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

Conditions

• Colorectal Adenocarcinoma
• Ewing Sarcoma

Eligibility Criteria

Sex

ALL

Age

12 Years - 85 Years

Healthy Volunteers

Not accepted

Interventions

• INBRX-109 — DRUG
  Tetravalent DR5 Agonist Antibody
• Irinotecan — DRUG
  Chemotherapy
• Temozolomide — DRUG
  Chemotherapy
• carboplatin — DRUG
  chemotherapy
• pemetrexed — DRUG
  chemotherapy
• Leucovorin — DRUG
  chemotherapy
• Fluorouracil — DRUG
  chemotherapy
• Bevacizumab — DRUG
  targeted therapy
• Trifluridine + Tipiracil — DRUG
  chemotherapy

Study Details

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).

Key Dates

Start date

Oct 8, 2018

Status verified

May 2026

Primary completion

Dec 31, 2028

Completion

Jun 30, 2029

Study Design

Enrollment

411 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: Dose Escalation (Complete)
  INBRX-109 will be escalated (3+3 design) in subjects with locally advanced or metastatic solid tumors including sarcomas.
• Experimental: Expansion Malignant Pleural Mesothelioma (Complete)
  Subjects with malignant pleural mesothelioma will be treated with single-agent INBRX-109 at either the MTD or RP2D.
• Experimental: Expansion Gastric Adenocarcinoma (Complete)
  Subjects with gastric adenocarcinoma will be treated with single-agent INBRX-109 at either the MTD or RP2D.
• Experimental: Expansion Colorectal Adenocarcinoma (Complete)
  Subjects with colorectal (CRC) adenocarcinoma will be treated with single-agent INBRX-109 at either the MTD or RP2D.
• Experimental: Expansion Sarcomas (Complete)
  Subjects with certain sarcoma subtypes will be treated with single-agent INBRX-109 at either the MTD or RP2D.
• Experimental: Combination Expansion Malignant Pleural Mesothelioma (Complete)
  Subjects with malignant pleural mesothelioma will be treated with INBRX-109 in combination with chemotherapies (carboplatin, cisplatin, carboplatin and pemetrexed, or cisplatin and pemetrexed)
• Experimental: Combination Expansion Pancreatic Adenocarcinoma (Complete)
  Subjects with pancreatic adenocarcinoma will be treated with INBRX-109 in combination with 5FU/irinotecan based chemotherapy
• Experimental: Combination Expansion Adult Ewing Sarcoma
  Adult subjects with Ewing Sarcoma will be treated with INBRX-109 in combination with irinotecan and temozolomide
• Experimental: Combination Expansion Colorectal Adenocarcinoma (Complete)
  Subjects with colorectal adenocarcinoma will be treated with INBRX-109 in combination with FOLFIRI based chemotherapy
• Experimental: Expansion Solid Tumors (Complete)
  Subjects with Solid tumors and high BMI will be treated with single-agent INBRX-109 at either the MTD or RP2D.
• Experimental: Combination Expansion SDH-deficient solid tumors or GIST (Complete)
  Subjects with SDH-deficient solid tumors or GIST will be treated with INBRX-109 in combination with temozolomide
• Experimental: Combination Expansion Colorectal Adenocarcinoma patients with FOLFIRI plus bevacizumab
  Colorectal adenocarcinoma will be treated with INBRX-109 with FOLFIRI (FU, leucovorin, and irinotecan) plus bevacizumab
• Experimental: Combination Expansion Colorectal Adenocarcinoma with FTD/TPI plus bevacizumab
  Colorectal adenocarcinoma will be treated with INBRX-109 with FTD/TPI plus bevacizumab
• Experimental: Combination Expansion Adolescent Ewing Sarcoma
  Adolescent (12 to \<18) subjects with Ewing Sarcoma will be treated with INBRX-109 in combination with irinotecan and temozolomide

Primary Outcome Measure

Frequency and severity of adverse events of INBRX-109 [ Time Frame: Up to 8 years ]

Central Contacts

• Study Director, -Inhibrx
  858-500-7833
  [email protected]

Locations (23)

Find similar trials in Scottsdale, AZ

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