Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)

Summary

This is a Phase 1/2, open-label, non-randomized, 4-part trial to determine the safety profile and identify the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of INBRX 106 administered as a single agent or in combination with the anti-PD-1 checkpoint inhibitor (CPI) pembrolizumab (Keytruda®). KEYTRUDA is a registered trademark of Merck Sharp \& Dohme LLC, a subsidiary of Merck \& Co., Inc., Rahway, NJ, USA.

Conditions

• Solid Tumor
• Non-Small Cell Lung Cancer
• Head and Neck Cancer
• Melanoma
• Gastric Cancer
• Renal Cell Carcinoma
• Urothelial Carcinoma

Interventions

DRUG

INBRX-106 - Hexavalent OX40 agonist antibody

The active ingredient of INBRX-106 is a recombinant, humanized, hexavalent IgG antibody that targets the human OX40 receptor (TNFRSF4).

DRUG

pembrolizumab 200 mg

pembrolizumab 200 mg by intravenous (IV) infusion, given on Day 1 of each 21-day cycle.

DRUG

pembrolizumab 400 mg

pembrolizumab 400 mg by IV infusion given on Day 1 of alternating 21-day cycles (every 6 weeks)

DRUG

Carboplatin AUC-5

carboplatin AUC-5 by intravenous (IV) infusion, given on Day 1 of each 21-day cycle of cycles 1-4

DRUG

Carboplatin AUC-6

carboplatin AUC-6 by intravenous (IV) infusion, given on Day 1 of each 21-day cycle of cycles 1-4

DRUG

Pemetrexed 500 mg/m2

pemetrexed 500 mg/m2 by IV infusion given on Day 1 of each 21-Day cycle for up to 35 cycles

DRUG

Cisplatin 75mg/m2

cisplatin 75mg/m2 by intravenous (IV) infusion, given on Day 1 of each 21-day cycle of cycles 1-4

DRUG

Paclitaxel 200mg/m2

paclitaxel 200mg/m2 by intravenous (IV) infusion, given on Day 1 of each 21-day cycle of cycles 1-4

DRUG

Nab paclitaxel 100mg/m2

Nab paclitaxel 100mg/m2 by intravenous (IV) infusion, given on Days 1, 8 and 15 of each 21-day cycle of cycles 1-4

Sponsors & Collaborators

• Merck Sharp & Dohme LLC

  collaborator INDUSTRY

• Inhibrx Biosciences, Inc

  lead INDUSTRY

Principal Investigators

• Clinical Lead · Inhibrx Biosciences, Inc

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

SEQUENTIAL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-12-10

Primary Completion

2026-10-30

Completion

2027-05-12

FDA Drug

Yes

Countries

• United States
• Singapore
• South Korea
• Taiwan

Study Locations