A Study of RGX-104 in Patients With Advanced Lung & Endometrial Cancer

Conditions

• Endometrial Cancer
• Endometrial Cancer Recurrent
• Lung Cancer
• Lung Cancer Recurrent
• Non-small Cell Carcinoma
• Non-small Cell Lung Cancer Metastatic

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• RGX-104 — DRUG
• Ipilimumab — DRUG
• Docetaxel — DRUG
• Pembrolizumab — DRUG
• Carboplatin — DRUG
• Pemetrexed — DRUG

Study Details

Study RGX-104-001 is a Phase 1, first-in-human, dose escalation and expansion study of RGX-104, an oral small molecule targeting the liver X receptor (LXR), as a single agent and in combination with nivolumab, ipilimumab, docetaxel, or pembrolizumab plus carboplatin/pemetrexed.

Key Dates

First listed

Oct 4, 2016

Start date

Nov 1, 2016

Status verified

Mar 2025

Primary completion

Jan 22, 2025

Completion

Jan 22, 2025

Study Design

Enrollment

146 participants (actual)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Recurrent NSCLC (2nd/3rd Line Lung Cancer). Expansion
  RGX-104 in combination docetaxel RGX104 120 mg BID (5day on/2days off)
• Experimental: Newly dignosed NSCLC Cohort Expansion
  RGX104 + pembrolizumab + carboplatin/pemetrexed RGX104 120 mg BID (5day on/2days off)
• Experimental: Recurrent/Relapsed Small Cell Lung Cancer (SCLC) Expansion
  RGX-104 + docetaxel RGX104 120 mg BID (5day on/2days off)
• Experimental: Recurrent/Relapsed Endometrial Cancer Expansion
  RGX-104 combined with ipilimumab RGX104 120 mg BID (5day on/2days off)

Primary Outcome Measure

Maximum tolerated dose (MTD), or the maximum tested dose at which multiple DLTs are not observed, of RGX-104 as a single agent, and separately, in combination with nivolumab, ipilimumab, docetaxel, or pembrolizumab plus carboplatin/pemetrexed. [ Time Frame: 6 months ]

Locations (21)

Find similar trials in Tucson, AZ

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