIRI based chemotherapy

INBRX-109 is already approved in United States for the following indications:

Approved in United States as INBRX-109 for:

• Chondrosarcoma (Orphan Drug Designation)

Who Is Running the Clinical Trial?

Inhibrx, Inc.

Lead Sponsor

Trials

9

Recruited

1,700+

Inhibrx Biosciences, Inc

Lead Sponsor

Trials

9

Recruited

1,700+