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Phase 1 Study of INBRX-109 in Subjects With Locally Advanced or Metastatic Solid Tumors Including Sarcomas

I

Inhibrx

Status and phase

Enrolling
Phase 1

Conditions

Malignant Pleural Mesothelioma
Colorectal Adenocarcinoma
SDH-deficient Solid Tumors
Chondrosarcoma
Sarcoma
Pancreatic Adenocarcinoma
Ewing Sarcoma
Solid Tumors
GIST
Gastric Adenocarcinoma

Treatments

Drug: 5-fluorouracil
Drug: Irinotecan
Drug: Cisplatin
Drug: INBRX-109
Drug: Carboplatin
Drug: Pemetrexed
Drug: Temozolomide

Study type

Interventional

Funder types

Industry

Identifiers

NCT03715933
Ph1 INBRX-109

Details and patient eligibility

About

This is a first-in-human, open-label, non-randomized, three-part phase 1 trial of INBRX-109, which is a recombinant humanized tetravalent antibody targeting the human death receptor 5 (DR5).

Enrollment

240 estimated patients

Sex

All

Ages

12 to 85 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Males or females aged ≥12 to <85 years for Ewing sarcoma and 18 to <85 years of age for GIST.
  • Escalation: Histologically or cytologically-confirmed advanced/metastatic or non-resectable solid tumors, including sarcoma, that are refractory or intolerant to standard therapy, or for which no standard therapy exists that is likely to confer any clinical benefit.
  • Expansion Cohorts: Malignant pleural mesothelioma, gastric adenocarcinoma, colorectal adenocarcinoma, pancreatic adenocarcinoma and certain sarcoma subtypes (e.g., chondrosarcoma, Ewing sarcoma), GIST, and SDH-def solid tumors with locally advanced or metastatic, non-resectable disease, that are refractory or intolerant to standard therapy, or for which no standard therapy exists that is likely to confer any clinical benefit.
  • Measurable disease as defined by RECISTv1.1 (or modified RECIST for mesothelioma) criteria.
  • Adequate hematologic, coagulation, hepatic and renal function as defined per protocol.
  • Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1 for Part 1 and ECOG PS of 0, 1 or 2 for Parts 2 and 3.

Exclusion criteria

  • Prior treatment with or exposure to DR5 agonists.
  • Receipt of any anticancer therapy (including investigational agents) within 4 weeks or within 5 half-lives prior to the first dose of study treatment. Exceptions per protocol.
  • Receipt of radiotherapy within 4 weeks prior to the first dose of study treatment, and liver-directed within 12 months prior to the first dose of study drug.
  • Subject has undergone allogeneic hematopoietic stem cell or bone marrow transplantation within the last 5 years. Exception: Participants who have had a stem cell or bone marrow transplant > 5 years ago are eligible for enrollment, as long as there are no symptoms of graft-versus-host disease (GVHD).
  • Prior or concurrent malignancies. Exception: Subjects with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessments of INBRX-109.
  • Hematologic malignancies.
  • Symptomatic active primary CNS tumors, leptomeningeal disease, and CNS metastases. Exceptions per protocol.
  • Chronic liver disease including but not limited to cirrhosis, non-alcoholic fatty liver disease (NAFLD) or non-alcoholic steatohepatitis (NASH), alcohol-related liver disease, hemochromatosis, Wilson's disease, alpha-1 antitrypsin deficiency, multiple liver hemangioma (except incidental finding of clinically nonsignificant liver hemangioma), hepatic or biliary autoimmune disorders (ie, primary biliary cholangitis, autoimmune hepatitis), history of portal or hepatic vein thrombosis, and sinusoidal occlusion syndrome. Exceptions per protocol.
  • Acute viral or toxic liver disease within 12 months prior to the first dose of study drug.
  • Evidence or history of hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) infection.
  • Clinically significant cardiac condition, including myocardial infarction, uncontrolled angina, cerebrovascular accident, or other acute uncontrolled heart disease < 3 months;
  • Sensitivity or contraindications to INBRX-109, irinotecan, or temozolomide.
  • Major surgery within 4 weeks prior to enrollment on this trial.
  • Systemic infection requiring antibiotics within 2 weeks prior to the first dose of study drug.
  • Pregnant or nursing females.
  • Patients who are receiving strong cytochrome P450 (CYP) 3A inhibitors and/or inducers, and/or UGT1A1 inhibitors within 14 days of Cycle 1 Day 1.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Sequential Assignment

Masking

None (Open label)

240 participants in 11 patient groups

Dose Escalation
Experimental group
Description:
INBRX-109 will be escalated (3+3 design) in subjects with locally advanced or metastatic solid tumors including sarcomas.
Treatment:
Drug: INBRX-109
Expansion Malignant Pleural Mesothelioma
Experimental group
Description:
Subjects with malignant pleural mesothelioma will be treated with single-agent INBRX-109 at either the MTD or RP2D.
Treatment:
Drug: INBRX-109
Expansion Gastric Adenocarcinoma
Experimental group
Description:
Subjects with gastric adenocarcinoma will be treated with single-agent INBRX-109 at either the MTD or RP2D.
Treatment:
Drug: INBRX-109
Expansion Colorectal Adenocarcinoma
Experimental group
Description:
Subjects with colorectal (CRC) adenocarcinoma will be treated with single-agent INBRX-109 at either the MTD or RP2D.
Treatment:
Drug: INBRX-109
Expansion Sarcomas
Experimental group
Description:
Subjects with certain sarcoma subtypes will be treated with single-agent INBRX-109 at either the MTD or RP2D.
Treatment:
Drug: INBRX-109
Combination Expansion Malignant Pleural Mesothelioma
Experimental group
Description:
Subjects with malignant pleural mesothelioma will be treated with INBRX-109 in combination with chemotherapies (carboplatin, cisplatin, carboplatin and pemetrexed, or cisplatin and pemetrexed)
Treatment:
Drug: Pemetrexed
Drug: Carboplatin
Drug: Cisplatin
Drug: INBRX-109
Combination Expansion Pancreatic Adenocarcinoma
Experimental group
Description:
Subjects with pancreatic adenocarcinoma will be treated with INBRX-109 in combination with 5FU/irinotecan based chemotherapy
Treatment:
Drug: INBRX-109
Drug: Irinotecan
Drug: 5-fluorouracil
Combination Expansion Ewing Sarcoma
Experimental group
Description:
Subjects with Ewing Sarcoma will be treated with INBRX-109 in combination with irinotecan and temozolomide
Treatment:
Drug: Temozolomide
Drug: INBRX-109
Drug: Irinotecan
Combination Expansion Colorectal Adenocarcinoma
Experimental group
Description:
Subjects with colorectal adenocarcinoma will be treated with INBRX-109 in combination with FOLFIRI based chemotherapy
Treatment:
Drug: INBRX-109
Drug: Irinotecan
Drug: 5-fluorouracil
Expansion Solid Tumors
Experimental group
Description:
Subjects with Solid tumors and high BMI will be treated with single-agent INBRX-109 at either the MTD or RP2D.
Treatment:
Drug: INBRX-109
Combination Expansion SDH-deficient solid tumors or GIST
Experimental group
Description:
Subjects with SDH-deficient solid tumors or GIST will be treated with INBRX-109 in combination with temozolomide
Treatment:
Drug: Temozolomide
Drug: INBRX-109

Trial contacts and locations

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Central trial contact

Study Director, -Inhibrx

Data sourced from clinicaltrials.gov

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